EMA/221460/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products Active substance(s): human tetanus immunoglobulin

Procedure No.: PSUSA/00002909/201708

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

Product Name (in

MRP/DCP

National Authorisation

MAH of product in the

Member State where

authorisation country)

Authorisation number

Number

member state

product is authorised

TETIG 250 NE oldatos injekció Humán tetanusz elleni immunglobulin TETIG 500 NE oldatos injekció Humán tetanusz elleni immunglobulin Gamma-Tet P 250 UI/1 ml soluzione iniettabile per uso intramuscolare Gamma-Tet P 500 UI/2 ml soluzione iniettabile per uso intramuscolare Tetagam ® P- Fertigspritze Tetagam P solução injectável 250 U.I./ml GAMMATETANOS 250 UI / 2 ml, solution injectable (IM) Tetagam P 250 i.e. raztopina za injiciranje Tetagam P Ενέσιμο διάλυμα Tetagam P Solution for injection for intramuscular use Tetagam® P Injektionslösung zur intramuskulären Anwendung

not available

OGYI-T-9471/01

HU

not available

OGYI-T-9471/02

not available

022635066

HUMAN BIOPLAZMA MANUFACTURING AND TRADING LLC HUMAN BIOPLAZMA MANUFACTURING AND TRADING LLC CSL BEHRING GMBH

not available

022635078

CSL BEHRING GMBH

IT

not available not available

2-00118 5039961

CSL BEHRING GMBH CSL BEHRING GMBH

AT PT

not available

34009 328 921 9 8

LFB BIOMEDICAMENTS

FR

not available

5363-I-2558/12

CSL BEHRING GMBH

SI

not available DE/H/1941/001

51171/15-07-2011 PA 800/9/2

CSL BEHRING MEPE CSL BEHRING GMBH

GR IE

DE/H/1941/001

108A/89

CSL BEHRING GMBH

DE

EMA/221460/2018

HU IT

Page 2/2

human tetanus immunoglobulin - European Medicines Agency

OGYI-T-9471/02. HUMAN BIOPLAZMA. MANUFACTURING AND. TRADING LLC. HU. Gamma-Tet P 250 UI/1 ml soluzione iniettabile per uso intramuscolare.

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