lidocaine: list of nationally authorised medicinal
TRANSCRIPT
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© European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged.
10 June 2021 EMA/333431/2021 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: lidocaine
Procedure no.: PSUSA/00001861/202009
List of nationally authorised medicinal products EMA/333431/2021 Page 2/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Xylocaine 10 mg/razpršek pršilo,
raztopina
not available H/94/01682/001 ASPEN PHARMA TRADING LIMITED
SI
Actilogic 700 mg apósito adhesivo medicamentoso
DE/H/5699/001 83398 GRÜNENTHAL PHARMA S.A. ES
Actilogic 700 mg wirkstoffhaltiges Pflaster
DE/H/5699/001 98976.00.00 GRÜNENTHAL GMBH DE
Asensil 40mg/g Crema IE/H/0727/001 043742016 LOGOFARMA S.R.L. IT
Asensil 40mg/g Crema IE/H/0727/001 043742028 LOGOFARMA S.R.L. IT
Asensil 40mg/g Crema IE/H/0727/001 043742030 LOGOFARMA S.R.L. IT
Asensil 40mg/g Crema IE/H/0727/001 043742042 LOGOFARMA S.R.L. IT
Asensil 40mg/g Crema IE/H/0727/001 043742055 LOGOFARMA S.R.L. IT
Calmotop® 700 mg wirkstoffhaltiges Pflaster
DE/H/5703/001 97540.00.00 GRÜNENTHAL GMBH DE
Dolocopin 40mg/g Cream IE/H/0727/001 PA22869/001/001 FERNDALE LABORATORIES LIMITED
IE
Dynexan 2 %, crème buccale
not available 3400935279897 CHEMISCHE FABRIK KREUSSLER & CO. GMBH
FR
Dynexangival 1 %, crème buccale
not available 34009 498 755 2 8 CHEMISCHE FABRIK KREUSSLER & CO. GMBH
FR
Endor 700 mg
wirkstoffhaltiges Pflaster
DE/H/5695/001 98972.00.00 GRÜNENTHAL GMBH DE
Esliva 700 mg
lääkelaastari
DE/H/5696/001 34621 GRÜNENTHAL GMBH FI
Esliva 700 mg
wirkstoffhaltiges Pflaster
DE/H/5696/001 98973.00.00 GRÜNENTHAL GMBH DE
Instillagel 20,9 mg gel not available 10132 FARCO-PHARMA GMBH SE
Intermed XYLOJELL®
Γέλη 2% w/w
not available 10876/15/12.10.2018 IOULIA AND IRENE TSETI
PHARMACEUTICAL LABORATORIES S.A.
GR
Intermed XYLOJELL® Εκνέφωμα 10% w/v
not available 28568/15/12.10.2018 IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.
GR
LAMBDALINA 40 mg/g SE/H/0699/001 69.789 ISDIN, S.A. ES
List of nationally authorised medicinal products EMA/333431/2021 Page 3/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
crema
LAMBDALINA 40 mg/g crema
SE/H/0699/001 69.789 ISDIN, S.A. ES
LAMBDALINA 40 mg/g creme
SE/H/0699/001 5095369 ISDIN LDA PT
LAMBDALINA 40 mg/g creme
SE/H/0699/001 5095377 ISDIN LDA PT
LAMBDALINA 40 mg/g
creme
SE/H/0699/001 5095369 ISDIN LDA PT
LAMBDALINA 40 mg/g
creme
SE/H/0699/001 5095377 ISDIN LDA PT
Licain PUREN 10 mg/ml
Injektionslösung
PT/H/1585/001 96439.00.00 PUREN PHARMA GMBH &
CO. KG
DE
Lidbree NL/H/4625/001 61872 GEDEON RICHTER PLC. DK
LIDBREE 42 mg/ml gel
cu cedare intrauterină
NL/H/4625/001 13518/2020/01 GEDEON RICHTER ROMÂNIA
S.A.
RO
Lidbree 42 mg/ml gel
intra-utérin
NL/H/4625/001 BE567146 GEDEON RICHTER PLC. BE
Lidbree 42 mg/ml gel intra-utérin
NL/H/4625/001 2020080203 GEDEON RICHTER PLC. LU
Lidbree 42 mg/ml gel
intrauterino
NL/H/4625/001 85483 GEDEON RICHTER PLC. ES
Lidbree 42 mg/mL gel intrauterino
NL/H/4625/001 047309012 GEDEON RICHTER ROMÂNIA S.A.
IT
Lidbree 42 mg/ml gel voor intra-uterien gebruik
NL/H/4625/001 BE567146 GEDEON RICHTER PLC. BE
Lidbree 42 mg/ml gel
voor intra-uterien gebruik
NL/H/4625/001 RVG 124015 GEDEON RICHTER PLC. NL
Lidbree 42 mg/ml Gel zur intrauterinen Anwendung
NL/H/4625/001 BE567146 GEDEON RICHTER PLC. BE
Lidbree 42 mg/ml Gel NL/H/4625/001 2203302.00.00 GEDEON RICHTER PLC. DE
List of nationally authorised medicinal products EMA/333431/2021 Page 4/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
zur intrauterinen Anwendung
Lidbree 42 mg/ml
gimdos ertmės gelis
NL/H/4625/001 LT/1/20/4598/001 GEDEON RICHTER PLC. LT
Lidbree 42 mg/ml
intrauteriingeel
NL/H/4625/001 1009320 GEDEON RICHTER PLC. EE
Lidbree 42 mg/ml
intrauterin gel
NL/H/4625/001 58469 GEDEON RICHTER PLC. SE
Lidbree 42 mg/ml intrauterin gél
NL/H/4625/001 OGYI-T-23713/01 GEDEON RICHTER PLC. HU
Lidbree 42 mg/ml intrauterīnais gels
NL/H/4625/001 20-0089 GEDEON RICHTER PLC. LV
Lidbree 42 mg/mL intrauterine gel
NL/H/4625/001 PL 04854/0166 GEDEON RICHTER PLC. UK
Lidbree 42 mg/mL intrauterine gel
NL/H/4625/001 PA1330/025/001 GEDEON RICHTER PLC. IE
Lidbree 42 mg/mL intrauterine gel
NL/H/4625/001 MA1031/00601 GEDEON RICHTER PLC. MT
Lidbree 42 mg/ml intrauterini gel
NL/H/4625/001 H/20/02742/001 GEDEON RICHTER PLC. SI
Lidbree 42 mg/ml
intrauterini gel
NL/H/4625/001 HR-H-772844274 GEDEON RICHTER PLC. HR
Lidbree 42 mg/ml
intrauterinní gel
NL/H/4625/001 01/467/18-C GEDEON RICHTER PLC. CZ
Lidbree 42 mg/ml
intrauterinný gél
NL/H/4625/001 01/0163/20-S GEDEON RICHTER PLC. SK
Lidbree 42 mg/ml
leghlaup
NL/H/4625/001 IS/1/20/079/01 GEDEON RICHTER PLC. IS
LIDBREE 42 mg/mL, gel intra-utérin
NL/H/4625/001 34009 302 121 2 7 GEDEON RICHTER PLC. FR
Lidbree® 42 mg/ml Gel zur intrauterinen Anwendung
NL/H/4625/001 140367 GEDEON RICHTER PLC. AT
LIDIAQ 40 mg/g cremă PL/H/0643/001 8940/2016/01 FERNDALE LABORATORIES RO
List of nationally authorised medicinal products EMA/333431/2021 Page 5/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
LIMITED
LIDIAQ 40 mg/g dermálny krém
PL/H/0643/001 01/0463/15-S FERNDALE LABORATORIES LIMITED
SK
LIDIQ 40mg/g krema PL/H/0643/001 H/16/02099/001 FERNDALE LABORATORIES LIMITED
SI
Lidocain Grünenthal 700 mg wirkstoffhaltiges
Pflaster
DE/H/5734/001 96944.00.00 GRÜNENTHAL GMBH DE
Lidocain Walter Ritter 100 mg/ml Spray zur Anwendung auf der Haut, Lösung
AT/H/0689/001/DC 137843 WALTER RITTER GMBH + CO. KG
AT
Lidocain Walter Ritter
100 mg/ml Spray zur Anwendung auf der Haut, Lösung
AT/H/0689/001/DC 137843 WALTER RITTER GMBH +
CO. KG
LI
Lidocaína 1% Braun 10 mg/ml solução injetável
not available 5184171 B. BRAUN MEDICAL LDA. PT
Lidocaína 1% Braun 10 mg/ml solução injetável
not available 3699188 B. BRAUN MEDICAL LDA. PT
Lidocaína Ferndale
Pharmaceuticals 40 mg/g
crema
IE/H/0727/001/DC 82.257 ISDIN, S.A. ES
Lidocaína Ferndale Pharmaceuticals 40 mg/g crema
IE/H/0727/001/DC 82.257 ISDIN, S.A. ES
Lidocaína Ferndale Pharmaceuticals 40 mg/g
creme
IE/H/0727/001 5717632 ISDIN LDA PT
Lidocaína Ferndale
Pharmaceuticals 40 mg/g creme
IE/H/0727/001 5715511 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g
IE/H/0727/001 5715545 ISDIN LDA PT
List of nationally authorised medicinal products EMA/333431/2021 Page 6/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
creme
Lidocaína Ferndale Pharmaceuticals 40 mg/g
creme
IE/H/0727/001 5715602 ISDIN LDA PT
Lidocaína Ferndale
Pharmaceuticals 40 mg/g creme
IE/H/0727/001 5715537 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g creme
IE/H/0727/001 5715560 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g
creme
IE/H/0727/001 5715503 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g creme
IE/H/0727/001 5715479 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g
creme
IE/H/0727/001 5715529 ISDIN LDA PT
Lidocaína Ferndale
Pharmaceuticals 40 mg/g
creme
IE/H/0727/001 5715552 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g creme
IE/H/0727/001 5717632 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g
creme
IE/H/0727/001 5715511 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g creme
IE/H/0727/001 5715545 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g
creme
IE/H/0727/001 5715602 ISDIN LDA PT
List of nationally authorised medicinal products EMA/333431/2021 Page 7/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Lidocaína Ferndale Pharmaceuticals 40 mg/g
creme
IE/H/0727/001 5715537 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g creme
IE/H/0727/001 5715560 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g
creme
IE/H/0727/001 5715503 ISDIN LDA PT
Lidocaína Ferndale
Pharmaceuticals 40 mg/g creme
IE/H/0727/001 5715479 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g creme
IE/H/0727/001 5715529 ISDIN LDA PT
Lidocaína Ferndale Pharmaceuticals 40 mg/g
creme
IE/H/0727/001 5715552 ISDIN LDA PT
Lidocaine 5% m/m Ointment
not available PL 00289/0761 TEVA UK LIMITED XI
LIDOCAINE
CHLORHYDRATE RENAUDIN 20 mg/mL,
solution pour injection/perfusion
NL/H/4574/001 34009 302 082 5 0 LABORATOIRE RENAUDIN FR
LIDOCAINE CHLORHYDRATE RENAUDIN 20 mg/mL,
solution pour injection/perfusion
NL/H/4574/001 34009 302 082 6 7 LABORATOIRE RENAUDIN FR
LIDOCAINE CHLORHYDRATE RENAUDIN 20 mg/mL,
solution pour
NL/H/4574/001 34009 302 082 7 4 LABORATOIRE RENAUDIN FR
List of nationally authorised medicinal products EMA/333431/2021 Page 8/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
injection/perfusion
Lidocaine Grünenthal 700 mg lääkelaastari
DE/H/5734/001 33896 GRÜNENTHAL GMBH FI
Lidocaine Hydrochloride Injection BP Minijet 1%
w/v
not available PL 03265/0005R INTERNATIONAL MEDICATION SYSTEMS (UK)
LIMITED
XI
Lidocaine Hydrochloride
Injection BP Minijet 1% w/v
not available PL 03265/0005R INTERNATIONAL
MEDICATION SYSTEMS (UK) LIMITED
XI
Lidocaine Hydrochloride Injection BP Minijet 1% w/v
not available PL 03265/0005R INTERNATIONAL MEDICATION SYSTEMS (UK) LIMITED
XI
Lidocaine Hydrochloride
Injection BP Minijet 1% w/v
not available PL 03265/0005R INTERNATIONAL
MEDICATION SYSTEMS (UK) LIMITED
XI
Lidocaine Hydrochloride Injection BP Minijet 1% w/v
not available PL 03265/0005R INTERNATIONAL MEDICATION SYSTEMS (UK) LIMITED
XI
Lidocaine Hydrochloride Injection BP Minijet 1%
w/v solution for
injection.
not available PA22684/008/001 DLRC PHARMA SERVICES LIMITED
IE
Lidocaine Hydrochloride Injection BP Minijet 1% w/v solution for
injection.
not available PA22684/008/001 DLRC PHARMA SERVICES LIMITED
IE
Lidocaine Hydrochloride
Injection BP Minijet 1% w/v solution for injection.
not available PA22684/008/001 DLRC PHARMA SERVICES
LIMITED
IE
Lidocaine Hydrochloride Injection BP Minijet 1%
w/v solution for injection.
not available PA22684/008/001 DLRC PHARMA SERVICES LIMITED
IE
List of nationally authorised medicinal products EMA/333431/2021 Page 9/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Lidocaine Hydrochloride Injection BP Minijet 2%
w/v Solution for Injection
not available PA22684/008/002 DLRC PHARMA SERVICES LIMITED
IE
Lidocaine Hydrochloride Injection BP Minijet 2% w/v Solution for Injection
not available PA22684/008/002 DLRC PHARMA SERVICES LIMITED
IE
Lidocaine Hydrochloride Injection BP Minijet 2%
w/v Solution for Injection
not available PA22684/008/002 DLRC PHARMA SERVICES LIMITED
IE
Lidocaine Hydrochloride
Injection BP Minijet 2% w/v Solution for Injection
not available PA22684/008/002 DLRC PHARMA SERVICES
LIMITED
IE
Lidocaïne Hydrochloride Renaudin 20 mg/ml, oplossing voor
injectie/infusie
NL/H/4574/001 RVG 123705 LABORATOIRE RENAUDIN NL
Lidocaine Injection BP
Minijet 2% w/v
not available PL 03265/0006R INTERNATIONAL
MEDICATION SYSTEMS (UK) LIMITED
XI
Lidocaine Injection BP Minijet 2% w/v
not available PL 03265/0006R INTERNATIONAL MEDICATION SYSTEMS (UK)
LIMITED
XI
Lidocaine Injection BP
Minijet 2% w/v
not available PL 03265/0006R INTERNATIONAL
MEDICATION SYSTEMS (UK) LIMITED
XI
Lidocaine Injection BP Minijet 2% w/v
not available PL 03265/0006R INTERNATIONAL MEDICATION SYSTEMS (UK) LIMITED
XI
Lidocaine Injection BP Minijet 2% w/v
not available PL 03265/0006R INTERNATIONAL MEDICATION SYSTEMS (UK)
LIMITED
XI
LIDOFAST 10 mg/g gel not available 034478014 AZIENDE CHIMICHE
RIUNITE ANGELINI FRANCESCO - A.C.R.A.F.
IT
List of nationally authorised medicinal products EMA/333431/2021 Page 10/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
S.P.A.
LIDOFAST 10 mg/g gel not available 034478014 AZIENDE CHIMICHE RIUNITE ANGELINI
FRANCESCO - A.C.R.A.F. S.P.A.
IT
LIDOFAST 25 mg/g gel uretrale
not available 034478026 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F.
S.P.A.
IT
LIDOFAST 25 mg/g gel
uretrale
not available 034478026 AZIENDE CHIMICHE
RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
LidoGalen 40 mg/g Creme
not available 91519.00.00 GALENPHARMA GMBH DE
Lidokain Isdin 40 mg/g kräm
SE/H/699/001 21239 ISDIN, S.A. SE
Lidokain Isdin 40 mg/g
kräm
SE/H/699/001 21239 ISDIN, S.A. SE
Lidoposterin 50 mg/g
tepalas
not available LT/1/02/2982/001 DR. KADE
PHARMAZEUTISCHE FABRIK
GMBH
LT
LIDOPOSTERIN 50 mg/g, maść
not available 11628 DR. KADE PHARMAZEUTISCHE FABRIK GMBH
PL
Lidotec® 700 mg wirkstoffhaltiges Pflaster
DE/H/5701/001 96984.00.00 GRÜNENTHAL GMBH DE
Linisol 1 %,
Injektionslösung
not available BE166695 B.BRAUN MELSUNGEN AG BE
Linisol 1 %, oplossing
voor injectie
not available BE166695 B.BRAUN MELSUNGEN AG BE
Linisol 1 %, solution
injectable
not available BE166695 B.BRAUN MELSUNGEN AG BE
Linisol 2 % oplossing not available BE166704 B.BRAUN MELSUNGEN AG BE
List of nationally authorised medicinal products EMA/333431/2021 Page 11/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
voor injectie
Linisol 2 %, Injektionslösung
not available BE166704 B.BRAUN MELSUNGEN AG BE
Linisol 2 %, solution injectable
not available BE166704 B.BRAUN MELSUNGEN AG BE
Lonioban 700 mg medicated plaster
DE/H/5702/001 PL 21727/0073 GRÜNENTHAL LTD. XI
Lonioban 700 mg
medicinskt plåster
DE/H/5702/001 54619 GRÜNENTHAL GMBH SE
Lonioban 700 mg
medisinert plaster
DE/H/5702/001 16-11135 GRÜNENTHAL GMBH NO
Lonioban, medicinsk
plaster
DE/H/5702/001 57581 GRÜNENTHAL GMBH DK
Lonioban® 700 mg wirkstoffhaltiges Pflaster
DE/H/5702/001 97539.00.00 GRÜNENTHAL GMBH DE
Luan 1% gel not available 005638022 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
IT
Luan 2,5% gel not available 005638 010 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI
ESERCIZIO S.P.A.
IT
Maxilene 40 mg/g kräm IE/H/0727/001 50469 FERNDALE LABORATORIES
LIMITED
SE
MESOCAINE 25 mg/5ml solution injectable
not available 34009 331 077 0 3 LABORATOIRES PHARMY II FR
MESOCAINE 25 mg/5ml solution injectable
not available 34009 331 077 0 3 LABORATOIRES PHARMY II FR
MESOCAINE 50 mg/5ml solution injectable
not available 34009 331 080 1 4 LABORATOIRES PHARMY II FR
MESOCAINE 50 mg/5ml solution injectable
not available 34009 331 080 1 4 LABORATOIRES PHARMY II FR
Nanolipo, 40 mg/g, krem UK/H/5616/001 23052 ADAMED PHARMA S.A. PL
Nydriar 700 mg cerotto medicato
DE/H/5697/001 045702014 GRÜNENTHAL ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/333431/2021 Page 12/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Nydriar 700 mg cerotto medicato
DE/H/5697/001 045702026 GRÜNENTHAL ITALIA S.R.L. IT
Nydriar 700 mg cerotto
medicato
DE/H/5697/001 045702038 GRÜNENTHAL ITALIA S.R.L. IT
Nydriar 700 mg cerotto
medicato
DE/H/5697/001 045702040 GRÜNENTHAL ITALIA S.R.L. IT
Nydriar 700 mg cerotto
medicato
DE/H/5697/001 045702053 GRÜNENTHAL ITALIA S.R.L. IT
ORTODERMINA crema al 5%
not available 005556028 SOFAR S.P.A. IT
ORTODERMINA crema al 5%
not available 005556016 SOFAR S.P.A. IT
ORTODERMINA crema al 5%
not available 005556030 SOFAR S.P.A. IT
ORTODERMINA crema al 5%
not available 005556042 SOFAR S.P.A. IT
Posterisan® akut 50 mg/g Rektalsalbe
not available 6077267.00.00 DR. KADE PHARMAZEUTISCHE FABRIK
GMBH
DE
Posterisan® akut 50
mg/g Rektalsalbe mit
Analdehner
not available 6077267.00.00 DR. KADE
PHARMAZEUTISCHE FABRIK
GMBH
DE
Premjact Desensitizing Spray for Men
MT/H/510/001 PL 02294/5000R POUND INTERNATIONAL LTD UK
Premjact Desensitizing Spray for Men, 9.6% w/w, cutaneous spray
MT/H/510/001 PL 02294/5000R POUND INTERNATIONAL LTD UK
Ralvo 700 mg medicated
plaster
UK/H/6362/001 PL 21727/0075 GRÜNENTHAL LTD. XI
Severtos 700 mg
emplâtre médicamenteux
DE/H/5702/001 BE505786 SA GRÜNENTHAL N.V. BE
Severtos 700 mg
emplâtre médicamenteux
DE/H/5702/001 2017070246 SA GRÜNENTHAL N.V. LU
Severtos 700 mg pleister DE/H/5702/001 BE505786 SA GRÜNENTHAL N.V. BE
List of nationally authorised medicinal products EMA/333431/2021 Page 13/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Severtos 700 mg wirkstoffhaltiges Pflaster
DE/H/5698/001 98975.00.00 GRÜNENTHAL GMBH DE
STUD 100 Desensitizing
Spray for Men
MT/H/510/001 MA526/00201 POUND INTERNATIONAL LTD MT
STUD 100 Desensitizing
Spray for Men
MT/H/510/001 PL 02294/5000R POUND INTERNATIONAL LTD UK
Truvinut 700 mg cerotto
medicato
DE/H/5696/001 045701012 GRÜNENTHAL ITALIA S.R.L. IT
Truvinut 700 mg cerotto medicato
DE/H/5696/001 045701024 GRÜNENTHAL ITALIA S.R.L. IT
Truvinut 700 mg cerotto medicato
DE/H/5696/001 045701036 GRÜNENTHAL ITALIA S.R.L. IT
Truvinut 700 mg cerotto medicato
DE/H/5696/001 045701048 GRÜNENTHAL ITALIA S.R.L. IT
Truvinut 700 mg cerotto medicato
DE/H/5696/001 045701051 GRÜNENTHAL ITALIA S.R.L. IT
Verira 700 mg apósito adhesivo medicamentoso
DE/H/5698/001 83397 GRÜNENTHAL PHARMA S.A. ES
Versatis 5 % liečivá náplasť
DE/H/5733/001 01/0054/10-S GRÜNENTHAL GMBH SK
Versatis 5% medicinski
flaster
not available UP/I-530-09/13-02/166 GRÜNENTHAL GMBH HR
Versatis 700 mg apósito
adhesivo medicamentoso
DE/H/5733/001 71848 GRÜNENTHAL PHARMA S.A. ES
Versatis 700 mg
ārstnieciskais plāksteris
DE/H/5733/001 10-0176 GRÜNENTHAL GMBH LV
Versatis 700 mg cerotto
medicato
DE/H/5733/001 040335010 GRÜNENTHAL ITALIA S.R.L. IT
Versatis 700 mg cerotto medicato
DE/H/5733/001 040335046 GRÜNENTHAL ITALIA S.R.L. IT
Versatis 700 mg cerotto medicato
DE/H/5733/001 040335022 GRÜNENTHAL ITALIA S.R.L. IT
Versatis 700 mg cerotto medicato
DE/H/5733/001 040335034 GRÜNENTHAL ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/333431/2021 Page 14/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Versatis 700 mg cerotto medicato
DE/H/5733/001 040335059 GRÜNENTHAL ITALIA S.R.L. IT
Versatis 700 mg
emplastru medicamentos
DE/H/5733/001 11189/2018/02 GRÜNENTHAL GMBH RO
Versatis 700 mg
emplastru medicamentos
DE/H/5733/001 11189/2018/03 GRÜNENTHAL GMBH RO
Versatis 700 mg
emplastru medicamentos
DE/H/5733/001 11189/2018/04 GRÜNENTHAL GMBH RO
Versatis 700 mg emplastru medicamentos
DE/H/5733/001 11189/2018/05 GRÜNENTHAL GMBH RO
Versatis 700 mg emplastru medicamentos
DE/H/5733/001 11189/2018/01 GRÜNENTHAL GMBH RO
Versatis 700 mg emplâtre médicamenteux
DE/H/5733/001 BE312462 SA GRÜNENTHAL N.V. BE
Versatis 700 mg emplâtre médicamenteux
DE/H/5733/001 2008040037 SA GRÜNENTHAL N.V. LU
Versatis 700 mg gyógyszeres tapasz
DE/H/5733/001 OGYI-T-21784/02 GRÜNENTHAL GMBH HU
Versatis 700 mg gyógyszeres tapasz
DE/H/5733/001 OGYI-T-21784/05 GRÜNENTHAL GMBH HU
Versatis 700 mg
gyógyszeres tapasz
DE/H/5733/001 OGYI-T-21784/03 GRÜNENTHAL GMBH HU
Versatis 700 mg
gyógyszeres tapasz
DE/H/5733/001 OGYI-T-21784/01 GRÜNENTHAL GMBH HU
Versatis 700 mg
gyógyszeres tapasz
DE/H/5733/001 OGYI-T-21784/04 GRÜNENTHAL GMBH HU
VERSATIS 700 mg léčivá
náplast
DE/H/5733/001 01/284/10-C GRÜNENTHAL GMBH CZ
Versatis 700 mg lyfjaplástur
DE/H/5733/001 IS/1/10/033/01 GRÜNENTHAL GMBH IS
Versatis 700 mg medicated plaster
DE/H/5733/001 PA 2242/7/1 GRÜNENTHAL PHARMA LTD. IE
Versatis 700 mg medicated plaster
DE/H/5733/001 MA840/00201 GRÜNENTHAL GMBH MT
List of nationally authorised medicinal products EMA/333431/2021 Page 15/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Versatis 700 mg medicated plaster
DE/H/5733/001 PL 21727/0016 GRÜNENTHAL LTD. XI
Versatis 700 mg
medicinskt plåster
DE/H/5733/001 25314 GRÜNENTHAL GMBH SE
Versatis 700 mg
medisinert plaster
DE/H/5733/001 10-7564 GRÜNENTHAL GMBH NO
Versatis 700 mg pleister DE/H/5733/001 BE312462 SA GRÜNENTHAL N.V. BE
Versatis 700 mg pleister DE/H/5733/001 RVG 113654 GRÜNENTHAL B.V. NL
Versatis 700 mg vaistinis pleistras
DE/H/5733/001 LT/1/10/2279/001 GRÜNENTHAL GMBH LT
Versatis 700 mg vaistinis pleistras
DE/H/5733/001 LT/1/10/2279/003 GRÜNENTHAL GMBH LT
Versatis 700 mg vaistinis
pleistras
DE/H/5733/001 LT/1/10/2279/002 GRÜNENTHAL GMBH LT
Versatis 700 mg vaistinis
pleistras
DE/H/5733/001 LT/1/10/2279/005 GRÜNENTHAL GMBH LT
Versatis 700 mg vaistinis
pleistras
DE/H/5733/001 LT/1/10/2279/004 GRÜNENTHAL GMBH LT
Versatis 700 mg wirkstoffhaltiges Pflaster
DE/H/5733/001 1-29025 GRÜNENTHAL GES. M.B.H. AT
Versatis 700 mg
wirkstoffhaltiges Pflaster
DE/H/5733/001 69088.00.00 GRÜNENTHAL GMBH DE
Versatis 700 mg zdravilni obliž
DE/H/5733/001 H/07/01632/002 GRÜNENTHAL GMBH SI
Versatis 700 mg zdravilni obliž
DE/H/5733/001 H/07/01632/003 GRÜNENTHAL GMBH SI
Versatis 700 mg zdravilni obliž
DE/H/5733/001 H/07/01632/004 GRÜNENTHAL GMBH SI
Versatis 700 mg zdravilni obliž
DE/H/5733/001 H/07/01632/005 GRÜNENTHAL GMBH SI
Versatis 700 mg zdravilni obliž
DE/H/5733/001 H/07/01632/001 GRÜNENTHAL GMBH SI
Versatis 700 mg
έμπλαστρο φαρμακούχο
DE/H/5733/001 22834 GRÜNENTHAL GMBH CY
List of nationally authorised medicinal products EMA/333431/2021 Page 16/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Versatis 700 mg έμπλαστρο φαρμακούχο
DE/H/5733/001 79655/24-09-2019 GRÜNENTHAL GMBH GR
VERSATIS 700 mg,
emplâtre médicamenteux
DE/H/5733/001 34009 382 853 8 3 LABORATOIRES
GRÜNENTHAL S.A.S.
FR
VERSATIS 700 mg,
emplâtre médicamenteux
DE/H/5733/001 34009 382 855 0 5 LABORATOIRES
GRÜNENTHAL S.A.S.
FR
VERSATIS 700 mg,
emplâtre médicamenteux
DE/H/5733/001 34009 382 854 4 4 LABORATOIRES
GRÜNENTHAL S.A.S.
FR
VERSATIS 700 mg, emplâtre médicamenteux
DE/H/5733/001 34009 382 852 1 5 LABORATOIRES GRÜNENTHAL S.A.S.
FR
VERSATIS 700 mg, emplâtre médicamenteux
DE/H/5733/001 34009 382 856 7 3 LABORATOIRES GRÜNENTHAL S.A.S.
FR
Versatis, 700 mg ravimplaaster
DE/H/5733/001 675610 GRÜNENTHAL GMBH EE
Versatis, 700 mg, plaster leczniczy
DE/H/5733/001 17841 GRÜNENTHAL GMBH PL
Versatis, medicinsk plaster
DE/H/5733/001 46834 GRÜNENTHAL GMBH DK
Vessatis 700 mg emplastro
medicamentoso
DE/H/5733/001 5669478 GRÜNENTHAL S.A. PT
Vessatis 700 mg
emplastro medicamentoso
DE/H/5733/001 5281472 GRÜNENTHAL S.A. PT
Vessatis 700 mg emplastro medicamentoso
DE/H/5733/001 5281514 GRÜNENTHAL S.A. PT
Vessatis 700 mg
emplastro medicamentoso
DE/H/5733/001 5281506 GRÜNENTHAL S.A. PT
Vobolon 700 mg apósito adhesivo medicamentoso
DE/H/5697/001 83399 GRÜNENTHAL PHARMA S.A. ES
Vobolon 700 mg medicated plaster
DE/H/5697/001 PA 2242/001/001 GRÜNENTHAL PHARMA LTD. IE
List of nationally authorised medicinal products EMA/333431/2021 Page 17/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Vobolon 700 mg wirkstoffhaltiges Pflaster
DE/H/5697/001 98974.00.00 GRÜNENTHAL GMBH DE
Xylocain - viscös oral 2
%
not available 8.840 ASPEN PHARMA TRADING
LIMITED
AT
Xylocain 1% -
Durchstechflasche
not available 16.720 ASPEN PHARMA TRADING
LIMITED
AT
Xylocain 10 mg/ml
injektionsvätska, lösning
not available 3841 ASPEN PHARMA TRADING
LIMITED
SE
Xylocain 10 mg/ml stungulyf, lausn
not available IS/1/02/134/01 ASPEN PHARMA TRADING LIMITED
IS
Xylocain 10% - Pumpspray
not available 12.979 ASPEN PHARMA TRADING LIMITED
AT
Xylocain 100 mg/ml kutan spray, lösning
not available 11258 ASPEN PHARMA TRADING LIMITED
SE
Xylocain 100 mg/ml spray
not available 4112 ASPEN PHARMA TRADING LIMITED
NO
Xylocain 2 % - Gel not available 8.456 ASPEN PHARMA TRADING LIMITED
AT
Xylocain 2% - Ampullen not available 16.722 ASPEN PHARMA TRADING LIMITED
AT
Xylocain 2% -
Durchstechflasche
not available 16.721 ASPEN PHARMA TRADING
LIMITED
AT
Xylocain 2% gel med
konserveringsmedel
not available 4114 ASPEN PHARMA TRADING
LIMITED
SE
Xylocain 2% gel utan
konserveringsmedel
not available 10445 ASPEN PHARMA TRADING
LIMITED
SE
Xylocain 2% hlaup not available 843388 ASPEN PHARMA TRADING
LIMITED
IS
Xylocain 2% hlaup not available 640474 ASPEN PHARMA TRADING LIMITED
IS
Xylocain 20 mg/ml injektionsvätska, lösning
not available 3553 ASPEN PHARMA TRADING LIMITED
SE
Xylocain 20 mg/ml stungulyf, lausn
not available IS/1/02/134/02 ASPEN PHARMA TRADING LIMITED
IS
List of nationally authorised medicinal products EMA/333431/2021 Page 18/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Xylocain 5 mg/ml injektionsvätska, lösning
not available 3840 ASPEN PHARMA TRADING LIMITED
SE
Xylocain 5% Salbe not available 8.498 ASPEN PHARMA TRADING
LIMITED
AT
Xylocain 5% salva not available 3601 ASPEN PHARMA TRADING
LIMITED
SE
Xylocain 5% smyrsli not available IS/1/03/126/01 ASPEN PHARMA TRADING
LIMITED
IS
Xylocain injeksjonsvæske, oppløsning 10 mg/ml
not available 3605 ASPEN PHARMA TRADING LIMITED
NO
Xylocain injeksjonsvæske,
oppløsning 20 mg/ml
not available 2162 ASPEN PHARMA TRADING LIMITED
NO
Xylocain liniment 3 % not available 6271 ASPEN PHARMA TRADING
LIMITED
NO
Xylocain salve 5 % not available 03-1921 ASPEN PHARMA TRADING
LIMITED
NO
Xylocain utan konserveringsmedel 10 mg/ml injektionsvätska,
lösning
not available 10598 ASPEN PHARMA TRADING LIMITED
SE
Xylocain utan
konserveringsmedel 20 mg/ml injektionsvätska, lösning
not available 10705 ASPEN PHARMA TRADING
LIMITED
SE
Xylocain Viskös 20 mg/ml oral lösning
not available 4546 ASPEN PHARMA TRADING LIMITED
SE
Xylocain, 100 mg/ml, húðúði, lausn
not available 640471 ASPEN PHARMA TRADING LIMITED
IS
Xylocain, gel not available 9467 ASPEN PHARMA TRADING LIMITED
DK
Xylocain, gel not available 9467 ASPEN PHARMA TRADING
LIMITED
DK
List of nationally authorised medicinal products EMA/333431/2021 Page 19/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Xylocain, injektionsvæske,
opløsning
not available 01109 ASPEN PHARMA TRADING LIMITED
DK
Xylocain, injektionsvæske, opløsning
not available 01109 ASPEN PHARMA TRADING LIMITED
DK
Xylocain, injektionsvæske,
opløsning
not available 09469 ASPEN PHARMA TRADING LIMITED
DK
Xylocain,
injektionsvæske, opløsning
not available 09469 ASPEN PHARMA TRADING
LIMITED
DK
Xylocain, kutanopløsning not available 14449 ASPEN PHARMA TRADING LIMITED
DK
Xylocain, kutanspray, opløsning
not available 3352 ASPEN PHARMA TRADING LIMITED
DK
Xylocain, salve not available 9470 ASPEN PHARMA TRADING LIMITED
DK
Xylocain® 1 % Injektionslösung
not available 6077072.01.00 ASPEN PHARMA TRADING LIMITED
DE
Xylocain® 100 mg/ml
kutan spray, lösning
not available 10384 ASPEN PHARMA TRADING
LIMITED
FI
Xylocain® 100 mg/ml
sumute iholle, liuos
not available 10384 ASPEN PHARMA TRADING
LIMITED
FI
Xylocain® 2 % gel not available 9058 ASPEN PHARMA TRADING
LIMITED
FI
Xylocain® 2 % gel not available 2779 ASPEN PHARMA TRADING
LIMITED
NO
Xylocain® 2 % Injektionslösung
not available 6077072.02.00 ASPEN PHARMA TRADING LIMITED
DE
Xylocain® 2 % Injektionslösung
not available 6225422.00.00 ASPEN PHARMA TRADING LIMITED
DE
Xylocain® 2% geeli not available 9058 ASPEN PHARMA TRADING LIMITED
FI
List of nationally authorised medicinal products EMA/333431/2021 Page 20/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Xylocain® Gel 2 % not available 6077215.00.00 ASPEN PHARMA TRADING LIMITED
DE
Xylocain® Pumpspray 10
mg/Sprühstoß Spray zur Anwendung auf der Haut, Lösung
not available 6084764.00.00 ASPEN PHARMA TRADING
LIMITED
DE
Xylocain® Pumpspray dental 10 mg/Sprühstoß
Spray zur Anwendung in der Mundhöhle
not available 6077184.00.00 ASPEN PHARMA TRADING LIMITED
DE
Xylocain® Viscös 2 % Lösung zum Einnehmen
not available 6077149.00.00 ASPEN PHARMA TRADING LIMITED
DE
XYLOCAINA 20 mg/ml soluzione iniettabile
not available 004535213 ASPEN PHARMA TRADING LIMITED
IT
XYLOCAINA 20 mg/ml soluzione iniettabile
not available 004535011 ASPEN PHARMA TRADING LIMITED
IT
XYLOCAINE 2% GEL (en tube), gel urétral
not available 2006048534 ASPEN PHARMA TRADING LIMITED
LU
XYLOCAINE 5%, pommade
not available 2006048535 ASPEN PHARMA TRADING LIMITED
LU
XYLOCAINE 1 %,
solution injectable
not available BE052631 ASPEN PHARMA TRADING
LIMITED
BE
XYLOCAINE 1 %,
solution injectable
not available 1995123279 ASPEN PHARMA TRADING
LIMITED
LU
XYLOCAINE 1%,
Injektionslösung
not available BE052631 ASPEN PHARMA TRADING
LIMITED
BE
XYLOCAINE 1%,
Injektionslösung
not available 1995123279 ASPEN PHARMA TRADING
LIMITED
LU
XYLOCAINE 1%, oplossing voor injectie
not available BE052631 ASPEN PHARMA TRADING LIMITED
BE
Xylocaine 10 mg Spray not available PL 39699/0086 ASPEN PHARMA TRADING LIMITED
XI
Xylocaine 10 mg/delivered dose
not available 1691/028/001 ASPEN PHARMA TRADING LIMITED
IE
List of nationally authorised medicinal products EMA/333431/2021 Page 21/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
Mucosal Spray
Xylocaine 10 mg/delivered dose
Mucosal Spray
not available MA955/01201 ASPEN PHARMA TRADING LIMITED
MT
XYLOCAINE 10 mg/ml
SANS CONSERVATEUR, solution injectable
not available 34009 560 066 7 0 ASPEN PHARMA TRADING
LIMITED
FR
XYLOCAINE 10 mg/ml SANS CONSERVATEUR, solution injectable
not available 34009 342 239 7 6 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 10 mg/ml SANS CONSERVATEUR,
solution injectable
not available 34009 348 086 8 5 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 10 mg/ml SANS CONSERVATEUR, solution injectable
not available 34009 551 658 2 8 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 10 mg/ml SANS CONSERVATEUR,
solution injectable
not available 34009 561 455 7 7 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 10 mg/ml
SANS CONSERVATEUR,
solution injectable
not available 34009 348 087 4 6 ASPEN PHARMA TRADING
LIMITED
FR
XYLOCAINE 10 mg/ml SANS CONSERVATEUR, solution injectable
not available 34009 348 085 1 7 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 10 mg/ml SANS CONSERVATEUR,
solution injectable
not available 34009 311 531 8 4 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 10 mg/ml SANS CONSERVATEUR, solution injectable
not available 34009 347 920 4 5 ASPEN PHARMA TRADING LIMITED
FR
Xylocaine 10% (pump spray) 10 mg/dose
εκνέφωμα
not available 0057007 ASPEN PHARMA TRADING LIMITED
GR
List of nationally authorised medicinal products EMA/333431/2021 Page 22/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
XYLOCAINE 10% , Spray, Lösung
not available BE052796 ASPEN PHARMA TRADING LIMITED
BE
XYLOCAINE 10% ,
Spray, Lösung
not available 2006048536 ASPEN PHARMA TRADING
LIMITED
LU
XYLOCAINE 10%,
solution pour pulvérisation
not available BE 052796 ASPEN PHARMA TRADING
LIMITED
BE
XYLOCAINE 10%, solution pour pulvérisation
not available 2006048536 ASPEN PHARMA TRADING LIMITED
LU
XYLOCAINE 10%, spray oplossing
not available BE 052796 ASPEN PHARMA TRADING LIMITED
BE
Xylocaine 100 mg/ml
Spray, spray
not available RVG 07831 ASPEN PHARMA TRADING
LIMITED
NL
XYLOCAINE 2 %, gel
urétral en seringue préremplie
not available 34009 363 446 1 7 ASPEN PHARMA TRADING
LIMITED
FR
XYLOCAINE 2 %, gel urétral en seringue préremplie
not available 34009 565 324 4 5 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 2 %,
solution injectable
not available BE052735 ASPEN PHARMA TRADING
LIMITED
BE
XYLOCAINE 2 %,
solution injectable
not available 1995123281 ASPEN PHARMA TRADING
LIMITED
LU
XYLOCAINE 2% GEL (en
seringue), gel urétral
not available BE 149843 ASPEN PHARMA TRADING
LIMITED
BE
XYLOCAINE 2% GEL (en
seringue), gel urétral
not available 0173/06048534 ASPEN PHARMA TRADING
LIMITED
LU
XYLOCAINE 2% GEL (en tube), gel urétral
not available BE052595 ASPEN PHARMA TRADING LIMITED
BE
XYLOCAINE 2% GEL (in einer Spritze), Uretralgel
not available BE149843 ASPEN PHARMA TRADING LIMITED
BE
XYLOCAINE 2% GEL (in einer Spritze), Uretralgel
not available 2006048534 ASPEN PHARMA TRADING LIMITED
LU
List of nationally authorised medicinal products EMA/333431/2021 Page 23/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
XYLOCAINE 2% GEL (in einer Tube), Uretralgel
not available BE052595 ASPEN PHARMA TRADING LIMITED
BE
XYLOCAINE 2% GEL (in
einer Tube), Uretralgel
not available 0173/06048534 ASPEN PHARMA TRADING
LIMITED
LU
XYLOCAINE 2% GEL (in
spuit), gel voor urethraal gebruik
not available BE149843 ASPEN PHARMA TRADING
LIMITED
BE
XYLOCAINE 2% GEL (in tube), gel voor urethraal gebruik
not available BE052595 ASPEN PHARMA TRADING LIMITED
BE
Xylocaine 2% w/w γέλη not available 0057004 ASPEN PHARMA TRADING LIMITED
GR
Xylocaine 2%, 20 mg/ml,
roztwór do wstrzykiwań
not available R/1309 ASPEN PHARMA TRADING
LIMITED
PL
XYLOCAINE 2%,
Injektionslösung
not available BE052735 ASPEN PHARMA TRADING
LIMITED
BE
XYLOCAINE 2%,
Injektionslösung
not available 1995123281 ASPEN PHARMA TRADING
LIMITED
LU
XYLOCAINE 2%, oplossing voor injectie
not available BE052735 ASPEN PHARMA TRADING LIMITED
BE
Xylocaine 20 mg/g gel not available H/94/01682/002 ASPEN PHARMA TRADING
LIMITED
SI
Xylocaine 20 mg/g Gel, catheterslijm
not available RVG 07830 ASPEN PHARMA TRADING LIMITED
NL
Xylocaine 20 mg/ml raztopina za injiciranje
not available H/94/01682/003 ASPEN PHARMA TRADING LIMITED
SI
XYLOCAINE 20 mg/ml SANS CONSERVATEUR,
solution injectable
not available 34009 348 083 9 5 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 20 mg/ml
SANS CONSERVATEUR, solution injectable
not available 34009 348 082 2 7 ASPEN PHARMA TRADING
LIMITED
FR
XYLOCAINE 20 mg/ml SANS CONSERVATEUR,
not available 34009 347 919 6 3 ASPEN PHARMA TRADING LIMITED
FR
List of nationally authorised medicinal products EMA/333431/2021 Page 24/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
solution injectable
XYLOCAINE 20 mg/ml SANS CONSERVATEUR,
solution injectable
not available 34009 561 454 0 9 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 20 mg/ml
SANS CONSERVATEUR, solution injectable
not available 34009 342 240 5 8 ASPEN PHARMA TRADING
LIMITED
FR
XYLOCAINE 20 mg/ml SANS CONSERVATEUR, solution injectable
not available 34009 560 067 3 1 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 20 mg/ml SANS CONSERVATEUR,
solution injectable
not available 34009 348 084 5 6 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 5 mg/ml SANS CONSERVATEUR, solution injectable
not available 34009 560 065 0 2 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 5 mg/ml SANS CONSERVATEUR,
solution injectable
not available 34009 348 089 7 5 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 5 mg/ml
SANS CONSERVATEUR,
solution injectable
not available 34009 347 921 0 6 ASPEN PHARMA TRADING
LIMITED
FR
XYLOCAINE 5 mg/ml SANS CONSERVATEUR, solution injectable
not available 34009 342 150 6 3 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 5 mg/ml SANS CONSERVATEUR,
solution injectable
not available 34009 561 456 3 8 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 5 mg/ml SANS CONSERVATEUR, solution injectable
not available 34009 348 088 0 7 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE 5 mg/ml SANS CONSERVATEUR,
solution injectable.
not available 34009 348 090 5 7 ASPEN PHARMA TRADING LIMITED
FR
List of nationally authorised medicinal products EMA/333431/2021 Page 25/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
XYLOCAINE 5%, pommade
not available BE 052561 ASPEN PHARMA TRADING LIMITED
BE
XYLOCAINE 5%, Salbe not available BE052561 ASPEN PHARMA TRADING
LIMITED
BE
XYLOCAINE 5%, Salbe not available 2006048535 ASPEN PHARMA TRADING
LIMITED
LU
XYLOCAINE 5%, zalf not available BE052561 ASPEN PHARMA TRADING
LIMITED
BE
Xylocaine 50 mg/g Zalf, hydrofiele zalf
not available RVG 01553 ASPEN PHARMA TRADING LIMITED
NL
XYLOCAINE PUMP SPRAY 10%, 10 mg/annuses, nahasprei, lahus
not available 287099 ASPEN PHARMA TRADING LIMITED
EE
XYLOCAINE VISQUEUSE 2 %, gel oral
not available 34009 311 537 6 4 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE VISQUEUSE 2 %, gel oral
not available 34009 551 645 8 6 ASPEN PHARMA TRADING LIMITED
FR
Xylocaine® 10 mg/ml,
oplossing voor injectie
not available RVG 07828 ASPEN PHARMA TRADING
LIMITED
NL
Xylocaine® 20 mg/ml,
oplossing voor injectie
not available RVG 07829 ASPEN PHARMA TRADING
LIMITED
NL
XYLOCAINE® 5 POUR
CENT NEBULISEUR, solution pour pulvérisation buccale
not available 34009 322 993 8 6 ASPEN PHARMA TRADING
LIMITED
FR
XYLOCAINE® 5 POUR CENT NEBULISEUR,
solution pour pulvérisation buccale
not available 34009 555 788 8 8 ASPEN PHARMA TRADING LIMITED
FR
XYLOCAINE® 5 POUR CENT NEBULISEUR, solution pour
pulvérisation buccale
not available 34009 555 760 6 8 ASPEN PHARMA TRADING LIMITED
FR
XYLOCARD 100, 20 not available BE052832 ASPEN PHARMA TRADING BE
List of nationally authorised medicinal products EMA/333431/2021 Page 26/26
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number MAH of product in the
member state
Member State where
product is authorised
mg/ml, Injektionslösung LIMITED
XYLOCARD 100, 20 mg/ml, Injektionslösung
not available 2006028435 ASPEN PHARMA TRADING LIMITED
LU
XYLOCARD 100, 20 mg/ml, oplossing voor
injectie
not available BE052832 ASPEN PHARMA TRADING LIMITED
BE
XYLOCARD 100, 20
mg/ml, solution injectable
not available BE 052832 ASPEN PHARMA TRADING
LIMITED
BE
XYLOCARD 100, 20 mg/ml, solution injectable
not available 2006028435 ASPEN PHARMA TRADING LIMITED
LU
Xylocard 20 mg/ml
injektionsvätska, lösning, glasampull
not available 22566 ASPEN PHARMA TRADING
LIMITED
SE
Xylocard 20 mg/ml stungulyf, lausn, glerlykja
not available 711443 ASPEN PHARMA TRADING LIMITED
IS
XYLOCARD® 20 mg/ml INTRAVEINEUX, solution
injectable
not available 374 970-9 ASPEN PHARMA TRADING LIMITED
FR
XYLOCARD® 20 mg/ml
INTRAVEINEUX, solution injectable
not available 377 810-2 ASPEN PHARMA TRADING
LIMITED
FR
XYLOCARD® 50mg/ml, solution injectable pour perfusion
not available 34009 550 941 2 8 ASPEN PHARMA TRADING LIMITED
FR
Xylonor Spray N 15%,
Dentallösung
not available 53314.00.00 SEPTODONT GMBH DE
Версатис 5% лечебен
пластир
DE/H/5733/001 20100719 GRÜNENTHAL GMBH BG
ЛИДБРИ 42 mg/ml
вътрематочен гел
NL/H/4625/001 20200188 GEDEON RICHTER PLC. BG