For help on how to get the results you want, see our search tips.
3 results
Medicine
Shortages Remove Shortages filter
Referrals Remove Referrals filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Biosimilar Remove Biosimilar filter
Conditional approval Remove Conditional approval filter
Referral status
European Commission final decision Remove European Commission final decision filter
Opinion provided by Committee for Medicinal Products for Human Use Remove Opinion provided by Committee for Medicinal Products for Human Use filter
Referral PRAC recommendation
Risk minimisation measures Remove Risk minimisation measures filter
-
List item
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 -
List item
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 -
List item
Referral: Iclusig
ponatinib, associated names: Iclusig, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 15/01/2015, Last updated: 02/03/2015