283 results
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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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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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National expert: Audrey Sultana, Medicines Authority (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 26.68 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) 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) 20-23 April 2015
CHMP, Last updated: 24/04/2015Aripiprazole 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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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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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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National expert: Silvia Cârstoiu, National Authority Of Medicines And Medical Devices (updated)
- Declaration of interests - 41.12 KB | PDF
- Curriculum Vitae - 25.33 KB | PDF
Country: Romania 2. Employer: Zentiva (at that time the Romanian … -
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National expert: John Joseph Borg, Medicines Authority (updated)
- Declaration of interests - 39.97 KB | PDF
- Curriculum Vitae - 35.89 KB | PDF
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National expert: Julia Pallos, National Institute of Pharmacy and Nutrition (updated)
- Declaration of interests - 39.86 KB | PDF
- Curriculum Vitae - 26.4 KB | PDF
Country: Hungary 6. Employer: Zentiva Ltd • Start date: 072007 • … -
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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 … -
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Press release: PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel
PRAC, Last updated: 09/06/2017Docetaxel Teva: EPAR Docetaxel Zentiva (previously Docetaxel Winthrop … Taxotere: EPAR Docetaxel Zentiva (previously Docetaxel Winthrop … -
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National expert: Miroslava Horváth Petriková, State Institute for Drug Control (updated)
- Declaration of interests - 40.64 KB | PDF
- Curriculum Vitae - 28.15 KB | PDF
the pharmaceutical company Zentiva k.s., awarded work: Preparation … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2016
CHMP, Last updated: 22/07/2016Tenofovir disoproxil Zentiva … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2013
CHMP, Last updated: 28/06/2013Irbesartan Zentiva INN irbesartan Marketing-authorisation … co-administer Irbesartan Zentiva with aliskiren-containing … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016
CHMP, Last updated: 16/12/2016Pregabalin Zentiva k.s …