16600 results
Keyword Omega 3 Doc Remove keyword
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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 use, Pharmaceutical form(s): Capsule, soft
Decision date: 01/12/2008, Last updated: 29/01/2009, Compliance check: XOmega-3-acid (85% ethyl esters of eicosapentaenoic … eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of … Key facts Omega-3-acid (85% ethyl esters of eicosapentaenoic … -
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Veterinary medicine European public assessment report (EPAR): Virbagen Omega
recombinant omega interferon of feline origin, Dogs; Cats
Date of authorisation: 05/11/2001, Revision: 12, Authorised, Last updated: 07/10/2021Virbagen Omega … Authorised interferon (omega) Overview This is a summary … a summary of the A set of documents describing the evaluation … -
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Referral: Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction
Omega-3 fatty acid ethyl esters, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2018, EC decision date: 06/06/2019, Last updated: 13/06/2019Omega-3 acid ethyl esters - containing … EMA has confirmed that omega-3 fatty acid medicines containing … eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a dose of 1 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-carboxylic acids
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001865-PIP02-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft, Age-appropriate dosage form, other
Decision date: 01/12/2017, Last updated: 06/02/2023, Compliance check: XKey facts Omega-3-carboxylic acids Cardiovascular diseasesP/0377/2017EMEA-001865-PIP02-16 … granting of a waiver for omega-3-carboxylic acids (EMEA-001865-PIP02-16 … EMA/704196/2017 Generic Related documents … -
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Opinion/decision on a Paediatric investigation plan (PIP): omega-3-acid ethyl esters 90, rosuvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002384-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 12/09/2018, Last updated: 18/01/2019, Compliance check: XKey facts omega-3-acid ethyl esters 90 rosuvastatin … product specific waiver for omega-3-acid ethyl esters 90 / rosuvastatin … omega-3-acid ethyl esters 90 rosuvastatin … -
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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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Orphan designation: S-[5-(omega-methoxypoly(oxyethylene)-2-oxopentyl)]-L-cysteinylglycyl-L-serinylglycylgylcyl-L-isoleucyl-L-lysyl-L-glutamyl-L-phenylalanyl-L-leucyl-L-glutaminyl-L-arginyl-L-phenylalanyl-L-isoleucyl-L-histyl-L-isoleucyl-L-valyl-L-glutaminyl-L-serinyl-L-isoleucyl-L-isoleucyl-L-asparaginyl-L-threonyl-L-serinamide, acetate salt for: Treatment of cutaneous T-cell lymphoma
Date of designation: 13/04/2021, Positive, Last updated: 21/01/2022S-[5-(omega-methoxypoly(oxyethylene)-2-oxopentyl)]-L-cysteinylglycyl-L-serinylglycylgylcyl-L-isoleucyl-L-lysyl-L-glutamyl-L-phenylalanyl-L-leucyl-L-glutaminyl-L-arginyl-L-phenylalanyl-L-isoleucyl-L-histyl-L-isoleucyl-L-valyl-L-glutaminyl-L-serinyl-L-isoleucyl-L-isoleucyl-L-asparaginyl-L-threonyl-L-serinamide … -
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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: 17/05/2018Ireland Limited, Ireland, for docosahexaenoic acid ethyl ester (also known … This medicine is made of docosahexaenoic acid (DHA), an omega-3 fatty acid, which is an important … type of fatty acid, called omega-6. This imbalance is believed … -
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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: 08/07/2013Spain, 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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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: poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with arginase 1 [cobalt cofactor] (synthetic human) (1:10), trimer (pegzilarginase) for: Treatment of hyperargininaemia
Date of designation: 14/07/2016, Positive, Last updated: 18/11/2022