240 results
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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 … the EPAR). What is Virbagen Omega? Virbagen Omega is a lyophilisate (freeze-dried … -
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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 confirms omega-3 fatty acid medicines are … Omega-3 acid ethyl esters - containing … -
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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: 05/03/2018, 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 … granting of a waiver for omega-3-carboxylic acids (EMEA-001865-PIP02-16 … -
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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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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 … Key facts Omega-3-acid (85% ethyl esters of eicosapentaenoic … Cardiovascular diseasesP/120/2008Omega-3-acid (85% ethyl esters … -
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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: 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 -
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Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with cystathionine γ-lyase [Pyridoxal 5’-phosphate cofactor] (synthetic engineered human), tetramer for: Treatment of homocystinuria
Date of designation: 19/10/2020, Positive, Last updated: 18/02/2021 -
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Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5-dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]carbonyl]-2-methylalanyl-teriparatide (2:1) for: Treatment of hypoparathyroidism
Date of designation: 19/10/2020, Positive, Last updated: 18/02/2021poly(oxy-1,2-ethanediyl), alpha-hydro-omega- methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5- dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]carbonyl]-2-methylalanyl-teriparatide … -
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Press release: Omega-3 fatty acid medicines no longer considered effective in preventing heart disease
CHMP, Last updated: 14/12/2018Omega-3 fatty acid medicines no longer … 14/12/2018 EMA has concluded that omega-3 fatty acid medicines are … authorised for such use. Omega-3 fatty acid medicines have … -
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Press release: EMA confirms omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack
Last updated: 29/03/2019EMA confirms omega-3 fatty acid medicines are … 29/03/2019 EMA has confirmed that omega-3 fatty acid medicines containing … fat called triglycerides. Omega-3 fatty acid medicines have … -
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Orphan designation: Poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-.alpha.-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide cyclic (2.fwdarw.12)-(disulfide); where two identical synthetic peptide domains are covalently linked at the ends of the polyethylene glycol chain for: Treatment of paroxysmal nocturnal haemoglobinuria
Date of designation: 22/05/2017, Positive, Last updated: 16/12/2021 -
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Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-alpha-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide cyclic (2.fwdarw.12)-(disulfide); where two identical synthetic peptide domains are covalently linked at the ends of the polyethylene glycol chain (pegcetacoplan) for: Treatment of C3 glomerulopathy
Date of designation: 21/08/2019, Positive, Last updated: 03/02/2021 -
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Human medicine European public assessment report (EPAR): Prialt
ziconotide, Injections, Spinal; Pain
Date of authorisation: 21/02/2005, Revision: 29, Authorised, Last updated: 25/10/2022natural substance called omega-conopeptide, which is found in the venom … natural substance called omega-conopeptide, which is found in the venom … -
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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 (DHA), an omega-3 fatty acid, which is an important … type of fatty acid, called omega-6. This imbalance is believed … docosahexaenoic acid (DHA), an omega-3 fatty acid, which is an important … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 March 2019
CHMP, Last updated: 29/03/2019re-examination of recommendation on omega-3 fatty acid medicines … -
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National expert: Teja Drofelnik, Agency for medicinal products and medical devices of the Republic of Slovenia (updated)
- Declaration of interests - 80.4 KB | PDF
- Curriculum Vitae - 16.56 KB | PDF
2018-December 2021 Junior Consultant OMEGA consult d.o.o. (Slovenia) EDUCATION … been employed by the company OMEGA consult, d.o.o., located … that during my employment at OMEGA consult, d.o.o. I was not … -
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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: 08/07/2013acid (DHA) is a so-called omega-three fatty acid. These acids are … acid (DHA) is a so-called omega three fatty acid. These acids … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018
CHMP, Last updated: 23/03/2018Start of referral: omega-3 fatty acid medicines … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018
CHMP, Last updated: 14/12/2018Outcome of review on omega-3 fatty acid medicines … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012
CHMP, Last updated: 14/12/2012Fenofibrato Pensa, Fenofibrato Ranbaxy INN fenofibrate … -
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Orphan designation: Eicosapentaenoic acid for: Treatment of familial adenomatous polyposis (FAP)
Date of designation: 08/10/2009, Positive, Last updated: 22/04/2021Eicosapentaenoic acid is an omega-3 fatty acid that is obtained … Eicosapentaenoic acid is an omega-3 fatty acid that is obtained … -
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Press release: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 15-16 April 2019
CVMP, Last updated: 23/04/2019Virbagen Omega … -
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Orphan designation: Epeleuton for: Treatment of sickle cell disease (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023belongs to the class of: Omega-3 fatty acids Epeleuton is … that contains a new type of omega 3 fatty acid. In sickle cell … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 2019
CHMP, Last updated: 01/02/2019re-examination of recommendation on omega-3 fatty acid medicines …