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Medicine Opinions on maximum residue limits Remove Opinions on maximum residue limits filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter Summaries of opinion Remove Summaries of opinion filter

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Veterinary medicine European public assessment report (EPAR): Purevax FeLV (updated)

feline leukaemia virus recombinant canarypox virus (vCP97), Cats
Date of authorisation: 13/04/2000, Revision: 12, Authorised, Last updated: 05/03/2021
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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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Veterinary medicine European public assessment report (EPAR): Gumbohatch (updated)

live attenuated infectious bursal disease virus (IBDV), strain 1052, Chicken, Embryonated chicken eggs
Date of authorisation: 12/11/2019, Revision: 2, 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
List item

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, , , , 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
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Human medicine European public assessment report (EPAR): Tandemact (updated)

pioglitazone, glimepiride, Diabetes Mellitus, Type 2
Date of authorisation: 08/01/2007, Revision: 18, Authorised, Last updated: 02/03/2021
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Human medicine European public assessment report (EPAR): Glustin (updated)

pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 11/10/2000, Revision: 26, Authorised, Last updated: 02/03/2021
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)

tafamidis, Amyloidosis
Date of authorisation: 16/11/2011, , , , Revision: 18, Authorised, Last updated: 02/03/2021
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Human medicine European public assessment report (EPAR): Neupro (updated)

rotigotine, Restless Legs Syndrome, Parkinson Disease
Date of authorisation: 15/02/2006, Revision: 30, Authorised, Last updated: 02/03/2021