14 results
Keyword Quark Remove keyword
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded small interfering RNA (siRNA) oligonucleotide specific to the mRNA of the caspase 2 gene
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002224-PIP01-17, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 19/12/2017, Last updated: 07/03/2018, Compliance check: XContact for public enquiries Quark Pharmaceuticals, Inc. Tel … application submitted by Quark Pharmaceuticals, Inc. on … decision is addressed to Quark Pharmaceuticals, Inc., 6501 … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded siRNA oligonucleotide directed against p53 mRNA (QPI-1002)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001993-PIP01-16, Route(s) of administration: Solution for injection, Pharmaceutical form(s): Solution for injection
Decision date: 05/12/2016, Last updated: 30/01/2017, Compliance check: XContact for public enquiries Quark Pharmaceuticals Inc. United … application submitted by Quark Pharmaceuticals Inc. on 11 … decision is addressed to Quark Pharmaceuticals Inc., 6501 … -
List item
Referral: Tritace
ramipril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 18/12/2008, EC decision date: 06/03/2009, Last updated: 24/04/2009Ramipril-Zentiva, Unipril, Quark, Zenra, Pramace. The company … Ramipril-Zentiva, Unipril, Quark, Zenra, Pramace. The company … -
List item
Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against p53 mRNA (teprasiran) for: Prevention of delayed graft function after renal transplantation
Date of designation: 06/06/2010, Withdrawn, Last updated: 28/02/2022 -
List item
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 -
List item
Paediatric Committee (PDCO): 12-14 October 2016
European Medicines Agency, London, UK, from 12/10/2016 to 14/10/2016, Last updated: 30/06/2014 -
List item
Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,15-18 December 2008
CHMP, Last updated: 18/12/2008 -
List item
Paediatric Committee (PDCO): 7-10 November 2017
European Medicines Agency, London, UK, from 07/11/2017 to 10/11/2017, Last updated: 03/07/2014EMEA-002224-PIP01-17, from Quark Pharmaceuticals, Inc., for … -
List item
Paediatric Committee (PDCO): 14-16 September 2016
European Medicines Agency, London, UK, from 14/09/2016 to 16/09/2016, Last updated: 30/06/2014 -
List item
News: EMA 2017 annual report published
Last updated: 02/05/2018 -
List item
News: Progress on science, medicines and health
Last updated: 10/05/2017 -
List item
Annual reports and work programmes
Last updated: 28/06/2023 -
List item
PDCO: meeting archive 2015-2017
Last updated: 19/04/2022 -
List item
Public data from Article 57 database
Last updated: 30/06/2023