17691 results
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Human medicine European public assessment report (EPAR): Nyvepria
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,
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, Authorised, Last updated: 23/11/2020
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News: Workshop on regulatory support for development of orphan medicines
COMP, Last updated: 23/11/2020 -
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News: Update on remdesivir - EMA will evaluate new data from Solidarity trial
Last updated: 20/11/2020 -
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News: HMA/EMA statement on approval of vaccines
Last updated: 20/11/2020 -
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Human medicine European public assessment report (EPAR): Azacitidine betapharm
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,
, Revision: 1, Authorised, Last updated: 20/11/2020
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Orphan designation: Retinol palmitate for: Prevention of bronchopulmonary dysplasia
Date of first decision: 27/07/2020, Positive, Last updated: 19/11/2020 -
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Orphan designation: Tinostamustine for: Treatment of T-cell prolymphocytic leukaemia
Date of first decision: 27/07/2020, Positive, Last updated: 19/11/2020 -
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Orphan designation: Imetelstat sodium for: Treatment of myelodysplastic syndromes
Date of first decision: 27/07/2020, Positive, Last updated: 19/11/2020 -
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Orphan designation: Maralixibat chloride for: Treatment of biliary atresia
Date of first decision: 27/07/2020, Positive, Last updated: 19/11/2020 -
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Orphan designation: Benzyl benzoate, beta-caryophyllene, cineole, cinnamaldehyde, cinnamyl acetate, linalool, trans-2-methoxycinnamaldehyde for: Treatment of eumycetoma
Date of first decision: 18/06/2020, Negative, Last updated: 19/11/2020 -
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Orphan designation: melatonin for: Treatment of intracerebral haemorrhage
Date of first decision: 06/07/2020, Negative, Last updated: 19/11/2020 -
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Orphan designation: Adeno-associated viral vector expressing acid alpha-glucosidase gene for: Treatment of glycogen storage disease type II (Pompe's disease)
Date of first decision: 27/07/2020, Positive, Last updated: 19/11/2020 -
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Orphan designation: Triheptanoin for: Treatment of carnitine-acylcarnitine translocase deficiency
Date of first decision: 27/07/2020, Positive, Last updated: 19/11/2020 -
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Orphan designation: Pegylated adrenomedullin for: Treatment of acute respiratory distress syndrome (ARDS)
Date of first decision: 27/07/2020, Positive, Last updated: 19/11/2020 -
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News: EMA organises public meeting on COVID-19 vaccines
Last updated: 19/11/2020 -
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Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU
Virtual meeting, 11/12/2020, Last updated: 19/11/2020 -
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EMA considerations on COVID-19 vaccine approval
Last updated: 19/11/2020 -
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Orphan designation: Fasudil hydrochloride for: Treatment of non-traumatic subarachnoid haemorrhage
Date of first decision: 27/07/2020, Positive, Last updated: 19/11/2020 -
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Orphan designation: C-type natriuretic peptide conjugated to multi-arm polyethylene glycol carrier through a cleavable linker for: Treatment of achondroplasia
Date of first decision: 27/07/2020, Positive, Last updated: 19/11/2020 -
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Orphan designation: Hemopexin for: Treatment of sickle cell disease
Date of first decision: 27/07/2020, Positive, Last updated: 19/11/2020 -
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Human medicine European public assessment report (EPAR): Arikayce liposomal
Amikacin sulfate, Respiratory Tract Infections
Date of authorisation: 27/10/2020,
, Authorised, Last updated: 18/11/2020
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News: EMA marks European Antibiotic Awareness Day
Last updated: 18/11/2020 -
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15th industry stakeholder platform - operation of European Union (EU) pharmacovigilance (updated)
30/10/2020, Last updated: 18/11/2020 -
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News: EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.
Last updated: 16/11/2020 -
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News: Emer Cooke takes office as head of EMA
Last updated: 16/11/2020