9 June 2017 EMA/370951/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: levosimendan

Procedure no.: PSUSA/00001858/201609

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, 2017. 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

SIMDAX 2,5 mg/ml

not available

41/0221/02-S

ORION CORPORATION

SK

Simdax 2,5 mg/ml -

SE/H/0233/001

1-24093

ORION CORPORATION

AT

SE/H/0233/001

3654787

ORION CORPORATION

PT

SE/H/0233/001

3654886

ORION CORPORATION

PT

SE/H/0233/001

3654985

ORION CORPORATION

PT

SE/H/0233/001

3655081

ORION CORPORATION

PT

SE/H/0233/001

3655180

ORION CORPORATION

PT

SE/H/0233/001

3655289

ORION CORPORATION

PT

not available

6449/2014/01

ORION CORPORATION

RO

Konzentrat zur Herstellung einer Infusionslösung Simdax 2,5 mg/ml concentrado para solução para perfusão Simdax 2,5 mg/ml concentrado para solução para perfusão Simdax 2,5 mg/ml concentrado para solução para perfusão Simdax 2,5 mg/ml concentrado para solução para perfusão Simdax 2,5 mg/ml concentrado para solução para perfusão Simdax 2,5 mg/ml concentrado para solução para perfusão Simdax 2,5 mg/ml concentrat pentru soluţie perfuzabilă

List of nationally authorised medicinal products EMA/370951/2017

Page 2/4

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

Simdax 2,5 mg/ml di

SE/H/0233/001

035108012

ORION CORPORATION

IT

SE/H/0233/001

035108024

ORION CORPORATION

IT

SE/H/0233/001

035108036

ORION CORPORATION

IT

SE/H/0233/001

035108048

ORION CORPORATION

IT

SE/H/0233/001

035108051

ORION CORPORATION

IT

SE/H/0233/001

035108063

ORION CORPORATION

IT

SE/H/0233/001

16326

ORION CORPORATION

FI

SE/H/0233/001

IS/1/01/002/01

ORION CORPORATION

IS

not available

41/282/02-C

ORION CORPORATION

CZ

concentrato per soluzione per infusione Simdax 2,5 mg/ml di concentrato per soluzione per infusione Simdax 2,5 mg/ml di concentrato per soluzione per infusione Simdax 2,5 mg/ml di concentrato per soluzione per infusione Simdax 2,5 mg/ml di concentrato per soluzione per infusione Simdax 2,5 mg/ml di concentrato per soluzione per infusione SIMDAX 2,5 mg/ml infuusiokonsentraatti, liuosta varten Simdax 2,5 mg/ml innrennslisþykkni, lausn SIMDAX 2,5 mg/ml Koncentrát pro infuzní roztok

List of nationally authorised medicinal products EMA/370951/2017

Page 3/4

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

SIMDAX 2,5 mg/ml

SE/H/233/01

16326

ORION CORPORATION

FI

SE/H/0233/001

15361

ORION CORPORATION

SE

not available

UP/I-530-09/11-02/209

MEDIS ADRIA D.O.O.

HR

not available

OGYI-T-8647/01

ORION CORPORATION

HU

not available

OGYI-T-8647/02

ORION CORPORATION

HU

SE/H/0233/001

00-9373

ORION CORPORATION

NO

SE/H/0233/001

31332/3-5-2012

ORION CORPORATION

GR

SE/H/0233/001

64.154

ORION CORPORATION

ES

not available

20040028

ORION CORPORATION

BG

koncentrat till infusionsvätska, lösning Simdax 2,5 mg/ml koncentrat till infusionsvätska, lösning Simdax 2,5 mg/ml koncentrat za otopinu za infuziju Simdax 2,5 mg/ml koncentrátum oldatos infúzióhoz Simdax 2,5 mg/ml koncentrátum oldatos infúzióhoz Simdax 2,5 mg/ml konsentrat til infusjonsvæske Simdax 2,5 mg/ml πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση SIMDAX 2.5 mg/ml de concentrado para solución para perfusión Симдакс 2,5 mg/ml концентрат за инфузионен разтвор

List of nationally authorised medicinal products EMA/370951/2017

Page 4/4

levosimendan List of nationally authorised medicinal products

Jun 9, 2017 - Send a question via our website www.ema.europa.eu/contact. © European ... Product Name (in authorisation ... not available. 41/0221/02-S.

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