20 results
Keyword Prozac Remove keyword
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Referral: Prozac
fluoxetine, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 01/06/2006, EC decision date: 21/08/2006, Last updated: 05/09/2006Prozac … its arbitration review of Prozac (fluoxetine) and associated … that the safety profile of Prozac remains acceptable. The new … -
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Referral: Prozac
fluoxetine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 19/09/2002, Last updated: 18/06/2003Prozac … harmonisation of the SPC for Prozac and associated names. The … Directive 2001/83/EC for Prozac and associated names International … -
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Press release: European Medicines Agency adopts a positive opinion for the use of Prozac in the treatment of children and adolescents suffering from depression
CHMP, Last updated: 06/06/2006positive opinion for the use of Prozac in the treatment of children … extend the indication for Prozac (fluoxetine) and associated … that the benefits of using Prozac in this indication outweigh … -
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Veterinary medicine European public assessment report (EPAR): Reconcile
fluoxetine, Dogs
Date of authorisation: 08/07/2008, Revision: 14, Authorised, Last updated: 16/06/2021 -
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Human medicine European public assessment report (EPAR): Edistride (updated)
dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Date of authorisation: 09/11/2015, Revision: 22, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, Revision: 35, Authorised, Last updated: 28/04/2023
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Human medicine European public assessment report (EPAR): Adasuve
loxapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/02/2013, Revision: 14, Authorised, Last updated: 14/11/2022 -
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Human medicine European public assessment report (EPAR): Forxiga (updated)
dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Date of authorisation: 11/11/2012, Revision: 28, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Neoclarityn
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 45, Authorised, Last updated: 15/12/2022 -
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Human medicine European public assessment report (EPAR): Azomyr
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 51, Authorised, Last updated: 15/12/2022 -
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Human medicine European public assessment report (EPAR): Aerius
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 49, Authorised, Last updated: 15/12/2022 -
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,
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, Revision: 37, Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Enbrel
etanercept, Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Arthritis, Psoriatic; Psoriasis; Arthritis, Rheumatoid
Date of authorisation: 02/02/2000, Revision: 70, Authorised, Last updated: 12/12/2022 -
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Referral: Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 19/08/2005, Last updated: 03/11/2005 -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 23-26 May 2005
CHMP, Last updated: 25/05/2005an arbitration review for Prozac (fluoxetine) and associated … States concerning the use of Prozac in this age group. The arbitration … Regulation (EC) No 1084/2003. Prozac is authorised in most EU … -
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Joint EMEA(NRG)/EFPIA Workshop on Invented Names
London, 11/09/2006, Last updated: 01/09/2006 -
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Press release: European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 17 to 19 September 2002
MB, Last updated: 19/09/2002Community-wide reviews for: Prozac and associated product names … -
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European Medicines Agency Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) and Healthcare Professionals' Organisations (HCPWP) joint meeting - Workshop on benefit-risk communication
European Medicines Agency, London, UK, 17/09/2014, Last updated: 08/12/2014 -
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CHMP: meeting archive 2001-2009
Last updated: 18/11/2013 -
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Public data from Article 57 database
Last updated: 17/10/2022