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6 results

Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Referrals Remove Referrals filter

Referral PRAC recommendation Revocation Remove Revocation filter Risk minimisation measures Remove Risk minimisation measures filter No further action Remove No further action filter Variation Remove Variation filter

Referral status CMDh final position Remove CMDh final position filter European Commission final decision Remove European Commission final decision filter

Referral decision making model PRAC-CHMP-EC Remove PRAC-CHMP-EC filter

Referral type Article 20 procedures Remove Article 20 procedures filter

Medicine type Accelerated assessment Remove Accelerated assessment filter Additional monitoring Remove Additional monitoring filter

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Referral: Janus kinase inhibitors (JAKi) (updated)

tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib, associated names: Xeljanz, Cibinqo, Olumiant, Rinvoq, Jyseleca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/01/2023, EC decision date: 10/03/2023, Last updated: 22/05/2023
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Referral: Lemtrada

alemtuzumab, associated names: Lemtrada, Article 20 procedures
Status: European Commission final decision, opinion/position date: 14/11/2019, EC decision date: 16/01/2020, Last updated: 04/02/2020
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Referral: Xofigo

radium Ra223 dichloride, associated names: Xofigo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 26/07/2018, EC decision date: 28/09/2018, Last updated: 11/10/2018
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Referral: Zinbryta

daclizumab, associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, opinion/position date: 09/11/2017, EC decision date: 08/01/2018, Last updated: 12/01/2018
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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: Zydelig

idelalisib, associated names: Zydelig, Article 20 procedures
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 15/09/2016, Last updated: 03/10/2016

6 results

Referral: Janus kinase inhibitors (JAKi) (updated)

Referral: Lemtrada

Referral: Xofigo

Referral: Zinbryta

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

Referral: Zydelig