11 January 2018 EMA/24814/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: human rabies immunoglobulin

Procedure no.: PSUSA/00001639/201704

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 authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Berirab ® P*

not available

2-00158

CSL BEHRING GMBH

AT

not available

107A/89

CSL BEHRING GMBH

DE

not available

MA049/00601

BIO PRODUCTS LABORATORY

MT

not available

PL 08801/0014

BIO PRODUCTS LABORATORY

UK

not available

56.139

SANOFI PASTEUR EUROPE

ES

not available

99-0170

SANOFI PASTEUR SA

LV

not available

LT/1/97/3291/001

SANOFI PASTEUR SA

LT

not available

LT/1/97/3291/002

SANOFI PASTEUR SA

LT

Fertigspritze Berirab® Injektionslösung zur intramuskulären Anwendung Human Rabies Immunoglobulin, not less than 150 IU/mL solution for injection Human Rabies Immunoglobulin, not less than 150 IU/mL solution for injection IMOGAM RABIA 150 UI/ml, solución inyectable IMOGAM RABIES 150 SV/ml, šķīdums injekcijām. Immunoglobulinum humanum rabicum IMOGAM RABIES 150 TV/ml injekcinis tirpalas Žmogaus pasiutligės imunoglobulinas IMOGAM RABIES 150 TV/ml injekcinis tirpalas Žmogaus pasiutligės List of nationally authorised medicinal products EMA/24814/2018

Page 2/3

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

not available

342101

SANOFI PASTEUR SA

EE

not available

NL 18 705

SANOFI PASTEUR SA

FR

not available

13A/97

SANOFI PASTEUR EUROPE

DE

imunoglobulinas

IMOGAM RABIES, PASTEURIZED, 150 RÜ/ml süstelahus IMOGAM RAGE 150 UI/ml, solution injectable Tollwutglobulin Mérieux P mind. 150 I.E./ml Injektionslösung

List of nationally authorised medicinal products EMA/24814/2018

Page 3/3

Human rabies immunoglobulin - European Medicines Agency

Jan 11, 2018 - SANOFI PASTEUR SA. LV. IMOGAM RABIES 150. TV/ml injekcinis tirpalas. Žmogaus pasiutligės imunoglobulinas not available. LT/1/97/3291/001. SANOFI PASTEUR SA. LT. IMOGAM RABIES 150. TV/ml injekcinis tirpalas. Žmogaus pasiutligės not available. LT/1/97/3291/002. SANOFI PASTEUR SA. LT ...

84KB Sizes 0 Downloads 250 Views

Recommend Documents

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.

Varicella zoster-immunoglobulin - European Medicines Agency
Sep 1, 2017 - Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525. Send a question via our website www.ema.europa.eu/contact. © European ...

Human Medicines Highlights Newsletter - European Medicines Agency
Mar 8, 2018 - Treatment of uterine fibroids. Haematology. New medicines authorised. • Adynovi (rurioctocog alfa pegol). Treatment and prevention of bleeding in patients with haemophilia A. New information on authorised medicines. • Feraccru (ferr

Human Medicines Highlights Newsletter - European Medicines Agency
Treatment of cystine crystal deposits in the eye. New information on authorised medicines. Lucentis (ranibizumab) - change in indication. Treatment of visual ...

Human Medicines Highlights Newsletter - European Medicines Agency
The new EudraVigilance system and the electronic reporting of individual case ... the ISO/ICH E2B(R3) format: hands-on training course - October 2017 ... granted a conditional marketing authorisation on the basis of less complete clinical data ...

Human medicines highlights newsletter - European Medicines Agency
PCWP and HCPWP joint meeting - Sept 2016 - meeting documents. • Workshop on identifying opportunities for 'big data' in medicines development and ...

Human Medicines Highlights Newsletter - European Medicines Agency
Used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss .... EMA's Business Continuity Plan for Brexit published.

Human Medicines Highlights Newsletter - European Medicines Agency
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a ... Withdrawal of applications for new medicines .... fifth annual regulatory conference on optimising the development of advanced therapies to.

Human Medicines Highlights Newsletter - European Medicines Agency
Implant used to help new bone develop in patients with spinal disc problems and leg fractures .... E-mail [email protected] Website www.ema.europa.eu.

Human Medicines Highlights Newsletter - European Medicines Agency
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a desktop news reader. For a list of RSS readers please refer to ...

Human medicines highlights - June 2017 - European Medicines Agency
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a desktop news reader. For a list of RSS readers please refer to ...

Human medicines highlights - European Medicines Agency - Europa EU
For a list of RSS readers please refer to our RSS guide and follow the instructions .... granted a conditional marketing authorisation on the basis of less complete ...

Notice - European Medicines Agency
Apr 28, 2017 - 2. The United Kingdom will then become a 'third country'. 3. Preparing for the withdrawal is therefore not just a matter for EU and national authorities, but also for private parties. In view of the considerable uncertainties, in parti

Report - European Medicines Agency
May 30, 2017 - Pharmaceutical companies are invited to present their pre-clinical data pertaining to ... patients per year, as many questions about the best use of ALK ... of knowledge and evidence to support the planning and regulatory.

Human medicines highlights - April 2016 - European Medicines Agency
monitoring. 5. Guidelines. 5. Scientific .... Updated list of medicinal products under additional monitoring. Other information. Guidelines. Guidelines open for consultation ... CHMP -applications for new human medicines under evaluation: April 2016

Human medicines highlights - European Medicines Agency - Europa EU
HUMAN MEDICINES. HIGHLIGHTS. Issue 105. December 2017. This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use

Human medicines highlights - European Medicines Agency - Europa EU
Jan 29, 2018 - professionals. It provides a summary of key information relating to medicines for human use published ... Information is selected based on recommendations from consulted patients, consumers and healthcare professionals, and .... 30 Chu

Human medicines highlights - April 2016 - European Medicines Agency
desktop news reader. For a list of RSS readers please .... CHMP -applications for new human medicines under evaluation: April 2016. • 2016 work plan for the ...

Veterinary medicines highlights 2016 - European Medicines Agency
Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...

Agenda - European Medicines Agency - europa.eu
4 days ago - EMA/CAT/426129/2018. Page 2/17. Table of contents. 1. Introduction. 5. 1.1. Welcome and declarations of interest of members, alternates and ...

Finasteride - European Medicines Agency - europa.eu
Apr 25, 2018 - Page 2/8. Product Name (in authorisation country). MRP/DCP. Authorisation number. National Authorisation Number. MAH of product in the.

Agenda - European Medicines Agency - europa.eu
Sep 8, 2016 - 3-year report on Pharmacovigilance activities. Helen Lee, European Commission. •. Scanning the horizon for 2016 – 2018. Peter Arlett, EMA.

Agenda - European Medicines Agency veterinary medicines ...
On arriving for your meeting at 30 Churchill Place, please report to reception where you will be issued with an access pass. This pass will allow you to enter our industry lounge, which you are welcome to utilise during your visit. The industry loung

Veterinary medicines highlights 2016 - European Medicines Agency
Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...