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Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine type Accelerated assessment Remove Accelerated assessment filter Generic Remove Generic filter Biosimilar Remove Biosimilar filter

Medicine Paediatric investigation plans Remove Paediatric investigation plans filter Referrals Remove Referrals filter

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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: 11/10/2021
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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

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Referral: Zynteglo

Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)