151 results
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Referral: Escitalopram
escitalopram, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 18/02/2010, Last updated: 29/09/2010Escitalopram … review of a group of generic escitalopram-containing medicines that were authorised … issued in due course. What is escitalopram? Escitalopram is an antidepressant used … -
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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: 03/11/2005atomoxetine, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … atomoxetine, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … citalopram, duloxetine 1 , escitalopram, fluoxetine,fluvoxamine, mianserine … -
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015acid ropinirole cefpodoxime quetiapine trimetazidine bosentan tramadol paracetamol escitalopram trimetazidine hydrochloride entacapone valsartan hydrochlorothiazide donepezil … hydrochloride clopidogrel hydrochloride escitalopram oxalate metformin hydrochloride trimetazidine … -
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Press release: EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU
Last updated: 15/10/2018under increased supervision; Aurobindo Pharma stopped from supplying … Aurobindo Pharma stopped from supplying … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 15-18 February 2010
CHMP, Last updated: 19/02/2010Referral on escitalopram concluded … granted. Referral on escitalopram concluded The Committee … authorisations of generic escitalopram-containing medicinal products from … -
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News: European Medicines Agency finalises review of antidepressants in children and adolescents
CHMP, Last updated: 25/04/2005atomoxetine, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … -
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Referral: Didanosine
didanosine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/09/2013, EC decision date: 20/11/2013, Last updated: 10/12/2013was Didanosine reviewed? Aurobindo Pharma (Malta) Limited submitted … was Didanosine reviewed? Aurobindo Pharma (Malta) Limited submitted … administration France Aurobindo Pharma (Malta) Limited … -
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National expert: Maria Formosa Cassar, Medicines Authority (updated)
- Declaration of interests - 80.36 KB | PDF
- Curriculum Vitae - 22.17 KB | PDF
Authorisations (pertaining to MAH: Aurobindo Pharma Malta) and PV documentation. Analytical … -
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National expert: Jogin Thakore, European Medicines Agency (updated)
- Declaration of interests - 83 KB | PDF
- Curriculum Vitae - 30.16 KB | PDF
01/1999-07/2014 Lundbeck Escitalopram Citalopram Depression 01/2009-12/2012 … -
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National expert: Nikica Mirošević Skvrce, Agency For Medicinal Products And Medical Devices Of Croatia (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 17.88 KB | PDF
minimisation measures for (es)citalopram October 2007-June 2014 PhD Doctoral … -
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National expert: Giacomo Capone, Italian Medicines Agency (updated)
- Declaration of interests - 79.77 KB | PDF
- Curriculum Vitae - 20.86 KB | PDF
quot;Time-dependent effects of escitalopram on brain derived neurotrophic … -
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National expert: Christine Greiner, Federal Institute For Drugs And Medical Devices (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 21.23 KB | PDF
Determination of citalopram and escitalopram together with their active … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013
CHMP, Last updated: 20/09/2013Marketing-authorisation holder Aurobindo Pharma (Malta) Limited More … -
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Human medicine European public assessment report (EPAR): Spravato (updated)
esketamine hydrochloride, Depressive Disorder
Date of authorisation: 18/12/2019,
, Revision: 7, Authorised, Last updated: 01/03/2023
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Human medicine European public assessment report (EPAR): Brintellix (updated)
Vortioxetine, Depressive Disorder, Major
Date of authorisation: 18/12/2013, Revision: 21, Authorised, Last updated: 01/03/2023 -
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Human medicine European public assessment report (EPAR): Sixmo
Buprenorphine hydrochloride, Opioid-Related Disorders
Date of authorisation: 19/06/2019,, Revision: 4, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Akynzeo
netupitant, palonosetron hydrochloride, Vomiting; Neoplasms; Nausea; Cancer
Date of authorisation: 27/05/2015, Revision: 15, Authorised, Last updated: 20/02/2023 -
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Human medicine European public assessment report (EPAR): Mysimba (updated)
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,, Revision: 24, Authorised, Last updated: 03/03/2023
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Human medicine European public assessment report (EPAR): Suboxone
buprenorphine, naloxone, Opioid-Related Disorders
Date of authorisation: 26/09/2006, Revision: 21, Authorised, Last updated: 17/01/2023 -
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,
, Revision: 15, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,
, Revision: 25, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Viekirax
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, Revision: 27, Authorised, Last updated: 12/08/2022 -
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Human medicine European public assessment report (EPAR): Cibinqo (updated)
Abrocitinib, Dermatitis, Atopic
Date of authorisation: 09/12/2021,
, , Revision: 3, Authorised, Last updated: 28/02/2023
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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: 24, Authorised, Last updated: 08/08/2022 -
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Human medicine European public assessment report (EPAR): Valdoxan
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009, Revision: 24, Authorised, Last updated: 08/08/2022