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2173 results
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Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,
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, Revision: 16, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Xolair (updated)
omalizumab, Asthma; Urticaria
Date of authorisation: 25/10/2005, Revision: 45, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): PreHevbri (updated)
hepatitis B surface antigen, Hepatitis B
Date of authorisation: 25/04/2022,, Revision: 01, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Hexyon (updated)
filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Diphtheria toxoid, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 29, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,
, , Revision: 20, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Keppra (updated)
levetiracetam, Epilepsy
Date of authorisation: 29/09/2000, Revision: 53, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Insulin lispro Sanofi (updated)
insulin lispro, Diabetes Mellitus
Date of authorisation: 19/07/2017,
, Revision: 8, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018,, Revision: 19, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Noxafil (updated)
posaconazole, Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis
Date of authorisation: 25/10/2005, Revision: 36, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Ultomiris (updated)
ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019,, Revision: 10, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Imcivree (updated)
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,, , Revision: 7, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Synagis (updated)
palivizumab, Respiratory Syncytial Virus Infections
Date of authorisation: 13/08/1999, Revision: 45, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Evicel (updated)
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 05/10/2008, Revision: 17, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): MicardisPlus (updated)
telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 19/04/2002, Revision: 33, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva (updated)
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,
, Revision: 16, Withdrawn, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Vihuma (updated)
simoctocog alfa, Hemophilia A
Date of authorisation: 13/02/2017,, Revision: 8, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Nuwiq (updated)
simoctocog alfa, Hemophilia A
Date of authorisation: 22/07/2014, Revision: 13, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Beyfortus (updated)
nirsevimab,
Date of authorisation: 31/10/2022,, Revision: 1, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Elocta (updated)
efmoroctocog alfa, Hemophilia A
Date of authorisation: 18/11/2015, Revision: 12, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Inrebic (updated)
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis
Date of authorisation: 08/02/2021,, , Revision: 4, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Vydura (updated)
Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022,, Revision: 4, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 12, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Revatio (updated)
sildenafil, Hypertension, Pulmonary
Date of authorisation: 28/10/2005, Revision: 49, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Symtuza (updated)
darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017, Revision: 17, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Ecalta (updated)
anidulafungin, Candidiasis
Date of authorisation: 20/09/2007, Revision: 24, Authorised, Last updated: 21/03/2023