365 results
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Human medicine European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)
clopidogrel, Acetylsalicylic acid, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 14/03/2010, Revision: 22, Authorised, Last updated: 13/11/2019idogrel/Acetylsalicylic acid Zentiva (previously DuoCover) Cardiovascular … idogrel/Acetylsalicylic acid Zentiva (previously DuoCover … Clopidogrel/Acetylsalicylic acid Zentiva1 clopidogrel / acetylsalicylic … -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan, olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021candesartan, irbesartan, losartan, olmesartan, valsartan) Questions … candesartan, irbesartan, losartan, olmesartan, valsartan) EMA/86733/2021 … candesartan, irbesartan, losartan, olmesartan, valsartan) EMA/86733/2021 … -
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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: 08/10/2014Krka) Irbesartan Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Karvea Sabervel CoAprovel Ifirmacombi Irbesartan/Hydrochlorothiazide … Teva Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … Krka) Irbesartan Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Karvea Sabervel CoAprovel Ifirmacombi Irbesartan/Hydrochlorothiazide … -
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Press release: European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor antagonists remains positive
CHMP, Last updated: 20/10/2011eprosartan, irbesartan, losartan, olmesartan, valsartan and telmisartan … Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … Irbesartan Teva: EPAR Irbesartan Zentiva (previously Irbesartan Winthrop … -
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Human medicine European public assessment report (EPAR): Edarbi
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011, Revision: 10, Authorised, Last updated: 17/03/2022ramipril, valsartan and olmesartan medoxomil). The patients … of valsartan (320 mg) and olmesartan medoxomil (40 mg). Edarbi … ramipril, valsartan and olmesartan medoxomil). The patients … -
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Press release: Valsartan: review of impurities extended to other sartan medicines
CHMP, Last updated: 21/09/2018irbesartan, losartan and olmesartan. Like valsartan, these active … irbesartan, losartan and olmesartan. Like valsartan, these active … Candesartan, irbesartan, losartan, olmesartan and valsartan belong to a … -
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News: Nitrosamines: EMA aligns recommendations for sartans with those for other medicines
CHMP, Last updated: 13/11/2020candesartan, irbesartan, losartan, olmesartan and valsartan, which belong … -
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Press release: EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU
Last updated: 15/10/2018candesartan, irbesartan, losartan, olmesartan and valsartan, which belong … -
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Press release: Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities
CHMP, Last updated: 01/02/2019Olmesartan (40 mg) 96.0 … -
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Press release: Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity
Last updated: 19/11/2018irbesartan, losartan and olmesartan. The review is being carried … -
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National expert: Marek Trneny, European Medicines Agency (updated)
- Declaration of interests - 44.82 KB | PDF
- Curriculum Vitae - 29.86 KB | PDF
Janssen, Morphosys, Novartis, Zentiva Advisory boards in the last … Janssen, Morphosys, Novartis, Zentiva Czech Lymphoma Study Group … -
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Opinion/decision on a Paediatric investigation plan (PIP): valsartan, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001343-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 20/11/2012, Last updated: 04/01/2013, Compliance check: XContact for public enquiries Zentiva, k.s. Czech Republic blanka.zoubkova@zentiva.com … application submitted by Zentiva, k.s. on 2 July 2012 under … decision is addressed to Zentiva, k.s., U kabelovny 130, 102 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001344-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 20/11/2012, Last updated: 04/01/2013, Compliance check: XContact for public enquiries Zentiva, k.s. Czech Republic blanka.zoubkova@zentiva.com … application submitted by Zentiva, k.s. on 2 July 2012 under … decision is addressed to Zentiva, k.s., U kabelovny 130, 102 … -
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Press release: PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system
PRAC, Last updated: 11/04/2014eprosartan, irbesartan, losartan, olmesartan, telmisartan or valsartan … eprosartan, irbesartan, losartan, olmesartan, telmisartan or valsartan … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001344-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/04/2018, Last updated: 26/07/2018, Compliance check: XContact for public enquiries Zentiva, k.s. Tel.: +420 267243574 … -
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Opinion/decision on a Paediatric investigation plan (PIP): hydrochlorothiazide, Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002174-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: XContact for public enquiries Zentiva, k.s. Tel. +42 267242361 E-mail … application submitted by Zentiva, k.s. on 4 May 2017 under … decision is addressed to Zentiva, k.s., U kabelovny 130, 102 … -
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Press release: EU inspection finds Zhejiang Huahai site non-compliant for manufacture of valsartan: EMA and national authorities considering impact on other active substances produced at the site
Last updated: 28/09/2018irbesartan, losartan and olmesartan. The review is being carried … -
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Opinion/decision on a Paediatric investigation plan (PIP): Indapamide, Perindopril erbumine, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001948-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 09/09/2016, Last updated: 27/10/2016, Compliance check: XContact for public enquiries Zentiva, k.s. Czech Republic Tel … application submitted by Zentiva, k.s. on 18 April 2016 under … decision is addressed to Zentiva, k.s., U kabelovny, 102 37 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Telmisartan, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001552-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 07/03/2014, Last updated: 16/04/2014, Compliance check: XContact for public enquiries Zentiva k.s. Czech Republic E-mail … application submitted by Zentiva k.s. on 25 September 2013 … decision is addressed to Zentiva k.s., U kabelovny 130, 102 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Perindopril erbumine, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
PIP number: EMEA-001467-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 23/09/2013, Last updated: 15/11/2013, Compliance check: XContact for public enquiries Zentiva k.s. Czech Republic Email … application submitted by Zentiva k.s. on 12 April 2013 under … decision is addressed to Zentiva k.s., U kabelovny, 102 37 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001319-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 22/10/2012, Last updated: 27/11/2012, Compliance check: XContact for public enquiries Zentiva k.s. Czech Republic blanka.zoubkova@zentiva.com … application submitted by Zentiva k.s. on 1 June 2012 under … decision is addressed to Zentiva k.s., U kabelovny 130, 102 … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-29 May 2019
CHMP, Last updated: 29/05/2019Ambrisentan Zentiva … -
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National expert: Audrey Sultana, Medicines Authority (updated)
- Declaration of interests - 39.2 KB | PDF
- Curriculum Vitae - 26.69 KB | PDF
Application Aripiprazole Zentiva –Marketing Authorisation … Authorisation Application Tenofovir Zentiva –Marketing Authorisation … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2019
CHMP, Last updated: 20/09/2019Bavencio, Benlysta, Docetaxel Zentiva, Dupixent, Lucentis, Remsima … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2015
CHMP, Last updated: 22/05/2015Pregabalin Zentiva …