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3 results
Medicine
Maximum residue limits Remove Maximum residue limits filter
Referrals Remove Referrals filter
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Human Remove Human filter
Referral type
Article 6(12) referrals (prior to January 2010) Remove Article 6(12) referrals (prior to January 2010) filter
Article 107i procedures Remove Article 107i procedures filter
Article 20 procedures Remove Article 20 procedures filter
Article 31 referrals Remove Article 31 referrals filter
Medicine type
Orphan medicine Remove Orphan medicine filter
Exceptional circumstances Remove Exceptional circumstances filter
Accelerated assessment Remove Accelerated assessment filter
Referral PRAC recommendation
Risk minimisation measures Remove Risk minimisation measures filter
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Referral: Zynteglo
betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 22/07/2021, EC decision date: 16/09/2021, Last updated: 08/07/2022 -
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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: 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