Latest news
EMA is publishing clinical data for COVID-19 medicines in line with its exceptional transparency measures for COVID-19.
Clinical data publication for all other centrally authorised products remains suspended until further notice.
25/02/2021: Clinical data for an existing COVID-19 medicine published
The clinical data for Veklury (remdesivir) correspond to a variation to the marketing authorisation updating the indication to specify patients requiring low- or high-flow oxygen or other non-invasive ventilation at start of treatment. Further information on this variation to the marketing authorisation is available on the EMA corporate website.
30/10/2020: Clinical data for new COVID-19 medicine published
Veklury (remdesivir) is an antiviral medicine used to treat coronavirus disease 2019 (COVID-19). It is used in adults and adolescents with pneumonia requiring supplemental oxygen. Further information on this medicine is available on the EMA corporate website.
20/12/2018: Temporary suspension of clinical data publication
EMA has temporarily suspended the publication of clinical data until further notice, as a result of the implementation of the third phase of its business continuity plan to help prepare for its relocation to the Netherlands.
4/12/2018: Clinical data for new medicine published
The clinical data for Inovelon correspond to a variation to the marketing authorisation to update sections 4.2, 4.8, 5.1, 5.2 and 5.3 of the summary of product characteristics with the key findings of a study in children aged 1 - 4 years with Lennox-Gastaut syndrome and of toxicity studies in juvenile animals. Further information on this variation to the marketing authorisation is available on the EMA corporate website.
12/11/2018: Clinical data for new medicine published
The clinical data for Ameluz correspond to a variation to the marketing authorisation to include treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults. Further information on this variation to the marketing authorisation is available on the EMA corporate website.
