For help on how to get the results you want, see our search tips.
2 results
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 type
Article 20 procedures Remove Article 20 procedures filter
Article 29(4) referrals Remove Article 29(4) referrals filter
Article 13 referrals Remove Article 13 referrals filter
Article 31 referrals Remove Article 31 referrals filter
Referral decision making model
PRAC-CHMP-EC Remove PRAC-CHMP-EC filter
Referral authorisation model
Centrally and nationally authorised products (mixed) Remove Centrally and nationally authorised products (mixed) filter
Centrally authorised product(s) Remove Centrally authorised product(s) filter
Referral PRAC recommendation
Risk minimisation measures Remove Risk minimisation measures filter
-
List item
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 -
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