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Referral: Xeljanz (updated)
tofacitinib, ?> associated names: Xeljanz, Article 20 procedures
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 14/11/2019, Last updated: 15/11/2019 -
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Referral: Lartruvo
olaratumab, ?> associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019 -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan and 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: 31/01/2019, EC decision date: 02/04/2019, Last updated: 20/08/2019 -
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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: 19/03/2019 -
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Referral: Xofigo
radium Ra223 dichloride, ?> associated names: Xofigo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 26/07/2018, EC decision date: 28/09/2018, -
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Referral: Zinbryta
daclizumab, ?> associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, EC decision date: 27/03/2018, -
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Referral: Zinbryta
daclizumab, ?> associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, opinion/position date: 09/11/2017, EC decision date: 08/01/2018, Last updated: 12/01/2018 -
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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, -
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Referral: SGLT2 inhibitors (previously canagliflozin)
canagliflozin, empagliflozin, dapagliflozin, canagliflozin / metformin, empagliflozin / metformin, dapagliflozin / metformin, ?> associated names: Xigduo, Ebymect, Edistride, Synjardy, Forxiga, Jardiance, Vokanamet, Invokana, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 04/05/2017, -
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Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir, ?> associated names: Sovaldi, Olysio, Viekirax, Harvoni, Exviera, Daklinza, Article 20 procedures
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 23/02/2017, -
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Referral: Metformin and metformin-containing medicines
metformin, ?> associated names: Xigduo, Vipdomet, Velmetia, Synjardy, Ristfor, Komboglyze, Jentadueto, Janumet, Icandra (previously Vildagliptin / metformin hydrochloride Novartis), Glubrava, Eucreas, Efficib, Ebymect, Competact, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/10/2016, EC decision date: 12/12/2016, -
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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, -
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Referral: Tysabri
natalizumab, ?> associated names: Tysabri, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 25/04/2016, Last updated: 12/05/2016 -
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, ?> associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014 -
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Referral: Picato
ingenol mebutate, ?> associated names: Picato, Article 20 procedures
Status: Under evaluation, Last updated: 06/09/2019 -
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Orphan designation: for: Treatment of hypophosphatasia (updated)
Date of first decision: 04/12/2008, Positive, Last updated: 20/11/2019 -
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Orphan designation: for: Treatment of lysosomal acid lipase deficiency (updated)
Date of first decision: 17/12/2010, Positive, Last updated: 20/11/2019 -
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Orphan designation: for: Treatment myasthenia gravis (updated)
Date of first decision: 29/07/2014, Positive, Last updated: 20/11/2019 -
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Orphan designation: for: Treatment of neuromyelitis optica spectrum disorders (updated)
Date of first decision: 05/08/2013, Positive, Last updated: 20/11/2019 -
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Orphan designation: for: Treatment of atypical haemolytic uraemic syndrome (aHUS) (updated)
Date of first decision: 24/07/2009, Positive, Last updated: 20/11/2019 -
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Orphan designation: for: Treatment of acute myeloid leukaemia
Date of first decision: 17/01/2018, Positive, Last updated: 08/11/2019 -
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Orphan designation: for: Treatment of hyperargininaemia
Date of first decision: 10/06/2010, Positive, Last updated: 12/07/2019 -
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Orphan designation: for: Ornithine translocase deficiency (hyperornithinaemia-hyperammonaemia homocitrullinuria (HHH) syndrom
Date of first decision: 10/06/2010, Positive, Last updated: 12/07/2019 -
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Orphan designation: for: Treatment of argininosuccinic aciduria
Date of first decision: 10/06/2010, Positive, Last updated: 12/07/2019 -
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Orphan designation: for: Treatment of citrullinaemia type 1
Date of first decision: 10/06/2010, Positive, Last updated: 12/07/2019