8 February 2018 EMA/88494/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal

Active substance: cilastatin / imipenem

Procedure no.: PSUSA/00000748/201706

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, 2018. 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

number TIENAM® 500 mg/500 mg, Pulver zur Herstellung einer Infusionslösung TIENAM 500 mg/500 mg σκόνη για διάλυμα προς έγχυση TIENAM 500 mg/500 mg pulver till infusionsvätska, lösning TIENAM 500 mg/500 mg por oldatos infúzióhoz TIENAM 500 mg/500 mg por oldatos infúzióhoz TIENAM I.V. 500 mg/500 mg milteliai infuziniam tirpalui TIENAM I.V. 500 mg/500 mg milteliai infuziniam tirpalui TIENAM 500 mg/500 mg prašek za raztopino za infundiranje TIENAM I.V. 500 mg/500 mg, infusioonilahuse pulber Tienam 500 mg/500 mg pulver til infusjonsvæske, oppløsning TIENAM 500 mg/500 mg polvo para solución para perfusión TIENAM 500 mg/500 mg, poudre pour solution pour perfusion List of nationally authorised medicinal EMA/88494/2018

NL/H/2160/001

BE135606

MSD BELGIUM BVBA/SPRL

BE

NL/H/2160/001

21719

MERCK SHARP & DOHME BV

CY

NL/H/2160/001

9375

MERCK SHARP & DOHME BV

FI

NL/H/2160/001

OGYI-T-1538/05

HU

NL/H/2160/001

OGYI-T-1538/04

NL/H/2160/001

LT/1/93/2969/002

MSD PHARMA HUNGARY KFT. MSD PHARMA HUNGARY KFT. MERCK SHARP & DOHME, UAB

NL/H/2160/001

LT/1/93/2969/003

MERCK SHARP & DOHME, UAB

LT

NL/H/2160/001

H/93/00417/001

SI

NL/H/2160/001

090094

MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. MERCK SHARP & DOHME OU

NL/H/2160/001

00-7308

MERCK SHARP & DOHME BV

NO

NL/H/2160/001

57.329

MERCK SHARP & DOHME DE ESPAÑA, S.A

ES

NL/H/2160/001

34009 571 937 4 4

MSD FRANCE

FR

HU LT

EE

Page 2/5

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number PRIMAXIN IV 500 mg/500 mg powder for solution for infusion Zienam 500 mg/500 mg - Pulver zur Herstellung einer Infusionslösung TIENAM 500 mg/500 mg, poudre pour solution pour perfusion TIENAM IV 500 mg + 500 mg Pó para solução para perfusão TIENAM I.V. 500 mg/500 mg milteliai infuziniam tirpalui ТИЕНАМ 500 mg/500 mg прах за инфузионен разтвор TIENAM, 500 mg + 500 mg, proszek do sporządzania roztworu do infuzji TIENAM 500 mg/500 mg poeder voor oplossing voor infusie Tienam 500 mg/500 mg infuusiokuiva-aine, liuosta varten TIENAM I.V. 500 mg/500 mg pulveris infūziju šķīduma pagatavošanai

List of nationally authorised medicinal EMA/88494/2018

NL/H/2160/001

PL 00025/0229

MERCK SHARP & DOHME LTD.

UK

NL/H/2160/001

1-18024

MERCK SHARP & DOHME GES.M.B.H.

AT

NL/H/2160/001

34009 383 370 0 6

MSD FRANCE

FR

NL/H/2160/001

5053376

MERCK SHARP & DOHME, LDA.

PT

NL/H/2160/001

LT/1/93/2969/001

MERCK SHARP & DOHME, UAB

LT

NL/H/2160/001

20020312

MERCK SHARP & DOHME BULGARIA EOOD

BG

NL/H/2160/001

R/0990

MSD POLSKA SP. Z O.O.

PL

NL/H/2160/001

RVG 11089

MERCK SHARP & DOHME BV

NL

NL/H/2160/001

9375

MERCK SHARP & DOHME BV

FI

NL/H/2160/001

93-0495

MERCK SHARP & DOHME LATVIJA SIA

LV

Page 3/5

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number ZIENAM® 500 mg/500 mg Pulver zur Herstellung einer Infusionslösung Wirkstoffe: Imipenem und Cilastatin TIENAM 500 mg/500 mg por oldatos infúzióhoz PRIMAXIN IV 500 mg/500 mg powder for solution for infusion TIENAM 500 mg/500 mg pulver till infusionsvätska, lösning TIENAM® 500 mg/500 mg, poudre pour solution pour perfusion PRIMAXIN IV 500 mg/500 mg powder for solution for infusion TIENAM 500 mg/500 mg polvere per soluzione per infusione TIENAM® 500 mg/500 mg, poeder voor oplossing voor infusie TIENAM® 500 mg/500 mg, poudre pour solution pour perfusion TIENAM® 500 mg/500 mg i.v. prášek pro infuzní roztok

List of nationally authorised medicinal EMA/88494/2018

NL/H/2160/001

4697.01.00

MSD SHARP & DOHME GMBH

DE

NL/H/2160/001

OGYI-T-1538/03

HU

NL/H/2160/001

MA 058/00901

MSD PHARMA HUNGARY KFT. MERCK SHARP & DOHME LTD.

NL/H/2160/001

10339

MERCK SHARP & DOHME BV

SE

NL/H/2160/001

2006129146

MSD BELGIUM BVBA/SPRL

LU

NL/H/2160/001

PA 1286/019/001

IE

NL/H/2160/001

025887062

MERCK SHARP & DOHME IRELAND (HUMAN HEALTH) LTD MSD ITALIA S.R.L.

NL/H/2160/001

BE135606

MSD BELGIUM BVBA/SPRL

BE

NL/H/2160/001

BE135606

MSD BELGIUM BVBA/SPRL

BE

NL/H/2160/001

15/104/87-A/C

MERCK SHARP & DOHME BV

CZ

MT

IT

Page 4/5

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. MERCK SHARP & DOHME ROMANIA SRL

SI

number Tienam 500 mg/500 mg prašek za raztopino za infundiranje Tienam 500 mg/500 mg prašek za raztopino za infundiranje TIENAM I.V. 500 mg/500 mg pulbere pentru soluţie perfuzabilă TIENAM I.V. 500 mg/500 mg pulbere pentru soluţie perfuzabilă TIENAM I.V. 500 mg/500 mg pulbere pentru soluţie perfuzabilă TIENAM 500 mg/500 mg powder for solution for infusion TIENAM 500 mg/500 mg, poudre pour solution pour perfusion PRIMAXIN 500 mg/500 mg σκόνη για διάλυμα προς έγχυση TIENAM 500 mg/500 mg prašak za otopinu za infuziju Имецитин 250 mg/250 mg прах за инфузионен разтвор Impecin 250 mg/250 mg por oldatos infúzióhoz

List of nationally authorised medicinal EMA/88494/2018

NL/H/2160/001

H/93/00417/003

NL/H/2160/001

H/93/00417/002

NL/H/2160/001

4955/2012/01

NL/H/2160/001

4955/2012/03

MERCK SHARP & DOHME ROMANIA SRL

RO

NL/H/2160/001

4955/2012/02

MERCK SHARP & DOHME ROMANIA SRL

RO

NL/H/2160/001

21719

MERCK SHARP & DOHME BV

CY

NL/H/2160/001

34009 571 938 0 5

MSD FRANCE

FR

not available

91867/12/06-07-2016

VIANEX S.A.

GR

NL/H/2160/001

HR-H-308882042

MERCK SHARP & DOHME D.O.O.

HR

UK/H/1704/001

20100618

ACTAVIS GROUP PTC EHF.

BG

UK/H/1704/001

OGYI-T-21662/01-02

ACTAVIS GROUP PTC EHF.

HU

SI RO

Page 5/5

PSUSA/00000748/201706 - European Medicines Agency - Europa EU

Feb 8, 2018 - HR-H-308882042. MERCK SHARP & DOHME. D.O.O.. HR. Имецитин 250 mg/250 mg прах за инфузионен разтвор. UK/H/1704/001. 20100618. ACTAVIS GROUP PTC EHF. BG. Impecin 250 mg/250 mg por oldatos infúzióhoz. UK/H/1704/001. OGYI-T-21662/01-02. ACTAVIS GROUP PTC EHF. HU.

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