7508 results
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Referral: Ketabel 100 mg/ml solution for injection and associated names
ketamine, associated names: Ketabel vet. 100 mg/ml solution for injection, Belatamin 100 mg/ml solution for injection, Belatamin vet. 100 mg/ml solution for injection, Article 33
Status: European Commission final decision, opinion/position date: 05/12/2019, EC decision date: 04/03/2020, Last updated: 16/04/2020Ketabel 100 mg/ml solution for injection and … the medicine Ketabel 100 mg/ml solution for injection and … injection and contains 100 mg ketamine as active substance … -
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Referral: Denagard 45%
tiamulin hydrogen fumarate, associated names: Tiamutin 45%, Denagard 450 mg/g, Denagard vet 450 mg/g, Article 34
Status: European Commission final decision, opinion/position date: 12/04/2017, EC decision date: 14/07/2017, Last updated: 11/08/2017drinking water and contains 450 mg tiamulin hydrogen fumarate … Tiamutin 45%, Denagard 450 mg/g and Denagard vet 450 mg/g) is marketed in Austria, Belgium … Tiamutin 45% Denagard 450 mg/g Denagard vet 450 … -
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Referral: Doxyfar 50%
doxycycline hyclate, associated names: Soludox 500 mg/g, Soludox Vet, Soludox 433 mg/g, Doxy Ort 50%, Article 34
Status: European Commission final decision, opinion/position date: 04/05/2011, EC decision date: 13/07/2011, Last updated: 24/08/2011substance doxycycline hyclate 500 mg/g. The product is indicated … 50%doxycycline hyclate Soludox 500 mg/g Soludox Vet Soludox 433 mg/g Doxy Ort 50% EMA/512470/2011 … substance doxycycline hyclate 500 mg/g. The product is indicated … -
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Referral: Prontax 5 mg/ml pour-on solution for cattle
doramectin, associated names: Dectomax 5 mg/ml pour-on Solution for cattle, Article 33
Status: European Commission final decision, opinion/position date: 08/02/2012, EC decision date: 25/05/2012, Last updated: 05/07/2012Prontax 5 mg/ml pour-on solution for cattle … decision Overview Prontax 5 mg/ml pour-on solution for cattle … benefit-risk profile of Prontax 5 mg/ml pour-on solution for cattle … -
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Referral: Prontax 10 mg/ml solution for injection for cattle, sheep and pigs
doramectin, associated names: Dectomax 10 mg/ml solution for injection for cattle sheep and pigs, Article 33
Status: European Commission final decision, opinion/position date: 08/02/2012, EC decision date: 25/05/2012, Last updated: 05/07/2012Prontax 10 mg/ml solution for injection for … decision Overview Prontax 10 mg/ml solution for injection for … benefit-risk profile of Prontax 10 mg/ml solution for injection for … -
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Referral: Zanil and associated names, and generic products thereof
oxyclozanide, associated names: Zanil Suspension, Zanil Fluke Drench, Zanil Fluke Drench 34 mg/ml Oral Suspension, Article 35
Status: European Commission final decision, opinion/position date: 13/07/2017, EC decision date: 28/09/2017, Last updated: 25/10/2017suspensions containing 34 mg oxyclozanide per ml. Oxyclozanide … suspensions containing 34 mg oxyclozanide per ml. Oxyclozanide … Galway Ireland Chanil 34 mg/ml Oral Suspension for Cattle … -
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Withdrawn application: Ximelagatran 36 mg film coated tablets
date of withdrawal: 14/02/2006, Initial authorisation, Last updated: 16/02/2006Ximelagatran 36 mg film coated tablets: Withdrawn … XIMELAGATRAN ASTRAZENECA 36 MG FILM COATED TABLETS International … authorisation for Ximelagatran 36 mg film coated tablets, for … -
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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 … available as tablets (50 mg/850 mg and 50 mg/1,000 mg), and the recommended dose … available as tablets (50 mg/850 mg and 50 mg/1,000 mg), and the recommended dose … -
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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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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: 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 (girentuximab … IgG monoclonal antibody cG250 for the treatment of renal … IgG monoclonal antibody cG250 for the treatment of renal … -
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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) VaccinesP/0210/2012EMEA-000124-PIP01-07-M02 … influenza Intramuscular use Novartis Vaccines & Diagnostics GmbH … reason (please specify: Novartis proposes that the above PIP … -
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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 … IgG monoclonal antibody cG250 … -
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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 … authorised form in the EU is a 50-mg tablet, making it difficult … authorised form in the EU is a 50 mg tablet, making it difficult … -
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Orphan designation: 505 amino acid protein, corresponding to amino acids 2-506 of the wild type human histidyl-tRNA synthetase for: treatment of facioscapulohumeral muscular dystrophy
Date of designation: 12/02/2015, Withdrawn, Last updated: 12/02/2020corresponding to amino acids 2-506 of the wild type human histidyl-tRNA … corresponding to amino acids 2-506 of the wild type human histidyl-tRNA … -
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Orphan designation: 505 amino acid protein, corresponding to amino acids 2-506 of the wild-type human histidyl-tRNA synthetase for: Treatment of limb-girdle muscular dystrophy
Date of designation: 27/02/2017, Withdrawn, Last updated: 12/02/2020corresponding to amino acids 2-506 of the wild-type human histidyl-tRNA … corresponding to amino acids 2-506 of the wild-type human histidyl-tRNA … -
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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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Press release: Novartis Europharm Ltd. withdraws its application for an extension of indication for Zometa (zoledronic acid)
Last updated: 15/12/2010Novartis Europharm Ltd. withdraws … been formally notified by Novartis Europharm Ltd. of its decision … Zometa (zoledronic acid) 4 mg powder and solvent for solution … -
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Referral: Novantrone and associated names
mitoxantrone, associated names: Elsep, Ralenova, Article 30 referrals
Status: European Commission final decision, opinion/position date: 28/04/2016, EC decision date: 24/06/2016, Last updated: 05/07/2016Novantrone and associated names … Agency completed a review of Novantrone. The Agency's Committee for … prescribing information for Novantrone in the European Union (EU … -
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Press release: Novartis withdraws its application to extend the marketing authorisation for Zometa
CHMP, Last updated: 20/11/2007Novartis withdraws its application … been formally notified by Novartis Pharma AG of its decision … pathological fractures, spinal compression, radiation or surgery to bone … -
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News: EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid
CHMP, Last updated: 17/11/2021marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid … marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid … -
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News: EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)
Last updated: 03/02/2021EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373 … vaccine being developed by Novavax CZ AS (a subsidiary of Novavax, Inc.). The CHMP’s decision … -
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Orphan designation: Humanised IgG1 monoclonal antibody against SEZ6 linked to N-acetyl-calicheamicin for: Treatment of small cell lung cancer
Date of designation: 15/10/2021, Withdrawn, Last updated: 31/07/2023EU/3/21/2502 … lung cancerWithdrawnEU/3/21/2502 15/10/2021 AbbVie Deutschland … -
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Orphan designation: Allogeneic retinal pigment epithelial cells genetically modified with a non-viral vector to express human alpha-L-iduronidase for: Treatment of mucopolysaccharidosis type I
Date of designation: 15/10/2021, Withdrawn, Last updated: 20/12/2022EU/3/21/2505 … EU/3/21/2505: Orphan designation for the …