1 December 2016 EMA/847829/2016 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: N(2)-L-alanyl-L-glutamine

Procedure no.: PSUSA/00003158/201603

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

MEDIAS INTERNATIONAL

SI

number Dipeptiven 200 mg/ml

not available

5363-I-324/09

koncentrat za raztopino

D.O.O.

za infundiranje Dipeptiven 200 mg/ml

not available

5363-I-325/09

koncentrat za raztopino

MEDIAS INTERNATIONAL

SI

D.O.O.

za infundiranje Dipeptiven 200 mg/ml

not available

5363-I-812/09

koncentrat za raztopino

MEDIAS INTERNATIONAL

SI

D.O.O.

za infundiranje Dipeptiven 200 mg/ml

not available

5363-I-813/09

koncentrat za raztopino

MEDIAS INTERNATIONAL

SI

D.O.O.

za infundiranje Dipeptiven, koncentrat til

DE/H/0101/001

17752

FRESENIUS KABI AB

DK

DE/H/0101/001

12262

FRESENIUS KABI AB

FI

DE/H/0101/001

12834

FRESENIUS KABI AB

SE

DE/H/0101/001

1-21428

FRESENIUS KABI AUSTRIA

AT

infusionsvæske, opløsning DIPEPTIVEN 200 mg/ml infuusiokonsentraatti, liuosta varten Dipeptiven 200 mg/ml, koncentrat till infusionsvätska, lösning Dipeptiven 200 mg/ml Konzentrat zur

GMBH

Herstellung einer Infusionslösung List of nationally authorised medicinal products EMA/847829/2016

Page 2/4

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

FRESENIUS KABI

DE

number Dipeptamin

DE/H/0101/001

31349.00.00

DEUTSCHLAND GMBH Dipeptiven, πυκνό

DE/H/0101/001

16113/05-03-2012

διάλυμα για παρασκευή

FRESENIUS KABI HELLAS

GR

A.E.

διαλύματος προς έγχυση Dipeptiven, concentraat

DE/H/0101/001

RVG 19489

voor oplossing voor

FRESENIUS KABI

NL

NEDERLAND B.V.

infusie Dipeptiven, koncentrat

not available

UP/I-530-09/13-02/121

FRESENIUS KABI D.O.O.

HR

not available

34009 344 250 8 0

FRESENIUS KABI FRANCE

FR

za otopinu za infuziju DIPEPTIVEN, solution à diluer pour perfusion Dipeptiven

S.A.S. not available

76/881/97-C

FRESENIUS KABI AB

CZ

DIPEPTIVEN

not available

76/0032/99-S

FRESENIUS KABI AB

SK

Dipeptiven 200 mg/ml

not available

96-976

FRESENIUS KABI NORGE AS

NO

DE/H/0101/001

BE177283

Fresenius Kabi Deutschland

BE

Koncentrát pro infuzní roztok

konsentrat til infusjonsvæske, oppløsning Dipeptiven

BR177301

List of nationally authorised medicinal products EMA/847829/2016

GmbH

Page 3/4

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

Fresenius Kabi Deutschland

IE

number Dipeptiven

DE/H/0101/001

PA 697/2/1

GmbH Dipeptiven

DE/H/0101/001

032188017 032188029

Fresenius Kabi Deutschland

IT

GmbH

032188043 032188056 Dipeptiven

DE/H/0101/001

List of nationally authorised medicinal products EMA/847829/2016

PL 08828/0154

Fresenius Kabi Limited UK

UK

Page 4/4

N(2)-L-alanyl-L-glutamine - European Medicines Agency - Europa EU

Dec 1, 2016 - Send a question via our website www.ema.europa.eu/contact. © European ... Product Name (in authorisation ... not available. 5363-I-324/09.

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