16595 results
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Referral: Etoricoxib
etoricoxib, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2008, Last updated: 21/11/2008Etoricoxib … the benefits and risks of etoricoxib-containing medicines. The Agency's Committee … concluded that the benefits of etoricoxib-containing medicines outweigh their … -
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Referral: Etoricoxib
etoricoxib, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/02/2004, EC decision date: 28/04/2004, Last updated: 09/06/2004Etoricoxib … COX-2 inhibitors celecoxib, etoricoxib, rofecoxib, parecoxib and … to primary dysmenorrhoea. Etoricoxib received later authorisation … -
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Referral: Etoricoxib
etoricoxib, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2005, EC decision date: 28/11/2005, Last updated: 06/12/2005Etoricoxib … COX-2 inhibitors celecoxib, etoricoxib, lumiracoxib, parecoxib, rofecoxib … products containing celecoxib, etoricoxib and lumiracoxib and subject … -
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Referral: Arcoxia
etoricoxib, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 26/06/2008, EC decision date: 09/09/2008, Last updated: 21/11/2008Commission final decision Overview Etoricoxib is a selective inhibitor … States regarding the safety of etoricoxib at the 90mg dose in the new … safety of a daily dose of 90mg etoricoxib in the view of possible increased … -
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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Date of authorisation: 20/04/2007, Revision: 30, Withdrawn, Last updated: 20/05/2022Docetaxel Zentiva (previously Docetaxel Winthrop) Neoplasms Cancer Breast … Docetaxel Zentiva (previously Docetaxel Winthrop …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Withdrawn application: Docetaxel Zentiva (previously Docetaxel Winthrop)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 Accord
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,
, Revision: 16, Authorised, Last updated: 20/03/2023
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 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: 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: 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 … authorisation of the medicine Docetaxel Teva Generics. The Agency's … concluded that the benefits of Docetaxel Teva Generics outweigh its … -
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Opinion/decision on a Paediatric investigation plan (PIP): Docosahexaenoic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002808-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 12/02/2021, Last updated: 08/10/2021, Compliance check: XKey facts Docosahexaenoic acid OphthalmologyP/0058/2021EMEA-002808-PIP01-20 … granting of a waiver for docosahexaenoic acid (EMEA-002808-PIP01-20 … granting of a waiver for docosahexaenoic acid (EMEA-002808-PIP01-20 … -
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Orphan designation: Docosahexaenoic acid ethyl ester for: Treatment of sickle cell disease
Date of designation: 21/03/2018, Positive, Last updated: 17/05/2018Docosahexaenoic acid ethyl ester … opinion on orphan designation Docosahexaenoic acid ethyl ester for the … 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 designation: 04/11/2006, Positive, Last updated: 08/07/20134,7,10,13,16,19-docosahexaenoic acid … designation 4,7,10,13,16,19-docosahexaenoic acid for the treatment of … scientific content of the document reflects the outcome of the … -
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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 designation: 09/10/2015, Withdrawn, Last updated: 02/09/2021N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)e … 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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Press release: EMEA recommends strengthening warnings and contraindications for etoricoxib-containing medicines used in the treatment of rheumatoid arthritis and ankylosing spondylitis
CHMP, Last updated: 26/06/2008and contraindications for etoricoxib-containing medicines used in the treatment … the benefits and risks of etoricoxib-containing medicines, the European Medicines … cardiovascular side effects. Etoricoxib is a non-steroidal anti-inflammatory … -
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Orphan designation: Sodium (4Z,7Z,10R,11E,13E,15Z,17S,19Z)10,17-dihydroxy-docosa-4,7,11,13,15,19-hexaenoate for: Prevention of retinopathy of prematurity
Date of designation: 21/06/2022, Positive, Last updated: 15/09/2022set of minutes is a working document primarily designed for COMP … undertakes. Note on access to documents Some documents mentioned in the minutes … a request for access to documents within the framework of Regulation …