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Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
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Human medicine European public assessment report (EPAR): Orserdu (updated)
elacestrant, Breast Neoplasms
Date of authorisation: 15/09/2023,, Authorised, Last updated: 27/11/2023
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Human medicine European public assessment report (EPAR): Triumeq (updated)
dolutegravir sodium, lamivudine, abacavir (as sulfate), HIV Infections
Date of authorisation: 31/08/2014, Revision: 32, Authorised, Last updated: 27/11/2023 -
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Human medicine European public assessment report (EPAR): Pluvicto (updated)
lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 09/12/2022,, Revision: 4, Authorised, Last updated: 27/11/2023
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Human medicine European public assessment report (EPAR): Prevenar 13 (updated)
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal Infections; Immunization
Date of authorisation: 09/12/2009, Revision: 45, Authorised, Last updated: 27/11/2023 -
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Human medicine European public assessment report (EPAR): Kivexa (updated)
abacavir, lamivudine, HIV Infections
Date of authorisation: 16/12/2004, Revision: 37, Authorised, Last updated: 27/11/2023 -
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Human medicine European public assessment report (EPAR): Apexxnar (updated)
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 8, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 10A, Pneumococcal polysaccharide serotype 11A, Pneumococcal polysaccharide serotype 12F, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 15b, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 22F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 33F, Pneumococcal Infections
Date of authorisation: 14/02/2022,, Revision: 6, Authorised, Last updated: 27/11/2023
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Human medicine European public assessment report (EPAR): Tasigna (updated)
nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 19/11/2007, Revision: 45, Authorised, Last updated: 27/11/2023 -
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Human medicine European public assessment report (EPAR): Somavert (updated)
Pegvisomant, Acromegaly
Date of authorisation: 12/11/2002, Revision: 28, Authorised, Last updated: 27/11/2023 -
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Human medicine European public assessment report (EPAR): Holoclar (updated)
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation; Corneal Diseases
Date of authorisation: 17/02/2015,,
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, Revision: 10, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Betaferon (updated)
interferon beta-1b, Multiple Sclerosis
Date of authorisation: 30/11/1995, Revision: 36, Authorised, Last updated: 24/11/2023 -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva (updated)
emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016,, Revision: 8, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Pradaxa (updated)
Dabigatran etexilate mesilate, Arthroplasty, Replacement; Venous Thromboembolism
Date of authorisation: 17/03/2008, Revision: 40, Authorised, Last updated: 24/11/2023 -
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Human medicine European public assessment report (EPAR): Zabdeno (updated)
Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,,
, Revision: 5, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Mvabea (updated)
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,,
, Revision: 4, Authorised, Last updated: 24/11/2023
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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,,
, Revision: 18, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius) (updated)
carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,, Revision: 9, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Symkevi (updated)
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,, Revision: 12, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Toujeo (previously Optisulin) (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 26/06/2000, Revision: 35, Authorised, Last updated: 24/11/2023 -
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Human medicine European public assessment report (EPAR): Talvey (updated)
talquetamab, Multiple Myeloma
Date of authorisation: 21/08/2023,,
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, Revision: 1, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Voxzogo (updated)
Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021,,
, Revision: 4, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Herwenda (updated)
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 15/11/2023,,
, Authorised, Last updated: 23/11/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 17, Authorised, Last updated: 22/11/2023
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Human medicine European public assessment report (EPAR): Takhzyro (updated)
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,,
, Revision: 12, Authorised, Last updated: 22/11/2023
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Human medicine European public assessment report (EPAR): Zynrelef (updated)
bupivacaine, meloxicam, Pain, Postoperative
Date of authorisation: 24/09/2020, Revision: 3, Withdrawn, Last updated: 22/11/2023 -
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Human medicine European public assessment report (EPAR): Aqumeldi (updated)
Enalapril (maleate), Heart Failure
Date of authorisation: 15/11/2023, Authorised, Last updated: 22/11/2023