13199 results
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Referral: Docetaxel Teva Generics
docetaxel, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 17/02/2011, EC decision date: 07/07/2011, Last updated: 03/07/2012Docetaxel Teva Generics … Docetaxel Teva Generics … Questions and answers on Docetaxel Teva Generics docetaxel, 20 mg and 80 mg powder and … -
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Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,
, Revision: 5, Authorised, Last updated: 01/12/2020
lmanco (previously Tadalafil Generics) Hypertension, Pulmonary … leaflet or contact their doctor or pharmacist. Expand section … tadalafil. Talmanco is a ‘generic medicine’. This means that … -
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Withdrawn application: Pioglitazone Teva Generics
pioglitazone, date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn application … authorisation) Pioglitazone Teva Generics pioglitazone On 22 September … product Pioglitazone Teva Generics 15, 30, 45 mg tablet intended … -
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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, Authorised, Last updated: 23/11/2020
Docetaxel Teva Head and Neck Neoplasms Carcinoma … Docetaxel Teva is a cancer medicine … of cancer: breast cancer. Docetaxel Teva can be used on its own … -
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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: 14, Authorised, Last updated: 28/10/2020
Docetaxel Accord Head and Neck Neoplasms Carcinoma … Docetaxel Accord is a cancer medicine … of cancer: breast cancer. Docetaxel Accord can be used on its … -
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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 Head and Neck Neoplasms Carcinoma … Docetaxel Kabi is a cancer medicine … of cancer: breast cancer. Docetaxel Kabi can be used on its own … -
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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 … Product details Name Docefrez Agency product number EMEA/H/C/001074 … EMEA/H/C/001074 Active substance docetaxel International non-proprietary … -
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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 … Product details Name Docetaxel Mylan Agency product number … EMEA/H/C/002317 Active substance docetaxel International non-proprietary … -
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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 … Product details Name Docetaxel Teva Pharma Agency product … EMEA/H/C/002032 Active substance docetaxel International non-proprietary … -
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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 … Name Taxespira (previously Docetaxel Hospira UK Limited ) Agency … EMEA/H/C/003925 Active substance docetaxel trihydrate International … -
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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, Authorised, Last updated: 20/12/2019Docetaxel Zentiva (previously Docetaxel Winthrop) Head and Neck … Docetaxel Zentiva (previously Docetaxel Winthrop … safety and efficacy of the Docetaxel Winthrop medicinal product … -
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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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Withdrawn application: Docetaxel Mylan
docetaxel, date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 26/03/2010Docetaxel Mylan: Withdrawn application … Questions and answers on generic medicines What is a generic medicine? A generic medicine is a medicine that … Docetaxel Mylan Docetaxel Mylan docetaxel docetaxel … -
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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): Zoledronic acid Teva Generics
zoledronic acid monohydrate, Osteoporosis, Osteitis Deformans
Date of authorisation: 27/03/2014,, Revision: 2, Withdrawn, Last updated: 08/08/2016
Zoledronic acid Teva Generics Osteoporosis Osteitis Defor … 07/2015 Zoledronic acid Teva Generics - EMEA/H/C/002805 - IAIN/0002 … that the size of the above document can exceed 50 pages. You … -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Generics B.V.
clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Acute Coronary Syndrome, Myocardial Infarction, Stroke
Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014
Clopidogrel Teva Generics B.V. Peripheral Vascular … 05/11/2013 Clopidogrel Teva Generics B.V. - EMEA/H/C/002254 … that the size of the above document can exceed 50 pages. You … -
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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: 48, Authorised, Last updated: 03/12/2020docetaxel … 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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Orphan designation: Docosahexaenoic acid ethyl ester for: Treatment of sickle cell disease
Date of first decision: 21/03/2018, Positive, Last updated: 17/05/2018Ireland Limited, Ireland, for docosahexaenoic acid ethyl ester (also known … This medicine is made of docosahexaenoic acid (DHA), an omega-3 fatty … opinion on orphan designation Docosahexaenoic acid ethyl ester for the … -
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Orphan designation: 4,7,10,13,16,19-docosahexaenoic acid for: Treatment of retinitis pigmentosa
Date of first decision: 04/11/2006, Positive, Last updated: 08/07/2013Spain, for 4,7,10,13,16,19-docosahexaenoic acid for the treatment of … opinion, please refer to the PDF document below. Expand section Collapse … to work? 4,7,10,13,16,19-Docosahexaenoic acid (DHA) is a so-called … -
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Orphan designation: N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide (edasalonexent) for: Treatment of Duchenne muscular dystrophy
Date of first decision: 09/10/2015, Positive, Last updated: 18/11/2015N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide … N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide … N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19- hexaenamido)ethyl)-2-hydroxybenzamide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5), simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5), simvastatin, Route(s) of administration: Oral route, Pharmaceutical form(s): Capsule, soft
Decision date: 01/12/2008, Last updated: 29/01/2009, Compliance check: Xeicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of … eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of … http://www.emea.europa.eu Doc. Ref. EMEA/624450/2008 P/120/2008 … -
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Referral: Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products
albendazole, Article 35
Status: European Commission final decision, opinion/position date: 05/11/2020, EC decision date: 18/01/2021, Last updated: 22/02/2021associated names, including its generic/hybrid products … Why were Valbazen and its generic/hybrid products reviewed? On 3 February … treated with Valbazen and its generic/hybrid products. The German authority … -
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Orphan designation: (S)-2-isobutyrylamino-pentanedioic acid 5-amide 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide} for: Treatment of Netherton syndrome
Date of first decision: 17/10/2019, Positive, Last updated: 21/01/20201-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide} (also known … 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide} …