list of nationally authorised medicinal products · dermatologie fr eryfluid 40 mg/ml soluţie...

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Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Classified as internal/staff & contractors by the European Medicines Agency 14 November 2019 EMA/270645/2015 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance: erythromycin Procedure no.: PSUSA/00001257/201903

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Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.

Classified as internal/staff & contractors by the European Medicines Agency

14 November 2019 EMA/270645/2015 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: erythromycin

Procedure no.: PSUSA/00001257/201903

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 2/21

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

Lauromicina “500 mg compresse” not available 019924012 NEW RESEARCH SRL IT

Erythromycin 250mg Gastro-resistant Tablets not available PL 44041/0015 NOUMED LIFE SCIENCES UK

CUSI ERYTHROMYCIN 0,5%, 5 mg/g, maść do oczu not available R/1880 NTC SRL PL

Pantomicina 500 mg, granulado para suspensión oral en sobres not available 57473 AMDIPHARM LIMITED ES

Pantomicina 1.000 mg, granulado para suspensión oral en sobres not available 58126 AMDIPHARM LIMITED ES

Erythroforte 500 - comprimés not available 1739/96083771 AMDIPHARM LIMITED LU

Erythroforte 500 - granulé not available 1739/96083772 AMDIPHARM LIMITED LU

Erythroforte 1000 - granulé not available 1739/96083773 AMDIPHARM LIMITED LU

Erythrocine 250 mg/5 ml, granulaat voor orale suspensie not available 1739/96083769 AMDIPHARM LIMITED LU

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 3/21

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

Erythroforte 500, Granulat not available 1739/96083772 AMDIPHARM LIMITED LU

Erythroforte 1000, Granulat not available 1739/96083773 AMDIPHARM LIMITED LU

Erythrocine 250 mg/5 ml, granulés pour suspension buvable not available 1739/96083769 AMDIPHARM LIMITED LU

Erythroforte 500, Tabletten not available 1739/96083771 AMDIPHARM LIMITED LU

Eritrocina 600 mg compresse rivestite con film not available 007893199 AMDIPHARM LIMITED IT

E.S.E. 500, 500 mg, Comprimidos revestidos not available 5546585 AMDIPHARM LIMITED PT

E.S.E. 1000 Sachets, 1000 mg, Granulado para suspensão oral not available 8467321 AMDIPHARM LIMITED PT

ERYTHROCINE 0,5 g, lyophilisat pour usage parentéral (IV) not available 557 518-8 AMDIPHARM LIMITED FR

Erythrocine I.V. 1 g, poeder voor oplossing voor infusie. not available BE 065414 AMDIPHARM LIMITED BE

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 4/21

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

Erythrocine I.V. 1 g, poudre pour solution pour perfusion not available BE 065414 AMDIPHARM LIMITED BE

ERYTHROCINE 500 mg, granulés pour solution buvable en sachet-dose not available 34009 324 962 2 8 AMDIPHARM LIMITED FR

ERYTHROCINE 500 mg, granulés pour solution buvable en sachet-dose not available 34009 324 963 9 6 AMDIPHARM LIMITED FR

ERYTHROCINE 500 mg, granulés pour solution buvable en sachet-dose not available 34009 333 933 1 1 AMDIPHARM LIMITED FR

ERYTHROCINE 500 mg, granulés pour solution buvable en sachet-dose not available 34009 333 934 8 9 AMDIPHARM LIMITED FR

ERYTHROCINE 500 mg, granulés pour solution buvable en sachet-dose not available 34009 333 935 4 0 AMDIPHARM LIMITED FR

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 5/21

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

ERYTHROCINE 500 mg, granulés pour solution buvable en sachet-dose not available 34009 320 215 8 1 AMDIPHARM LIMITED FR

ERYTHROCINE 1000 mg, granulés pour solution buvable en sachet-dose not available 34009 324 958 5 6 AMDIPHARM LIMITED FR

ERYTHROCINE 1000 mg, granulés pour solution buvable en sachet-dose not available 34009 324 959 1 7 AMDIPHARM LIMITED FR

ERYTHROCINE 1000 mg, granulés pour solution buvable en sachet-dose not available 34009 324 961 6 7 AMDIPHARM LIMITED FR

ERYTHROCINE 1000 mg, granulés pour solution buvable en sachet-dose not available 34009 333 936 0 1 AMDIPHARM LIMITED FR

ERYTHROCINE 1000 mg, granulés pour solution buvable en sachet-dose not available 34009 333 937 7 9 AMDIPHARM LIMITED FR

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 6/21

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

ERYTHROCINE 1000 mg, granulés pour solution buvable en sachet-dose not available 34009 333 938 3 0 AMDIPHARM LIMITED FR

ERYTHROCINE 1000 mg, granulés pour solution buvable en sachet-dose not available 34009 333 940 8 0 AMDIPHARM LIMITED FR

ERYTHROCINE 1000 mg, granulés pour solution buvable en sachet-dose not available 34009 320 216 4 2 AMDIPHARM LIMITED FR

ERITROCINA, 250 mg/5 ml, Granulado para suspensão oral not available 8362780 AMDIPHARM LIMITED PT

Erythrocine-ES 500 mg tabletten not available RVG 09314 AMDIPHARM LIMITED NL

Erythrocine I.V. 1 g, 1 g, Pulver zur Herstellung einer Infusionslösung not available BE 065414 AMDIPHARM LIMITED BE

Erythrocine ES 125 mg/5 ml, granulaat voor orale suspensie not available RVG 10248 AMDIPHARM LIMITED NL

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 7/21

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

EGERY, microgranules gastro-résistants en gélule not available 34009 335 781 4 5 LABORATOIRES BAILLEUL SA FR

EGERY, microgranules gastro-résistants en gélule not available 34009 335 782 0 6 LABORATOIRES BAILLEUL SA FR

ERYTHROGEL 4 % gel pour application cutanée not available 34009 326 709 2 5 LABORATOIRES BAILLEUL SA FR

ERYTHROGEL 4 %, gel pour application cutanée not available 34009 334 837 6 0 LABORATOIRES BAILLEUL SA FR

ERYTHROMYCINE BAILLEUL 4%, solution pour application cutanée not available 34009 331 141 0 7 LABORATOIRES BAILLEUL SA FR

ERYTHROMYCINE BAILLEUL 4%, solution pour application cutanée not available 34009 331 803 3 1 LABORATOIRES BAILLEUL SA FR

ERYTHROMYCINE BAILLEUL 4%, solution pour application cutanée not available 34009 331 802 7 0 LABORATOIRES BAILLEUL SA FR

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 8/21

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

ERYTHROMYCINE BAILLEUL 4%, solution pour application cutanée not available 1999010015 LABORATOIRES BAILLEUL SA LU

AKNEMYCIN 2000 Mast not available 46/244/93-C ALMIRALL HERMAL GMBH CZ

Ery-Max not available 11292 MEDA AB SE

Aknemycin 20 mg/g, maść not available R/2120 ALMIRALL HERMAL GMBH PL

Inderm, applicatievloeistof 1% not available RVG 14095 CENTRAFARM B.V. NL

ERYFLUID, lotion not available 34009 326 710 0 7 PIERRE FABRE DERMATOLOGIE FR

ERYFLUID, lotion not available 0040913 PIERRE FABRE DERMATOLOGIE LU

Eryfluid 40 mg/ml soluţie cutanatǎ not available 6282/2006/01

PIERRE FABRE DERMATOLOGIE RO

ERYFLUID 40 mg/ml dermálny roztok not available 46/0957/92-S

PIERRE FABRE DERMATOLOGIE SK

ERYFLUID, lotion not available 34009 327 058 5 6 PIERRE FABRE DERMATOLOGIE FR

ERYFLUID, lotion not available 34009 328 402 1 2 PIERRE FABRE DERMATOLOGIE FR

Eryfluid 40 mg/ml soluţie cutanatǎ not available 6282/2006/02

PIERRE FABRE DERMATOLOGIE RO

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 9/21

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

ERYFLUID 40 mg/ml dermálny roztok not available 46/0957/92-S

PIERRE FABRE DERMATOLOGIE SK

Aknefug-EL, 10 mg/ml nahalahus not available 209298

DR. AUGUST WOLFF GMBH & CO. KG ARZNEIMITTEL EE

Erythrocine I.V. 1 g, poudre pour solution pour perfusion not available 1739/96063720 AMDIPHARM LIMITED LU

ERITROCINA FORTE, 500 mg/5 ml, Granulado para suspensão oral not available 4547683 AMDIPHARM LIMITED PT

ERITROCINA FORTE, 500 mg/5 ml, Granulado para suspensão oral not available 8362798 AMDIPHARM LIMITED PT

Erythrocine I.V. 1 g, 1 g, Pulver zur Herstellung einer Infusionslösung not available 1739/96063720 AMDIPHARM LIMITED LU

Erythromycin Lactobionate 1g Powder for Solution for Infusion not available PL 20072/0038 AMDIPHARM UK LIMITED UK

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 10/21

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

Erythroped Forte SF 500 mg/5 ml Granules for Oral Suspension not available PA 1142/6/3 AMDIPHARM LIMITED IE

Erythrocin 250 not available PL 20072/0036 AMDIPHARM UK LIMITED UK

Erythromycin Stearate BP 250mg not available PL 20072/0036 AMDIPHARM UK LIMITED UK

Erythrocin I.V. Lactobionate 1g Powder for Solution for Infusion not available PL 20072/0038 AMDIPHARM UK LIMITED UK

Erythromycin 250 mg Gastro-resistant Tablets not available PL 25298/0036 BROWN & BURK UK LIMITED UK

Erythromycin 250 mg Gastro-resistant Tablets not available PL 25298/0036 BROWN & BURK UK LIMITED UK

Aknemycin Salbe not available 2684.00.01 ALMIRALL HERMAL GMBH DE

Ery-Max not available 9632 MEDA AB SE

Erythrocin 250 mg Tablets not available PA 1142/8/2 AMDIPHARM LIMITED IE

Abboticin 40 mg/ml granulat til mikstur, suspensjon not available 5585 AMDIPHARM LIMITED NO

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 11/21

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

Erythroped SF not available PL 20072/0042 AMDIPHARM UK LIMITED UK

Erythromycin Ethylsuccinate SF 250mg/5ml not available PL 20072/0042 AMDIPHARM UK LIMITED UK

Erythromycin SF 250mg/5ml not available PL 20072/0042 AMDIPHARM UK LIMITED UK

Erythromycin Suspension 250mg/5ml SF not available PL 20072/0042 AMDIPHARM UK LIMITED UK

Erythromycin Ethylsuccinate SF Suspension 250mg/5ml not available PL 20072/0042 AMDIPHARM UK LIMITED UK

Pantomicina 1g polvo para solución para perfusión not available 55771 AMDIPHARM LIMITED ES

Abboticin Novum, filmovertrukne tabletter not available 12869 AMDIPHARM LIMITED DK

Abboticin ES 500 mg tabletter not available 7375 AMDIPHARM LIMITED NO

Erythrocine i.v. 1 g poeder voor oplossing voor infusie not available RVG 01800 AMDIPHARM LIMITED NL

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 12/21

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

Aknemycin Lösung not available 2684.00.00 ALMIRALL HERMAL GMBH DE

Aknefug-EL 10 mg/ml odos tirpalas not available LT/1/95/1777/001

DR. AUGUST WOLFF GMBH & CO. KG ARZNEIMITTEL LT

Aknefug-EL 10 mg/ml odos tirpalas not available LT/1/95/1777/002

DR. AUGUST WOLFF GMBH & CO. KG ARZNEIMITTEL LT

ERYFLUID not available 8754705

PIERRE FABRE DERMO-COSMÉTIQUE PORTUGAL, LDA. PT

Erythroforte 500, Granulat not available BE 095347 AMDIPHARM LIMITED BE

Erythroforte 1000, Granulat not available BE 095356 AMDIPHARM LIMITED BE

ERYTHROFORTE Erythromycini Ethylsuccinas. not available BE 095347 AMDIPHARM LIMITED BE

ERYTHROFORTE Erythromycine-ethylsuccinaat not available BE 095347 AMDIPHARM LIMITED BE

ERYTHROFORTE Erythromycini Ethylsuccinas. not available BE 095356 AMDIPHARM LIMITED BE

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 13/21

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

ERYTHROFORTE Erythromycine-ethylsuccinaat not available BE 095356 AMDIPHARM LIMITED BE

Aknemycin 20 mg/g kožní roztok not available 46/056/93-C ALMIRALL HERMAL GMBH CZ

Erythromycin 250mg gastro-resistant tablets not available PL 17907/0005

BRISTOL LABORATORIES LTD (BERKHAMSTED) UK

Aknemycin 2000 20 mg/g dermálna mast' not available 46/0509/95-S ALMIRALL HERMAL GMBH SK

Erythroforte 500, Tabletten not available BE 126463 AMDIPHARM LIMITED BE

ERYTHROFORTE Erythromycini Ethylsuccinas. not available BE 126463 AMDIPHARM LIMITED BE

ERYTHROFORTE Erythromycine-ethylsuccinaat not available BE 126463 AMDIPHARM LIMITED BE

Eryderm, oplossing voor cutaan gebruik 2% not available RVG 10399 AMDIPHARM LIMITED NL

ERYTHROCIN 500 mg - Filmtabletten not available 1-18764 AMDIPHARM LIMITED AT

Erythrocine 250 mg/5 ml, granulés pour suspension buvable not available BE 128703 AMDIPHARM LIMITED BE

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 14/21

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

Pantomicina 500 mg, comprimidos recubiertos con película not available 57474 AMDIPHARM LIMITED ES

Eritrocina 500 mg granulato per sospensione orale not available 007893163 AMDIPHARM LIMITED IT

Erythrocine 250 mg/5 ml, Granulat zur Herstellng einer Suspension zum Einnehmen not available BE 128703 AMDIPHARM LIMITED BE

Erythrocine 250 mg/5 ml, granulaat voor orale suspensie not available BE 128703 AMDIPHARM LIMITED BE

Abboticin, granulat til oral suspension not available 06278 AMDIPHARM LIMITED DK

Erythrocin 500 mg Neo, Filmtabletten not available 1579.00.00 AMDIPHARM LIMITED DE

Abboticin Novum 500 mg tabletter not available 10446 AMDIPHARM LIMITED SE

Erythrocine ES 1000 mg, granulaat voor orale suspensie not available RVG 08335 AMDIPHARM LIMITED NL

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 15/21

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

ERYTHROCIN 1000 mg - Granulat für orale Suspension not available 1-18178 AMDIPHARM LIMITED AT

Erythroped Adult 500 mg Film-coated Tablets not available PA 1142/6/4 AMDIPHARM LIMITED IE

Erythrocin IV Lactobionate 1 g Powder for Concentrate for Solution for Infusion not available PA 1142/8/1 AMDIPHARM LIMITED IE

Abboticin, filmovertrukne tabletter not available 06209 AMDIPHARM LIMITED DK

Abboticin, pulver til infusionsvæske, opløsning not available 09260 AMDIPHARM LIMITED DK

Erythrocine ES 250 mg/5 ml, granulaat voor orale suspensie not available RVG 10247 AMDIPHARM LIMITED NL

Aknemycin 20 mg/g, maść not available R/2120 ALMIRALL HERMAL GMBH PL

Erythrocin 500 not available PL 20072/0037 AMDIPHARM UK LIMITED UK

Erythromycin Stearate BP 500mg not available PL 20072/0037 AMDIPHARM UK LIMITED UK

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 16/21

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

ERY-MAX 100 mg granulat til mikstur not available 7982 MEDA AS NO

Ery-Max 250 mg sýruþolin hylki, hörð not available 843426 MEDA AB IS

ERY-MAX 250 mg, harde enterokapsler not available 6693 MEDA AS NO

Aknemycin 20 mg/g kenőcs not available OGYI-T-2373/01 ALMIRALL HERMAL GMBH HU

Aknemycin 20 mg/g dermálny roztok not available 46/0508/95-S ALMIRALL HERMAL GMBH SK

ERITROMICINA NORMON 500 MG COMPRIMIDOS RECUBIERTOS not available 39690

LABORATORIOS NORMON, S.A. ES

Inderm Lotion 10 mg/g oplossing voor cutaan gebruik not available BE149913 EUROGENERICS N.V./S.A. BE

Inderm Lotion 10 mg/g solution pour application cutanée not available 2001116929 EUROGENERICS N.V./S.A. LU

Inderm Lotion 10 mg/g Lösung zur Anwendung auf der Haut not available BE149913 EUROGENERICS N.V./S.A. BE

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 17/21

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

Inderm Lotion 10 mg/g solution pour application cutanée not available BE149913 EUROGENERICS N.V./S.A. BE

Abboticin Novum 500 mg filmdragerade tabletter not available 12860 AMDIPHARM LIMITED FI

Abboticin Novum 500 mg tabletti, kalvopäällysteinen not available 12860 AMDIPHARM LIMITED FI

ERITROCINA I.V., 1000 mg, Pó para solução injectável not available 8203208 AMDIPHARM LIMITED PT

ERYTHROCIN - Lactobionat 1,0 g - Trockensubstanz zur Infusionsbereitung not available 9741 AMDIPHARM LIMITED AT

Abboticin 1 g pulver til infusjonsvæske, oppløsning not available 2995 AMDIPHARM LIMITED NO

Erythrocine ES 500 mg/5 ml, granulaat voor orale suspensie not available RVG 10246 AMDIPHARM LIMITED NL

Eritrocina 1000 mg granulato per sospensione orale not available 007893175 AMDIPHARM LIMITED IT

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 18/21

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

Erythrocin 500 mg Tablets not available PA 1142/8/3 AMDIPHARM LIMITED IE

Abboticin, granulat til oral suspension not available 11917 AMDIPHARM LIMITED DK

Erythrocin®-i.v. 500 mg not available 7663.00.00 AMDIPHARM LIMITED DE

Abboticin 1 g pulver till infusionsvätska, lösning not available 5172 AMDIPHARM LIMITED SE

Erythroped A Tablets not available PL 20072/0040 AMDIPHARM UK LIMITED UK

ERY NOURRISSONS 125 mg, granulés en sachet not available 34009 324 256 0 0 BOUCHARA RECORDATI FR

ERY NOURRISSONS 125 mg, granulés en sachet not available 0040832 BOUCHARA RECORDATI LU

Erythromycin 250mg Gastro-resistant Tablets not available PL 21880/0069 MEDREICH PLC UK

Aknemycin Salbe not available 0423/00/06/5765 ALMIRALL HERMAL GMBH LU

ACNE HERMAL® not available 6895 /02-02-2006 OLVOS SCIENCE S.A. GR

Erythrocine 250 mg tabletten not available RVG 01799 AMDIPHARM LIMITED NL

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 19/21

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

Ery-Max 250 mg enterokapsel, hård not available 9628 MEDA AB SE

Aknemycin Lösung not available 0423/03/08/7994 ALMIRALL HERMAL GMBH LU

ERYACNE 4 POUR CENT, solution pour application cutanée not available 336 081-6 GALDERMA INTERNATIONAL FR

ERYACNE 4 POUR CENT, solution pour application cutanée not available 336 079-1 GALDERMA INTERNATIONAL FR

Erythroped PI SF 125 mg/5 ml Granules for Oral Suspension not available PA 1142/6/2 AMDIPHARM LIMITED IE

Erythroped SF 250 mg/5 ml Granules for Oral Suspension not available PA 1142/6/1 AMDIPHARM LIMITED IE

Abboticin 100 mg/ml granulat til mikstur, suspensjon not available 7220 AMDIPHARM LIMITED NO

Erythroped PI SF not available PL 20072/0041 AMDIPHARM UK LIMITED UK

Erythromycin Ethylsuccinate SF 125mg/5ml not available PL 20072/0041 AMDIPHARM UK LIMITED UK

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 20/21

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

Erythromycin SF 125mg/5ml not available PL 20072/0041 AMDIPHARM UK LIMITED UK

Erythromycin Suspension 125mg/5ml SF not available PL 20072/0041 AMDIPHARM UK LIMITED UK

Erythromycin Ethylsuccinate SF Suspension 125mg/5ml not available PL 20072/0041 AMDIPHARM UK LIMITED UK

Erythroped Forte SF not available PL 20072/0043 AMDIPHARM UK LIMITED UK

Erythromycin Ethylsuccinate SF 500mg/5ml not available PL 20072/0043 AMDIPHARM UK LIMITED UK

Erythromycin SF 500mg/5ml not available PL 20072/0043 AMDIPHARM UK LIMITED UK

Erythromycin Suspension 500mg/5ml SF not available PL 20072/0043 AMDIPHARM UK LIMITED UK

Erythromycin Ethylsuccinate SF Suspension 500mg/5ml not available PL 20072/0043 AMDIPHARM UK LIMITED UK

Pantomicina 100mg/ml, granulado para suspensión oral not available 58767 AMDIPHARM LIMITED ES

List of nationally authorised medicinal products EMA/556781/2019 Classified as internal/staff & contractors by the European Medicines Agency Page 21/21

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

ERYTHROCINE 1 g I.V., lyophilisat pour préparation injectable not available 34009 552 805 9 0 AMDIPHARM LIMITED FR

Erythrocin®-i.v. 1,0 g not available 6262208.00.00 AMDIPHARM LIMITED DE

Akne-mycin, 20 mg/g, creme not available 8710210 ALMIRALL HERMAL GMBH PT

Aknemycin 20 mg/g külsőleges oldat not available OGYI-T-4166/01 ALMIRALL HERMAL GMBH HU