14753 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Date of authorisation: 20/04/2007, Revision: 30, Withdrawn, Last updated: 20/05/2022Docetaxel Zentiva (previously Docetaxel Winthrop) Neoplasms Cancer Breast … Withdrawn docetaxel Overview The The approval … marketing authorisation for Docetaxel Zentiva has been withdrawn … -
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Withdrawn application: Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, date of withdrawal: 14/11/2008, Post-authorisation, Last updated: 17/11/2008Docetaxel Winthrop: Withdrawn applicati … acknowledged.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 Accord
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: 21/12/2021
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Date of authorisation: 26/01/2010,, Revision: 18, Withdrawn, Last updated: 14/12/2021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 Kabi
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020
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 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: 49, Authorised, Last updated: 14/12/2021docetaxel … 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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Human medicine European public assessment report (EPAR): Amlodipine / Valsartan Mylan
Amlodipine besilate, valsartan, Hypertension
Date of authorisation: 22/03/2016,, Revision: 7, Authorised, Last updated: 05/07/2021
Amlodipine / Valsartan Mylan Cardiovascular Diseases Vascular … a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Amlodipine/Valsartan … -
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Human medicine European public assessment report (EPAR): Neparvis
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,
, Revision: 14, Authorised, Last updated: 13/09/2021
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Neparvis … substances sacubitril and valsartan. It is used in adults with … -
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Human medicine European public assessment report (EPAR): Entresto
sacubitril, valsartan, Heart Failure
Date of authorisation: 19/11/2015, Revision: 14, Authorised, Last updated: 13/07/2021leaflet or contact their doctor or pharmacist. Expand section … substances sacubitril and valsartan. It is used in adults with … 24 mg sacubitril / 26 mg valsartan, 49 mg sacubitril / 51 mg … -
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Human medicine European public assessment report (EPAR): Dafiro
amlodipine, valsartan, Hypertension
Date of authorisation: 15/01/2007, Revision: 29, Authorised, Last updated: 14/10/2021the EPAR) or contact your doctor or pharmacist. If you want … substances, amlodipine and valsartan. It is available as tablets … 5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg … -
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Human medicine European public assessment report (EPAR): Copalia HCT
amlodipine, valsartan, hydrochlorothiazide, Hypertension
Date of authorisation: 03/11/2009, Revision: 21, Authorised, Last updated: 04/04/2022the EPAR) or contact your doctor or pharmacist. If you want … active substances, amlodipine, valsartan and hydrochlorothiazide … tablets containing amlodipine, valsartan and hydrochlorothiazide in … -
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Human medicine European public assessment report (EPAR): Dafiro HCT
valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension
Date of authorisation: 03/11/2009, Revision: 23, Authorised, Last updated: 04/04/2022the EPAR) or contact your doctor or pharmacist. If you want … active substances, amlodipine, valsartan and hydrochlorothiazide … tablets containing amlodipine, valsartan and hydrochlorothiazide in … -
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Human medicine European public assessment report (EPAR): Exforge HCT
valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension
Date of authorisation: 15/10/2009, Revision: 21, Authorised, Last updated: 01/04/2022active substances, amlodipine, valsartan and hydrochlorothiazide … tablets containing amlodipine, valsartan and hydrochlorothiazide in … combination of amlodipine, valsartan and hydrochlorothiazide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Entresto, sacubitril, valsartan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000316-PIP02-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 11/09/2019, Last updated: 26/03/2020, Compliance check: XActive substance sacubitril valsartan Therapeutic area Cardiovascular … resto Entresto sacubitril valsartan sacubitril valsartan sacubitril valsartan … -
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Human medicine European public assessment report (EPAR): Exforge
valsartan, amlodipine (as amlodipine besilate), Hypertension
Date of authorisation: 16/01/2007, Revision: 30, Authorised, Last updated: 28/10/2021substances, amlodipine and valsartan. It is available as tablets … 5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan). What is Exforge used for … irbesartan, telmisartan, and valsartan) centrally. ARBs are available … -
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Human medicine European public assessment report (EPAR): Copalia
valsartan, amlodipine (as amlodipine besilate), Hypertension
Date of authorisation: 15/01/2007, Revision: 28, Authorised, Last updated: 26/10/2021the EPAR) or contact your doctor or pharmacist. If you want … substances, amlodipine and valsartan. It is available as tablets … 5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg … -
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Opinion/decision on a Paediatric investigation plan (PIP): Entresto, sacubitril, valsartan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000316-PIP03-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Film-coated tablet, Granules
Decision date: 14/08/2020, Last updated: 18/06/2021, Compliance check: XActive substance sacubitril valsartan Therapeutic area Cardiovascular … specific waiver for sacubitril / valsartan (Entresto and associated … specific waiver for sacubitril / valsartan (Entresto and associated …