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

Categories Human Remove Human filter

Referral PRAC recommendation Risk minimisation measures Remove Risk minimisation measures filter Suspension Remove Suspension filter No further action Remove No further action 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 status European Commission final decision Remove European Commission final decision filter

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

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

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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: Renin-angiotensin-system (RAS)-acting agents

captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014

2 results

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

Referral: Renin-angiotensin-system (RAS)-acting agents