7890 results
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Orphan designation: N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine for: Treatment in solid organ transplantation
Date of designation: 13/04/2022, Positive, Last updated: 19/07/2022N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn … n-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3- phosphatidylethanolamine … N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn … -
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Referral: Doxyfar 50%
doxycycline hyclate, associated names: Soludox 500 mg/g, Soludox Vet, Soludox 433 mg/g, Doxy Ort 50%, Article 34
Status: European Commission final decision, opinion/position date: 04/05/2011, EC decision date: 13/07/2011, Last updated: 24/08/2011substance doxycycline hyclate 500 mg/g. The product is indicated … PDF icon application/pdf WC500110851_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500110851_bg.pdf PDF icon application/pdf … -
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Referral: Strenzen 500/125-mg/g powder
amoxicillin, clavulanic acid, Article 33
Status: European Commission final decision, opinion/position date: 10/04/2013, EC decision date: 12/08/2013, Last updated: 19/09/2013Strenzen 500/125-mg/g powder … decision Overview Strenzen 500/125-mg/g powder for use in drinking … decentralised procedure for Strenzen 500/125-mg/g powder for use in drinking … -
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Referral: Gluscan 500
fludeoxyglucose (18F), Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/03/2009, EC decision date: 29/05/2009, Last updated: 23/06/2009Gluscan 500 … authorisation of the medicine Gluscan 500. The Agency's Committee for … that the benefits of Gluscan 500 outweigh its risks, and the … -
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Orphan designation: Recombinant human rod-derived cone viability factor for: Treatment of retinitis pigmentosa
Date of designation: 29/11/2007, Withdrawn, Last updated: 06/03/2015EU/3/07/500 … EU/3/07/500: Orphan designation for the … orphan designation (EU/3/07/500) was granted by the European … -
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Referral: Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets
paracetamol, ibuprofen, associated names: Paracomb, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/05/2017, EC decision date: 07/08/2017, Last updated: 18/08/2017Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets … medicine Paracetamol/ibuprofen 500mg/150mg film-coated tablets. The … of Paracetamol/ibuprofen 500mg/150mg film-coated tablets outweigh … -
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Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Sterility issue with the infusion device co-packed with Respreeza 4.000 mg and 5.000 mg
Active substance: Human alpha1-proteinase inhibitor, DHPC type: Medicine shortage, Last updated: 26/03/2021with Respreeza 4.000 mg and 5.000 mg Genetic Diseases, Inborn Lung … with Respreeza 4.000 mg and 5.000 mg … with Respreeza 4.000 mg and 5.000 mg Dear Healthcare professional … -
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Human medicine European public assessment report (EPAR): Nuwiq
simoctocog alfa, Hemophilia A
Date of authorisation: 22/07/2014, Revision: 13, Authorised, Last updated: 21/03/2023PDF icon application/pdf WC500179343_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500179343_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500179343_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Vokanamet (updated)
canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 23/04/2014, Revision: 21, Authorised, Last updated: 30/05/2023The studies, involving over 5,000 adults with type 2 diabetes … studies, involving over 5,000 adults with type 2 diabetes … http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Risk-management-plan_summary/human/002656/WC500162270.pdf http … -
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Human medicine European public assessment report (EPAR): Synjardy (updated)
empagliflozin, metformin, Diabetes Mellitus, Type 2
Date of authorisation: 27/05/2015, Revision: 25, Authorised, Last updated: 07/06/2023WC500184711_en.pdf … -
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Human medicine European public assessment report (EPAR): Rapilysin (updated)
reteplase, Myocardial Infarction
Date of authorisation: 29/08/1996, Revision: 27, Authorised, Last updated: 01/06/2023PDF icon application/pdf WC500046728_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500046728_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500046728_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Xigduo (updated)
metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 21, Authorised, Last updated: 30/05/2023PDF icon application/pdf WC500161034_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500161034_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500161034_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Colobreathe (updated)
Colistimethate sodium, Cystic Fibrosis
Date of authorisation: 13/02/2012, Revision: 14, Authorised, Last updated: 11/05/2023PDF icon application/pdf WC500123694_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500123694_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500123694_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Controloc Control (updated)
pantoprazole, Gastroesophageal Reflux
Date of authorisation: 11/06/2009, Revision: 15, Authorised, Last updated: 25/05/2023PDF icon application/pdf WC500034151_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500034151_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500034151_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Actavis (updated)
zoledronic acid monohydrate, Fractures, Bone
Date of authorisation: 20/04/2012,
, Revision: 15, Authorised, Last updated: 01/06/2023
PDF icon application/pdf WC500127039_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500127039_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500127039_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Myozyme (updated)
alglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 28/03/2006, Revision: 25, Authorised, Last updated: 07/06/2023PDF icon application/pdf WC500032126_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500032126_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500032126_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Xenical (updated)
orlistat, Obesity
Date of authorisation: 29/07/1998, Revision: 25, Authorised, Last updated: 10/05/2023PDF icon application/pdf WC500058422_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500058422_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500058422_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Invokana (updated)
canagliflozin, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2013, Revision: 22, Authorised, Last updated: 30/05/2023PDF icon application/pdf WC500156458_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500156458_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500156458_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Fendrix (updated)
hepatitis B surface antigen, Hepatitis B; Immunization
Date of authorisation: 02/02/2005, Revision: 12, Authorised, Last updated: 24/05/2023PDF icon application/pdf WC500021703_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500021703_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500021703_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Oxervate (updated)
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,
, 
, 
, Revision: 2, Authorised, Last updated: 02/06/2023
PDF icon application/pdf WC500232108_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500232108_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500232108_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Tadalafil Mylan (updated)
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 15, Authorised, Last updated: 01/06/2023
PDF icon application/pdf WC500179399_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500179399_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500179399_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Telmisartan Actavis (updated)
Telmisartan, Hypertension
Date of authorisation: 29/09/2010,, Revision: 12, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Actelsar HCT (updated)
Telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013,, Revision: 15, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Pioglitazone Actavis (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2012,, Revision: 9, Authorised, Last updated: 01/06/2023
PDF icon application/pdf WC500126563_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500126563_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500126563_es.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Rapiscan (updated)
regadenoson, Myocardial Perfusion Imaging
Date of authorisation: 06/09/2010, Revision: 15, Authorised, Last updated: 25/05/2023PDF icon application/pdf WC500097101_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500097101_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500097101_es.pdf PDF icon application/pdf …