146 results
-
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
National expert: Michela Piezzo, Italian Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 23.43 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 Survival … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
Human medicine European public assessment report (EPAR): Temodal (updated)
temozolomide, Glioma; Glioblastoma
Date of authorisation: 26/01/1999, Revision: 36, Authorised, Last updated: 22/02/2023Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide … that markets Fenofibrato Pensa and Fenofibrato Ranbaxy … should); Fenofibrato Pensa and Fenofibrato Ranbaxy … -
List item
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
-
List item
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 -
List item
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 … -
List item
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
-
List item
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 -
List item
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
-
List item
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 -
List item
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
-
List item
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
-
List item
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
-
List item
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 -
List item
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 -
List item
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