Genzyme Europe

Health Care Professionals

Health Care Professionals

Products Approved under the Centralised Procedure

This table contains information for the Genzyme products which have been granted Marketing Authorisation by the European Commission through the Centralised (or ‘Community’) procedure. These marketing authorisations are valid in all European Union (EU) and EEA-EFTA states (Iceland, Liechtenstein and Norway). Due to the nature of this authorisation, information regarding these products is harmonised across these markets. These links point to the English language version, but identical product information is available within each market in the national languages of these countries. However Genzyme Europe is also the Marketing Authorisation Holder for several other products which are either medical devices or have been authorised under national or mutual recognition procedures. Because the labelling and use of these products can vary from one member state to another the English language product information is not representative for all member states, and is not presented here.

Genzyme Product

Product Information
(SmPC, PIL, Labeling)

Direct Health Care Professional Communications

Aldurazyme®
(Laronidase)

Product Information


Cerezyme®
(Imiglucerase)

Product Information

DHPC 2010-09-23
DHPC 2010-07-05
DHPC 2010-04-22
DHPC 2010-02-17
DHPC 2009-12-01
DHPC 2009-10

Cholestagel®
(Colesevelam Hydrochloride)

Product Information


Evoltra®
(Clofarabine)

Product Information


Fabrazyme®
(Agalsidase beta)

Product Information

EMA Press Release 2010-10-22

DHPC 2010-07-05
DHPC 2010-04-22
DHPC 2010-02-17

DHPC 2009-12-01
DHPC 2009-09

MabCampath®
(Alemtuzumab)

Product Information


Mozobil®
(Plerixafor)

Product Information


Myozyme®
(Alglucosidase alfa)

Product Information


Renagel®
(Sevelamer)

Product Information


Renvela®
(Sevelamer Carbonate)

Product Information


Thyrogen®
(Thyrotropin alfa)

Product Information

DHPC 2009-12-01

Contact Info:

Genzyme Europe B.V.
Gooimeer 10
1411 DD Naarden
The Netherlands
Chamber of Commerce (KvK): 32050737
VAT (BTW): NL800256888B01
Tel: +31 35 699 1200
Fax: +31 35 694 3214
genzymeEU@genzyme.com
Email Genzyme