153 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: 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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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012
CHMP, Last updated: 14/12/2012Fenofibrato Pensa, Fenofibrato Ranbaxy INN fenofibrate … -
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National expert: Caroline Gjestad, Norwegian Medicines Agency (updated)
- Declaration of interests - 39.35 KB | PDF
- Curriculum Vitae - 27.06 KB | PDF
Reuptake Inhibitors Citalopram, Escitalopram, and Sertraline; Therapeutic … -
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National expert: Michela Piezzo, Italian Medicines Agency (updated)
- Declaration of interests - 39.43 KB | PDF
- Curriculum Vitae - 33.62 KB | PDF
G, Martinelli C, Nuzzo F, Pensabene M, Laurentiis M. Targeting … Iodice G, Nuzzo F, Pacilio C, Pensabene M and De Laurentiis M. Progression_Free … -
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National expert: Nikica Mirošević Skvrce, Agency For Medicinal Products And Medical Devices Of Croatia (updated)
- Declaration of interests - 39.43 KB | PDF
- Curriculum Vitae - 25.79 KB | PDF
minimisation measures for (es)citalopram • Country: 1. Subject … -
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National expert: Magnus Ingelman-Sundberg, Medical Products Agency (updated)
- Declaration of interests - 10.92 KB | PDF
- Curriculum Vitae - 156.22 KB | PDF
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National expert: Christine Greiner, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 30.87 KB | PDF
Determination of citalopram and escitalopram together with their active … -
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National expert: Hedvig Marie Egeland Nordeng, European Medicines Agency (updated)
- Declaration of interests - 40.23 KB | PDF
- Curriculum Vitae - 71.92 KB | PDF
of prenatal exposure to (es)citalopram and maternal depression … -
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Human medicine European public assessment report (EPAR): Xospata (updated)
gilteritinib fumarate, Leukemia, Myeloid, Acute
Date of authorisation: 24/10/2019,
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, Revision: 5, Authorised, Last updated: 07/11/2023
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Human medicine European public assessment report (EPAR): Temodal
temozolomide, Glioma; Glioblastoma
Date of authorisation: 26/01/1999, Revision: 37, Authorised, Last updated: 20/06/2023Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide … that markets Fenofibrato Pensa and Fenofibrato Ranbaxy … should); Fenofibrato Pensa and Fenofibrato Ranbaxy … -
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Human medicine European public assessment report (EPAR): Brintellix
Vortioxetine, Depressive Disorder, Major
Date of authorisation: 18/12/2013, Revision: 23, Authorised, Last updated: 24/10/2023 -
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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: 22, Authorised, Last updated: 20/11/2023 -
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Human medicine European public assessment report (EPAR): Spravato
esketamine hydrochloride, Depressive Disorder
Date of authorisation: 18/12/2019,, Revision: 8, Authorised, Last updated: 14/07/2023
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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: 16, Authorised, Last updated: 08/09/2023 -
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Human medicine European public assessment report (EPAR): Orkambi
Lumacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 19/11/2015, Revision: 32, Authorised, Last updated: 27/07/2023 -
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Human medicine European public assessment report (EPAR): Zubsolv
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 10/11/2017, Revision: 10, Authorised, Last updated: 10/10/2023 -
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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: 16, Authorised, Last updated: 08/09/2023
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Human medicine European public assessment report (EPAR): Tygacil
Tigecycline, Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections
Date of authorisation: 24/04/2006, Revision: 34, Authorised, Last updated: 11/10/2022Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide … that markets Fenofibrato Pensa and Fenofibrato Ranbaxy … should); Fenofibrato Pensa and Fenofibrato Ranbaxy … -
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,
, Revision: 26, Authorised, Last updated: 13/04/2023
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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: 28, Authorised, Last updated: 12/04/2023 -
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Human medicine European public assessment report (EPAR): Lumeblue (previously known as Methylthioninium chloride Cosmo)
methylthioninium chloride, Colorectal Neoplasms; Colonoscopy
Date of authorisation: 19/08/2020, Revision: 3, Authorised, Last updated: 18/09/2023