16928 results
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Human medicine European public assessment report (EPAR): Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 20/04/2007, Revision: 30, Withdrawn, Last updated: 20/05/2022Docetaxel Zentiva (previously Docetaxel Winthrop) Neoplasms Cancer Breast … Docetaxel Zentiva (previously Docetaxel Winthrop … EMEA/H/C/000808 Public statement Docetaxel Zentiva Withdrawal of the … -
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Withdrawn application: Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, date of withdrawal: 14/11/2008, Post-authorisation, Last updated: 17/11/2008Docetaxel Winthrop: Withdrawn applicati … acknowledged. London, 24 July 2008 Doc. Ref. EMEA/384759/2008 … AUTHORISATION for Taxotere/Docetaxel Winthrop International … -
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Human medicine European public assessment report (EPAR): Docetaxel Kabi
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,
, Revision: 15, Authorised, Last updated: 29/09/2023
Docetaxel Kabi Cancer Neoplasms Breast … Docetaxel Kabi … initial authorisation) Docetaxel Kabi docetaxel On 15 March 2012 the Committee … -
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Human medicine European public assessment report (EPAR): Docetaxel Accord
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 17, Authorised, Last updated: 14/09/2023
Docetaxel Accord Cancer Neoplasms Breast … Docetaxel Accord … Package size EU/1/12/769/001 Docetaxel Accord 20 mg/1 ml Concentrate … -
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Human medicine European public assessment report (EPAR): Docetaxel Teva
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 26/01/2010,, Revision: 18, Withdrawn, Last updated: 14/12/2021
Docetaxel Teva Cancer Neoplasms Breast … Docetaxel Teva … EMEA/H/C/001107 Public statement Docetaxel Teva Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Docetaxel Mylan
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 31/01/2012,, Revision: 6, Withdrawn, Last updated: 12/03/2015
Docetaxel Mylan Head and Neck Neoplasms Carcinoma … Docetaxel Mylan … Rev. 1 Public statement Docetaxel Mylan Cessation of validity … -
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Human medicine European public assessment report (EPAR): Docefrez
docetaxel, Stomach Neoplasms; Adenoma; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Prostatic Neoplasms
Date of authorisation: 10/05/2010,, Revision: 1, Withdrawn, Last updated: 14/06/2012
Docefrez Stomach Neoplasms Adenoma Breast … Docefrez … Docefrez, INN docetaxel 7 Westferry Circus … -
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Withdrawn application: Docetaxel Mylan
docetaxel, date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 26/03/2010Docetaxel Mylan: Withdrawn application … Docetaxel Mylan: Withdrawal of the … authorisation application for Docetaxel Mylan docetaxel) On 8 March 2010, Mylan … -
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Human medicine European public assessment report (EPAR): Docetaxel Teva Pharma
docetaxel, Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms
Date of authorisation: 21/01/2011,, Revision: 6, Withdrawn, Last updated: 21/01/2014
Docetaxel Teva Pharma Carcinoma, Non-Small-Cell … Docetaxel Teva Pharma … Public statement on Docetaxel Teva Pharma 7 Westferry … -
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Withdrawn application: Docetaxel SUN
docetaxel, date of withdrawal: 06/06/2016, Initial authorisation, Last updated: 29/09/2016Docetaxel SUN: Withdrawn application … authorisation application for Docetaxel Sun docetaxel) On 6 June 2016, Sun … marketing authorisation for Docetaxel Sun, for the treatment of … -
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Human medicine European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited )
docetaxel trihydrate, Stomach Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 28/08/2015,, Revision: 8, Withdrawn, Last updated: 15/10/2019
Taxespira (previously Docetaxel Hospira UK Limited ) Stomach … Taxespira (previously Docetaxel Hospira UK Limited … Taxespira (previously Docetaxel Hospira UK Limited docetaxel docetaxel trihydrate … -
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Human medicine European public assessment report (EPAR): Taxotere
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 27/11/1995, Revision: 50, Authorised, Last updated: 24/03/2023docetaxel … EMEA/H/C/000073 Taxotere (docetaxel) An overview of Taxotere … contains the active substance docetaxel. How is Taxotere used … -
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Opinion/decision on a Paediatric investigation plan (PIP): Taxotere, docetaxel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: Docetaxel, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate and solvent for solution for infusion
Decision date: 16/05/2008, Last updated: 04/06/2008, Compliance check: XDocetaxel Oncology … Docetaxel … Word - Decision and Opinon docetaxel 0000029-PIP01-07 to be publi… … -
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Withdrawn application: Taxotere
docetaxel, date of withdrawal: 14/11/2008, Post-authorisation, Last updated: 17/11/2008acknowledged. London, 24 July 2008 Doc. Ref. EMEA/384759/2008 … AUTHORISATION for Taxotere/Docetaxel Winthrop International … non-proprietary name (INN): docetaxel On 24 July 2008, the Committee … -
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Referral: Vasotop P
ramipril, Article 13
Status: European Commission final decision, opinion/position date: 08/12/2009, EC decision date: 27/04/2010, Last updated: 14/08/2014contain the active ingredient ramipril at concentrations of 0.625 … and 2.5 mg respectively. Ramipril is an angiotensin-converting … to assess the efficacy of ramipril in cats to reduce systolic … -
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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: 24/04/2009active substance in Tritace, ramipril, is an angiotensin-converting … Protect Startset, Delix P, Ramipril Winthrop Ramipril Prevent, Loavel, Ramiwin Ramipril Medgenerics, Ramilich, Tritace … London, 18 March 2009 Doc. Ref. EMEA/CHMP/233264/2009 … -
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Orphan designation: Ramiprilat for: Treatment of Stargardt's disease
Date of designation: 12/03/2013, Positive, Last updated: 17/01/2023Ramiprilat Overview On 12 March 2013 … Iris Pharma, France, for ramiprilat for the treatment of Stargardt's … medicine expected to work? Ramiprilat is an angiotensin-converting-enzyme … -
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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: 14/04/2009contains two active substances, ramipril and hydrochlorothiazide Ramipril is an angiotensin converting … adequately controlled with ramipril alone or hydrochlorothiazide … Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor … -
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Referral: Rambis and associated names
ramipril, bisoprolol fumarate, associated names: Ralbior, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/12/2022, EC decision date: 15/02/2023, Last updated: 08/03/2023authorisation of Rambis (ramipril / bisoprolol) in the EU On … combination of two medicines called ramipril and bisoprolol. Rambis contains … bisoprolol. Rambis contains both ramipril and bisoprolol and is intended … -
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Opinion/decision on a Paediatric investigation plan (PIP): Telmisartan, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000045-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 01/02/2008, Last updated: 15/02/2008, Compliance check: XActive substance Telmisartan Ramipril Therapeutic area Cardiovascular … and/or distribution of this document is authorised for non-commercial … EMEA is acknowledged Doc. Ref.:EMEA/43360/2008 P/3/2008 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, Indapamide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002081-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 05/05/2017, Last updated: 04/07/2017, Compliance check: XActive substance Ramipril Indapamide Therapeutic area … product specific waiver for ramipril / indapamide (EMEA-002081-PIP01-16 … product specific waiver for ramipril / indapamide (EMEA-002081-PIP01-16 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001871-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 04/02/2016, Last updated: 22/04/2016, Compliance check: XKey facts Ramipril amlodipine Cardiovascular … product specific waiver for ramipril / amlodipine (EMEA-001871-PIP01-15 … product specific waiver for ramipril / amlodipine (EMEA-001871-PIP01-15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: P/0323/2014, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 19/12/2014, Last updated: 23/02/2015, Compliance check: XKey facts amlodipine Ramipril Cardiovascular diseasesP/0323/2014P/0323/2014 … specific waiver for amlodipine / ramipril (EMEA-001685-PIP01-14) PDF … product-specific waiver: Amlodipine / ramipril for treatment of hypertension … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001464-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 30/07/2013, Last updated: 03/09/2013, Compliance check: XKey facts amlodipine Ramipril Cardiovascular diseasesP/0180/2013EMEA-001464-PIP01-13 … product-specific waiver for amlodipine / ramipril (EMEA-001464-PIP01-13) PDF … specific waiver for amlodipine / ramipril (EMEA-001464-PIP01-13) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000887-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 28/07/2010, Last updated: 26/08/2010, Compliance check: XKey facts amlodipine Ramipril Cardiovascular diseasesP/136/2010EMEA-000887-PIP01-10 … specific waiver for amlodipine/ramipril (EMEA-000887-PIP01-10) in … specific waiver for amlodipine/ramipril (EMEA-000887-PIP01-10) in …