183 results
Keyword Olmesartan HCS Remove keyword
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma (previously Clopidogrel HCS)
clopidogrel (as hydrochloride), Myocardial Infarction; Peripheral Vascular Diseases; Stroke
Date of authorisation: 21/09/2009,
, Revision: 9, Withdrawn, Last updated: 24/10/2017
Pharma (previously Clopidogrel HCS) Myocardial Infarction Peripheral … Pharma (previously Clopidogrel HCS) … Previously known as Clopidogrel HCS. Me dic ina l p ro du ct … -
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Human medicine European public assessment report (EPAR): Clopidogrel HCS
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/10/2010,, Revision: 8, Authorised, Last updated: 01/08/2018
Clopidogrel HCS Vascular Diseases Cardiovascular … report (EPAR) for Clopidogrel HCS. It explains how the The committee … conditions of use for Clopidogrel HCS. What is Clopidogrel HCS? Clopidogrel HCS is a blood-thinning medicine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, rosuvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001914-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/06/2016, Last updated: 26/08/2016, Compliance check: XKey facts Olmesartan medoxomil rosuvastatin calcium … product specific waiver for olmesartan (medoxomil) / rosuvastatin … product specific waiver for olmesartan (medoxomil) / rosuvastatin … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, 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-001852-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/11/2015, Last updated: 07/01/2016, Compliance check: XKey facts Olmesartan medoxomil Amlodipine besilate … product specific waiver for olmesartan medoxomil / amlodipine (besilate … product specific waiver for olmesartan medoxomil / amlodipine (besilate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, 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-001538-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/12/2013, Last updated: 05/02/2014, Compliance check: XKey facts Olmesartan medoxomil Amlodipine besilate … for amlodipine (besilate) / olmesartan (medoxomil) (EMEA-001538-PIP01-13 … for amlodipine (besilate) / olmesartan (medoxomil) (EMEA-001538-PIP01-13 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate … Key facts Olmesartan medoxomil Amlodipine besilate … product specific waiver for olmesartan medoxomil / amlodipine besilate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate … Key facts Olmesartan medoxomil Amlodipine besilate … product specific waiver for olmesartan medoxomil / amlodipine besilate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate … Key facts Olmesartan medoxomil Amlodipine besilate … product specific waiver for olmesartan medoxomil / amlodipine besilate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, hydrochlorothiazide, 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-002104-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 03/07/2017, Last updated: 24/07/2017, Compliance check: XActive substance Olmesartan medoxomil hydrochlorothiazide … product specific waiver for olmesartan medoxomil / amlodipine (besilate … product specific waiver for olmesartan medoxomil / amlodipine (besilate … -
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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: 08/10/2014Actavis captopril imidapril zofenopril candesartan delapril telmisartan aliskiren moexipril enalapril valsartan fosinopril irbesartan perindopril quinapril ramipril eprosartan olmesartan trandolapril losartan azilsartan lisinopril spirapril benazepril cilazapril telmisartan hydrochlorothiazide telmisartan telmisartan telmisartan telmisartan amlodipine telmisartan amlodipine telmisartan hydrochlorothiazide telmisartan hydrochlorothiazide telmisartan hydrochlorothiazide amlodipine valsartan hydrochlorothiazide amlodipine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin calcium, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001364-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: Xand dyslipidaemia Oral use HCS bvba E-mail: info hcsbvba.be Country: Belgium Tel … application submitted by HCS bvba on 26 September 2012 … decision is addressed to HCS bvba, H Kennisstraat 53 … -
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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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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2010
CHMP, Last updated: 23/07/2010Clopidogrel HCS and Clopidogrel Teva Generics … Plavix. • Clopidogrel HCS and Clopidogrel Teva Generics … Teva Pharma B.V. and from HCS bvba, for the prevention … -
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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: 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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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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National expert: Harald Hundsberger, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 79.91 KB | PDF
- Curriculum Vitae - 24.34 KB | PDF
drug discovery, HTS-Assays, HCS- Assays; 2005- Present Prof … -
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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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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 … eprosartan, irbesartan, losartan, olmesartan, valsartan and telmisartan … eprosartan, irbesartan, losartan, olmesartan, telmisartan and valsartan … -
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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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National expert: Antonio Portolés, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 83 KB | PDF
- Curriculum Vitae - 41.23 KB | PDF
Biomedical Research Foundation of HCSC Antonio Portolés Pérez … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018
CHMP, Last updated: 21/09/2018irbesartan, losartan and olmesartan. For more information, please …