16797 results
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Withdrawn application: Diractin
date of withdrawal: 23/07/2008, Initial authorisation, Last updated: 24/07/2008Diractin: Withdrawn application … Diractin, INN ketoprofen European Medicines … London, 21 August 2008 Doc. Ref. EMEA/402553/2008 … -
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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 is a cancer medicine … of cancer: breast cancer. Docetaxel Zentiva 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): 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 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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Referral: Ketoprofene Ethypharm LP
ketoprofen, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 29/06/2000, EC decision date: 27/12/2000, Last updated: 28/12/2000Ketoprofene Ethypharm LP … mg of the active substance ketoprofen, which is a non-steroidal … for about 25 years under different tradenames. Kétoprofène … -
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Referral: Ketoprofen topical
ketoprofen, associated names: Fastum, Ketum, Orudis, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 22/07/2010, EC decision date: 29/11/2010, Last updated: 28/10/2011Ketoprofen topical … procedure under Article 107 of Directive 2001/83/EC The European Medicines … safety and effectiveness of ketoprofen-containing medicines used topically … -
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Referral: Dolovet Rifen
Ketoprofen, Article 33
Status: European Commission final decision, opinion/position date: 09/11/2006, EC decision date: 17/04/2007, Last updated: 07/12/201115g, each containing 2.4g ketoprofen and is authorised for the … procedure under Article 33(4) of Directive 2001/82/EC, as amended. The … the number of animals used did not allow equivalence to … -
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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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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 … dose(s) to treat the same disease(s) as the reference medicine … and its packaging can be different from those of the reference … -
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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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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): 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: 03/12/2020contains the active substance docetaxel. Expand section Collapse section … under the supervision of a doctor who is qualified in the use … treatment interrupted or discontinued, if the patient develops certain … -
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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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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 … arbitration procedure following a disagreement among Member States of the … authorisation of the medicine Docetaxel Teva Generics. The Agency's … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): ketoprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001783-PIP02-15, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Medicated plaster
Decision date: 21/12/2015, Last updated: 02/02/2016, Compliance check: XActive substance ketoprofen Therapeutic area Pain Decision … product specific waiver for ketoprofen (EMEA-001783-PIP02-15 … product specific waiver for ketoprofen (EMEA-001783-PIP02-15) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): ketoprofen, omeprazole
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001361-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Modified release capsule
Decision date: 03/07/2013, Last updated: 13/08/2013, Compliance check: XActive substance ketoprofen omeprazole Therapeutic area … product specific waiver for ketoprofen / omeprazole (EMEA-001361-PIP01-12 … product specific waiver for ketoprofen / omeprazole (EMEA-001361-PIP01-12 … -
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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 … treatment of sickle cell disease. Expand section Collapse section … section What is sickle cell disease? Sickle cell … -
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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 … simvastatin Cardiovascular diseases … eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of … -
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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 … is a genetic (hereditary) disorder, characterised by progressive … -
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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 … dystrophy (DMD) is a genetic disease that gradually causes weakness … affects boys, and is usually diagnosed before the age of six years …