For help on how to get the results you want, see our search tips.
2 results
Medicine type
Generic Remove Generic filter
Accelerated assessment Remove Accelerated assessment filter
Conditional approval Remove Conditional approval filter
Additional monitoring Remove Additional monitoring filter
Medicine
Referrals Remove Referrals filter
Withdrawn applications Remove Withdrawn applications filter
Referral PRAC recommendation
Risk minimisation measures Remove Risk minimisation measures filter
Variation Remove Variation filter
Categories
Human Remove Human filter
Referral authorisation model
Centrally and nationally authorised products (mixed) Remove Centrally and nationally authorised products (mixed) filter
Referral safety status
Yes Remove Yes filter
-
List item
Referral: Quinolone- and fluoroquinolone-containing medicinal products
nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin, associated names: Quinsair, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 11/03/2019, Last updated: 08/06/2023 -
List item
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