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Conditional approval Remove Conditional approval filter
Accelerated assessment Remove Accelerated assessment filter
Referral decision making model
PRAC-CHMP-EC Remove PRAC-CHMP-EC filter
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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: 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