173 results
-
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: 03/11/2005substances: atomoxetine, citalopram, duloxetine, escitalopram … SSRIs / SNRIs: atomoxetine, citalopram, duloxetine, escitalopram … the product information of citalopram, duloxetine 1 , escitalopram … -
List item
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 … -
List item
News: European Medicines Agency finalises review of antidepressants in children and adolescents
CHMP, Last updated: 25/04/2005substances: atomoxetine, citalopram, duloxetine, escitalopram … substances: atomoxetine, citalopram, duloxetine, escitalopram … SSRIs/SNRIs: atomoxetine, citalopram, duloxetine, escitalopram … -
List item
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 … -
List item
National expert: Abdul Karim Barakat, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 24.27 KB | PDF
GV, Jaehde U, Stingl JC. Citalopram_induced pathways regulation and tentative … -
List item
National expert: Maria Formosa Cassar, Medicines Authority (updated)
- Declaration of interests - 40.37 KB | PDF
- Curriculum Vitae - 31.13 KB | PDF
Authorisations (pertaining to MAH: Aurobindo Pharma Malta) and PV documentation … -
List item
National expert: Jogin Thakore, European Medicines Agency (updated)
- Declaration of interests - 44.31 KB | PDF
- Curriculum Vitae - 41.54 KB | PDF
product related Escitalopram Citalopram Depression null Current 01-04- 2018 22-03- 2023 Leyden … -
List item
National expert: Anya Staal, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 39.33 KB | PDF
- Curriculum Vitae - 34.34 KB | PDF
Jaehde, U.; Stingl, J.C. Citalopram_induced pathways regulation and tentative … -
List item
National expert: Christine Greiner, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 39.2 KB | PDF
- Curriculum Vitae - 30.89 KB | PDF
Haen E. Determination of citalopram and escitalopram together … -
List item
National expert: Anette Solli Karlsen, Norwegian Medicines Agency (updated)
- Declaration of interests - 39.36 KB | PDF
- Curriculum Vitae - 34.75 KB | PDF
quot;Simultaneous determination of citalopram, fluoxetine, paroxetine and … -
List item
National expert: Nikica Mirošević Skvrce, Agency For Medicinal Products And Medical Devices Of Croatia (updated)
- Declaration of interests - 39.42 KB | PDF
- Curriculum Vitae - 25.79 KB | PDF
minimisation measures for (es)citalopram • Country: 1. Subject … -
List item
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 … -
List item
Human medicine European public assessment report (EPAR): Orkambi (updated)
Lumacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 18/11/2015, Revision: 31, Authorised, Last updated: 25/05/2023 -
List item
Human medicine European public assessment report (EPAR): Nexium Control
esomeprazole, Gastroesophageal Reflux
Date of authorisation: 26/08/2013, Revision: 17, Authorised, Last updated: 24/04/2023 -
List item
Human medicine European public assessment report (EPAR): Quviviq
daridorexant hydrochloride, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/04/2022,
, Revision: 4, Authorised, Last updated: 17/03/2023
-
List item
Human medicine European public assessment report (EPAR): Xenpozyme (updated)
Olipudase alfa, Acid sphingomyelinase deficiency (ASMD) type A/B or type B
Date of authorisation: 24/06/2022,, 
, Revision: 1, Authorised, Last updated: 03/05/2023
-
List item
Human medicine European public assessment report (EPAR): Sivextro
tedizolid phosphate, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 23/03/2015, Revision: 21, Authorised, Last updated: 29/03/2023 -
List item
Human medicine European public assessment report (EPAR): Nimvastid
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/05/2009,
, Revision: 10, Authorised, Last updated: 22/02/2023
-
List item
Human medicine European public assessment report (EPAR): Mysimba
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): 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): Viekirax
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, Revision: 28, Authorised, Last updated: 12/04/2023 -
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): Sancuso
granisetron, Vomiting; Cancer
Date of authorisation: 20/04/2012, Revision: 14, Authorised, Last updated: 29/03/2023 -
List item
Human medicine European public assessment report (EPAR): Cibinqo
Abrocitinib, Dermatitis, Atopic
Date of authorisation: 09/12/2021,
, , Revision: 3, Authorised, Last updated: 30/03/2023
-
List item
Human medicine European public assessment report (EPAR): Aloxi
palonosetron hydrochloride, Vomiting; Cancer
Date of authorisation: 22/03/2005, Revision: 22, Authorised, Last updated: 24/02/2023