155 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 childrenand 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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National expert: Maria Formosa Cassar, Medicines Authority (updated)
- Declaration of interests - 80.33 KB | PDF
- Curriculum Vitae - 21.4 KB | PDF
Authorisations (pertaining to MAH: Aurobindo Pharma Malta) and PV documentation … -
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National expert: Abdul Karim Barakat, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 16.72 KB | PDF
Kalayda GV, Jaehde U, Stingl JC. Citalopram-induced pathways regulation and tentative treatment-outcome-predicting … -
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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: Jogin Thakore, European Medicines Agency (updated)
- Declaration of interests - 82.96 KB | PDF
- Curriculum Vitae - 30.04 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 - 79.75 KB | PDF
- Curriculum Vitae - 17.77 KB | PDF
Serotonin Reuptake Inhibitors Citalopram, Escitalopram, and Sertraline … -
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National expert: Carmen Verge Gonzalez, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 19.76 KB | PDF
M.D., C. Verge M.D., et al. Citalopram, a new instance of hepatotoxicity … -
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National expert: Christine Greiner, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 79.77 KB | PDF
- Curriculum Vitae - 21.01 KB | PDF
Haen E. Determination of citalopram and escitalopram together … -
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National expert: Anette Solli Karlsen, Norwegian Medicines Agency (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 86.76 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 - 79.8 KB | PDF
- Curriculum Vitae - 18.07 KB | PDF
minimisation measures for (es)citalopram October 2007-June 2014 PhD Doctoral … -
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Human medicine European public assessment report (EPAR): Orkambi (updated)
Lumacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 18/11/2015,
, Revision: 25, Authorised, Last updated: 28/07/2021
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Human medicine European public assessment report (EPAR): Diacomit
stiripentol, Myoclonic Epilepsy, Juvenile
Date of authorisation: 03/01/2007,
Date of refusal: 11/02/2009, Revision: 17, Authorised, Last updated: 15/06/2021 -
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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: 2, Authorised, Last updated: 16/06/2021 -
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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: 19, Authorised, Last updated: 13/07/2021
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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: 10, Authorised, Last updated: 30/04/2021 -
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Human medicine European public assessment report (EPAR): Zubsolv (updated)
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 10/11/2017, Revision: 7, Authorised, Last updated: 29/07/2021 -
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Human medicine European public assessment report (EPAR): Nexium Control
esomeprazole, Gastroesophageal Reflux
Date of authorisation: 26/08/2013, Revision: 15, Authorised, Last updated: 03/03/2021 -
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Human medicine European public assessment report (EPAR): Brilique
ticagrelor, Peripheral Vascular Diseases, Acute Coronary Syndrome
Date of authorisation: 03/12/2010, Revision: 16, Authorised, Last updated: 12/05/2021 -
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Human medicine European public assessment report (EPAR): Akynzeo (updated)
netupitant, palonosetron hydrochloride, Vomiting, Cancer, Nausea
Date of authorisation: 27/05/2015, Revision: 10, Authorised, Last updated: 07/07/2021 -
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Human medicine European public assessment report (EPAR): Prometax
rivastigmine, Alzheimer Disease, Parkinson Disease, Dementia
Date of authorisation: 03/12/1998, Revision: 40, Authorised, Last updated: 09/06/2021 -
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Human medicine European public assessment report (EPAR): Mysildecard (updated)
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,
, Revision: 4, Authorised, Last updated: 30/07/2021
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Human medicine European public assessment report (EPAR): Exelon
rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease
Date of authorisation: 11/05/1998, Revision: 41, Authorised, Last updated: 07/06/2021 -
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Human medicine European public assessment report (EPAR): Buvidal
buprenorphine, Opioid-Related Disorders
Date of authorisation: 20/11/2018, Revision: 5, Authorised, Last updated: 26/05/2021