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Medicine
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Human medicine European public assessment report (EPAR): Somac Control (updated)
pantoprazole, Gastroesophageal Reflux
Date of authorisation: 12/06/2009, Revision: 14, Authorised, Last updated: 08/03/2021 -
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Human medicine European public assessment report (EPAR): Instanyl (updated)
Fentanyl citrate, Pain, Cancer
Date of authorisation: 20/07/2009, Revision: 27, Authorised, Last updated: 08/03/2021 -
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Human medicine European public assessment report (EPAR): Spravato (updated)
esketamine hydrochloride, Depressive Disorder
Date of authorisation: 18/12/2019,, Revision: 2, Authorised, Last updated: 08/03/2021
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Human medicine European public assessment report (EPAR): Vargatef (updated)
nintedanib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/11/2014, Revision: 14, Authorised, Last updated: 08/03/2021 -
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Human medicine European public assessment report (EPAR): Gardasil 9 (updated)
human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed), Condylomata Acuminata, Papillomavirus Infections, Immunization, Uterine Cervical Dysplasia
Date of authorisation: 09/06/2015, Revision: 15, Authorised, Last updated: 08/03/2021 -
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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos) (updated)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,, Revision: 5, Authorised, Last updated: 08/03/2021
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Human medicine European public assessment report (EPAR): Vizarsin (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009,, Revision: 16, Authorised, Last updated: 05/03/2021
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Human medicine European public assessment report (EPAR): Tecentriq (updated)
atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Urologic Neoplasms, Breast Neoplasms, Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017,, Revision: 13, Authorised, Last updated: 05/03/2021
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Human medicine European public assessment report (EPAR): Iressa (updated)
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 24/06/2009, Revision: 14, Authorised, Last updated: 05/03/2021 -
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Human medicine European public assessment report (EPAR): Trizivir (updated)
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 36, Authorised, Last updated: 05/03/2021 -
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Human medicine European public assessment report (EPAR): Pemetrexed Accord (updated)
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 6, Authorised, Last updated: 05/03/2021
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Human medicine European public assessment report (EPAR): Integrilin (updated)
eptifibatide, Angina, Unstable, Myocardial Infarction
Date of authorisation: 01/07/1999, Revision: 25, Authorised, Last updated: 05/03/2021 -
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Human medicine European public assessment report (EPAR): Xtandi (updated)
enzalutamide, Prostatic Neoplasms
Date of authorisation: 21/06/2013,
Date of refusal: 26/04/2013, Revision: 16, Authorised, Last updated: 05/03/2021 -
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Human medicine European public assessment report (EPAR): Azomyr (updated)
desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 45, Authorised, Last updated: 04/03/2021 -
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Human medicine European public assessment report (EPAR): Vipdomet (updated)
alogliptin benzoate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 18/09/2013, Revision: 7, Authorised, Last updated: 04/03/2021 -
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,,
, Revision: 3, Authorised, Last updated: 04/03/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
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), COVID-19 virus infection
Date of authorisation: 06/01/2021,,
, Authorised, Last updated: 04/03/2021
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Human medicine European public assessment report (EPAR): Xgeva (updated)
denosumab, Fractures, Bone, Neoplasm Metastasis
Date of authorisation: 13/07/2011, Revision: 21, Authorised, Last updated: 04/03/2021 -
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Human medicine European public assessment report (EPAR): Nimenrix (updated)
Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 20/04/2012, Revision: 32, Authorised, Last updated: 04/03/2021 -
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Human medicine European public assessment report (EPAR): Glubrava (updated)
metformin hydrochloride, pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 11/12/2007, Revision: 17, Authorised, Last updated: 04/03/2021 -
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Human medicine European public assessment report (EPAR): Competact (updated)
pioglitazone, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 28/07/2006, Revision: 18, Authorised, Last updated: 04/03/2021 -
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Human medicine European public assessment report (EPAR): Actos (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 13/10/2000, Revision: 27, Authorised, Last updated: 04/03/2021 -
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,,
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, Revision: 9, Authorised, Last updated: 03/03/2021
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Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,,
, Revision: 11, Authorised, Last updated: 03/03/2021
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Human medicine European public assessment report (EPAR): Nexium Control (updated)
esomeprazole, Gastroesophageal Reflux
Date of authorisation: 26/08/2013, Revision: 15, Authorised, Last updated: 03/03/2021