3943 results
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Opinion/decision on a Paediatric investigation plan (PIP): 5%-Δ9-tetrahydrocannabinol standardised Cannabis extract
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002668-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 18/03/2020, Last updated: 30/07/2020, Compliance check: XActive substance 5%-Δ9-tetrahydrocannabinol standardised Cannabis extract … 5%-Δ9-tetrahydrocannabinol standardised Cannabis extract … -
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Withdrawn application: Canakinumab Novartis
canakinumab, date of withdrawal: 04/12/2018, Initial authorisation, Last updated: 07/05/2019Canakinumab Novartis: Withdrawn application … Canakinumab Novartis Canakinumab Novartis canakinumab Canakinumab … -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 … metformin hydrochloride Novartis) … 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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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)
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 … authorisation) Mercaptopurine Nova Laboratories mercaptopurine … product Mercaptopurine Nova Laboratories, 20mg/ml oral … -
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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 Diagnostics … -
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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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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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National expert: Dimitrina Novakova, Bulgarian Agency For Food Safety (updated)
- Declaration of interests - 39.37 KB | PDF
- Curriculum Vitae - 25.79 KB | PDF
Dimitrina Novakova … Dimitrina Novakova … Vitae Personal information Dimitrina Novakova Work experience … -
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Press release: Update on seasonal-influenza vaccines produced by Novartis Vaccines
Last updated: 26/10/2012seasonal-influenza vaccines produced by Novartis Vaccines … vaccines manufactured by Novartis Vaccines, because of a suspected … defect by the manufacturer (Novartis Vaccines) located in Italy … -
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Press release: Novartis withdraws its marketing authorisation application for Joicela (lumiracoxib)
Last updated: 19/04/2011Novartis withdraws its marketing authorisation … been formally notified by Novartis of its decision to withdraw … Office Press release Novartis withdraws its marketing authorisation … -
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Press release: Novartis Europharm Ltd withdraws its marketing-authorisation application for Ruvise (imatinib mesilate)
CHMP, Last updated: 24/01/2013Novartis Europharm Ltd withdraws its … Novartis Europharm Ltd withdraws its … Office Press release Novartis Europharm Ltd withdraws its … -
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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 … infusion. On 22 December 2009, Novartis Europharm Ltd. submitted … -
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Press release: Novartis Europharm Ltd withdraws its marketing authorisation application for Rasival (aliskiren/valsartan)
Last updated: 17/09/2010Novartis Europharm Ltd withdraws its … been formally notified by Novartis Europharm Ltd of its decision … application at a later stage Novartis Europharm Ltd withdraws its … -
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Press release: Novartis Europharm Ltd withdraws its marketing authorisation application for Joulferon (albinterferon alfa-2b)
Last updated: 19/04/2010Novartis Europharm Ltd withdraws its … been formally notified by Novartis Europharm Ltd of its decision … application at a later stage. Novartis Europharm Ltd withdraws its … -
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Press release: Novartis Vaccines and Diagnostics S.r.l. withdraws its marketing authorisation application for the pre-pandemic vaccine Aflunov
Last updated: 16/06/2008Novartis Vaccines and Diagnostics … Novartis Vaccines and Diagnostics … EMEA/306734/2008 PRESS RELEASE Novartis Vaccines and Diagnostics … -
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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 … hypercalcaemia. On 20 December 2006, Novartis Pharma submitted an application … -
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Press release: Novagali Pharma S.A. withdraws its marketing authorisation application for Vekacia (ciclosporin)
Last updated: 17/11/2008Novagali Pharma S.A. withdraws its … been formally notified by Novagali Pharma S.A. of its decision … EMEA/610677/2008 PRESS RELEASE Novagali Pharma S.A. withdraws its … -
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Press release: Novartis withdraws its application to extend the marketing authorisation for Glivec
CHMP, Last updated: 23/10/2006Novartis withdraws its application … Novartis withdraws its application … EMEA/423844/2006 PRESS RELEASE Novartis withdraws its application … -
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Press release: Novartis Europharm Ltd withdraws its applications for an extension of the indication for Exelon and Prometax (rivastigmine)
Last updated: 15/03/2012Novartis Europharm Ltd withdraws its … been formally notified by Novartis Europharm Ltd of its decision … patches. On 30 March 2011, Novartis Europharm Ltd submitted an … -
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Press release: Novartis Vaccines and Diagnostics S.r.l. withdraws its application for paediatric use marketing authorisation for Fluad Paediatric (influenza vaccine)
Last updated: 16/02/2012Novartis Vaccines and Diagnostics … been formally notified by Novartis Vaccines and Diagnostics … Office Press release Novartis Vaccines and Diagnostics … -
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Human medicine European public assessment report (EPAR): Wegovy
semaglutide, Obesity; Overweight
Date of authorisation: 06/01/2022,
, Revision: 2, Authorised, Last updated: 26/08/2022
them achieving at least a 5% weight reduction. Three of … Wegovy group were able to lose 5% of their weight compared … Wegovy group lost at least 5% of their weight compared … -
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Human medicine European public assessment report (EPAR): Ilumetri
tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018,, Revision: 8, Authorised, Last updated: 22/02/2023
skin clearance compared with 7% given placebo. The second … 48% given etanercept and 5% given placebo. What are the …