11 January 2018 EMA/24814/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: human rabies immunoglobulin

Procedure no.: PSUSA/00001639/201704

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

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

Berirab ® P*

not available

2-00158

CSL BEHRING GMBH

AT

not available

107A/89

CSL BEHRING GMBH

DE

not available

MA049/00601

BIO PRODUCTS LABORATORY

MT

not available

PL 08801/0014

BIO PRODUCTS LABORATORY

UK

not available

56.139

SANOFI PASTEUR EUROPE

ES

not available

99-0170

SANOFI PASTEUR SA

LV

not available

LT/1/97/3291/001

SANOFI PASTEUR SA

LT

not available

LT/1/97/3291/002

SANOFI PASTEUR SA

LT

Fertigspritze Berirab® Injektionslösung zur intramuskulären Anwendung Human Rabies Immunoglobulin, not less than 150 IU/mL solution for injection Human Rabies Immunoglobulin, not less than 150 IU/mL solution for injection IMOGAM RABIA 150 UI/ml, solución inyectable IMOGAM RABIES 150 SV/ml, šķīdums injekcijām. Immunoglobulinum humanum rabicum IMOGAM RABIES 150 TV/ml injekcinis tirpalas Žmogaus pasiutligės imunoglobulinas IMOGAM RABIES 150 TV/ml injekcinis tirpalas Žmogaus pasiutligės List of nationally authorised medicinal products EMA/24814/2018

Page 2/3

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

not available

342101

SANOFI PASTEUR SA

EE

not available

NL 18 705

SANOFI PASTEUR SA

FR

not available

13A/97

SANOFI PASTEUR EUROPE

DE

imunoglobulinas

IMOGAM RABIES, PASTEURIZED, 150 RÜ/ml süstelahus IMOGAM RAGE 150 UI/ml, solution injectable Tollwutglobulin Mérieux P mind. 150 I.E./ml Injektionslösung

List of nationally authorised medicinal products EMA/24814/2018

Page 3/3

Human rabies immunoglobulin - European Medicines Agency

Jan 11, 2018 - SANOFI PASTEUR SA. LV. IMOGAM RABIES 150. TV/ml injekcinis tirpalas. Žmogaus pasiutligės imunoglobulinas not available. LT/1/97/3291/001. SANOFI PASTEUR SA. LT. IMOGAM RABIES 150. TV/ml injekcinis tirpalas. Žmogaus pasiutligės not available. LT/1/97/3291/002. SANOFI PASTEUR SA. LT ...

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