15904 results
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Orphan designation: Refusal of orphan designation for the treatment of poisoning by local anaesthetics
Date of refusal of designation: 03/04/2017, Negative, Last updated: 15/05/20171.2% egg yolk phospholipids, 2.25% glycerin, and water for … 1.2% egg yolk phospholipids, 2.25% glycerin, and water for … egg yolk phospholipids, 2.25% glycerin, and water for … -
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Orphan designation: 225Ac-lintuzumab for: Treatment of acute myeloid leukaemia
Date of designation: 22/05/2017, Positive, Last updated: 13/10/2021225Ac-lintuzumab … opinion on orphan designation 225Ac-lintuzumab for the treatment of acute … opinion on orphan designation 225Ac-lintuzumab for the treatment of acute … -
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Human medicine European public assessment report (EPAR): Primavax
Diphtheria toxoid, hepatitis B, recombinant surface antigen, tetanus toxoid, Hepatitis B; Tetanus; Immunization; Diphtheria
Date of authorisation: 05/02/1998, Withdrawn, Last updated: 04/12/2000Primavax Hepatitis B Tetanus Immuni … Primavax … THE MEDICINAL PRODUCT “PRIMAVAX - Diphtheria, Tetanus and … -
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Withdrawn application: Canakinumab Novartis
canakinumab, date of withdrawal: 04/12/2018, Initial authorisation, Last updated: 07/05/2019Canakinumab Novartis: Withdrawn application … Canakinumab Novartis Canakinumab Novartis canakinumab Canakinumab … -
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Human medicine European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis)
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 30/11/2008, Revision: 25, Authorised, Last updated: 09/11/2022metformin hydrochloride Novartis) Nutritional and Metabolic … Vildagliptin/metformin hydrochloride Novartis received a The approval to … Vildagliptin/metformin hydrochloride Novartis Icandra (vildagliptin … -
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Veterinary medicine European public assessment report (EPAR): Novaquin
meloxicam, Horses
Date of authorisation: 08/09/2015, Revision: 4, Authorised, Last updated: 28/01/2022Novaquin … assessment report (EPAR) for Novaquin. It explains how the Agency … practical advice on how to use Novaquin. For practical information … -
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Orphan designation: H-Arg-Pro-Lys-Pro-Gln-Gln-Phe-2Thi-Gly-Leu-Met(O2)-NH2-DOTA-225-Actinium for: Treatment of glioma
Date of designation: 25/05/2018, Positive, Last updated: 24/07/2018On 25 May 2018, orphan designation … H-Arg-Pro-Lys-Pro-Gln-Gln-Phe-2Thi-Gly-Leu-Met(O 2 )-NH 2 -DOTA-225-Actinium for the treatment … sponsorship was transferred to NovaCurie GmbH in November 2019. Expand … -
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012, Revision: 15, Authorised, Last updated: 25/05/2023previously Mercaptopurine Nova Laboratories) Cancer Leukemia Neoplasms Lymphoproliferative … ema-other-h-2022-aa_es.pdf 28/03/2012 25/05/2023 Generic Pharmacotherapeutic … h-2022-steps_after_en.pdf 27/09/2012 25/05/2023 Generic Xaluprine-H-C-PSUSA-00001988-202109 … -
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Orphan designation: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate (larotrectinib) for: Treatment of soft tissue sarcoma
Date of designation: 11/01/2016, Withdrawn, Last updated: 24/10/2019S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide … S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide … -
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Opinion/decision on a Paediatric investigation plan (PIP): (2R,3S,5R)-2-(2,5-Difluorophenyl)-5-[2,6-dihydro-2-(methylsulfonyl)pyrrolo[3,4-c]pyrazol-5(4H)-yl]tetrahydro-2H-pyran-3-amine (MK-3102)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001234-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, Capsule, hard
Decision date: 20/11/2012, Last updated: 04/01/2013, Compliance check: XActive substance (2R,3S,5R)-2-(2,5-Difluorophenyl)-5-[2,6-dihydro-2-(methylsulfonyl)pyrrolo[3,4-c]pyrazol-5(4H)-yl]tetrahydro-2H-pyran-3-amine … of a waiver for (2R,3S,5R)-2-(2,5-Difluorophenyl)-5-[2,6-dihydro-2- (methylsulfonyl)pyrrolo[3,4-c]pyrazol-5(4H)-yl]tetrahydro-2H-pyran-3-amine … -
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Orphan designation: Norrin (25-133), Lys86Pro for: Treatment of familial exudative vitreoretinopathy
Date of designation: 10/12/2021, Positive, Last updated: 03/05/2022EU/3/21/2549 … EU/3/21/2549: Orphan designation for the … minutes is a working document primarily designed for COMP members … -
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Summary of opinion: Bovilis Nasalgen-C
bovine coronavirus, strain CA25, live, opinion date: 15/02/2023, Positive, Last updated: 17/02/2023bovine coronavirus, strain CA25, live Opinion On 15 February … bovine coronavirus, strain CA25, live attenuated (ATCvet … bovine coronavirus, strain CA25, live Species Cattle Active … -
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Orphan designation: Chimeric IgG monoclonal antibody cG250 (girentuximab) for: Treatment of renal-cell carcinoma
Date of designation: 19/03/2002, Withdrawn, Last updated: 02/09/2021IgG monoclonal antibody cG250 for the treatment of renal … system to fight cancer). The primary therapies for advanced cancer … expected to act? The antibody cG250 reacts with an antigen, which … -
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Referral: Metformin and metformin-containing medicines
metformin, associated names: Xigduo, Vipdomet, Velmetia, Synjardy, Ristfor, Komboglyze, Jentadueto, Janumet, Icandra (previously Vildagliptin / metformin hydrochloride Novartis), Glubrava, Eucreas, Efficib, Ebymect, Competact, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/10/2016, EC decision date: 12/12/2016, Last updated: 21/12/2016metformin hydrochloride Novartis) Glubrava Eucreas Efficib Ebymect Competact Xigduo Vipdomet Velmetia Synjardy Ristfor Komboglyze Jentadueto Janumet Icandra … metformin hydrochloride Novartis) Glubrava Eucreas Efficib Ebymect Competact metformin dapagliflozin metformin alogliptin metformin sitagliptin metformin empagliflozin metformin sitagliptin metformin … -
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Human medicine European public assessment report (EPAR): Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 29/11/2010, Revision: 2, Withdrawn, Last updated: 07/03/2016inactivated, adjuvanted) Novartis Vaccines and Diagnostics Influenza … inactivated, adjuvanted) Novartis Vaccines and Diagnostics … inactivated, adjuvanted) Novartis Vaccines and Diagnostic Expiry … -
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Orphan designation: Iodine (131I) chimeric IgG monoclonal antibody cG250 for: Treatment of renal-cell carcinoma
Date of designation: 19/03/2002, Withdrawn, Last updated: 18/06/2014IgG monoclonal antibody cG250 for the treatment of renal … system to fight cancer). The primary therapies for advanced cancer … designation. Iodine ( 131 I)- cG250 might be of potential significant … -
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Veterinary medicine European public assessment report (EPAR): Eurifel RCP FeLV
canarypox virus expressing feline leukemia virus, live, feline calicivirus, strain 255, inactivated, feline panleucopenia virus, strain PLI IV, live, feline rhinotracheitis virus, strain C27, antigen, Cats
Date of authorisation: 08/03/2002, Revision: 8, Withdrawn, Last updated: 23/07/2004livefeline calicivirus, strain 255, inactivatedfeline panleucopenia … live feline calicivirus, strain 255, inactivated feline panleucopenia … -
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Orphan designation: W253R/R275S tissue plasminogen activator for: Treatment of non-traumatic spontaneous intracerebral haemorrhage
Date of designation: 18/07/2022, Positive, Last updated: 23/01/2023W253R/R275S tissue plasminogen … minutes are a working document primarily designed for COMP members … W253R/R275S tissue plasminogen … -
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Opinion/decision on a Paediatric investigation plan (PIP): 3-(1H-indol-3-yl)-4-(2-(4-methyl-1-piperazinyl)-4-quinazolinyl)-1H-pyrrole-2,5-dione acetate(1:1)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: 3-(1H-indol-3-yl)-4-(2-(4-methyl-1-piperazinyl)-4-quinazolinyl)-1H-pyrrole-2,5-dione acetate(1:1), Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/12/2008, Last updated: 29/01/2009, Compliance check: XContact for public enquiries Novartis Europharm Limited E-mail … application submitted by Novartis Europharm Limited on 15 November … Having regard to Article 25 of Regulation (EC) No 1901/2006 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Optaflu, Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia/2506/2004)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000124-PIP01-07-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in pre-filled syringe
Decision date: 28/09/2012, Last updated: 27/02/2019, Compliance check: XNYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia 2506/2004) Therapeutic area Vaccines … Contact for public enquiries Novartis Vaccines & Diagnostics GmbH … reason (please specify: Novartis proposes that the above PIP … -
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Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidine-3-yl)chroman-2-carboxamide hydrochloride for: Treatment of maternally-inherited diabetes and deafness
Date of designation: 28/06/2019, Positive, Last updated: 27/03/2023S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidine-3-yl)chroman-2-carboxamide … S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidine-3-yl)chroman-2-carboxamide … -
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Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 10/08/2015, Positive, Last updated: 27/03/2023S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide … designation (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide … designation (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2- carboxamide … -
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Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for: Treatment of Leigh syndrome
Date of designation: 15/10/2014, Positive, Last updated: 27/03/2023S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide … designation (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide … designation (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2- carboxamide … -
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Opinion/decision on a Paediatric investigation plan (PIP): 3,6-diamino-2,5-bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine (MB-102)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Diagnostic; Uro-nephrology
PIP number: EMEA-001983-PIP01-16-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 28/10/2022, Last updated: 05/10/2023, Compliance check: XKey facts 3,6-diamino-2,5-bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine … investigation plan for 3,6-diamino-2,5- bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine … investigation plan for 3,6-diamino-2,5- bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine … -
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Human medicine European public assessment report (EPAR): Fluenz Tetra
A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) / A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) / B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) / B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444), Influenza, Human
Date of authorisation: 04/12/2013, Revision: 24, Authorised, Last updated: 07/08/2023MEDI 355293) / A/Victoria/2570/2019 (H1N1)pdm09 - like strain …