35 results
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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 … under increased supervision; Aurobindo Pharma stopped from supplying … -
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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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Human medicine European public assessment report (EPAR): Actelsar HCT
telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013,, Revision: 12, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Mysildecard (updated)
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,, Revision: 3, Authorised, Last updated: 15/02/2021
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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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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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Referral: Ranitidine-containing medicinal products (updated)
ranitidine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 17/09/2020, EC decision date: 24/11/2020, Last updated: 17/02/2021 -
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Referral: Simvastatin Vale
simvastatin, associated names: Simvastatin Vale pharmaceuticals, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/03/2013, EC decision date: 27/05/2013, Last updated: 22/07/2013Co. Tipperary Ireland Simvastatina Vale Pharmaceuticals 20mg/5ml … Co. Tipperary Ireland Simvastatina Vale Pharmaceuticals 40mg/5ml … -
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Referral: Micro Therapeutic Research
-, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/03/2017, EC decision date: 23/06/2017, Last updated: 10/07/2017 -
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Referral: Retinoid-containing medicinal products
acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene, associated names: Targretin, Panretin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/03/2018, EC decision date: 21/06/2018, Last updated: 02/07/2018 -
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Referral: Metformin and metformin-containing medicines
metformin, associated names: Xigduo, Vipdomet, Velmetia, Synjardy, Ristfor, Komboglyze, Jentadueto, Janumet, Icandra (previously Vildagliptin / metformin hydrochloride Novartis), Glubrava, Eucreas, Efficib, Ebymect, Competact, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/10/2016, EC decision date: 12/12/2016, Last updated: 21/12/2016 -
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014 -
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Referral: Methotrexate containing medicinal products
methotrexate, associated names: Nordimet, Jylamvo, Ledertrexate, Maxtrex, Metex, Metoject, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/08/2019, EC decision date: 21/10/2019, Last updated: 31/10/2019 -
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Referral: Zolpidem-containing medicines
zolpidem, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 23/06/2014, Last updated: 04/08/2014 -
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Referral: Dienogest/ethinylestradiol-containing medicinal products indicated in acne
dienogest / ethinylestradiol, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/01/2017, EC decision date: 22/03/2017, Last updated: 24/03/2017 -
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Referral: Codeine-containing medicines
codeine, Article 31 referrals
Status: CMDh final position, opinion/position date: 26/06/2013, Last updated: 02/08/2013 -
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Referral: Bisphosphonates
alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid, associated names: Actonel, Aredia, Bonefos, Didronel, Fosamax, Nerixia, Skelid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/04/2011, EC decision date: 13/07/2011, Last updated: 28/10/2011 -
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Referral: Ibuprofen- and dexibuprofen-containing medicines
ibuprofen and dexibuprofen, Article 31 referrals
Status: CMDh final position, opinion/position date: 20/05/2015, Last updated: 14/07/2015 -
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Referral: Domperidone-containing medicines
domperidone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 01/09/2014, Last updated: 11/09/2014 -
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Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 20/01/2012, Last updated: 19/04/2012 -
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Public data from Article 57 database (updated)
Last updated: 16/02/2021 -
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List of medicines under additional monitoring (updated)
Last updated: 24/02/2021 -
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EudraVigilance: electronic reporting
Last updated: 23/04/2020 -
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Deadlines for placing paediatric medicines on the market
Last updated: 10/08/2015 -
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Press release: EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
Last updated: 24/03/2017