172 results
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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: 03/11/2005substances: atomoxetine, citalopram, duloxetine, escitalopram … SSRIs / SNRIs: atomoxetine, citalopram, duloxetine, escitalopram … the product information of citalopram, duloxetine 1 , escitalopram … -
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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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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 … -
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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: Abdul Karim Barakat, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 16.82 KB | PDF
Kalayda GV, Jaehde U, Stingl JC. Citalopram-induced pathways regulation and tentative treatment-outcome-predicting … -
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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: Caroline Gjestad, Norwegian Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 17.94 KB | PDF
Serotonin Reuptake Inhibitors Citalopram, Escitalopram, and Sertraline … -
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National expert: Anya Staal, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 23.35 KB | PDF
Jaehde, U.; Stingl, J.C. Citalopram-induced pathways regulation and tentative treatment-outcome-predicting … -
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National expert: Anette Solli Karlsen, Norwegian Medicines Agency (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 23.29 KB | PDF
quot;Simultaneous determination of citalopram, fluoxetine, paroxetine and … -
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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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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): Prometax (updated)
rivastigmine, Alzheimer Disease; Parkinson Disease; Dementia
Date of authorisation: 03/12/1998, Revision: 44, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Exelon (updated)
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/05/1998, Revision: 45, Authorised, Last updated: 02/02/2023 -
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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: 21, Authorised, Last updated: 17/01/2023 -
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Human medicine European public assessment report (EPAR): Quviviq
daridorexant hydrochloride, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/04/2022,
, Revision: 3, Authorised, Last updated: 11/11/2022
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Human medicine European public assessment report (EPAR): Mysimba
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,, Revision: 23, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Sivextro
tedizolid phosphate, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 23/03/2015, Revision: 20, Authorised, Last updated: 16/12/2022 -
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Human medicine European public assessment report (EPAR): Rivastigmine 1 A Pharma
rivastigmine, Alzheimer Disease; Dementia; Parkinson Disease
Date of authorisation: 11/12/2009, Revision: 14, Authorised, Last updated: 13/10/2022 -
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Human medicine European public assessment report (EPAR): Rivastigmine Sandoz
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 10/12/2009, Revision: 13, Authorised, Last updated: 13/10/2022 -
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Human medicine European public assessment report (EPAR): Rivastigmine Hexal
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/12/2009, Revision: 14, Authorised, Last updated: 13/10/2022 -
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Human medicine European public assessment report (EPAR): Methylthioninium chloride Proveblue
methylthioninium chloride, Methemoglobinemia
Date of authorisation: 06/05/2011, Revision: 25, Authorised, Last updated: 15/12/2022 -
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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: 14, Authorised, Last updated: 09/11/2022 -
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Human medicine European public assessment report (EPAR): Orkambi
Lumacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 18/11/2015,, Revision: 29, Authorised, Last updated: 25/07/2022
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Human medicine European public assessment report (EPAR): Mysildecard
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,
, Revision: 7, Authorised, Last updated: 30/11/2022