169 results
Keyword Fluoxetine Remove keyword
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Referral: Fluoxetin NM
Fluoxetin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/12/1997, EC decision date: 09/06/1998, Last updated: 19/06/1998Fluoxetin NM … Fluoxetin NM … FOLLOWING AN ARTICLE 10 REFERRAL FLUOXETIN NM International Non-Proprietary … -
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Referral: Prozac
fluoxetine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 19/09/2002, Last updated: 18/06/2003Fluoxetine is a Selective Serotonin … the benefit/risk ratio of fluoxetine is considered to be favourable … NonProprietary Name (INN): fluoxetine BACKGROUND INFORMATION Fluoxetine is a Selective Serotonin … -
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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: 05/09/2006arbitration review of Prozac (fluoxetine) and associated names 1 … arbitration review of Prozac (fluoxetine) and associated names1, and … Non-Proprietary Name (INN): Fluoxetine BACKGROUND INFORMATION … -
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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: 03/11/2005duloxetine, escitalopram, fluoxetine, fluvoxamine, mianserine … duloxetine, escitalopram, fluoxetine, fluvoxamine, mianserine … duloxetine 1 , escitalopram, fluoxetine,fluvoxamine, mianserine, milnacipran … -
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Human medicine European public assessment report (EPAR): Valdoxan
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009, Revision: 22, Authorised, Last updated: 14/01/2021other antidepressants, either fluoxetine or paroxetine, as an ‘active … placebo. However, no effect of fluoxetine or paroxetine was seen in … other antidepressants, either fluoxetine or paroxetine, as an ‘active … -
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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: 06/06/2006the indication for Prozac (fluoxetine) and associated names to … SSRI) medicines, including fluoxetine, regarding the increased risk … the indication for Prozac (fluoxetine) and associated names to … -
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Human medicine European public assessment report (EPAR): Thymanax
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009,
Date of refusal: 18/11/2006, Revision: 22, Authorised, Last updated: 14/01/2021other antidepressants, either fluoxetine or paroxetine, as an ‘active … placebo. However, no effect of fluoxetine or paroxetine was seen in … other antidepressants, either fluoxetine or paroxetine, as an ‘active … -
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News: European Medicines Agency finalises review of antidepressants in childrenand adolescents
CHMP, Last updated: 25/04/2005duloxetine, escitalopram, fluoxetine, fluvoxamine, mianserine … duloxetine, escitalopram, fluoxetine, fluvoxamine, mianserine … duloxetine, escitalopram, fluoxetine, fluvoxamine, mianserine … -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (updated)
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,
, Revision: 6, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Duloxetine Zentiva (updated)
duloxetine, Anxiety Disorders, Depressive Disorder, Major, Neuralgia, Diabetes Mellitus
Date of authorisation: 20/08/2015,, Revision: 8, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Brintellix
Vortioxetine, Depressive Disorder, Major
Date of authorisation: 18/12/2013, Revision: 16, Authorised, Last updated: 15/01/2021 -
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Human medicine European public assessment report (EPAR): Palonosetron Accord (updated)
Palonosetron, Vomiting, Nausea, Cancer
Date of authorisation: 26/05/2016,, Revision: 4, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Stocrin (updated)
efavirenz, HIV Infections
Date of authorisation: 28/05/1999, Revision: 45, Authorised, Last updated: 18/02/2021 -
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Human medicine European public assessment report (EPAR): Nodetrip (previously Xeristar)
duloxetine, Anxiety Disorders, Depressive Disorder, Major, Diabetic Neuropathies
Date of authorisation: 17/12/2004, Revision: 31, Authorised, Last updated: 07/12/2020 -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)
clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009,, Revision: 16, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Lojuxta
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,
, 
, Revision: 13, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Apotex) (updated)
clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 20, Authorised, Last updated: 17/02/2021
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Human medicine European public assessment report (EPAR): Yentreve
duloxetine hydrochloride, Urinary Incontinence, Stress
Date of authorisation: 11/08/2004, Revision: 27, Authorised, Last updated: 22/09/2020the paediatric population: fluoxetine, fluvoxamine, sertraline … -
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Human medicine European public assessment report (EPAR): Cymbalta
duloxetine, Anxiety Disorders, Diabetic Neuropathies, Depressive Disorder, Major
Date of authorisation: 17/12/2004, Revision: 30, Authorised, Last updated: 25/09/2020 -
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Human medicine European public assessment report (EPAR): Clopidogrel Zentiva (previously Clopidogrel Winthrop) (updated)
clopidogrel, Stroke, Peripheral Vascular Diseases, Myocardial Infarction, Acute Coronary Syndrome
Date of authorisation: 15/07/2008, Revision: 27, Authorised, Last updated: 02/02/2021 -
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Human medicine European public assessment report (EPAR): Suboxone (updated)
buprenorphine, naloxone, Opioid-Related Disorders
Date of authorisation: 26/09/2006, Revision: 19, Authorised, Last updated: 26/02/2021 -
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Human medicine European public assessment report (EPAR): Wakix
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, 
, Revision: 9, Authorised, Last updated: 21/01/2021
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm GmbH
clopidogrel, Peripheral Vascular Diseases, Acute Coronary Syndrome, Myocardial Infarction, Stroke
Date of authorisation: 28/07/2009,, Revision: 12, Withdrawn, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Neoclarityn (updated)
desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 39, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Clopidogrel TAD
clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 12, Authorised, Last updated: 18/01/2021