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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,
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, Authorised, Last updated: 02/03/2021
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Human medicine European public assessment report (EPAR): Flixabi (updated)
infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis
Date of authorisation: 26/05/2016,, 
, Revision: 16, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 08/02/2018,, , Revision: 11, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, , Revision: 8, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Yuflyma
adalimumab, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Arthritis, Psoriatic, Colitis, Ulcerative, Crohn Disease, Arthritis, Juvenile Rheumatoid, Hidradenitis Suppurativa, Uveitis
Date of authorisation: 11/02/2021,, Authorised, Last updated: 26/02/2021
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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: 25/02/2021
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Human medicine European public assessment report (EPAR): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, , Revision: 17, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Remsima (updated)
infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 22, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Benepali (updated)
etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016,, Revision: 13, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Nepexto (updated)
etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020,, , Revision: 3, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Kanjinti (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 16/05/2018,, , Revision: 7, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, 
, , Revision: 20, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Crysvita (updated)
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 7, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine AstraZeneca
Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), COVID-19 virus infection
Date of authorisation: 29/01/2021,, , Authorised, Last updated: 18/02/2021
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Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 05/02/2021, Last updated: 16/02/2021, Compliance check: X -
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Human medicine European public assessment report (EPAR): Udenyca (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, , Revision: 3, Withdrawn, Last updated: 15/02/2021
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Human medicine European public assessment report (EPAR): Ritemvia (updated)
rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 13/07/2017,, , Revision: 8, Authorised, Last updated: 11/02/2021
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Human medicine European public assessment report (EPAR): Blitzima (updated)
rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, , Revision: 10, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Ontruzant (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017,, , Revision: 8, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020,, Revision: 1, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , , Revision: 1, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Zercepac (updated)
trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020,, , Revision: 2, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Authorised, Last updated: 08/02/2021
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Human medicine European public assessment report (EPAR): Omnitrope (updated)
somatropin, Turner Syndrome, Prader-Willi Syndrome, Dwarfism, Pituitary
Date of authorisation: 12/04/2006,, Revision: 16, Authorised, Last updated: 05/02/2021
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Orphan designation: pemigatinib for: Treatment of myeloid/lymphoid neoplasms with eosinophilia and rearrangement of PDGFRA, PDGFRB, or FGFR1, or with PCM1-JAK (updated)
Date of first decision: 17/10/2019, Positive, Last updated: 01/02/2021