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243 results
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Summary of opinion: Flynpovi (updated)
eflornithine, sulindac, opinion date: 24/06/2021, Negative, Last updated: 23/07/2021 -
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Summary of opinion: Abevmy
bevacizumab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Lextemy
bevacizumab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Koselugo
selumetinib, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Darzalex
daratumumab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Summary of opinion: Galafold
migalastat, opinion date: 24/06/2021, Positive, Last updated: 25/06/2021 -
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Summary of opinion: Voxzogo
vosoritide, opinion date: 24/06/2021, Positive, Last updated: 25/06/2021 -
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Summary of opinion: Minjuvi
tafasitamab, opinion date: 24/06/2021, Positive, Last updated: 25/06/2021 -
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Summary of opinion: Byooviz
ranibizumab, opinion date: 24/06/2021, Positive, Last updated: 24/06/2021 -
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Summary of opinion: Abecma
idecabtagene vicleucel, opinion date: 24/06/2021, Positive, Last updated: 25/06/2021 -
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Summary of opinion: Nexviadyme (new)
Avalglucosidase alfa, opinion date: 23/07/2021, Positive, Last updated: 23/07/2021 -
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Summary of opinion: Vosevi (new)
sofosbuvir, velpatasvir, voxilaprevi, opinion date: 22/07/2021, Positive, Last updated: 23/07/2021 -
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Summary of opinion: Deltyba (new)
delamanid, opinion date: 22/07/2021, Positive, Last updated: 23/07/2021 -
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Summary of opinion: Maviret
glecaprevir, pibrentasvir, opinion date: 22/04/2021, Positive, Last updated: 26/04/2021 -
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Referral: Zynteglo (updated)
betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 22/07/2021, Last updated: 23/07/2021 -
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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: 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, Last updated: 09/03/2017 -
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Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid for: Treatment of progressive familial intrahepatic cholestasis (updated)
Date of designation: 17/07/2012, Positive, Last updated: 28/07/2021 -
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Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA (elivaldogene autotemcel) for: Treatment of adrenoleukodystrophy (updated)
Date of designation: 06/06/2012, Positive, Last updated: 27/07/2021 -
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Orphan designation: Setmelanotide for: Treatment of pro-opiomelanocortin deficiency (updated)
Date of designation: 14/07/2016, Positive, Last updated: 22/07/2021 -
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Orphan designation: Setmelanotide for: Treatment of leptin receptor deficiency (updated)
Date of designation: 19/11/2018, Positive, Last updated: 22/07/2021 -
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Orphan designation: Treprostinil sodium for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (updated)
Date of designation: 14/04/2004, Positive, Last updated: 16/07/2021 -
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Orphan designation: Carboxypeptidase G2 (glucarpidase) for: Adjunctive treatment in patients at risk of methotrexate toxicity (updated)
Date of designation: 03/02/2003, Positive, Last updated: 06/07/2021 -
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Orphan designation: "Synthetic 47-amino-acid N-myristoylated lipopeptide, derived from the preS region of hepatitis B virus (bulevirtide) for: Treatment of hepatitis delta virus infection (updated)
Date of designation: 19/06/2015, Positive, Last updated: 30/06/2021 -
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Orphan designation: Humanised anti-IL-6 receptor monoclonal antibody (satralizumab) for: Treatment of neuromyelitis optica spectrum disorders (updated)
Date of designation: 27/06/2016, Positive, Last updated: 30/06/2021