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Referral: Zinbryta
daclizumab, associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, EC decision date: 27/03/2018, Last updated: 11/07/2018 -
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Referral: Factor VIII
associated names: Iblias, Elocta, Kovaltry, Nuwiq, Obizur, NovoEight, Voncento, ReFacto AF, Kogenate Bayer, Helixate NexGen, Advate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/09/2017, EC decision date: 10/10/2017, Last updated: 05/12/2017 -
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Referral: Picato
ingenol mebutate, associated names: Picato, Article 20 procedures
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 06/07/2020, Last updated: 16/11/2020 -
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Referral: Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum
bromocriptine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/08/2014, EC decision date: 30/10/2014, Last updated: 08/12/2014 -
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Referral: Combined hormonal contraceptives
desogestrel, gestodene, norgestimate, etonogestrel, drospirenone, dienogest, chlormadinone, nomegestrol, norelgestromin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/01/2014, Last updated: 31/01/2014 -
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Referral: Corlentor and Procoralan
ivabradine, associated names: Corlentor and Procoralan, Article 20 procedures
Status: European Commission final decision, opinion/position date: 20/11/2014, EC decision date: 15/01/2015, Last updated: 16/02/2015 -
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Referral: Cyproterone- and ethinylestradiol-containing medicines
cyproterone / ethinylestradiol, associated names: Acnemine, Acneson, Chloe, Clairette, Cyprest, Cyprodiol, Diane 35, Dianette, Feminil, Minerva, Zyrona, Article 107i procedures
Status: European Commission final decision, opinion/position date: 29/05/2013, EC decision date: 25/07/2013, Last updated: 05/08/2013 -
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Referral: Diacerein-containing medicines for oral administration
diacerein, associated names: Zondar, Article 31 referrals
Status: European Commission final decision, EC decision date: 04/09/2014, Last updated: 19/09/2014 -
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Referral: Diclofenac-containing medicines
diclofenac, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 25/09/2013, Last updated: 27/11/2013 -
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Referral: Domperidone-containing medicines
domperidone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 01/09/2014, Last updated: 11/09/2014 -
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Referral: SGLT2 inhibitors
canagliflozin, dapagliflozin,empagliflozin, associated names: Edistride, Ebymect, Xigduo, Vokanamet, Synjardy, Jardiance, Invokana, Forxiga, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 28/04/2016, Last updated: 18/05/2016 -
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Referral: Esmya
ulipristal acetate, associated names: Esmya, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/05/2018, EC decision date: 26/07/2018, Last updated: 08/08/2018 -
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Referral: Flupirtine-containing medicines
flupirtine, Article 107i procedures
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 05/09/2013, Last updated: 21/11/2013 -
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Referral: Ambroxol and bromhexine-containing medicines
ambroxol and bromhexine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/11/2015, EC decision date: 14/01/2016, Last updated: 05/02/2016 -
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Referral: Hydroxyethyl starch (HES) containing medicinal products
hydroxyethyl starch (HES), Article 107i procedures
Status: European Commission final decision, opinion/position date: 26/10/2017, EC decision date: 17/07/2018, Last updated: 27/07/2018 -
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Referral: Hydroxyethyl starch solutions for infusion
hydroxyethyl starch, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/10/2013, EC decision date: 19/12/2013, Last updated: 12/01/2018 -
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Referral: Hydroxyethyl starch solutions for infusion
hydroxyethyl starch, Article 107i procedures
Status: European Commission final decision, opinion/position date: 23/10/2013, EC decision date: 19/12/2013, Last updated: 06/03/2014 -
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Referral: Iclusig
ponatinib, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 15/01/2015, Last updated: 02/03/2015 -
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Referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease
beclomethasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 28/04/2016, EC decision date: 29/06/2016, Last updated: 15/07/2016 -
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Referral: Kogenate Bayer and Helixate NexGen
octocog alfa, Article 20 procedures
Status: European Commission final decision, opinion/position date: 19/12/2013, EC decision date: 20/02/2014, Last updated: 09/04/2014 -
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Referral: Lemtrada
alemtuzumab, associated names: Lemtrada, Article 20 procedures
Status: European Commission final decision, opinion/position date: 14/11/2019, EC decision date: 16/01/2020, Last updated: 04/02/2020 -
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Referral: Methotrexate containing medicinal products
methotrexate, associated names: Nordimet, Jylamvo, Ledertrexate, Maxtrex, Metex, Metoject, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/08/2019, EC decision date: 21/10/2019, Last updated: 31/10/2019 -
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Referral: Gadolinium-containing contrast agents
gadobenic acid / gadobutrol / gadodiamide / gadopentetic acid / gadoteric acid / gadoteridol / gadoversetamide / gadoxetic acid, associated names: Optimark, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/07/2017, EC decision date: 23/11/2017, Last updated: 04/12/2017 -
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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: Protelos and Osseor
strontium ranelate, Article 20 procedures
Status: European Commission final decision, opinion/position date: 20/02/2014, EC decision date: 15/04/2014, Last updated: 18/09/2014