8781 results
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva
emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016,
, Revision: 6, Authorised, Last updated: 21/07/2021
itabine/Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … itabine/Tenofovir disoproxil Zentiva … product characteristics, the labelling and the package leaflet … -
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Human medicine European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)
clopidogrel, Acetylsalicylic acid, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 14/03/2010, Revision: 22, Authorised, Last updated: 13/11/2019idogrel/Acetylsalicylic acid Zentiva (previously DuoCover) Cardiovascular … idogrel/Acetylsalicylic acid Zentiva (previously DuoCover … Clopidogrel/Acetylsalicylic acid Zentiva1 clopidogrel / acetylsalicylic … -
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Human medicine European public assessment report (EPAR): Sibnayal
Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular
Date of authorisation: 30/04/2021, Revision: 1, Authorised, Last updated: 26/04/2022Diseases Acid-Base Imbalance Acidosis Acidosis, Renal Tubular … with distal renal tubular acidosis (dRTA), a disease in which … with distal renal tubular acidosis (dRTA), a disease in which … -
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Press release: Updated advice on body fat changes and lactic acidosis with HIV medicines
CHMP, Last updated: 23/10/2015body fat changes and lactic acidosis with HIV medicines … body fat changes and lactic acidosis with medicines for the treatment … require a warning about lactic acidosis. … -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan, olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021orothiazide Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Irbesartan … Teva Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … CoAprovel Karvezide Karvea Irbesartan/Hydrochlorothiazide Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Irbesartan … -
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Human medicine European public assessment report (EPAR): Tractocile
atosiban (as acetate), Premature Birth
Date of authorisation: 20/01/2000, Revision: 24, Authorised, Last updated: 30/03/2022Complications Obstetric Labor Complications Obstetric Labor, Premature Premature Birth … the treatment of pre-term labour. Treatment should be started … after diagnosis of pre-term labour. Tractocile is given into … -
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Human medicine European public assessment report (EPAR): Atosiban SUN
atosiban (as acetate), Premature Birth
Date of authorisation: 31/07/2013,, Revision: 9, Authorised, Last updated: 09/02/2022
Atosiban SUN Obstetric Labor, Premature Obstetric Labor Complications Pregnancy … the treatment of pre-term labour. Treatment should be started … after diagnosis of pre-term labour. Atosiban SUN is available … -
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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: 08/10/2014Krka) Irbesartan Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Karvea Sabervel CoAprovel Ifirmacombi Irbesartan/Hydrochlorothiazide … Teva Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … Krka) Irbesartan Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Karvea Sabervel CoAprovel Ifirmacombi Irbesartan/Hydrochlorothiazide … -
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News: Panexcell Clinical Laboratories: suspension of medicines over flawed studies
CHMP, Last updated: 24/07/2020Panexcell Clinical Laboratories: suspension of medicines over … Panexcell Clinical Laboratories: suspension of medicines over … -
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IMI ADAPT SMART, IMI GetReal and MIT NEW Drug Development ParadIGmS (NEWDIGS) “Adaptive Design Laboratory” workshop
European Medicines Agency, London, UK, from 01/06/2016 to 02/06/2016, Last updated: 21/04/2016NEWDIGS) “Adaptive Design Laboratory” workshop … summary - Adaptive Design Laboratory workshop PDF icon application/pdf … Adaptive Design Laboratory workshop … -
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Excipients labelling
Last updated: 11/12/2020Excipients labelling … Excipients labelling …
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National expert: Lise Laborieux, National Veterinary Medicines Agency (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 23.24 KB | PDF
Lise Laborieux … Lise Laborieux … Vitae Personal information Lise Laborieux Work experience … -
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Good laboratory practice compliance
Last updated: 21/12/2015Good laboratory practice compliance … Good laboratory practice compliance … Human/Veterinary use • GLP Good Laboratory Practice • JAR Joint …
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National expert: Cristina Irigoyen Laborra, European Medicines Agency (updated)
- Declaration of interests - 39.22 KB | PDF
- Curriculum Vitae - 33.9 KB | PDF
Cristina Irigoyen Laborra … Cristina Irigoyen Laborra … information Cristina Irigoyen Laborra Work experience … -
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Exemptions to labelling and package-leaflet obligations
Last updated: 19/04/2023Exemptions to labelling and package-leaflet obligatio … Exemptions to labelling and package-leaflet obligatio …
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Press release: Alcon Laboratories withdraws its application for RETAANE
Last updated: 02/03/2006Alcon Laboratories withdraws its application … formally notified by Alcon Laboratories (UK) Ltd of its decision … for depot injection. Alcon Laboratories (UK) Ltd submitted an application … -
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Direct healthcare professional communication (DHPC): Spikevax bivalent Original/Omicron BA.1, pre-filled syringe - Labelling deviation
Active substance: CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), DHPC type: Adverse event, Last updated: 21/02/2023BA.1, pre-filled syringe - Labelling deviation COVID-19 virus … BA.1, pre-filled syringe - Labelling deviation … BA.1, pre-filled syringe Labelling deviation Dear Healthcare … -
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Changing the labelling and package leaflet (Article 61(3) notifications)
Last updated: 16/04/2021Changing the labelling and package leaflet (Article … Changing the labelling and package leaflet (Article …
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News: Better labelling of excipients for safe use of medicines
Last updated: 09/10/2017Better labelling of excipients for safe use … guideline on excipients in the labelling and package leaflet of medicinal … These must be declared in the labelling of the medicine for its safe … -
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Emerging medicinal products: from laboratory to patient use
London, UK, 14/12/2015, Last updated: 13/11/2015medicinal products: from laboratory to patient use … Medicinal Products – from laboratory to patient use”. This conference … medicinal products: from laboratory to patient use PDF icon application/pdf … -
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Press release: Fournier Laboratories withdraws its marketing authorisation application for Synordia
Last updated: 08/12/2006Fournier Laboratories withdraws its marketing authorisation … formally notified by Fournier Laboratories Ireland Ltd of their decision … PRESS RELEASE Fournier Laboratories withdraws its marketing authorisation … -
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Press release: EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
Last updated: 24/03/2017Micro Therapeutic Research Labs … Micro Therapeutic Research Labs … Micro Therapeutic Research Labs 30 Churchill Place … -
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Off-label use of antimicrobials in veterinary medicine in the European Union - Scientific guideline
Last updated: 21/11/2018Off-label use of antimicrobials in … Off-label use of antimicrobials in … Reflection paper on off-label use of antimicrobials in …
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News: Reducing off-label use of antimicrobials in veterinary medicine to reduce risk of resistance
CVMP, Last updated: 25/07/2017Reducing off-label use of antimicrobials in … application/pdf Reflection paper on off-label use of antimicrobials in … vet-guidelines@ema.europa.eu . Off-label use, which includes the use … -
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Press release: Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU
CHMP, Last updated: 24/06/2016Studies from Alkem Laboratories Ltd cannot be used to support … were conducted at the Alkem Laboratories Ltd site in Taloja, India … conduct of studies by Alkem Laboratories Ltd, the studies cannot be …