Latest news
4/12/18: Publication of clinical data temporarily suspended
Updated on 20/12/18: 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.
4/12/18: 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.
12/11/18: 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.
09/11/18: Clinical data for new medicine published
Truxima is a biosimilar medicine used in adults to treat of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, and granulomatosis with polyangiitis and microscopic polyangiitis. Further information on this medicine is available on the EMA corporate website.
17/10/18: Clinical data for new medicine published
Alecensa is used as monotherapy to treat adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously treated with crizotinib. Further information on this medicine is available on the EMA corporate website.
12/10/18: Clinical data for new medicine published
The clinical data for Lucentis correspond to a variation to the marketing authorisation to include treatment of visual impairment due to choroidal neovascularization based on data from the MINERVA study. Further information on this variation to the marketing authorisation is available on the EMA corporate website.
02/10/18: Clinical data for two new medicines published
Movymia is a biosimilar medicine used to treat osteoporosis in postmenopausal women and in men at increased risk of bone fracture, and osteoporosis associated with sustained systemic glucocorticoid therapy in men and women at increased risk of bone fracture. Further information on this medicine is available on the EMA corporate website.
Terrosa is a biosimilar medicine used to treat osteoporosis in postmenopausal women and in men at increased risk of bone fracture, and osteoporosis associated with sustained systemic glucocorticoid therapy in men and women at increased risk of bone fracture. Further information on this medicine is available on the EMA corporate website.
01/10/18: Clinical data for new medicine published
The clinical data for Jardiance correspond to a variation to the marketing authorisation to reword the indication and sections 4.4, 4.5 and 5.1 of the Summary of Product characteristics (SPC) to reflect new data on cardiovascular outcomes from the phase III EMPA-REG OUTCOME clinical trial. Further information on this variation to the marketing authorisation is available on the EMA corporate website.
28/09/18: Clinical data for new medicine published
Ledaga is used for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma in adult patients. Further information on this medicine is available on the EMA corporate website.
27/09/18: Clinical data for new medicine published
Ivabradine Accord is used to treat chronic stable angina pectoris in coronary artery disease in adults with normal sinus rhythm, heart rate ≥ 70 bpm and with a contra-indication to beta-blockers, or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. It is also used in chronic heart failure (NYHA II to IV class) with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. Further information on this medicine is available on the EMA corporate website.
