348 results
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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: Committee for Medicinal Products for Human Use 26-28 June 2006
CHMP, Last updated: 29/06/2006medicinal products containing doxazosin, concluding that the benefit-risk … authorisation should be granted. Doxazosin-containing medicines are approved in … medicinal products containing doxazosin, concluding that the benefit-risk … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 20-23 March 2006
CHMP, Last updated: 24/03/2006doxazosin … procedure for three generic doxazosin-containing medicines: Cardoreg from … and the generic versions. Doxazosin-containing medicines are approved in … -
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National expert: Jan Smolka, State Institute for Drug Control (updated)
- Declaration of interests - 41.21 KB | PDF
- Curriculum Vitae - 32.32 KB | PDF
Employer: Zentiva k.s. • Start date: 042015 • … indication Past 01-12- 2015 01-10- 2018 Zentiva, k.s. Cross product responsibility … -
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National expert: María Estela Moreno Martín, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 39.35 KB | PDF
- Curriculum Vitae - 26.19 KB | PDF
P2_16 • Calderón A et al. Doxazosine GITS is safe and more effective … A et al. The addition of doxazosine GITS in diabetic hypertensive … -
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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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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: Xessential hypertension Oral use Zentiva k.s. Czech Republic E-mail … application submitted by Zentiva k.s. on 9 July 2013 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-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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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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Referral: Tritazide
ramipril, hydrochlorothiazide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 18/12/2008, EC decision date: 06/03/2009, Last updated: 14/04/2009Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur, Idroquark … Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur, Idroquark … -
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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) 20-23 April 2015
CHMP, Last updated: 24/04/2015Aripiprazole Zentiva … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected)
CHMP, Last updated: 21/09/2016Ivabradine Zentiva … -
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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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Referral: Ikorel and Dancor
nicorandil, Article 30 referrals
Status: European Commission final decision, opinion/position date: 26/03/2015, EC decision date: 05/06/2015, Last updated: 30/06/2015Adancor, Angicor and Nicorandil Zentiva. The companies that market … Adancor, Angicor and Nicorandil Zentiva. The companies that market … Paris France NICORANDIL ZENTIVA 10 mg scored tablet oral … -
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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) 15-18 May 2017
CHMP, Last updated: 19/05/2017Emtricitabine / Tenofovir disoproxil Zentiva … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2015
CHMP, Last updated: 26/06/2015Duloxetine Zentiva … -
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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 … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 November 2014
CHMP, Last updated: 21/11/2014Sevelamer carbonate Zentiva …