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Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Referrals Remove Referrals filter
Categories
Human Remove Human filter
Referral type
Article 6(13) referrals (prior to January 2010) Remove Article 6(13) referrals (prior to January 2010) filter
Article 31 referrals Remove Article 31 referrals filter
Article 107 procedures (prior to July 2012) Remove Article 107 procedures (prior to July 2012) filter
Article 20 procedures Remove Article 20 procedures filter
Referral status
Opinion provided by Committee for Medicinal Products for Human Use Remove Opinion provided by Committee for Medicinal Products for Human Use filter
European Commission final decision Remove European Commission final decision filter
Referral decision making model
PRAC-CHMP-EC Remove PRAC-CHMP-EC filter
Medicine type
Generic Remove Generic filter
Exceptional circumstances Remove Exceptional circumstances filter
Accelerated assessment Remove Accelerated assessment filter
Referral safety status
Yes Remove Yes filter
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan, olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021 -
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Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products
capecitabine, fluorouracil, tegafur, flucytosine, associated names: Xeloda, Teysuno, Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Ecansya (previously Capecitabine Krka), Article 31 referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 07/07/2020, Last updated: 23/07/2020