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3 results
Referral authorisation model
Nationally authorised product(s) Remove Nationally authorised product(s) filter
Centrally and nationally authorised products (mixed) Remove Centrally and nationally authorised products (mixed) filter
Medicine
Periodic safety update report single assessments Remove Periodic safety update report single assessments filter
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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 -
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Referral: Paracetamol modified-release
paracetamol, associated names: Alvedon, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2017, EC decision date: 19/02/2018, Last updated: 01/03/2018 -
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Referral: Tetrazepam-containing medicines
tetrazepam, associated names: Myolastan and generics, Article 107i procedures
Status: European Commission final decision, opinion/position date: 24/04/2013, EC decision date: 29/05/2013, Last updated: 18/07/2013