Pharmaceuticals - Community Register

  

List of referrals for human medicinal products

Gadolinium

Product name: Gadolinium
Also marketed in the EU under the name(s): Dotarem, Gadograf, Gadopentetat Insight, Gadopentetat-Dimeglumin, Gadopentetat-MRT-ratiopharm, Gadopentetate Curagita, Gadopentetate Insight, Gadopentetsyrad imegluminat Insight, Gadopentetsäure Insight, Gadovist, Magnegita, Magnevision, Magnevist, Magnograf, Marktiv, MR-Lux, MultiHance, Omniscan, Primovist, Prohance, Vasovist
INN: gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoteridol, gadobutrol and gadoteric acid
Indication: The gadolinium-containing contrast agents (GdCAs) are intravenous agents used for contrast enhancement with magnetic resonance imaging (MRI) and with magnetic resonance angiography (MRA)
Marketing Authorisation Holder: Not applicable

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
05/07/2010 Referral EMEA/H/A-31/1097 (2010)4676 of 01/07/2010
15/10/2010 Corrigendum (2010)4676 cor of 14/10/2010
13/05/2011 Corrigendum (2010)4676 CORR of 12/05/2011