list of nationally authorised medicinal products · active substance(s): propofol . procedure no.:...
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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
25 July 2018 EMA/475638/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): propofol
Procedure No.: PSUSA/00002555/201711
List of nationally authorised medicinal products EMA/475638/2018 Page 2/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Anesia 10 mg/ml Emulsion zur Injektion/Infusion
DE/H/2426/001 1-31303 NORAMEDA UAB AT
Anesia 10 mg/ml emulziós injekció vagy infúzió
DE/H/2426/001 OGYI-T-22024/01 NORAMEDA UAB HU
Anesia 10 mg/ml emulziós injekció vagy infúzió
DE/H/2426/001 OGYI-T-22024/02 NORAMEDA UAB HU
Anesia 10 mg/ml emulziós injekció vagy infúzió
DE/H/2426/001 OGYI-T-22024/03 NORAMEDA UAB HU
Anesia 10 mg/ml emulziós injekció vagy infúzió
DE/H/2426/001 OGYI-T-22024/04 NORAMEDA UAB HU
Anesia 10 mg/ml emulziós injekció vagy infúzió
DE/H/2426/001 OGYI-T-22024/05 NORAMEDA UAB HU
Anesia 10 mg/ml emulziós injekció vagy infúzió
DE/H/2426/001 OGYI-T-22024/06 NORAMEDA UAB HU
Anesia 10 mg/ml injekcní/infuzní emulze
DE/H/2426/001 05/600/11-C NORAMEDA UAB CZ
Anesia 20 mg/ml Emulsion zur Injektion/Infusion
DE/H/2426/002 1-31304 NORAMEDA UAB AT
Anesia 20 mg/ml emulziós injekció vagy infúzió
DE/H/2426/002 OGYI-T-22024/07 NORAMEDA UAB HU
Anesia 20 mg/ml emulziós injekció vagy infúzió
DE/H/2426/002 OGYI-T-22024/08 NORAMEDA UAB HU
Anesia 20 mg/ml injekční/infuzní emulze
DE/H/2426/002 05/601/11-C NORAMEDA UAB CZ
Diprivan 1% w/v Emulsion for Injection or Infusion, Pre-filled Syringe
not available PA 1691/022/001 ASPEN PHARMA TRADING LIMITED
IE
Diprivan 1% w/v Emulsion for Injection or Infusion, Pre-filled Syringe
not available MA 955/00901 ASPEN PHARMA TRADING LIMITED
MT
Diprivan 1%, emulsie voor injectie of infusie
not available BE146002 ASPEN PHARMA TRADING LIMITED
BE
Diprivan 1%, emulsie voor injectie of infusie
not available BE233861 ASPEN PHARMA TRADING LIMITED
BE
Diprivan 1%, emulsie voor injectie of infusie
not available BE133752 ASPEN PHARMA TRADING LIMITED
BE
Diprivan 1%, emulsie voor injectie of infusie
not available BE169872 ASPEN PHARMA TRADING LIMITED
BE
List of nationally authorised medicinal products EMA/475638/2018 Page 3/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Diprivan 1%, émulsion injectable ou pour perfusion
not available BE233861 ASPEN PHARMA TRADING LIMITED
BE
Diprivan 1%, émulsion injectable ou pour perfusion
not available BE169872 ASPEN PHARMA TRADING LIMITED
BE
Diprivan 1%, émulsion injectable ou pour perfusion
not available BE146002 ASPEN PHARMA TRADING LIMITED
BE
Diprivan 1%, émulsion injectable ou pour perfusion
not available BE133752 ASPEN PHARMA TRADING LIMITED
BE
DIPRIVAN 1%, émulsion injectable ou pour perfusion
not available 2009020216 ASPEN PHARMA TRADING LIMITED
LU
DIPRIVAN 1%, Emulsion zur Injektion oder zur Infusion
not available BE233861 ASPEN PHARMA TRADING LIMITED
BE
DIPRIVAN 1%, Emulsion zur Injektion oder zur Infusion
not available BE133752 ASPEN PHARMA TRADING LIMITED
BE
DIPRIVAN 1%, Emulsion zur Injektion oder zur Infusion
not available BE146002 ASPEN PHARMA TRADING LIMITED
BE
DIPRIVAN 1%, Emulsion zur Injektion oder zur Infusion
not available BE169872 ASPEN PHARMA TRADING LIMITED
BE
DIPRIVAN 1%, Emulsion zur Injektion oder zur Infusion
not available 2009020216 ASPEN PHARMA TRADING LIMITED
LU
Diprivan 10 mg/ml (1%) emulsion for injection or infusion
not available PL 39699/0074 ASPEN PHARMA TRADING LIMITED
UK
Diprivan 10 mg/ml emulsão injectável ou para perfusão
not available 8666818 ASTRAZENECA PRODUTOS FARMACEUTICOS LDA
PT
Diprivan 10 mg/ml emulsão injectável ou para perfusão
not available 8666834 ASTRAZENECA PRODUTOS FARMACEUTICOS LDA
PT
Diprivan 10 mg/ml emulsão injectável ou para perfusão
not available 8666826 ASTRAZENECA PRODUTOS FARMACEUTICOS LDA
PT
Diprivan 10 mg/ml emulsão injectável ou para perfusão
not available 8666842 ASTRAZENECA PRODUTOS FARMACEUTICOS LDA
PT
Diprivan 10 mg/ml emulsão injectável ou para perfusão
not available 8666800 ASTRAZENECA PRODUTOS FARMACEUTICOS LDA
PT
Diprivan 10 mg/ml emulsija injekcijām vai infūzijām
not available 98-0543 ASTRAZENECA UK LIMITED LV
Diprivan 10 mg/ml emulsión inyectable y para perfusión
not available 58.785 ASTRAZENECA FARMACÉUTICA SPAIN, S.A.
ES
List of nationally authorised medicinal products EMA/475638/2018 Page 4/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Diprivan 10 mg/ml emulsione iniettabile per uso endovenoso
not available 026114013 ASPEN PHARMA TRADING LIMITED
IT
Diprivan 10 mg/ml emulsione per infusione
not available 026114049 ASPEN PHARMA TRADING LIMITED
IT
Diprivan 10 mg/ml emulsione per infusione
not available 026114052 ASPEN PHARMA TRADING LIMITED
IT
Diprivan 10 mg/ml emulsione per infusione
not available 026114025 ASPEN PHARMA TRADING LIMITED
IT
Diprivan 10 mg/ml injeksjons-/infusjonsvæske, emulsjon
not available 7333 ASTRAZENECA AS NO
DIPRIVAN 10 mg/ml, émulsion injectable (IV) en ampoule
not available 34009 555 583 7 8 ASPEN PHARMA TRADING LIMITED
FR
DIPRIVAN 10 mg/ml, émulsion injectable en seringue pré-remplie
not available 34009 559 777 0 4 ASPEN PHARMA TRADING LIMITED
FR
Diprivan 10 mg/ml, injektions-/infusionsvätska, emulsion
not available 10573 ASTRAZENECA AB SE
DIPRIVAN 10mg/ml (1%) γαλάκτωμα για ένεση ή έγχυση
not available 11119 ASPEN PHARMA TRADING LIMITED
CY
DIPRIVAN 10mg/ml (1%) γαλάκτωμα για ένεση ή έγχυση
not available 14327 ASPEN PHARMA TRADING LIMITED
CY
DIPRIVAN 10mg/ml (1%) γαλάκτωμα για ένεση ή έγχυση
not available 78816/16/22-03-17 ASPEN PHARMA TRADING LIMITED
GR
Diprivan 2% 20 mg/ml emulsão para perfusão
not available 3059383 ASTRAZENECA PRODUTOS FARMACEUTICOS LDA
PT
Diprivan 2% 20 mg/ml emulsão para perfusão
not available 3059482 ASTRAZENECA PRODUTOS FARMACEUTICOS LDA
PT
Diprivan 2%, emulsie voor infusie
not available BE173022 ASPEN PHARMA TRADING LIMITED
BE
List of nationally authorised medicinal products EMA/475638/2018 Page 5/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Diprivan 2%, emulsie voor infusie
not available BE196804 ASPEN PHARMA TRADING LIMITED
BE
Diprivan 2%, emulsie voor infusie
not available BE173013 ASPEN PHARMA TRADING LIMITED
BE
Diprivan 2%, émulsion pour perfusion
not available BE196804 ASPEN PHARMA TRADING LIMITED
BE
Diprivan 2%, émulsion pour perfusion
not available BE173013 ASPEN PHARMA TRADING LIMITED
BE
Diprivan 2%, émulsion pour perfusion
not available BE173022 ASPEN PHARMA TRADING LIMITED
BE
DIPRIVAN 2%, émulsion pour perfusion
not available 2009020217 ASPEN PHARMA TRADING LIMITED
LU
DIPRIVAN 2%, Emulsion zur Infusion
not available BE173013 ASPEN PHARMA TRADING LIMITED
BE
DIPRIVAN 2%, Emulsion zur Infusion
not available BE173022 ASPEN PHARMA TRADING LIMITED
BE
DIPRIVAN 2%, Emulsion zur Infusion
not available BE196804 ASPEN PHARMA TRADING LIMITED
BE
DIPRIVAN 2%, Emulsion zur Infusion
not available 2009020217 ASPEN PHARMA TRADING LIMITED
LU
Diprivan 20 mg/ml (2%) emulsion for injection or infusion
not available PL 39699/0075 ASPEN PHARMA TRADING LIMITED
UK
Diprivan 20 mg/ml (2%) emulsion for injection or infusion
not available PL 39699/0076 ASPEN PHARMA TRADING LIMITED
UK
Diprivan 20 mg/ml emulsión para perfusión
not available 60.744 ASTRAZENECA FARMACÉUTICA SPAIN, S.A.
ES
Diprivan 20 mg/ml emulsione per infusione
not available 026114076 ASPEN PHARMA TRADING LIMITED
IT
Diprivan 20 mg/ml emulsione per infusione
not available 026114088 ASPEN PHARMA TRADING LIMITED
IT
Diprivan 20 mg/ml emulsione per infusione
not available 026114064 ASPEN PHARMA TRADING LIMITED
IT
Diprivan 20 mg/ml injeksjons-/infusjonsvæske, emulsjon
not available 94-1710 ASTRAZENECA AS NO
List of nationally authorised medicinal products EMA/475638/2018 Page 6/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DIPRIVAN 20 mg/ml, émulsion injectable en seringue pré-remplie
not available 34009 563 611 6 8 ASPEN PHARMA TRADING LIMITED
FR
Diprivan 20 mg/ml, injektions-/infusionsvätska, emulsion
not available 12279 ASTRAZENECA AB SE
DIPRIVAN 20mg/ml (2%) γαλάκτωμα για ένεση ή έγχυση
not available 18330 ASPEN PHARMA TRADING LIMITED
CY
DIPRIVAN 20mg/ml (2%) γαλάκτωμα για ένεση ή έγχυση
not available 78817/16/22-03-17 ASPEN PHARMA TRADING LIMITED
GR
DIPRIVAN, 10 mg/ml, emulsja do wstrzykiwań
not available R/1700 ASPEN PHARMA TRADING LIMITED
PL
Diprivan, Injektions- og infusionsvæske, emulsion
not available 15836 ASTRAZENECA A/S DK
Diprivan, Injektions- og infusionsvæske, emulsion
not available 12090 ASTRAZENECA A/S DK
Diprivan-10, emulsie voor injectie of infusie, 10 mg/ml
not available RVG 11549 ASPEN PHARMA TRADING LIMITED
NL
Diprivan-20, emulsie voor injectie of infusie, 20 mg/ml
not available RVG 18473 ASPEN PHARMA TRADING LIMITED
NL
Disoprivan® 1 %, Emulsion zur Injektion/Infusion
not available 31362.00.00 ASPEN PHARMA TRADING LIMITED
DE
Disoprivan® 2 %, Emulsion zur Injektion/Infusion
not available 19817.01.00 ASPEN PHARMA TRADING LIMITED
DE
Fresenius Propoven 1% emulsion for injection or infusion
DE/H/0490/001 PA 566/36/1 FRESENIUS KABI LIMITED IE
Fresenius Propoven 1% emulsion for injection or infusion
DE/H/0490/001 PA 566/36/2 FRESENIUS KABI LIMITED IE
Fresenius Propoven 1% emulsion for injection or infusion
DE/H/0490/001 PL 08828/0167 FRESENIUS KABI LIMITED UK
List of nationally authorised medicinal products EMA/475638/2018 Page 7/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fresenius Propoven 2% emulsion for injection or infusion
DE/H/0490/002 PA 566/036/003 FRESENIUS KABI LIMITED IE
Fresenius Propoven 2% emulsion for injection or infusion
DE/H/0490/002 PL 08828/0168 FRESENIUS KABI LIMITED UK
HIREMON 10 mg/mL γαλάκτωμα για ένεση ή έγχυση
PT/H/1620/001 022683 DEMO ABEE CY
HIREMON 10 mg/mL γαλάκτωμα για ένεση ή έγχυση
PT/H/1620/001 3132701 DEMO ABEE GR
HIREMON 20mg/mL γαλάκτωμα για έγχυση
PT/H/1620/002 022684 DEMO ABEE CY
HIREMON 20mg/mL γαλάκτωμα για έγχυση
PT/H/1620/002 3132702 DEMO ABEE GR
PLOFED 1%, 10 mg/ml, emulsja do wstrzykiwań/do infuzji
not available 8415 WARSZAWSKIE ZAKLADY FARMACEUTYCZNE POLFA S.A.
PL
Profast 10 mg/ml emulsie injectabila/perfuzabila
DE/H/2426/001 4612/2012/01 NORAMEDA UAB RO
Profast 10 mg/ml emulsie injectabila/perfuzabilă
DE/H/2426/001 4612/2012/07 NORAMEDA UAB RO
Profast 10 mg/ml emulsie injectabila/perfuzabilă
DE/H/2426/001 4612/2012/06 NORAMEDA UAB RO
Profast 10 mg/ml emulsie injectabila/perfuzabilă
DE/H/2426/001 4612/2012/04 NORAMEDA UAB RO
Profast 10 mg/ml emulsie injectabila/perfuzabilă
DE/H/2426/001 4612/2012/05 NORAMEDA UAB RO
Profast 10 mg/ml emulsie injectabila/perfuzabilă
DE/H/2426/001 4612/2012/03 NORAMEDA UAB RO
Profast 10 mg/ml emulsie injectabila/perfuzabilă
DE/H/2426/001 4612/2012/02 NORAMEDA UAB RO
Profast 10 mg/ml injektio-/infuusioneste, emulsio
DE/H/2426/01/DC 27983 CLARIS LIFESCIENCES (UK) LIMITED
FI
List of nationally authorised medicinal products EMA/475638/2018 Page 8/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Profast 10 mg/ml injektionsvätska/infusionsvätska, emulsion
DE/H/2426/01/DC 43111 CLARIS LIFESCIENCES (UK) LIMITED
SE
Profast 10mg/ml, injektions- og infusionsvæske, emulsion
DE/H/2426/01/DC 46296 CLARIS LIFESCIENCES (UK) LIMITED
DK
Profast 20 mg/ml emulsie injectabila/perfuzabila
DE/H/2426/002 4613/2012/02 NORAMEDA UAB RO
Profast 20 mg/ml emulsie injectabila/perfuzabilă
DE/H/2426/002 4613/2012/01 NORAMEDA UAB RO
Profast 20 mg/ml injektio-/infuusioneste, emulsio
DE/H/2426/02/DC 27984 CLARIS LIFESCIENCES (UK) LIMITED
FI
Profast 20 mg/ml injektionsvätska/infusionsvätska, emulsion
DE/H/2426/02/DC 43112 CLARIS LIFESCIENCES (UK) LIMITED
SE
Profast 20mg/ml, injektions- og infusionsvæske, emulsion
DE/H/2426/02/DC 46297 CLARIS LIFESCIENCES (UK) LIMITED
DK
Profol 10 mg/ml (1%) emulsion for infusion
not available 20060028 CLARIS LIFESCIENCES (UK) LIMITED
BG
Propofol - Lipuro 1% (10 mg/ml) γαλάκτωμα για ένεση ή έγχυση
DE/H/0185/001 20498 B.BRAUN MELSUNGEN AG CY
Propofol ”B. Braun” DE/H/0185/001 31140 B.BRAUN MELSUNGEN AG DK Propofol ”B. Braun” 20 mg/ml injektions- og infusionsvæske, emulsion
DE/H/0185/002 32940 B.BRAUN MELSUNGEN AG DK
Propofol ”B.Braun”, injektions- og infusionsvæske, emulsion 5 mg/ml
DE/H/0185/003 41677 B. BRAUN MELSUNGEN AG ART 57
DK
Propofol „Fresenius" 1 % mit MCT - Emulsion zur Injektion oder Infusion
DE/H/0490/001 1-25830 FRESENIUS KABI AUSTRIA GMBH
AT
Propofol 1 % (10 mg/1 ml) Fresenius emulsion for injection or infusion
DE/H/0122/001 PA 566/21/001 FRESENIUS KABI LIMITED IE
List of nationally authorised medicinal products EMA/475638/2018 Page 9/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol 1 % (10 mg/1 ml) Fresenius emulsion for injection or infusion
DE/H/0122/001 PA 566/21/002 FRESENIUS KABI LIMITED IE
Propofol 1 % (10 mg/1 ml) Fresenius emulsion for injection or infusion
DE/H/0122/001 PL 08828/0144 FRESENIUS KABI LIMITED UK
Propofol 1 % (10mg/1 ml) Fresenius Emulsion zur Injektion oder Infusion
DE/H/0122/001 39034.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
PROPOFOL 1 % FRESENIUS, 1 O mg/ml, emulsja do wstrzykiwań lub infuzji
not available 4663 FRESENIUS KABI DEUTSCHLAND GMBH
PL
PROPOFOL 1 % FRESENIUS, 1 O mg/ml, emulsja do wstrzykiwań lub infuzji
not available 4663 FRESENIUS KABI DEUTSCHLAND GMBH
PL
Propofol 1 % MCT/LCT Fresenius, 10 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/001 5347588 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1 % MCT/LCT Fresenius, 10 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/001 5347687 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1 % MCT/LCT Fresenius, 10 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/001 5347786 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1 % MCT/LCT Fresenius, 10 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/001 5347885 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1 % MCT/LCT Fresenius, 10 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/001 5348081 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
List of nationally authorised medicinal products EMA/475638/2018 Page 10/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol 1 % MCT/LCT Fresenius, 10 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/001 5348180 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1 % MCT/LCT Fresenius, 10 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/001 5348289 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1 % MCT/LCT Fresenius, 10 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/001 5348388 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1 % MCT/LCT Fresenius, 10 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/001 5348487 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1 % MCT/LCT Fresenius, 10 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/001 5347984 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1% (10 mg/ 1ml) MCT/LCT Fresenius, emulsão injetável ou para perfusão
DE/H/0490/001 5721543 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1% (10 mg/1 ml) MCT Fresenius Emulsion zur Injektion oder Infusion
DE/H/0490/001 48850.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Propofol 1% (10 mg/1 ml) MCT Fresenius, Emulsion zur Injektion oder Infusion
not available 48813.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Propofol 1% (10 mg/1 ml) MCT Fresenius, Emulsion zur Injektion oder Infusion
DE/H/0490/001 0452/10040766 FRESENIUS KABI DEUTSCHLAND GMBH
LU
Propofol 1% (10 mg/1 ml) MCT/LCT Fresenius emulsão injetável ou para perfusão em seringa pré-cheia
DE/H/0490/003 5563036 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
List of nationally authorised medicinal products EMA/475638/2018 Page 11/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol 1% (10 mg/1ml) Fresenius emulsão injetável ou para perfusão
DE/H/0122/001 2657484 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1% (10 mg/1ml) Fresenius emulsão injetável ou para perfusão
DE/H/0122/001 2657682 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1% (10 mg/1ml) Fresenius emulsão injetável ou para perfusão
DE/H/0122/001 2657781 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1% (10 mg/1ml) Fresenius emulsão injetável ou para perfusão
DE/H/0122/001 2657880 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1% (10 mg/1ml) Fresenius emulsão injetável ou para perfusão
DE/H/0122/001 4992384 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1% (10 mg/1ml) Fresenius emulsão injetável ou para perfusão
DE/H/0122/001 4992483 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1% (10 mg/1ml) Fresenius emulsão injetável ou para perfusão
DE/H/0122/001 2657583 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1% (10 mg/1ml) Fresenius emulsão injetável ou para perfusão
DE/H/0122/001 5718259 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 1% Fresenius emulsie voor injectie of infusie
DE/H/0122/001 BE193934 FRESENIUS KABI DEUTSCHLAND GMBH
BE
Propofol 1% Fresenius emulsie voor injectie of infusie
DE/H/0122/001 BE193943 FRESENIUS KABI DEUTSCHLAND GMBH
BE
Propofol 1% Fresenius emulsie voor injectie of infusie
DE/H/0122/001 BE193925 FRESENIUS KABI DEUTSCHLAND GMBH
BE
Propofol 1% Fresenius émulsion injectable ou pour perfusion
DE/H/0122/001 BE193934 FRESENIUS KABI DEUTSCHLAND GMBH
BE
List of nationally authorised medicinal products EMA/475638/2018 Page 12/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol 1% Fresenius émulsion injectable ou pour perfusion
DE/H/0122/001 BE193943 FRESENIUS KABI DEUTSCHLAND GMBH
BE
Propofol 1% Fresenius émulsion injectable ou pour perfusion
DE/H/0122/001 BE193925 FRESENIUS KABI DEUTSCHLAND GMBH
BE
Propofol 1% Fresenius Emulsion zur Injektion oder Infusion
DE/H/0122/001 BE193934 FRESENIUS KABI DEUTSCHLAND GMBH
BE
Propofol 1% Fresenius Emulsion zur Injektion oder Infusion
DE/H/0122/001 BE193943 FRESENIUS KABI DEUTSCHLAND GMBH
BE
Propofol 1% Fresenius Emulsion zur Injektion oder Infusion
DE/H/0122/001 BE193925 FRESENIUS KABI DEUTSCHLAND GMBH
BE
Propofol 1% MCT/LCT Fresenius
DE/H/0490/001 05/109/05-C FRESENIUS KABI DEUTSCHLAND GMBH
CZ
Propofol 1% MCT/LCT Fresenius emulzió injekcióhoz vagy infúzióhoz
DE/H/0490/001 OGYI-T-10105/02 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Propofol 1% MCT/LCT Fresenius emulzió injekcióhoz vagy infúzióhoz
DE/H/0490/001 OGYI-T-10105/03 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Propofol 1% MCT/LCT Fresenius emulzió injekcióhoz vagy infúzióhoz
DE/H/0490/001 OGYI-T-10105/12 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Propofol 1% MCT/LCT Fresenius emulzió injekcióhoz vagy infúzióhoz
DE/H/0490/001 OGYI-T-10105/01 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Propofol 1% MCT/LCT Fresenius, 10 mg/ml, emulsja do wstrzykiwań/ do infuzji
DE/H/0490/001 11898 FRESENIUS KABI DEUTSCHLAND GMBH
PL
List of nationally authorised medicinal products EMA/475638/2018 Page 13/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol 1% MCT/LCT Fresenius, 10 mg/ml, emulsja do wstrzykiwań/do infuzji w ampułko-strzykawce
DE/H/0490/003 21359 FRESENIUS KABI DEUTSCHLAND GMBH
PL
Propofol 1% MCT/LCT Fresenius, injekčná/infúzna emulzia
DE/H/0490/001 05/0042/05-S FRESENIUS KABI DEUTSCHLAND GMBH
SK
Propofol 10 mg/ml (1%) Emulsion for Injection/Infusion
NL/H/2283/001 PL 04416/1316 SANDOZ LTD UK
Propofol 10 mg/ml Emulsion for injection/infusion
DE/H/2426/001 PA1472/2/1 NORAMEDA UAB IE
Propofol 10 mg/ml Fresenius, süste- või infusiooniemulsioon
not available 391002 FRESENIUS KABI DEUTSCHLAND GMBH
EE
Propofol 10 mg/ml MCT Fresenius emulzija za injekciju/infuziju
not available HR-H-289447943 FRESENIUS KABI D.O.O. HR
Propofol 10 mg/ml MCT/LCT Fresenius emulsie voor injectie of infusie
DE/H/0490/001 RVG 31762 FRESENIUS KABI NEDERLAND B.V.
NL
Propofol 10 mg/ml MCT/LCT Fresenius, emulsie voor injectie/infusie in een voorgevulde spuit
DE/H/0490/003 RVG 110627 FRESENIUS KABI NEDERLAND B.V.
NL
Propofol 10 mg/ml Teva, emulsie voor injectie of infusie
DE/H/2517/001 RVG 106397 TEVA NEDERLAND B.V. NL
Propofol 10 mg/ml Teva, emulsie voor injectie of infusie
DE/H/2517/001 RVG 106397 TEVA NEDERLAND B.V. NL
Propofol 10 mg/ml, emulsion for injection and infusion
UK/H/0285/001 PL 15919/0023 GENTHON BV UK
Propofol 2 % MCT Fresenius DE/H/0490/002 0452/10040767 FRESENIUS KABI DEUTSCHLAND GMBH
LU
List of nationally authorised medicinal products EMA/475638/2018 Page 14/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol 2 % ( 20 mg/ml) Fresenius Emulsion zur Injektion oder Infusion
DE/H/0122/002 39034.01.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Propofol 2 % (20 mg/1 ml) Fresenius emulsion for injection or infusion
DE/H/0122/002 PA 566/21/003 FRESENIUS KABI LIMITED IE
Propofol 2 % (20 mg/1 ml) Fresenius emulsion for injection or infusion
DE/H/0122/002 PA 566/21/004 FRESENIUS KABI LIMITED IE
Propofol 2 % (20 mg/1 ml) Fresenius emulsion for injection or infusion
DE/H/0122/002 PL 08828/0155 FRESENIUS KABI LIMITED UK
Propofol 2 % MCT/LCT Fresenius, 20 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/002 5348685 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 2 % MCT/LCT Fresenius, 20 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/002 5348784 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 2 % MCT/LCT Fresenius, 20 mg/ml, emulsão injetável ou para perfusão
DE/H/0490/002 5348586 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 2% (20 mg/1 ml) Fresenius, emulsão injetável ou para perfusão
DE/H/0122/002 3602588 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 2% (20 mg/1 ml) Fresenius, emulsão injetável ou para perfusão
DE/H/0122/002 3602786 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 2% (20 mg/1 ml) Fresenius, emulsão injetável ou para perfusão
DE/H/0122/002 3602885 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 2% (20 mg/1 ml) Fresenius, emulsão injetável ou para perfusão
DE/H/0122/002 3602984 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
List of nationally authorised medicinal products EMA/475638/2018 Page 15/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol 2% (20 mg/1 ml) Fresenius, emulsão injetável ou para perfusão
DE/H/0122/002 3602687 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 2% (20 mg/1 ml) MCT Fresenius Emulsion zur Injektion oder Infusion
DE/H/0490/002 48541.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Propofol 2% (20 mg/1 ml) MCT/LCT Fresenius emulsão injetável ou para perfusão em seringa pré-cheia
DE/H/0490/004 5563317 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Propofol 2% Fresenius emulsie voor injectie of infusie
DE/H/0122/002 BE225662 FRESENIUS KABI NV/SA BE
Propofol 2% Fresenius emulsie voor injectie of infusie
DE/H/0122/002 BE225671 FRESENIUS KABI NV/SA BE
Propofol 2% Fresenius emulsie voor injectie of infusie
DE/H/0122/002 BE225653 FRESENIUS KABI NV/SA BE
Propofol 2% Fresenius émulsion injectable ou pour perfusion
DE/H/0122/002 BE225662 FRESENIUS KABI NV/SA BE
Propofol 2% Fresenius émulsion injectable ou pour perfusion
DE/H/0122/002 BE225671 FRESENIUS KABI NV/SA BE
Propofol 2% Fresenius émulsion injectable ou pour perfusion
DE/H/0122/002 BE225653 FRESENIUS KABI NV/SA BE
Propofol 2% Fresenius Emulsion zur Injektion oder Infusion
DE/H/0122/002 BE225662 FRESENIUS KABI NV/SA BE
Propofol 2% Fresenius Emulsion zur Injektion oder Infusion
DE/H/0122/002 BE225671 FRESENIUS KABI NV/SA BE
Propofol 2% Fresenius Emulsion zur Injektion oder Infusion
DE/H/0122/002 BE225653 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/475638/2018 Page 16/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol 2% MCT/LCT Fresenius
DE/H/0490/002 05/110/05-C FRESENIUS KABI DEUTSCHLAND GMBH
CZ
Propofol 2% MCT/LCT Fresenius emulzió injekcióhoz vagy infúzióhoz
DE/H/0490/002 OGYI-T-10105/05 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Propofol 2% MCT/LCT Fresenius emulzió injekcióhoz vagy infúzióhoz
DE/H/0490/002 OGYI-T-10105/04 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Propofol 2% MCT/LCT Fresenius injekčná/infúzna emulzia
DE/H/0490/002 05/0043/05-S FRESENIUS KABI DEUTSCHLAND GMBH
SK
Propofol 2% MCT/LCT Fresenius, 20 mg/ml, emulsja do wstrzykiwań/ do infuzji
DE/H/0490/002 11917 FRESENIUS KABI DEUTSCHLAND GMBH
PL
Propofol 2% MCT/LCT Fresenius, 20 mg/ml, emulsja do wstrzykiwań/do infuzji w ampułko-strzykawce
DE/H/0490/004 21360 FRESENIUS KABI DEUTSCHLAND GMBH
PL
Propofol 20 mg/ml (2%) Emulsion for Injection/Infusion
NL/H/2283/002 PL 04416/1317 SANDOZ LTD UK
Propofol 20 mg/ml Emulsion for injection/infusion
DE/H/2426/002 PA1472/2/2 NORAMEDA UAB IE
Propofol 20 mg/ml MCT Fresenius emulzija za injekciju/infuziju
not available HR-H-936593514 FRESENIUS KABI D.O.O. HR
Propofol 20 mg/ml Teva , emulsie voor injectie of infusie
DE/H/2517/002 RVG 106399 TEVA NEDERLAND B.V. NL
Propofol 20 mg/ml Teva , emulsie voor injectie of infusie
DE/H/2517/002 RVG 106399 TEVA NEDERLAND B.V. NL
Propofol 20 mg/ml, emulsion for injection and infusion
UK/H/0285/002 PL 15919/0024 GENTHON BV UK
List of nationally authorised medicinal products EMA/475638/2018 Page 17/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol B. Braun 1 % (10 mg/ml), émulsion injectable ou pour perfusion
not available BE369731 B.BRAUN MELSUNGEN AG BE
Propofol B. Braun 1 % (10 mg/ml), Emulsion zur Injektion oder Infusion
not available BE369747 B.BRAUN MELSUNGEN AG BE
Propofol B. Braun 1 % (10 mg/ml), Emulsion zur Injektion oder Infusion
not available BE369731 B.BRAUN MELSUNGEN AG BE
Propofol B. Braun 1% (10 mg/ml) emulsione iniettabile o per infusione
DE/H/0185/001 035911027 B.BRAUN MELSUNGEN AG IT
Propofol B. Braun 1% (10 mg/ml) emulsione iniettabile o per infusione
DE/H/0185/001 035911039 B.BRAUN MELSUNGEN AG IT
Propofol B. Braun 1% (10 mg/ml) emulsione iniettabile o per infusione
DE/H/0185/001 035911041 B.BRAUN MELSUNGEN AG IT
Propofol B. Braun 1% (10 mg/ml) emulsione iniettabile o per infusione
DE/H/0185/001 035911054 B.BRAUN MELSUNGEN AG IT
Propofol B. Braun 1% (10 mg/ml) emulsione iniettabile o per infusione
DE/H/0185/001 035911092 B.BRAUN MELSUNGEN AG IT
Propofol B. Braun 1% (10 mg/ml) emulsione iniettabile o per infusione
DE/H/0185/001 035911015 B.BRAUN MELSUNGEN AG IT
Propofol B. Braun 1% (10 mg/ml), emulsie voor injectie of infusie
not available BE369747 B.BRAUN MELSUNGEN AG BE
Propofol B. Braun 2 % (20 mg/ml), émulsion injectable ou pour perfusion
not available BE369765 B.BRAUN MELSUNGEN AG BE
Propofol B. Braun 2 % (20 mg/ml), émulsion injectable ou pour perfusion
not available BE369765 B.BRAUN MELSUNGEN AG BE
List of nationally authorised medicinal products EMA/475638/2018 Page 18/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol B. Braun 2 % (20 mg/ml), Emulsion zur Injektion oder Infusion
not available BE369765 B.BRAUN MELSUNGEN AG BE
Propofol B. Braun 2 % (20 mg/ml), Emulsion zur Injektion oder Infusion
not available BE369765 B.BRAUN MELSUNGEN AG BE
Propofol B. Braun 2% (20 mg/ml) emulsione iniettabile o per infusione
DE/H/0185/002 035911066 B.BRAUN MELSUNGEN AG IT
Propofol B. Braun 2% (20 mg/ml) emulsione iniettabile o per infusione
DE/H/0185/002 035911078 B.BRAUN MELSUNGEN AG IT
Propofol B. Braun 2% (20 mg/ml), emulsie voor injectie of infusie
not available BE369765 B.BRAUN MELSUNGEN AG BE
Propofol B. Braun 2% (20 mg/ml), emulsie voor injectie of infusie
not available BE369765 B.BRAUN MELSUNGEN AG BE
Propofol B. Braun 5 mg/ml emulsione iniettabile o per infusione
DE/H/0185/003 035911080 B. BRAUN MELSUNGEN AG ART 57
IT
Propofol BioQ 10 mg/ml emulsión inyectable/para perfusión EFG
NL/H/2284/001 76393 BIOQ PHARMA LTD ES
Propofol BioQ 10 mg/ml Emulsion zur Injektion/Infusion
NL/H/2284/001 84703.00.00 BIOQ PHARMA LTD DE
Propofol BioQ 10 mg/ml emulsione iniettabile/per infusione
NL/H/2284/001 040963023/M BIOQ PHARMA LTD IT
Propofol BioQ 10 mg/ml emulsione iniettabile/per infusione
NL/H/2284/001 040963011/M BIOQ PHARMA LTD IT
Propofol BioQ 10 mg/ml emulsione iniettabile/per infusione
NL/H/2284/001 040963047/M BIOQ PHARMA LTD IT
List of nationally authorised medicinal products EMA/475638/2018 Page 19/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol BioQ 10 mg/ml emulsione iniettabile/per infusione
NL/H/2284/001 040963035/M BIOQ PHARMA LTD IT
Propofol BioQ 20 mg/ml emulsión inyectable/para perfusión EFG
NL/H/2284/002 76394 BIOQ PHARMA LTD ES
Propofol BioQ 20 mg/ml emulsione iniettabile/per infusione
NL/H/2284/002 040963050/M BIOQ PHARMA LTD IT
Propofol BioQ Pharma 10 mg/ml (1%) emulsion for injection/infusion
NL/H/2284/001 PL 45205/001 BIOQ PHARMA LTD UK
Propofol BioQ Pharma 10 mg/ml Emulsie voor injectie of infusie
NL/H/2284/001 109300 BIOQ PHARMA LTD NL
Propofol BioQ Pharma 20 mg/ml (2%) emulsion for injection/infusion
NL/H/2284/002 PL 45205/002 BIOQ PHARMA LTD UK
Propofol BioQ Pharma 20 mg/ml Emulsie voor injectie of infusie
NL/H/2284/002 109303 BIOQ PHARMA LTD NL
Propofol Claris 1 % (10 mg/ml) MCT Emulsion zur Injektion/Infusion
DE/H/2426/01/DC 78222.00.00 CLARIS LIFESCIENCES (UK) LIMITED
DE
Propofol Claris 10 mg/ml emulsija injekcijam vai infuzijam
NL/H/1268/01/MR 09-0146 CLARIS LIFESCIENCES (UK) LIMITED
LV
Propofol Claris 10 mg/ml injekcine/infuzine emulsija
NL/H/1268/01/MR LT/1/09/1589/004 CLARIS LIFESCIENCES (UK) LIMITED
LT
Propofol Claris 10 mg/ml injekcine/infuzine emulsija
NL/H/1268/01/MR LT/1/09/1589/003 CLARIS LIFESCIENCES (UK) LIMITED
LT
Propofol Claris 10 mg/ml injekcine/infuzine emulsija
NL/H/1268/01/MR LT/1/09/1589/007 CLARIS LIFESCIENCES (UK) LIMITED
LT
Propofol Claris 10 mg/ml injekcine/infuzine emulsija
NL/H/1268/01/MR LT/1/09/1589/006 CLARIS LIFESCIENCES (UK) LIMITED
LT
Propofol Claris 10 mg/ml injekcine/infuzine emulsija
NL/H/1268/01/MR LT/1/09/1589/002 CLARIS LIFESCIENCES (UK) LIMITED
LT
List of nationally authorised medicinal products EMA/475638/2018 Page 20/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol Claris 10 mg/ml injekcine/infuzine emulsija
NL/H/1268/01/MR LT/1/09/1589/001 CLARIS LIFESCIENCES (UK) LIMITED
LT
Propofol Claris 10 mg/ml, emulsie voor injectie of infusie
NL/H/1268/01/MR RVG 31923 CLARIS LIFESCIENCES (UK) LIMITED
NL
Propofol Claris 2 % (20 mg/ml) MCT Emulsion zur Injektion/Infusion
DE/H/2426/02/DC 78223.00.00 CLARIS LIFESCIENCES (UK) LIMITED
DE
Propofol Claris 20 mg/ml emulsija injekcijam vai infuzijam
NL/H/1268/02/MR 09-0145 CLARIS LIFESCIENCES (UK) LIMITED
LV
Propofol Claris 20 mg/ml injekcine/infuzine emulsija
NL/H/1268/01/MR LT/1/09/1589/005 CLARIS LIFESCIENCES (UK) LIMITED
LT
Propofol Claris 20 mg/ml, emulsie voor injectie of infusie
NL/H/1268/02/MR RVG 32676 CLARIS LIFESCIENCES (UK) LIMITED
NL
Propofol Claris, 10 mg/ml süste-/infusiooniemulsioon
NL/H/1268/01/MR 630809 CLARIS LIFESCIENCES (UK) LIMITED
EE
Propofol Claris, 20 mg/ml süste-/infusiooniemulsioon
NL/H/1268/02/MR 630709 CLARIS LIFESCIENCES (UK) LIMITED
EE
Propofol DEMO 10 mg/mL emulsão injetável ou para perfusão
PT/H/1620/001 5714175 DEMO ABEE PT
Propofol DEMO 10 mg/mL emulsão injetável ou para perfusão
PT/H/1620/001 5714134 DEMO ABEE PT
Propofol DEMO 10 mg/mL emulsão injetável ou para perfusão
PT/H/1620/001 5714076 DEMO ABEE PT
Propofol DEMO 10 mg/mL emulsão injetável ou para perfusão
PT/H/1620/001 5714209 DEMO ABEE PT
Propofol DEMO 10 mg/mL emulsão injetável ou para perfusão
PT/H/1620/001 5714100 DEMO ABEE PT
List of nationally authorised medicinal products EMA/475638/2018 Page 21/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol DEMO 10 mg/mL emulsão injetável ou para perfusão
PT/H/1620/001 5714142 DEMO ABEE PT
Propofol DEMO 10 mg/mL emulsão injetável ou para perfusão
PT/H/1620/001 5714217 DEMO ABEE PT
Propofol DEMO 10 mg/mL emulsão injetável ou para perfusão
PT/H/1620/001 5714159 DEMO ABEE PT
Propofol DEMO 10 mg/mL emulsão injetável ou para perfusão
PT/H/1620/001 5714118 DEMO ABEE PT
Propofol DEMO 10 mg/mL emulsão injetável ou para perfusão
PT/H/1620/001 5714225 DEMO ABEE PT
Propofol DEMO 10 mg/mL emulsão injetável ou para perfusão
PT/H/1620/001 5714167 DEMO ABEE PT
Propofol DEMO 10 mg/mL emulsão injetável ou para perfusão
PT/H/1620/001/DC 5714126 DEMO ABEE PT
Propofol DEMO 20 mg/mL emuls ﾃ｣o para perfus ﾃ｣o
PT/H/1620/002 5714068 DEMO ABEE PT
Propofol DEMO 20 mg/mL emuls ﾃ｣o para perfus ﾃ｣o
PT/H/1620/002 5714050 DEMO ABEE PT
Propofol DEMO 20 mg/mL emuls ﾃ｣o para perfus ﾃ｣o
PT/H/1620/002 5714043 DEMO ABEE PT
Propofol DEMO 20 mg/mL emuls ﾃ｣o para perfus ﾃ｣o
PT/H/1620/002 5714035 DEMO ABEE PT
Propofol EG 10 mg/ml emulsie voor injectie of infusie
NL/H/1268/001 BE333706 EUROGENERICS N.V./S.A. BE
Propofol EG 10 mg/ml emulsie voor injectie of infusie
NL/H/1268/001 BE333715 EUROGENERICS N.V./S.A. BE
List of nationally authorised medicinal products EMA/475638/2018 Page 22/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol EG 10 mg/ml emulsie voor injectie of infusie
NL/H/1268/001 BE333697 EUROGENERICS N.V./S.A. BE
Propofol EG 10 mg/ml emulsie voor injectie of infusie
NL/H/1268/001 BE333681 EUROGENERICS N.V./S.A. BE
Propofol EG 10 mg/ml émulsion injectable ou pour perfusion
NL/H/1268/001 BE333681 EUROGENERICS SA BE
Propofol EG 10 mg/ml émulsion injectable ou pour perfusion
NL/H/1268/001 BE333697 EUROGENERICS N.V./S.A. BE
Propofol EG 10 mg/ml émulsion injectable ou pour perfusion
NL/H/1268/001 BE333706 EUROGENERICS N.V./S.A. BE
Propofol EG 10 mg/ml émulsion injectable ou pour perfusion
NL/H/1268/001 BE333715 EUROGENERICS N.V./S.A. BE
Propofol EG 10 mg/ml émulsion injectable ou pour perfusion
NL/H/1268/001 0019/01040046 EUROGENERICS N.V./S.A. LU
Propofol EG 10 mg/ml Emulsion zur Injektion oder Infusion
NL/H/1268/001 BE333681 EUROGENERICS SA BE
Propofol EG 10 mg/ml Emulsion zur Injektion oder Infusion
NL/H/1268/001 BE333706 EUROGENERICS N.V./S.A. BE
Propofol EG 10 mg/ml Emulsion zur Injektion oder Infusion
NL/H/1268/001 BE333715 EUROGENERICS N.V./S.A. BE
Propofol EG 10 mg/ml Emulsion zur Injektion oder Infusion
NL/H/1268/001 BE333697 EUROGENERICS N.V./S.A. BE
Propofol EG 20 mg/ml emulsie voor injectie of infusie
NL/H/1268/002 BE 333724 EUROGENERICS SA BE
List of nationally authorised medicinal products EMA/475638/2018 Page 23/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol EG 20 mg/ml émulsion injectable ou pour perfusion
NL/H/1268/002 BE333724 EUROGENERICS SA BE
Propofol EG 20 mg/ml émulsion injectable ou pour perfusion
NL/H/1268/002 0019/11040047 EUROGENERICS N.V./S.A. LU
Propofol EG 20 mg/ml Emulsion zur Injektion oder Infusion
NL/H/1268/002 BE333724 EUROGENERICS SA BE
Propofol Fresenius 1 % mit MCT Emulsion zur Injektion oder Infusion in einer Fertigspritze
DE/H/0490/003 1-31915 FRESENIUS KABI AUSTRIA GMBH
AT
Propofol Fresenius 1% emulsija injekcijām vai infūzijām
not available 03-0174 FRESENIUS KABI DEUTSCHLAND GMBH
LV
Propofol Fresenius 1% injekcine/infuzine emulsija
not available LT/1/02/2377/002 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propofol Fresenius 1% injekcine/infuzine emulsija
not available LT/1/02/2377/004 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propofol Fresenius 1% injekcine/infuzine emulsija
not available LT/1/02/2377/003 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propofol Fresenius 10 mg/ml emulsie perfuzabilă/injectabilă
not available 7811/2006/02 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Propofol Fresenius 10 mg/ml emulsie perfuzabilă/injectabilă
not available 7811/2006/03 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Propofol Fresenius 10 mg/ml emulsie perfuzabilă/injectabilă
not available 7811/2006/04 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Propofol Fresenius 10 mg/ml emulsie perfuzabilă/injectabilă
not available 7811/2006/05 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Propofol Fresenius 10 mg/ml emulsie perfuzabilă/injectabilă
not available 7811/2006/06 FRESENIUS KABI DEUTSCHLAND GMBH
RO
List of nationally authorised medicinal products EMA/475638/2018 Page 24/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol Fresenius 10 mg/ml emulsie perfuzabilă/injectabilă
not available 7811/2006/07 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Propofol Fresenius 10 mg/ml emulsie perfuzabilă/injectabilă
not available 7811/2006/01 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Propofol Fresenius 10 mg/ml emulsión para inyección o perfusión EFG
DE/H/0122/001 62.134 FRESENIUS KABI DEUTSCHLAND GMBH
ES
PROPOFOL FRESENIUS 10 mg/ml, émulsion injectable ou pour perfusion
DE/H/0122/001 34009 560 999 3 1 FRESENIUS KABI FRANCE S.A.S.
FR
PROPOFOL FRESENIUS 10 mg/ml, émulsion injectable ou pour perfusion
DE/H/0122/001 34009 561 002 2 4 FRESENIUS KABI FRANCE S.A.S.
FR
PROPOFOL FRESENIUS 10 mg/ml, émulsion injectable ou pour perfusion
DE/H/0122/001 34009 561 001 6 3 FRESENIUS KABI FRANCE S.A.S.
FR
PROPOFOL FRESENIUS 10 mg/ml, émulsion injectable ou pour perfusion
DE/H/0122/001 34009 565 313 2 5 FRESENIUS KABI FRANCE S.A.S.
FR
PROPOFOL FRESENIUS 10 mg/ml, émulsion injectable ou pour perfusion
DE/H/0122/001 34009 561 003 9 2 FRESENIUS KABI FRANCE S.A.S.
FR
PROPOFOL FRESENIUS 10 mg/ml, émulsion injectable ou pour perfusion
DE/H/0122/001 34009 561 004 5 3 FRESENIUS KABI FRANCE S.A.S.
FR
PROPOFOL FRESENIUS 10 mg/ml, émulsion injectable ou pour perfusion
DE/H/0122/001 34009 565 314 9 3 FRESENIUS KABI FRANCE S.A.S.
FR
Propofol Fresenius 2 % mit MCT - Emulsion zur Injektion oder Infusion
DE/H/0490/002 1-25831 FRESENIUS KABI AUSTRIA GMBH
AT
Propofol Fresenius 2 % mit MCT Emulsion zur Injektion oder Infusion in einer Fertigspritze
DE/H/0490/004 1-31916 FRESENIUS KABI AUSTRIA GMBH
AT
List of nationally authorised medicinal products EMA/475638/2018 Page 25/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol Fresenius 20 mg/ml emulsie perfuzabilă/injectabilă
not available 7812/2006/02 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Propofol Fresenius 20 mg/ml emulsie perfuzabilă/injectabilă
not available 7812/2006/03 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Propofol Fresenius 20 mg/ml emulsie perfuzabilă/injectabilă
not available 7812/2006/04 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Propofol Fresenius 20 mg/ml emulsie perfuzabilă/injectabilă
not available 7812/2006/05 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Propofol Fresenius 20 mg/ml emulsie perfuzabilă/injectabilă
not available 7812/2006/01 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Propofol Fresenius 20 mg/ml emulsija injekcijām/infūzijām
not available 03-0175 FRESENIUS KABI DEUTSCHLAND GMBH
LV
Propofol Fresenius 20 mg/ml emulsión para inyección o perfusión EFG
DE/H/0122/002 64.033 FRESENIUS KABI DEUTSCHLAND GMBH
ES
Propofol Fresenius 20 mg/ml injekcinė ar infuzinė emulsija
not available LT/1/02/2377/001 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propofol Fresenius 20 mg/ml, süste- või infusiooniemulsioon
not available 390902 FRESENIUS KABI DEUTSCHLAND GMBH
EE
Propofol Fresenius Kabi 10 mg/ml injektionsvätska/infusionsvätska, emulsion
DE/H/0122/001 14080 FRESENIUS KABI AB SE
Propofol Fresenius MCT 10 mg/ml Emulsion zur Injektion/Infusion in einer Fertigspritze
DE/H/0490/003 85980.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
List of nationally authorised medicinal products EMA/475638/2018 Page 26/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol Fresenius MCT 20 mg/ml Emulsion zur Injektion/Infusion in einer Fertigspritze
DE/H/0490/004 85981.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Propofol Genthon 10 mg/ml emulsie voor injectie of infusie
not available RVG 24882 GENTHON BV NL
Propofol Genthon 20 mg/ml emulsie voor injectie of infusie
not available RVG 24883 GENTHON BV NL
Propofol HEXAL 10 mg/ml Emulsion zur Injektion/Infusion
NL/H/2283/001 84701.00.00 HEXAL AG DE
Propofol HEXAL 20 mg/ml Emulsion zur Injektion/Infusion
NL/H/2283/002 84702.00.00 HEXAL AG DE
Propofol Hospira 10 mg/ml emulsión para inyección y perfusión EFG
UK/H/0285/001 62.938 HOSPIRA INVICTA, S.A. ES
Propofol Hospira 20 mg/ml emulsión para inyección y perfusión EFG
UK/H/0285/002 63.503 HOSPIRA INVICTA, S.A. ES
Propofol IBI 10 mg/ml emulsione per iniezione o infusione
UK/H/0285/001 034407078 IBI G. LORENZINI SPA IT
Propofol IBI 10 mg/ml emulsione per iniezione o infusione
UK/H/0285/001 034407041 IBI G. LORENZINI SPA IT
Propofol IBI 10 mg/ml emulsione per iniezione o infusione
UK/H/0285/001 034407027 IBI G. LORENZINI SPA IT
Propofol IBI 10 mg/ml emulsione per iniezione o infusione
UK/H/0285/001 034407092 IBI G. LORENZINI SPA IT
Propofol IBI 10 mg/ml emulsione per iniezione o infusione
UK/H/0285/001 034407080 IBI G. LORENZINI SPA IT
List of nationally authorised medicinal products EMA/475638/2018 Page 27/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol IBI 10 mg/ml emulsione per iniezione o infusione
UK/H/0285/001 034407066 IBI G. LORENZINI SPA IT
Propofol IBI 10 mg/ml emulsione per iniezione o infusione
UK/H/0285/001 034407054 IBI G. LORENZINI SPA IT
Propofol IBI 10 mg/ml emulsione per iniezione o infusione
UK/H/0285/001 034407039 IBI G. LORENZINI SPA IT
Propofol IBI 10 mg/ml emulsione per iniezione o infusione
UK/H/0285/001 034407015 IBI G. LORENZINI SPA IT
Propofol IBI 20 mg/ml emulsione per iniezione o infusione
UK/H/0285/002 034407130 IBI G. LORENZINI SPA IT
Propofol IBI 20 mg/ml emulsione per iniezione o infusione
UK/H/0285/002 034407181 IBI G. LORENZINI SPA IT
Propofol IBI 20 mg/ml emulsione per iniezione o infusione
UK/H/0285/002 034407179 IBI G. LORENZINI SPA IT
Propofol IBI 20 mg/ml emulsione per iniezione o infusione
UK/H/0285/002 034407167 IBI G. LORENZINI SPA IT
Propofol IBI 20 mg/ml emulsione per iniezione o infusione
UK/H/0285/002 034407155 IBI G. LORENZINI SPA IT
Propofol IBI 20 mg/ml emulsione per iniezione o infusione
UK/H/0285/002 034407142 IBI G. LORENZINI SPA IT
Propofol IBI 20 mg/ml emulsione per iniezione o infusione
UK/H/0285/002 034407128 IBI G. LORENZINI SPA IT
Propofol IBI 20 mg/ml emulsione per iniezione o infusione
UK/H/0285/002 034407116 IBI G. LORENZINI SPA IT
List of nationally authorised medicinal products EMA/475638/2018 Page 28/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol IBI 20 mg/ml emulsione per iniezione o infusione
UK/H/0285/002 034407104 IBI G. LORENZINI SPA IT
Propofol Kabi 10 mg/ml emulsione iniettabile o per infusione
DE/H/0490/001 036849014 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml emulsione iniettabile o per infusione
DE/H/0490/001 036849026 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml emulsione iniettabile o per infusione
DE/H/0490/001 036849038 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml emulsione iniettabile o per infusione
DE/H/0490/001 036849040 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml emulsione iniettabile o per infusione
DE/H/0490/001 036849065 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml emulsione iniettabile o per infusione
DE/H/0490/001 036849077 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml emulsione iniettabile o per infusione
DE/H/0490/001 036849089 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml emulsione iniettabile o per infusione
DE/H/0490/001 036849091 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml emulsione iniettabile o per infusione
DE/H/0490/001 036849103 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml emulsione iniettabile o per infusione
DE/H/0490/001 036849053 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml, emulsione iniettabile o per infusione in siringa preriempita.
DE/H/0490/003 036849141 FRESENIUS KABI ITALIA S.R.L.
IT
List of nationally authorised medicinal products EMA/475638/2018 Page 29/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol Kabi 10 mg/ml, emulsione iniettabile o per infusione in siringa preriempita.
DE/H/0490/003 036849166 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml, emulsione iniettabile o per infusione in siringa preriempita.
DE/H/0490/003 036849178 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml, emulsione iniettabile o per infusione in siringa preriempita.
DE/H/0490/003 036849180 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 10 mg/ml, emulsione iniettabile o per infusione in siringa preriempita
DE/H/0490/003 036849192 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 20 mg/1 ml - Emulsione iniettabile o per infusione in siringa preriempita
DE/H/0490/004 036849154 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 20 mg/ml emulsione iniettabile o per infusione
DE/H/0490/002 036849127 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 20 mg/ml emulsione iniettabile o per infusione
DE/H/0490/002 036849139 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Kabi 20 mg/ml emulsione iniettabile o per infusione
DE/H/0490/002 036849115 FRESENIUS KABI ITALIA S.R.L.
IT
Propofol Lipomed Fresenius 1% (10 mg/ml) emulsión para inyección o perfusión
DE/H/0490/001 67.164 FRESENIUS KABI DEUTSCHLAND GMBH
ES
Propofol Lipomed Fresenius 20 mg/ml emulsión inyectable y para perfusión
DE/H/0490/002 67.216 FRESENIUS KABI DEUTSCHLAND GMBH
ES
List of nationally authorised medicinal products EMA/475638/2018 Page 30/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PROPOFOL LIPURO 1 % (10 mg/ml), émulsion injectable ou pour perfusion
DE/H/0185/001 3400957173524 B.BRAUN MELSUNGEN AG FR
PROPOFOL LIPURO 1 % (10 mg/ml), émulsion injectable ou pour perfusion
DE/H/0185/001 3400957173692 B.BRAUN MELSUNGEN AG FR
PROPOFOL LIPURO 1 % (10 mg/ml), émulsion injectable ou pour perfusion
DE/H/0185/001 3400956360857 B.BRAUN MELSUNGEN AG FR
PROPOFOL LIPURO 1 % (10 mg/ml), émulsion injectable ou pour perfusion
DE/H/0185/001 3400958344602 B.BRAUN MELSUNGEN AG FR
PROPOFOL LIPURO 1 % (10 mg/ml), émulsion injectable ou pour perfusion
DE/H/0185/001 3400956360918 B.BRAUN MELSUNGEN AG FR
PROPOFOL LIPURO 1 % (10 mg/ml), émulsion injectable ou pour perfusion
DE/H/0185/001 3400956360796 B.BRAUN MELSUNGEN AG FR
Propofol Lipuro 10 mg/ml emulsión inyectable o para perfusión
DE/H/0185/001 62953 B.BRAUN MELSUNGEN AG ES
PROPOFOL LIPURO 2 % (20 mg/ml), émulsion injectable ou pour perfusion
DE/H/0185/002 3400957052775 B.BRAUN MELSUNGEN AG FR
PROPOFOL LIPURO 2 % (20 mg/ml), émulsion injectable ou pour perfusion
DE/H/0185/002 3400957052836 B.BRAUN MELSUNGEN AG FR
Propofol Lipuro 20 mg/ml emulsión inyectable y para perfusión
DE/H/0185/002 64868 B.BRAUN MELSUNGEN AG ES
Propofol Lipuro 5 mg/ml emulsión inyectable y para perfusión
DE/H/0185/003 70956 B. BRAUN MELSUNGEN AG ART 57
ES
PROPOFOL LIPURO 5 mg/ml, émulsion injectable ou pour perfusion
DE/H/0185/003 3400957386214 B.BRAUN MELSUNGEN AG FR
List of nationally authorised medicinal products EMA/475638/2018 Page 31/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol MCT Fresenius 10 mg/ml emulziós injekció vagy infúzió előretöltött fecskendőben
DE/H/0490/003 OGYI-T-10105/06 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Propofol MCT Fresenius 10 mg/ml emulziós injekció vagy infúzió előretöltött fecskendőben
DE/H/0490/003 OGYI-T-10105/08 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Propofol MCT Fresenius 10 mg/ml emulziós injekció vagy infúzió előretöltött fecskendőben
DE/H/0490/003 OGYI-T-10105/09 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Propofol MCT Fresenius 10 mg/ml emulziós injekció vagy infúzió előretöltött fecskendőben
DE/H/0490/003 OGYI-T-10105/10 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Propofol MCT Fresenius 10 mg/ml emulziós injekció vagy infúzió előretöltött fecskendőben
DE/H/0490/003 OGYI-T-10105/11 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Propofol MCT Fresenius 10 mg/ml injekčná/infúzna emulzia v naplnenej injekčnej striekačke
DE/H/0490/003 05/0379/13-S FRESENIUS KABI DEUTSCHLAND GMBH
SK
Propofol MCT Fresenius 10 mg/ml injekční/infuzní emulze v předplněné injekční stříkačce
DE/H/0490/003 05/255/13-C FRESENIUS KABI DEUTSCHLAND GMBH
CZ
Propofol MCT Fresenius 20 mg/ml emulziós injekció vagy infúzió előretöltött fecskendőben
DE/H/0490/004 OGYI-T-10105/07 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Propofol MCT Fresenius 20 mg/ml injekčná/infúzna emulzia v naplnenej injekčnej striekačke
DE/H/0490/004 05/0380/13-S FRESENIUS KABI DEUTSCHLAND GMBH
SK
List of nationally authorised medicinal products EMA/475638/2018 Page 32/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol MCT Fresenius 20 mg/ml injekční/infuzní emulze v předplněné injekční stříkačce
DE/H/0490/004 05/256/13-C FRESENIUS KABI DEUTSCHLAND GMBH
CZ
Propofol MCT/LCT/Fresenius 10 mg/1 ml ενέσιμο γαλάκτωμα/ γαλάκτωμα για έγχυση σε προγεμισμένη σύριγγα
DE/H/0490/003 49291/5-6-2014 FRESENIUS KABI HELLAS A.E.
GR
Propofol MCT/LCT/Fresenius 10mg/ml (1%) ενέσιμο γαλάκτωμα / γαλάκτωμα για έγχυση σε προγεμισμένη σύριγγα
DE/H/0490/003 021907 FRESENIUS KABI HELLAS A.E.
CY
Propofol MCT/LCT/Fresenius 2% ( 20mg/ 1ml) ενέσιμο γαλάκτωμα /γαλάκτωμα για έγχυση σε|προγεμισμένη σύριγγα
DE/H/0490/004 49292/5-6-14 FRESENIUS KABI HELLAS A.E.
GR
Propofol MCT/LCT/Fresenius 2% (20mg/ml), γαλάκτωμα για ένεση ή έγχυση
DE/H/0490/002 81063/18-11-2011 FRESENIUS KABI HELLAS A.E.
GR
Propofol MCT/LCT/Fresenius 20 mg/1 ml ενέσιμο γαλάκτωμα/γαλάκτωμα για έγχυση σε προγεμισμένη σύριγγα
DE/H/0490/004 021908 FRESENIUS KABI HELLAS A.E.
CY
Propofol MCT/LCT/Fresenius, γαλάκτωμα για ένεση ή έγχυση, 2% (20mg/ml)
DE/H/0490/002 020064 FRESENIUS KABI HELLAS A.E.
CY
Propofol MTL 10 mg/ml, emulsion for injection
not available NL31271 CLARIS LIFESCIENCES (UK) LIMITED
FR
PROPOFOL MYLAN 20 mg/ml, émulsion injectable (IV)
not available NL27735 MYLAN S.A.S FR
List of nationally authorised medicinal products EMA/475638/2018 Page 33/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol Norameda 10 mg/ml Emulsão Injectável ou para Perfusão
DE/H/2426/001 5390836 NORAMEDA UAB PT
Propofol Norameda 10 mg/ml Emulsão Injectável ou para Perfusão
DE/H/2426/001 5390869 NORAMEDA UAB PT
Propofol Norameda 10 mg/ml Emulsão Injectável ou para Perfusão
DE/H/2426/001 5390844 NORAMEDA UAB PT
PROPOFOL NORAMEDA 10 mg/ml emulsija injekcijām vai infūzijām
DE/H/2426/001 11-0316 NORAMEDA UAB LV
Propofol Norameda 10 mg/ml injekcine/infuzine emulsija
DE/H/2426/001 LT/1/11/2765/001 NORAMEDA UAB LT
Propofol Norameda 10 mg/ml injekcine/infuzine emulsija
DE/H/2426/001 LT/1/11/2765/002 NORAMEDA UAB LT
Propofol Norameda 10 mg/ml injekcine/infuzine emulsija
DE/H/2426/001 LT/1/11/2765/003 NORAMEDA UAB LT
Propofol Norameda 10 mg/ml injekcine/infuzine emulsija
DE/H/2426/001 LT/1/11/2765/004 NORAMEDA UAB LT
Propofol Norameda 10 mg/ml injekcine/infuzine emulsija
DE/H/2426/001 LT/1/11/2765/005 NORAMEDA UAB LT
Propofol Norameda 10 mg/ml injekcine/infuzine emulsija
DE/H/2426/001 LT/1/11/2765/006 NORAMEDA UAB LT
Propofol Norameda 10 mg/ml injekcine/infuzine emulsija
DE/H/2426/001 LT/1/11/2765/007 NORAMEDA UAB LT
Propofol Norameda 10 mg/ml, emulsie voor injectie of infusie
DE/H/2426/001 RVG 106061 NORAMEDA UAB NL
List of nationally authorised medicinal products EMA/475638/2018 Page 34/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol Norameda 20 mg/ml emulsão injectável ou para perfusão
DE/H/2426/002 5390877 NORAMEDA UAB PT
Propofol Norameda 20 mg/ml emulsão injectável ou para perfusão
DE/H/2426/002 5390851 NORAMEDA UAB PT
PROPOFOL NORAMEDA 20 mg/ml emulsija injekcijām vai infūzijām
DE/H/2426/002 11-0317 NORAMEDA UAB LV
Propofol Norameda 20 mg/ml injekcinė/infuzinė emulsija
DE/H/2426/002 LT/1/11/2765/008 NORAMEDA UAB LT
Propofol Norameda 20 mg/ml injekcinė/infuzinė emulsija
DE/H/2426/002 LT/1/11/2765/009 NORAMEDA UAB LT
Propofol Norameda 20 mg/ml, emulsie voor injectie of infusie
DE/H/2426/002 RVG 106063 NORAMEDA UAB NL
Propofol Norameda, 10 mg/ml süste-/infusiooniemulsioon
DE/H/2426/001 750511 NORAMEDA UAB EE
Propofol Norameda, 10 mg/ml, emulsja do wstrzykiwan / do infuzji
DE/H/2426/001 19686 NORAMEDA UAB PL
Propofol Norameda, 20 mg/ml süste-/infusiooniemulsioon
DE/H/2426/002 750611 NORAMEDA UAB EE
Propofol Norameda, 20 mg/ml, emulsja do wstrzykiwan / do infuzji
DE/H/2426/002 19687 NORAMEDA UAB PL
PROPOFOL PANPHARMA 10 mg/ml, émulsion injectable
not available 34009 572 939 0 1 CLARIS LIFESCIENCES (UK) LIMITED
FR
PROPOFOL PANPHARMA 10 mg/ml, émulsion injectable
not available 34009 572 942 1 2 CLARIS LIFESCIENCES (UK) LIMITED
FR
PROPOFOL PANPHARMA 10 mg/ml, émulsion injectable
not available 34009 572 941 5 1 CLARIS LIFESCIENCES (UK) LIMITED
FR
List of nationally authorised medicinal products EMA/475638/2018 Page 35/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PROPOFOL PANPHARMA 10 mg/ml, émulsion injectable
not available 34009 572 940 9 0 CLARIS LIFESCIENCES (UK) LIMITED
FR
Propofol Primex 10 mg/ml injektio-/infuusioneste, emulsio
FI/H/0787/001 26884 PRIMEX PHARMACEUTICALS OY
FI
Propofol Primex 10 mg/ml injektions-/infusionsvätska, emulsion
FI/H/0787/001 26884 PRIMEX PHARMACEUTICALS OY
FI
Propofol Primex 20 mg/ml injektio-/infuusioneste, emulsio
FI/H/0787/002 26885 PRIMEX PHARMACEUTICALS OY
FI
Propofol Primex 20 mg/ml injektions-/infusionsvätska, emulsion
FI/H/0787/002 26885 PRIMEX PHARMACEUTICALS OY
FI
Propofol Sandoz 10 mg/ml emulsie voor injectie / infusie
NL/H/2283/001 BE459360 SANDOZ N.V. BE
Propofol Sandoz 10 mg/ml emulsie voor injectie / infusie
NL/H/2283/001 BE459377 SANDOZ N.V. BE
Propofol Sandoz 10 mg/ml emulsie voor injectie / infusie
NL/H/2283/001 BE459386 SANDOZ N.V. BE
Propofol Sandoz 10 mg/ml emulsie voor injectie / infusie
NL/H/2283/001 BE459395 SANDOZ N.V. BE
Propofol Sandoz 10 mg/ml emulsion for injection/infusion
NL/H/2283/001 022120 SANDOZ GMBH CY
Propofol Sandoz 10 mg/ml emulsion for injection/infusion
NL/H/2283/001 022120 SANDOZ GMBH CY
Propofol Sandoz 10 mg/ml emulsion for injection/infusion
NL/H/2283/001 022120 SANDOZ GMBH CY
List of nationally authorised medicinal products EMA/475638/2018 Page 36/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol Sandoz 10 mg/ml emulsion for injection/infusion
NL/H/2283/001 022120 SANDOZ GMBH CY
Propofol Sandoz 10 mg/ml emulsion inyectable y para perfusión EFG
NL/H/2283/001 76391 SANDOZ FARMACÉUTICA, S.A.
ES
Propofol Sandoz 10 mg/ml injektioneste-/infuusioneste, emulsio
NL/H/2283/001 31499 SANDOZ A/S FI
Propofol Sandoz 10 mg/ml injektionsvätska/infusionsvätska, emulsion
NL/H/2283/001 49323 SANDOZ A/S SE
Propofol Sandoz 10 mg/ml, emulsie voor injectie of infusie
NL/H/2283/001 RVG 109287 SANDOZ B.V. NL
Propofol Sandoz 10 mg/ml, émulsion injectable ou pour perfusion
NL/H/2283/001 2014120425 SANDOZ N.V. LU
Propofol Sandoz 20 mg/ml emulsie voor injectie / infusie
NL/H/2283/002 BE459404 SANDOZ N.V. BE
Propofol Sandoz 20 mg/ml emulsion for injection/infusion
NL/H/2283/002 022119 SANDOZ GMBH CY
Propofol Sandoz 20 mg/ml emulsion inyectable y para perfusión EFG
NL/H/2283/002 76392 SANDOZ FARMACÉUTICA, S.A.
ES
Propofol Sandoz 20 mg/ml injektioneste/infuusioneste, emulsio
NL/H/2283/002 31500 SANDOZ A/S FI
Propofol Sandoz 20 mg/ml injektionsvätska/infusionsvätska, emulsion
NL/H/2283/002 49324 SANDOZ A/S SE
Propofol Sandoz 20 mg/ml, emulsie voor injectie of infusie
NL/H/2283/002 RVG 109292 SANDOZ B.V. NL
List of nationally authorised medicinal products EMA/475638/2018 Page 37/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol Sandoz 20 mg/ml, émulsion injectable ou pour perfusion
NL/H/2283/002 2014120426 SANDOZ N.V. LU
Propofol Sandoz, 10 mg/ml, emulsja do wstrzykiwan/do infuzji
NL/H/2283/001 22039 SANDOZ GMBH PL
PROPOFOL® MCT/LCT/FRESENIUS, γαλάκτωμα για έγχυση ή ένεση 1%
DE/H/0490/001 020063 FRESENIUS KABI HELLAS A.E.
CY
PROPOFOL® MCT/LCT/FRESENIUS, γαλάκτωμα για έγχυση ή ένεση 1%
DE/H/0490/001 81062/18-11-2011 FRESENIUS KABI HELLAS A.E.
GR
Propofol-®Lipuro 20 mg/ml injektio-/infuusioneste, emulsio
DE/H/0185/002 16780 B.BRAUN MELSUNGEN AG FI
Propofol-®Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion
DE/H/0185/003 1-27991 B.BRAUN MELSUNGEN AG AT
Propofol-Lipuro 0,5 % (5 mg/ml), injekční/infuzní emulze
DE/H/0185/003 05/419/08-C B.BRAUN MELSUNGEN AG CZ
Propofol-Lipuro 0,5% (5 mg/ml) emulsão injetável ou para perfusão
DE/H/0185/003 5121777 B.BRAUN MELSUNGEN AG PT
Propofol-Lipuro 0,5% (5mg/ml) injekčná alebo infúzna emulzia
DE/H/0185/003 05/0087/09-S B. BRAUN MELSUNGEN AG ART 57
SK
Propofol-Lipuro 0.5 % (5 mg/ml) emulsion for injection or infusion
DE/H/0185/003 PL 03551/0113 B.BRAUN MELSUNGEN AG UK
Propofol-Lipuro 0.5% (5 mg/ml) emulsion for injection or infusion
DE/H/0185/003 PA0736/018/004 B.BRAUN MELSUNGEN AG IE
List of nationally authorised medicinal products EMA/475638/2018 Page 38/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol-Lipuro 1 % (10 mg/ml) emulsion for injection or infusion
DE/H/0185/001 PA 736/18/01 B.BRAUN MELSUNGEN AG IE
Propofol-Lipuro 1 % (10 mg/ml) emulsion for injection or infusion
DE/H/0185/001 PA 736/18/02 B.BRAUN MELSUNGEN AG IE
Propofol-Lipuro 1 % (10 mg/ml) emulsion for injection or infusion
DE/H/0185/001 PA 736/18/02 B.BRAUN MELSUNGEN AG IE
Propofol-Lipuro 1 % (10 mg/ml) emulsion for injection or infusion
DE/H/0185/001 PA 736/18/02 B.BRAUN MELSUNGEN AG IE
Propofol-Lipuro 1 % (10 mg/ml) emulsion for injection or infusion
DE/H/0185/001 PA 736/18/02 B.BRAUN MELSUNGEN AG IE
Propofol-Lipuro 1 % (10 mg/ml) emulsion for injection or infusion
DE/H/0185/001 MA 223/00601 B.BRAUN MELSUNGEN AG MT
Propofol-Lipuro 1 % (10 mg/ml) emulsion for injection or infusion
DE/H/0185/001 PL 03551/0055 B.BRAUN MELSUNGEN AG UK
Propofol-Lipuro 1 % (10 mg/ml) injekčná alebo infúzna emulzia
DE/H/0185/001 05/0079/08-S B.BRAUN MELSUNGEN AG SK
Propofol-Lipuro 1 % (10 mg/ml), injekční/infuzní emulze
DE/H/0185/001 05/111/08-C B.BRAUN MELSUNGEN AG CZ
Propofol-Lipuro 1% (10 mg/ml) γαλάκτωμα για ένεση ή έγχυση
DE/H/0185/001 35680/00/4-5-2001 VIOSER S.A. GR
Propofol-Lipuro 1% (10 mg/ml) γαλάκτωμα για ένεση ή έγχυση
DE/H/0185/001 35680/00/4-5-2001 VIOSER S.A. GR
Propofol-Lipuro 1% (10 mg/ml), emulsão injectável ou para perfusão
DE/H/0185/001 3129988 B. BRAUN MEDICAL, LDA. PT
List of nationally authorised medicinal products EMA/475638/2018 Page 39/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol-Lipuro 1% (10 mg/ml), emulsão injectável ou para perfusão
DE/H/0185/001 4320982 B. BRAUN MEDICAL, LDA. PT
Propofol-Lipuro 1% (10 mg/ml), emulsão injectável ou para perfusão
DE/H/0185/001 3130085 B. BRAUN MEDICAL, LDA. PT
Propofol-Lipuro 1% (10 mg/ml), emulsão injectável ou para perfusão
DE/H/0185/001 4321089 B. BRAUN MEDICAL, LDA. PT
Propofol-Lipuro 1% (10 mg/ml), emulsão injectável ou para perfusão
DE/H/0185/001 5464045 B. BRAUN MEDICAL, LDA. PT
Propofol-Lipuro 1% (10 mg/ml), emulsão injectável ou para perfusão
DE/H/0185/001 3129889 B. BRAUN MEDICAL, LDA. PT
Propofol-Lipuro 10 mg/ml emulsija injekcijām vai infūzijām
DE/H/0185/001 08-0018 B.BRAUN MELSUNGEN AG LV
Propofol-Lipuro 10 mg/ml Emulsion zur Injektion oder Infusion
DE/H/0185/001 1-23864 B.BRAUN MELSUNGEN AG AT
Propofol-Lipuro 10 mg/ml Emulsion zur Injektion oder Infusion
DE/H/0185/001 41913.00.00 B.BRAUN MELSUNGEN AG DE
Propofol-Lipuro 10 mg/ml Emulsion zur Injektion oder Infusion
DE/H/0185/001 0667/10020715 B.BRAUN MELSUNGEN AG LU
Propofol-Lipuro 10 mg/ml emulzija za injekciju ili infuziju
not available UP/I-530-09/13-02/04 B.BRAUN ADRIA D.O.O. HR
Propofol-Lipuro 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0185/001 H/07/01297/001 B.BRAUN MELSUNGEN AG SI
Propofol-Lipuro 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0185/001 H/07/01297/002 B.BRAUN MELSUNGEN AG SI
List of nationally authorised medicinal products EMA/475638/2018 Page 40/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol-Lipuro 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0185/001 H/07/01297/004 B.BRAUN MELSUNGEN AG SI
Propofol-Lipuro 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0185/001 H/07/01297/005 B.BRAUN MELSUNGEN AG SI
Propofol-Lipuro 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0185/001 H/07/01297/006 B.BRAUN MELSUNGEN AG SI
Propofol-Lipuro 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0185/001 H/07/01297/009 B.BRAUN MELSUNGEN AG SI
Propofol-Lipuro 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0185/001 H/07/01297/003 B.BRAUN MELSUNGEN AG SI
Propofol-Lipuro 10 mg/ml emulziós injekció vagy infúzió
DE/H/0185/001 OGYI-T-20483/04 B.BRAUN MELSUNGEN AG HU
Propofol-Lipuro 10 mg/ml emulziós injekció vagy infúzió
DE/H/0185/001 OGYI-T-20483/05 B.BRAUN MELSUNGEN AG HU
Propofol-Lipuro 10 mg/ml emulziós injekció vagy infúzió
DE/H/0185/001 OGYI-T-20483/03 B.BRAUN MELSUNGEN AG HU
Propofol-Lipuro 10 mg/ml emulziós injekció vagy infúzió
DE/H/0185/001 OGYI-T-20483/06 B.BRAUN MELSUNGEN AG HU
Propofol-Lipuro 10 mg/ml injekcinė ar infuzinė emulsija
DE/H/0185/001 LT/1/08/1075/003 B.BRAUN MELSUNGEN AG LT
Propofol-Lipuro 10 mg/ml injekcinė ar infuzinė emulsija
DE/H/0185/001 LT/1/08/1075/004 B.BRAUN MELSUNGEN AG LT
Propofol-Lipuro 10 mg/ml injekcinė ar infuzinė emulsija
DE/H/0185/001 LT/1/08/1075/002 B.BRAUN MELSUNGEN AG LT
List of nationally authorised medicinal products EMA/475638/2018 Page 41/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol-Lipuro 10 mg/ml injekcinė ar infuzinė emulsija
DE/H/0185/001 LT/1/08/1075/008 B.BRAUN MELSUNGEN AG LT
Propofol-Lipuro 10 mg/ml injekcinė ar infuzinė emulsija
DE/H/0185/001 LT/1/08/1075/001 B.BRAUN MELSUNGEN AG LT
Propofol-Lipuro 10 mg/ml injekcinė ar infuzinė emulsija
DE/H/0185/001 LT/1/08/1075/005 B.BRAUN MELSUNGEN AG LT
Propofol-Lipuro 10 mg/ml injeksjons-/infusjonsvæske, emulsjon
DE/H/0185/001 01-8317 B.BRAUN MELSUNGEN AG NO
Propofol-Lipuro 10 mg/ml injektio-/infuusioneste, emulsio
DE/H/0185/001 14787 B.BRAUN MELSUNGEN AG FI
Propofol-Lipuro 10 mg/ml injektionsvätska/infusionsvätska, emulsion
DE/H/0185/001 15779 B.BRAUN MELSUNGEN AG SE
Propofol-Lipuro 10 mg/ml, 10 mg/ml, emulsie injectabilă/ perfuzabilă
not available 4067/2003/02 B.BRAUN MELSUNGEN AG RO
Propofol-Lipuro 10 mg/ml, 10 mg/ml, emulsie injectabilă/ perfuzabilă
not available 4067/2003/03 B.BRAUN MELSUNGEN AG RO
Propofol-Lipuro 10 mg/ml, 10 mg/ml, emulsie injectabilă/ perfuzabilă
not available 4067/2003/01 B.BRAUN MELSUNGEN AG RO
Propofol-Lipuro 10 mg/ml, emulsie voor injectie of infusie
DE/H/0185/001 RVG 24720 B.BRAUN MELSUNGEN AG NL
Propofol-Lipuro 10 mg/ml, süste- või infusiooniemulsioon
DE/H/0185/001 574808 B.BRAUN MELSUNGEN AG EE
Propofol-Lipuro 2 % (20 mg/ml) emulsija injekcijām vai infūzijām
DE/H/0185/002 07-0006 B. BRAUN MELSUNGEN AG ART 57
LV
List of nationally authorised medicinal products EMA/475638/2018 Page 42/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol-Lipuro 2 % (20 mg/ml) emulsion for injection or infusion
DE/H/0185/002 PA 0736/018/003 B.BRAUN MELSUNGEN AG IE
Propofol-Lipuro 2 % (20 mg/ml) emulsion for injection or infusion
DE/H/0185/002 PL 03551/0066 B.BRAUN MELSUNGEN AG UK
Propofol-Lipuro 2 % (20 mg/ml) injekčná alebo infúzna emulzia
DE/H/0185/002 05/0031/07-S B.BRAUN MELSUNGEN AG SK
Propofol-Lipuro 2 % (20 mg/ml), injekční/infuzní emulze
DE/H/0185/002 05/131/07-C B.BRAUN MELSUNGEN AG CZ
Propofol-Lipuro 2% (20 mg/ml) emulsão injetável ou para perfusão
DE/H/0185/002 3892288 B.BRAUN MELSUNGEN AG PT
Propofol-Lipuro 2% (20 mg/ml) emulsão injetável ou para perfusão
DE/H/0185/002 4990487 B.BRAUN MELSUNGEN AG PT
Propofol-Lipuro 2% (20 mg/ml) emulsja do wstrzykiwań lub infuzji
DE/H/0185/002 12962 B.BRAUN MELSUNGEN AG PL
Propofol-Lipuro 20 mg/ml Emulsion zur Injektion oder Infusion
DE/H/0185/002 1-24488 B.BRAUN MELSUNGEN AG AT
Propofol-Lipuro 20 mg/ml Emulsion zur Injektion oder Infusion
DE/H/0185/002 41913.01.00 B.BRAUN MELSUNGEN AG DE
Propofol-Lipuro 20 mg/ml Emulsion zur Injektion oder Infusion
DE/H/0185/002 0667/02040022 B.BRAUN MELSUNGEN AG LU
Propofol-Lipuro 20 mg/ml emulzija za injekciju ili infuziju
not available UP/I-530-09/13-02/05 B.BRAUN ADRIA D.O.O. HR
Propofol-Lipuro 20 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0185/002 H/07/01297/008 B.BRAUN MELSUNGEN AG SI
List of nationally authorised medicinal products EMA/475638/2018 Page 43/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol-Lipuro 20 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0185/002 H/07/01297/007 B.BRAUN MELSUNGEN AG SI
Propofol-Lipuro 20 mg/ml emulziós injekció vagy infúzió
DE/H/0185/002 OGYI-T-20483/01 B.BRAUN MELSUNGEN AG HU
Propofol-Lipuro 20 mg/ml injekcinė ar infuzinė emulsija
DE/H/0185/002 LT/1/08/1075/007 B.BRAUN MELSUNGEN AG LT
Propofol-Lipuro 20 mg/ml injekcinė ar infuzinė emulsija
DE/H/0185/002 LT/1/08/1075/006 B.BRAUN MELSUNGEN AG LT
Propofol-Lipuro 20 mg/ml injeksjons-/infusjonsvæske, emulsjon
DE/H/0185/002 06-4346 B.BRAUN MELSUNGEN AG NO
Propofol-Lipuro 20 mg/ml injektionsvätska/infusionsvätska, emulsion
DE/H/0185/002 17646 B.BRAUN MELSUNGEN AG SE
Propofol-Lipuro 20 mg/ml, emulsie voor injectie of infusie
DE/H/0185/002 RVG 27043 B.BRAUN MELSUNGEN AG NL
Propofol-Lipuro 20 mg/ml, süste- või infusiooniemulsioon
DE/H/0185/002 533507 B.BRAUN MELSUNGEN AG EE
Propofol-Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion
DE/H/0185/003 69927.00.00 B.BRAUN MELSUNGEN AG DE
Propofol-Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion
DE/H/0185/003 0667/09060038 B. BRAUN MELSUNGEN AG ART 57
LU
Propofol-Lipuro 5 mg/ml emulziós injekció vagy infúzió
DE/H/0185/003 OGYI-T-20483/02 B.BRAUN MELSUNGEN AG HU
Propofol-Lipuro 5 mg/ml injeksjons-/infusjonsvæske, emulsjon
DE/H/0185/003 07-5055 B.BRAUN MELSUNGEN AG NO
List of nationally authorised medicinal products EMA/475638/2018 Page 44/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propofol-Lipuro 5 mg/ml injektio-/infuusioneste, emulsio
DE/H/0185/003 23783 B. BRAUN MELSUNGEN AG ART 57
FI
Propofol-Lipuro 5 mg/ml injektionsvätska/infusionsvätska, emulsion
DE/H/0185/003 25669 B.BRAUN MELSUNGEN AG SE
Propofol-Lipuro, 10 mg/ml, emulsja do wstrzykiwań lub infuzji
DE/H/0185/001 15085 B.BRAUN MELSUNGEN AG PL
Propofol-Lipuro, 5 mg/ml, emulsja do wstrzykiwań lub infuzji
DE/H/0185/003 16149 B.BRAUN MELSUNGEN AG PL
Propofol-ratiopharm® MCT 10 mg/ml Emulsion zur Injektion und Infusion
DE/H/2517/001 78430.00.00 RATIOPHARM GMBH DE
Propofol-ratiopharm® MCT 10 mg/ml Emulsion zur Injektion und Infusion
DE/H/2517/001 78430.00.00 RATIOPHARM GMBH DE
Propofol-ratiopharm® MCT 20 mg/ml Emulsion zur Injektion und Infusion
DE/H/2517/002 78431.00.00 RATIOPHARM GMBH DE
Propofol-ratiopharm® MCT 20 mg/ml Emulsion zur Injektion und Infusion
DE/H/2517/002 78431.00.00 RATIOPHARM GMBH DE
Propolipid 1% emulsie voor injectie of infusie
DE/H/0490/001 BE279824 FRESENIUS KABI NV/SA BE
Propolipid 1% emulsie voor injectie of infusie
DE/H/0490/001 BE279833 FRESENIUS KABI NV/SA BE
Propolipid 1% emulsie voor injectie of infusie
DE/H/0490/001 BE279842 FRESENIUS KABI NV/SA BE
Propolipid 1% emulsie voor injectie of infusie
DE/H/0490/001 BE279815 FRESENIUS KABI NV/SA BE
Propolipid 1% emulsie voor injectie/infusie in een voorgevulde spuit
DE/H/0490/003 BE439415 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/475638/2018 Page 45/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propolipid 1% emulsie voor injectie/infusie in een voorgevulde spuit
DE/H/0490/003 BE444132 FRESENIUS KABI NV/SA BE
Propolipid 1% emulsie voor injectie/infusie in een voorgevulde spuit
DE/H/0490/003 BE444141 FRESENIUS KABI NV/SA BE
Propolipid 1% emulsie voor injectie/infusie in een voorgevulde spuit
DE/H/0490/003 BE471244 FRESENIUS KABI NV/SA BE
Propolipid 1% émulsion injectable ou pour perfusion
DE/H/0490/001 BE279824 FRESENIUS KABI NV/SA BE
Propolipid 1% émulsion injectable ou pour perfusion
DE/H/0490/001 BE279833 FRESENIUS KABI NV/SA BE
Propolipid 1% émulsion injectable ou pour perfusion
DE/H/0490/001 BE279842 FRESENIUS KABI NV/SA BE
Propolipid 1% émulsion injectable ou pour perfusion
DE/H/0490/001 BE279815 FRESENIUS KABI NV/SA BE
Propolipid 1% émulsion injectable/pour perfusion en seringue pré-remplie
DE/H/0490/003 BE439415 FRESENIUS KABI NV/SA BE
Propolipid 1% émulsion injectable/pour perfusion en seringue pré-remplie
DE/H/0490/003 BE444132 FRESENIUS KABI NV/SA BE
Propolipid 1% émulsion injectable/pour perfusion en seringue pré-remplie
DE/H/0490/003 BE444141 FRESENIUS KABI NV/SA BE
Propolipid 1% émulsion injectable/pour perfusion en seringue pré-remplie
DE/H/0490/003 BE471244 FRESENIUS KABI NV/SA BE
Propolipid 1% Emulsion zur Injektion oder Infusion
DE/H/0490/001 BE279824 FRESENIUS KABI NV/SA BE
Propolipid 1% Emulsion zur Injektion oder Infusion
DE/H/0490/001 BE279833 FRESENIUS KABI NV/SA BE
Propolipid 1% Emulsion zur Injektion oder Infusion
DE/H/0490/001 BE279842 FRESENIUS KABI NV/SA BE
Propolipid 1% Emulsion zur Injektion oder Infusion
DE/H/0490/001 BE279815 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/475638/2018 Page 46/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propolipid 1%, Emulsion zur Injektion/Infusion in einer Fertigspritze
DE/H/0490/003 BE439415 FRESENIUS KABI NV/SA BE
Propolipid 1%, Emulsion zur Injektion/Infusion in einer Fertigspritze
DE/H/0490/003 BE444132 FRESENIUS KABI NV/SA BE
Propolipid 1%, Emulsion zur Injektion/Infusion in einer Fertigspritze
DE/H/0490/003 BE444141 FRESENIUS KABI NV/SA BE
Propolipid 1%, Emulsion zur Injektion/Infusion in einer Fertigspritze
DE/H/0490/003 BE471244 FRESENIUS KABI NV/SA BE
Propolipid 10 mg/ml injeksjons-/infusjonsvæske, emulsjon
DE/H/0490/001 04-2932 FRESENIUS KABI NORGE AS NO
Propolipid 10 mg/ml injeksjons-/infusjonsvæske, emulsjon i ferdigfylt sprøyte
DE/H/0490/003 11-8634 FRESENIUS KABI NORGE AS NO
Propolipid 10 mg/ml injektio/infuusioneste, emulsio
DE/H/0490/001 20006 FRESENIUS KABI AB FI
Propolipid 10 mg/ml injektio-/infuusioneste, emulsio, esitäytetty ruisku
DE/H/0490/003 30192 FRESENIUS KABI AB FI
Propolipid 10 mg/ml, injektions/infusionsvätska, emulsion
DE/H/0490/001 21533 FRESENIUS KABI AB SE
Propolipid 10 mg/ml, stungulyf/ innrennslislyf, fleyti, í áfylltri sprautu
DE/H/0490/003 IS/1/13/036/01 FRESENIUS KABI AB IS
Propolipid 10 mg/ml, stungulyf/innrennslislyf, fleyti
DE/H/0490/001 IS/1/04/058/01 FRESENIUS KABI AB IS
Propolipid 2% - emulsie voor injectie of infusie in een voorgevulde spuit
DE/H/0490/004 BE439424 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/475638/2018 Page 47/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propolipid 2% emulsie voor injectie of infusie
DE/H/0490/002 BE 279851 FRESENIUS KABI NV/SA BE
Propolipid 2% émulsion injectable ou pour perfusion
DE/H/0490/002 BE 279851 FRESENIUS KABI NV/SA BE
Propolipid 2% émulsion injectable/pour perfusion en seringue pré-remplie
DE/H/0490/004 BE439424 FRESENIUS KABI NV/SA BE
Propolipid 2% Emulsion zur Injektion oder Infusion
DE/H/0490/002 BE 279851 FRESENIUS KABI NV/SA BE
Propolipid 2%, Emulsion zur Injektion/Infusion in einer Fertigspritze
DE/H/0490/004 BE439424 FRESENIUS KABI NV/SA BE
Propolipid 20 mg/ ml injektions-/infusionsvätska, emulsion i förfylld spruta
DE/H/0490/004 46860 FRESENIUS KABI AB SE
Propolipid 20 mg/ml injeksjons-/infusjonsvæske emulsjon
DE/H/0490/002 04-2933 FRESENIUS KABI NORGE AS NO
Propolipid 20 mg/ml injeksjons-/infusjonsvæske, emulsjon i ferdigfylt sprøyte
DE/H/0490/004 11-8635 FRESENIUS KABI NORGE AS NO
Propolipid 20 mg/ml injektio/infuusioneste, emulsio
DE/H/0490/002 20007 FRESENIUS KABI AB FI
Propolipid 20 mg/ml injektio-/infuusioneste, emulsio, esitäytetty ruisku
DE/H/0490/004 30193 FRESENIUS KABI AB FI
Propolipid 20 mg/ml, injektions/infusionsvätska, emulsion
DE/H/0490/002 21534 FRESENIUS KABI AB SE
Propolipid 20 mg/ml, stungu- eða innrennslislyf, fleyti
DE/H/0490/002 IS/1/04/058/02 FRESENIUS KABI AB IS
Propolipid 20 mg/ml, stungulyf/innrennslislyf, fleyti, í áfylltri sprautu
DE/H/0490/004 IS/1/13/036/02 FRESENIUS KABI AB IS
List of nationally authorised medicinal products EMA/475638/2018 Page 48/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propolipid, injektions- og infusionsvæske, emulsion 10 mg/ml
DE/H/0490/001 37162 FRESENIUS KABI AB DK
Propolipid, injektions- og infusionsvæske, emulsion 20 mg/ml
DE/H/0490/002 37163 FRESENIUS KABI AB DK
Propolipid, injektions- og infusionsvæske, emulsion, fyldt injektionssprøjte 20 mg/ml
DE/H/0490/004 49590 FRESENIUS KABI AB DK
Propolipid, injektions- og infusionsvæske, emulsion, fyldt injektionssprøjte 10 mg/ml
DE/H/0490/003 49586 FRESENIUS KABI AB DK
Propolipid10 mg/ ml injektions/infusionsvätska, emulsion i förfylld spruta
DE/H/0490/003 46859 FRESENIUS KABI AB SE
Propoven 1 % injekcinė ar infuzinė emulsija
DE/H/0490/001 LT/1/05/0195/020 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1 % injekcinė ar infuzinė emulsija
DE/H/0490/001 LT/1/05/0195/020 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% emulsija injekcijām vai infūzijām
DE/H/0490/001 05-0045 FRESENIUS KABI DEUTSCHLAND GMBH
LV
Propoven 1% emulsija injekcijām/infūzijām pilnšļircē
DE/H/0490/003 13-0187 FRESENIUS KABI DEUTSCHLAND GMBH
LV
Propoven 1% emulsion for injection/infusion in pre-filled syringe
DE/H/0490/003 PA 566/036/004 FRESENIUS KABI LIMITED IE
Propoven 1% emulsion for injection/infusion in pre-filled syringe
DE/H/0490/003 PA 566/036/006 FRESENIUS KABI LIMITED IE
Propoven 1% emulsion for injection/infusion in pre-filled syringe
DE/H/0490/003 PL 08828/0239 FRESENIUS KABI LIMITED UK
List of nationally authorised medicinal products EMA/475638/2018 Page 49/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propoven 1% injekcinė ar infuzinė emulsija užpildytame švirkšte
DE/H/0490/003 LT/1/05/0195/014 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė ar infuzinė emulsija užpildytame švirkšte
DE/H/0490/003 LT/1/05/0195/016 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė ar infuzinė emulsija užpildytame švirkšte
DE/H/0490/003 LT/1/05/0195/017 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė ar infuzinė emulsija užpildytame švirkšte
DE/H/0490/003 LT/1/05/0195/018 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė/infuzinė emulsija
DE/H/0490/001 LT/1/05/0195/001 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė/infuzinė emulsija
DE/H/0490/001 LT/1/05/0195/002 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė/infuzinė emulsija
DE/H/0490/001 LT/1/05/0195/003 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė/infuzinė emulsija
DE/H/0490/001 LT/1/05/0195/004 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė/infuzinė emulsija
DE/H/0490/001 LT/1/05/0195/006 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė/infuzinė emulsija
DE/H/0490/001 LT/1/05/0195/007 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė/infuzinė emulsija
DE/H/0490/001 LT/1/05/0195/008 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė/infuzinė emulsija
DE/H/0490/001 LT/1/05/0195/009 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė/infuzinė emulsija
DE/H/0490/001 LT/1/05/0195/010 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1% injekcinė/infuzinė emulsija
DE/H/0490/001 LT/1/05/0195/005 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 1%, süste- või infusiooniemulsioon
DE/H/0490/001 460705 FRESENIUS KABI DEUTSCHLAND GMBH
EE
Propoven 1%, süste- või infusiooniemulsioon süstlis
DE/H/0490/003 815113 FRESENIUS KABI DEUTSCHLAND GMBH
EE
List of nationally authorised medicinal products EMA/475638/2018 Page 50/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propoven 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/001 H/05/01298/006 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/001 H/05/01298/007 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/001 H/05/01298/008 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/001 H/05/01298/009 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/001 H/05/01298/010 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/001 H/05/01298/011 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/001 H/05/01298/012 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/001 H/05/01298/015 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/001 H/05/01298/013 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/001 H/05/01298/014 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje/infundiranje v napolnjeni injekcijski brizgi
DE/H/0490/003 H/05/01298/001 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje/infundiranje v napolnjeni injekcijski brizgi
DE/H/0490/003 H/05/01298/002 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje/infundiranje v napolnjeni injekcijski brizgi
DE/H/0490/003 H/05/01298/003 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje/infundiranje v napolnjeni injekcijski brizgi
DE/H/0490/003 H/05/01298/004 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 10 mg/ml emulzija za injiciranje/infundiranje v napolnjeni injekcijski brizgi
DE/H/0490/003 H/05/01298/019 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 2 % emulsija injekcijām vai infūzijām
DE/H/0490/002 05-0046 FRESENIUS KABI DEUTSCHLAND GMBH
LV
List of nationally authorised medicinal products EMA/475638/2018 Page 51/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Propoven 2% injekcinė/infuzinė emulsija
DE/H/0490/002 LT/1/05/0195/012 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 2% injekcinė/infuzinė emulsija
DE/H/0490/002 LT/1/05/0195/013 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 2% injekcinė/infuzinė emulsija
DE/H/0490/002 LT/1/05/0195/011 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 2% emulsija injekcijām/ infūzijām pilnšļircē
DE/H/0490/004 13-0188 FRESENIUS KABI DEUTSCHLAND GMBH
LV
Propoven 2% emulsion for injection/infusion in pre-filled syringe
DE/H/0490/004 PA 566/036/005 FRESENIUS KABI LIMITED IE
Propoven 2% emulsion for injection/infusion in pre-filled syringe
DE/H/0490/004 PL 08828/0240 FRESENIUS KABI LIMITED UK
Propoven 2% injekcinė ar infuzinė emulsija užpildytame švirkšte
DE/H/0490/004 LT/1/05/0195/015 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Propoven 2%, süste- või infusiooniemulsioon
DE/H/0490/002 460805 FRESENIUS KABI DEUTSCHLAND GMBH
EE
Propoven 2%, süste- või infusiooniemulsioon süstlis
DE/H/0490/004 815213 FRESENIUS KABI DEUTSCHLAND GMBH
EE
Propoven 20 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/002 H/05/01298/016 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 20 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/002 H/05/01298/017 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 20 mg/ml emulzija za injiciranje ali infundiranje
DE/H/0490/002 H/05/01298/018 MEDIAS INTERNATIONAL D.O.O.
SI
Propoven 20 mg/ml emulzija za injiciranje/infundiranje v napolnjeni injekcijski brizgi
DE/H/0490/004 H/05/01298/005 MEDIAS INTERNATIONAL D.O.O.
SI
Provive 10mg/ml emulsja do wstrzykiwañ lub infuzji
NL/H/1268/01/MR 15862 CLARIS LIFESCIENCES (UK) LIMITED
PL
Provive 20mg/ml emulsja do wstrzykiwañ lub infuzji
NL/H/1268/02/MR 15863 CLARIS LIFESCIENCES (UK) LIMITED
PL
Rapiva 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/2426/001 5363-I-1617/11 NORAMEDA UAB SI
List of nationally authorised medicinal products EMA/475638/2018 Page 52/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Rapiva 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/2426/001 5363-I-1618/11 NORAMEDA UAB SI
Rapiva 10 mg/ml emulzija za injiciranje ali infundiranje
DE/H/2426/001 5363-I-1619/11 NORAMEDA UAB SI
Rapiva 20 mg/ml emulzija za injiciranje ali infundiranje
DE/H/2426/002 5363-I-1620/11 NORAMEDA UAB SI
Recofol 10 mg/ml injeksjonsvæske/infusjonsvæske, emulsjon
FI/H/0787/001 08-6300 PRIMEX PHARMACEUTICALS OY
NO
Recofol 10 mg/ml injektionsvätska/infusionsvätska, emulsion
FI/H/0787/001 41558 PRIMEX PHARMACEUTICALS OY
SE
Recofol 20 mg/ml injeksjonsvæske/infusjonsvæske, emulsjon
FI/H/0787/002 08-6301 PRIMEX PHARMACEUTICALS OY
NO
Recofol 20 mg/ml injektionsvätska/infusionsvätska, emulsion
FI/H/0787/002 41559 PRIMEX PHARMACEUTICALS OY
SE
Recofol N 10 mg/ml emulsion for injection or infusion
FI/H/0787/001 MA249/00101 PRIMEX PHARMACEUTICALS OY
MT
Recofol N 10 mg/ml emulsión inyectable o para perfusión
FI/H/0787/001 72928 PRIMEX PHARMACEUTICALS OY
ES
Recofol N 10 mg/ml ενέσιμο γαλάκτωμα ή γαλάκτωμα για έγχυση
FI/H/0787/001 20674 PRIMEX PHARMACEUTICALS OY
CY
Recofol N 20 mg/ml emulsion for injection or infusion
FI/H/0787/002 MA249/00102 PRIMEX PHARMACEUTICALS OY
MT
Recofol N 20 mg/ml emulsión inyectable o para perfusión
FI/H/0787/002 72929 PRIMEX PHARMACEUTICALS OY
ES
Recofol N 20 mg/ml ενέσιμο γαλάκτωμα ή γαλάκτωμα για έγχυση
FI/H/0787/002 20675 PRIMEX PHARMACEUTICALS OY
CY
List of nationally authorised medicinal products EMA/475638/2018 Page 53/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Ripol 10 mg/ml emulsione per iniezione/infusione
IT/H/0476/001 041732013 CORDEN PHARMA S.P.A. IT
Ripol 10 mg/ml emulsione per iniezione/infusione
IT/H/0476/001 041732025 CORDEN PHARMA S.P.A. IT
Ripol 10 mg/ml emulsione per iniezione/infusione
IT/H/0476/001 041732037 CORDEN PHARMA S.P.A. IT
Ripol 10 mg/ml emulsione per iniezione/infusione
IT/H/0476/001 041732049 CORDEN PHARMA S.P.A. IT
Ripol 20 mg/ml emulsione per iniezione/infusione
IT/H/0476/002 041732052 CORDEN PHARMA S.P.A. IT
Spifol 10 mg/ml injeksjons-/infusjonsvæske, emulsjon
DE/H/2426/01/DC 09-7020 CLARIS LIFESCIENCES (UK) LIMITED
NO
Spifol 20 mg/ml injeksjons-/infusjonsvæske, emulsjon
DE/H/2426/02/DC 09-7021 CLARIS LIFESCIENCES (UK) LIMITED
NO
Spiva 10 mg/ml Γαλάκτωμα για ένεση/έγχυση
DE/H/2426/001 77684/8-11-2012 NORAMEDA UAB GR
Spiva 10 mg/ml Γαλάκτωμα για ένεση/έγχυση
DE/H/2426/001 14304/26-05-2015 ALVION PHARMACEUTICALS P.C.
GR
UNIFOL 10 mg/ml, emulsione per iniezione o infusione
NL/H/1268/01/MR 039184041 CLARIS LIFESCIENCES (UK) LIMITED
IT
UNIFOL 10 mg/ml, emulsione per iniezione o infusione
NL/H/1268/01/MR 039184039 CLARIS LIFESCIENCES (UK) LIMITED
IT
UNIFOL 10 mg/ml, emulsione per iniezione o infusione
NL/H/1268/01/MR 039184027 CLARIS LIFESCIENCES (UK) LIMITED
IT
UNIFOL 10 mg/ml, emulsione per iniezione o infusione
NL/H/1268/01/MR 039184015 CLARIS LIFESCIENCES (UK) LIMITED
IT
UNIFOL 10 mg/ml, emulsione per iniezione o infusione
NL/H/1268/01/MR 039184078 CLARIS LIFESCIENCES (UK) LIMITED
IT
UNIFOL 10 mg/ml, emulsione per iniezione o infusione
NL/H/1268/01/MR 039184066 CLARIS LIFESCIENCES (UK) LIMITED
IT
List of nationally authorised medicinal products EMA/475638/2018 Page 54/54
Product full name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UNIFOL 20 mg/ml, emulsione per iniezione o infusione
NL/H/1268/02/MR 039184054 CLARIS LIFESCIENCES (UK) LIMITED
IT
Диприван 10 mg/ml инжекционна/инфузионна емулсия
not available 20020223 ASTRAZENECA UK LIMITED BG
ПЛОФЕД 10 mg/ml инжекционна/инфузионна емулсия
not available 20060744 WARSZAWSKIE ZAKLADY FARMACEUTYCZNE POLFA S.A.
BG
ПРОПОФОЛ САНДОЗ 10 MG/ML ИНЖЕКЦИОННА/ИНФУЗИОННА ЕМУЛСИЯ
NL/H/2283/001 20140297 SANDOZ PHARMACEUTICALS D.D.
BG
ПРОПОФОЛ САНДОЗ 20 MG/ML ИНЖЕКЦИОННА/ИНФУЗИОННА ЕМУЛСИЯ
NL/H/2283/002 20140298 SANDOZ PHARMACEUTICALS D.D.
BG
Пропофол Фрезениус 1% инжекционна/инфузионна емулсия
not available 20011101 FRESENIUS KABI DEUTSCHLAND GMBH
BG
Пропофол Фрезениус 2% инжекционна/инфузионна емулсия пропофол
not available 20040068 FRESENIUS KABI DEUTSCHLAND GMBH
BG
Пропофол-Липуро 10 mg/ml инжекционна/инфузионна емулсия
not available 20010466 B.BRAUN MELSUNGEN AG BG