9 February 2017 EMA/112843/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: ganciclovir

Procedure no.: PSUSA/00001516/201606

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

Cymevene 500 mg

NL/H/3775/001

BE143157

N.V. ROCHE S.A.

BE

NL/H/3775/001

BE143157

N.V. ROCHE S.A.

BE

NL/H/3775/001

BE143157

N.V. ROCHE S.A.

BE

NL/H/3775/001

10049

ROCHE OY

FI

not available

20010180

ROCHE BULGARIA EOOD

BG

NL/H/3775/001

032837015

ROCHE S.P.A.

IT

NL/H/3775/001

0178/04048212

N.V. ROCHE S.A.

LU

FR/H/0264/001

67075

LABORATOIRES THEA

ES

poudre pour solution à diluer pour perfusion Cymevene 500 mg poeder voor concentraat voor oplossing voor infusie Cymevene Pulver für ein Konzentrat zur Herstellung einer Infusionslösung Cymevene 500 mg pulver till infusionsvätska, lösning Симевен 500 mg прах за инфузионен разтвор Citovirax 500 mg polvere per concentrato per soluzione per infusione Cymevene Pulver für ein Konzentrat zur Herstellung einer Infusionslösung VIRGAN 1,5 mg/g gel oftálmico

List of nationally authorised medicinal products EMA/112843/2017

Page 2/8

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

VIRGAN 1,5 mg/g, gel

not available

339512-8

LABORATOIRES THEA

FR

VIRGAN eye gel

not available

PL 20162/0006

LABORATOIRES THEA

UK

Virgan Gele Oftálmico 1,5

not available

3549680

LABORATOIRES THEA

PT

FR/H/0264/001

64/365/05-C

LABORATOIRES THEA

CZ

NL/H/3775/001

74045/13.10.2014

ROCHE (HELLAS) SA

GR

FR/H/0264/001

61789.00.00

LABORATOIRES THEA

DE

FR/H/0264/001

11808

LABORATOIRES THEA

PL

NL/H/3775/001

58.266

ROCHE FARMA, S.A.

ES

NL/H/3775/001

LT/1/96/2511/001

UAB "ROCHE LIETUVA"

LT

ophtalmique

mg/g VIRGAN 1,5 mg/g oční gel Cymevene 500 mg/vial κόνις για διάλυμα προς έγχυση VIRGAN 1,5 mg/g Augengel VIRGAN, 1,5 mg/g, żel do oczu Cymevene 500 mg polvo para solución para perfusion Cymevene 500 mg milteliai infuzinio tirpalo koncentratui

List of nationally authorised medicinal products EMA/382258/2015

Page 3/8

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

Cymevene® 500 mg

NL/H/3775/001

10049

ROCHE OY

FI

NL/H/3775/001

142696

ROCHE EESTI OÜ

EE

NL/H/3775/001

34009 347 804 4 8

ROCHE

FR

NL/H/3775/001

PA 50/125/2

ROCHE PRODUCTS LTD

IE

NL/H/3775/001

PL 0031/0465

ROCHE PRODUCTS LTD

UK

NL/H/003775

14837.00.00

ROCHE PHARMA AG

DE

NL/H/3775/001

10934

ROCHE AB

SE

NL/H/3775/001

OGYI-T-1491/01

ROCHE (MAGYARORSZÁG)

HU

infuusiokuiva-aine, liuosta varten Cymevene infusioonilahuse kontsentraadi pulber Cymevan 500 mg poudre pour solution à diluer pour perfusion Cymevene 500 mg powder for concentrate for solution for infusion Cymevene® 500 mg powder for concentrate for solution for infusion Cymeven® i.v. 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung Cymevene, 500 mg, pulver till infusionsvätska, lösning Cymevene 500 mg por oldatos infúzióhoz való

KFT

koncentrátumhoz

List of nationally authorised medicinal products EMA/382258/2015

Page 4/8

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

Cymevene 500 mg

NL/H/3775/001

42/138/91-C

ROCHE S.R.O.

CZ

Cymevene 500 mg

NL/H/3775/001

42/0138/91-C/S

ROCHE SLOVENSKO S.R.O.

SK

Cymevene 500 mg

NL/H/3775/001

RVG 13007

ROCHE NEDERLAND B.V.

NL

NL/H/3775/001

0178/04048212

N.V. ROCHE S.A.

LU

not available

7775/2006/01

LABORATOIRES THEA

RO

NL/H/3775/001

1-19235

ROCHE AUSTRIA GMBH

AT

FR/H/0264/001

037145012/M

LABORATOIRES THEA

IT

NL/H/3775/001

7417

F. HOFFMANN-LA ROCHE AG

NO

NL/H/3775/001

13137

ROCHE A/S

DK

prášek pro koncentrát pro infuzní roztok

poeder voor concentraat voor oplossing voor infusie Cymevene 500 mg poudre pour solution à diluer pour perfusion VIRGAN 1,5 mg/g gel oftalmic Cymevene "Roche" 500 mg - Trockensubstanz zur Infusionsbereitung VIRGAN 1.5 mg/g gel oftalmico Cymevene 500 mg pulver til infusjonsvæske, oppløsning Cymevene, pulver til infusionsvæske, opløsning List of nationally authorised medicinal products EMA/382258/2015

Page 5/8

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

Cymevene 500 mg pó

NL/H/3775/001

8766709

ROCHE FARMACÊUTICA

PT

para concentrado para

QUÍMICA, LDA.

solução para perfusão Cymevene 500 mg pó

NL/H/3775/001

8766717

para concentrado para

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

solução para perfusão Cymevene 500 mg

NL/H/3775/001

7024/2014/01

ROCHE ROMANIA SRL

RO

NL/H/3775/001

R/1898

ROCHE POLSKA SP.O.O.

PL

Cymevene

NL/H/3775/001

PL 70204 (IS)

ROCHE A/S

IS

Virgan 1,50 mg/g gel

not available

BE204145

THEA PHARMA

BE

not available

BE204145

THEA PHARMA

BE

FR/H/0264/001

1596/11-1-2006

LABORATOIRES THEA

GR

NL/H/3775/001

HR-H-230718931

ROCHE D.O.O.

HR

pulbere pentru concentrat pentru soluţie perfuzabilă Cymevene, 500 mg, proszek do sporządzania koncentratu roztworu do infuzji

ophtalmique VIRGAN 1,50 mg/g ooggel VIRGAN 1,5 mg/g οφθαλμική γέλη Cymevene 500 mg prašak za koncentrat za otopinu za infuziju List of nationally authorised medicinal products EMA/382258/2015

Page 6/8

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

VIRGAN 1,5 mg/g, gel

FR/H/0264/001

1536/06060036

LABORATOIRES THEA

LU

Virgan 1,5 mg/g szemgél

FR/H/0264/001

OGYI-T 20035/01

LABORATOIRES THEA

HU

VIRGAN 1,5 mg/g gel

FR/H/0264/001

67075

LABORATOIRES THEA

ES

not available

339512-8

LABORATOIRES THEA

FR

VIRGAN eye gel

not available

PL 20162/0006

LABORATOIRES THEA

UK

Virgan Gele Oftálmico 1,5

not available

3549680

LABORATOIRES THEA

PT

FR/H/0264/001

64/365/05-C

LABORATOIRES THEA

CZ

FR/H/0264/001

61789.00.00

LABORATOIRES THEA

DE

FR/H/0264/001

11808

LABORATOIRES THEA

PL

ophtalmique

oftálmico VIRGAN 1,5 mg/g, gel ophtalmique

mg/g VIRGAN 1,5 mg/g oční gel VIRGAN 1,5 mg/g Augengel VIRGAN, 1,5 mg/g, żel do oczu

List of nationally authorised medicinal products EMA/382258/2015

Page 7/8

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

VIRGAN 1,5 mg/g gel

not available

7775/2006/01

LABORATOIRES THEA

RO

FR/H/0264/001

037145012/M

LABORATOIRES THEA

IT

not available

BE204145

THEA PHARMA

BE

not available

BE204145

THEA PHARMA

BE

FR/H/0264/001

1596/11-1-2006

LABORATOIRES THEA

GR

FR/H/0264/001

1536/06060036

LABORATOIRES THEA

LU

FR/H/0264/001

OGYI-T 20035/01

LABORATOIRES THEA

HU

oftalmic VIRGAN 1.5 mg/g gel oftalmico Virgan 1,50 mg/g gel ophtalmique VIRGAN 1,50 mg/g ooggel VIRGAN 1,5 mg/g οφθαλμική γέλη VIRGAN 1,5 mg/g, gel ophtalmique Virgan 1,5 mg/g szemgél

List of nationally authorised medicinal products EMA/382258/2015

Page 8/8

ganciclovir - European Medicines Agency - Europa EU

Feb 9, 2017 - Send a question via our website www.ema.europa.eu/contact. © European ... Product Name (in authorisation ... not available. 20010180.

122KB Sizes 28 Downloads 242 Views

Recommend Documents

Agenda - European Medicines Agency - Europa EU
Jul 7, 2017 - COMMUNITY MARKETING AUTHORISATIONS AND EXTENSIONS. 2.1. Opinions ... Quality. Rapp: E. Werner .... solutions table with EMA and CVMP responses to the recommendations made by the FishMed Plus. Coalition ...

May 2016 - European Medicines Agency - Europa EU
Jun 22, 2016 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.

Eleclazine - European Medicines Agency - Europa EU
Feb 9, 2017 - Notification of discontinuation of a paediatric development which is covered by an agreed ... for the following reason(s): (tick all that apply).

July 2017 - European Medicines Agency - Europa EU
Jul 5, 2017 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).

July 2016 - European Medicines Agency - Europa EU
Jul 4, 2016 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).

SME Office - European Medicines Agency - Europa EU
maximises the chances of a successful marketing authorisation. ... marketing authorisation. • inclusion in the public SME ... E-mail [email protected]. Website ...

Agenda - European Medicines Agency - Europa EU
Jun 19, 2017 - and may also vary during the course of the review. ...... ViiV Healthcare UK Limited; Treatment of Human Immunodeficiency Virus ..... adjunctive administration of brivaracetam, Treatment of paediatric patients with partial.

Action plan - European Medicines Agency - Europa EU
5 days ago - Guidelines should include more details on the principles of good information design in which content and layout are ... relevance and importance of the QRD template is also acknowledged in this respect as it is the main tool .... databas

Agenda - European Medicines Agency - Europa EU
Jun 15, 2016 - Agenda - EMA Human Scientific Committees' Working. Parties with Healthcare Professionals' Organisations. (HCPWP) meeting. 15 June 2016, 08:45hrs to 10:30hrs – meeting room: 3E. Chairs: I. Moulon (EMA) and Gonzalo Calvo (HCPWP). 15 Ju

Agenda - European Medicines Agency - Europa EU
Jun 26, 2018 - oxadiazole-3-carboximidamide - EMEA-002072-PIP01-16-M01 . ..... Human alpha-galactosidase A - Orphan - EMEA-001828-PIP01-15-M01 .

Agenda - European Medicines Agency - Europa EU
Jul 16, 2018 - Cladribine, EMA/OD/087/17 Recombinant monoclonal antibody to sialic acid-binding Ig-like lectin 8. 2.2.6. - EMA/OD/098/18. Treatment of ...

SPOR - European Medicines Agency - Europa EU
Feb 7, 2017 - Add an existing Tag to a specific Term . ...... This service creates an email body (text/html) of a user's notification data, a notification is based on.

ATMP - European Medicines Agency - Europa EU
Nov 24, 2017 - E8. 09/08/2017. 10/08/2017. 24/08/2017 17/08/2017 22/08/2017. 24/08/2017. 30/08/2017. 01/09/2017. 04/09/2017. 08/09/2017. 14/09/2017.

Agenda - European Medicines Agency - Europa EU
Feb 9, 2018 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union ... product information. For information: Summary of opinion. 2.2. Oral explanations and list of outstanding issues. •. Product

Agenda - European Medicines Agency - Europa EU
Oct 23, 2017 - Page 2/61. Table of contents. 1. Introduction. 11. 1.1. Welcome and declarations of interest of members, alternates and experts .......... 11. 1.2. Agenda of the meeting on 23-26 October 2017 . ...... different database to study the ri

Evofosfamide - European Medicines Agency - Europa EU
Notification of discontinuation of a paediatric development which is covered by an agreed ... for the following reason(s): (tick all that apply). (possible) lack of ...

Agenda - European Medicines Agency - Europa EU
17 Jan 2018 - Expert meeting on adeno-associated viral vectors, 06 September 2017, EMA, London. CAT: Martina Schüßler-Lenz. Scope: report of the meeting that took place on 6 September 2017. Action: for adoption. 7.6.3. Environmental assessment of g

minoxidil - European Medicines Agency - Europa EU
Jun 14, 2018 - Page 2/26. Product Name (in authorisation country). MRP/DCP Authorisation number. National Authorisation. Number. MAH of product in the.

Influenza vaccine - European Medicines Agency - Europa EU
Oct 26, 2017 - Injektionssuspension in einer Fertigspritze. Influenza-Impfstoff. (Spaltimpfstoff, inaktiviert, in Zellkulturen hergestellt) not available. BE393556. NANOTHERAPEUTICS. BOHUMIL, S.R.O.. BE. Preflucel injektionsvätska, suspension i för

latanoprost - European Medicines Agency - Europa EU
May 13, 2016 - Send a question via our website www.ema.europa.eu/contact. © European ... Product Name (in authorisation ..... Xaloptic Free. NL/H/3193/001.

Cyproterone/ethinylestradiol - European Medicines Agency - Europa EU
March 2016 a joint database drug utilisation final study report to the European .... With regards to prescription of CPA/EE for contraceptive management, ...

July 2016 - European Medicines Agency - Europa EU
For a list of RSS readers please refer to our RSS guide and follow the instructions ..... PCWP and HCPWP joint meeting: Workshop on social media - Sep 2016.

Stem cell - European Medicines Agency - Europa EU
Jul 14, 2016 - Stem cell-based products for veterinary use: specific ... potentially delay time to rejection providing a window of therapeutic benefit but limiting ...

and academia - European Medicines Agency - Europa EU
Aug 1, 2016 - call from academics to the regulators for supporting independent research (i.e. ... Page 3/5. In this context, the European Medicines Agency has ...