Europe – EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
EMA’s safety committee (PRAC) has confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June 2022, which was...
Europe – EMA recommends measures to minimise risk of serious side effects with Janus...
EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat...
Europe – EMA recommends approval of second adapted Spikevax vaccine
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the...
Europe – EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from...
EMA’s human medicines committee (CHMP) has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2. The Committee recommended including...
UK – Grifols’ Tavlesse receives NICE recommendation
Therapy treats refractory chronic immune thrombocytopenia and is available across UK.
Grifols has announced that its treatment for adults with chronic immune thrombocytopenia (ITP), Tavlesse...
Europe – Codéine et ibuprofène (Antarene codeine) : cas d’abus/dépendance et mise en garde...
Le comité de pharmacovigilance (PRAC) de l’Agence européenne des médicaments (EMA) recommande de nouvelles mesures pour réduire les risques d’insuffisance respiratoire et de sepsis...
Europe – New vaccine to protect people in the EU and worldwide against dengue
EMA’s human medicines committee (CHMP) has adopted a positive opinion for Dengue Tetravalent Vaccine (live, attenuated) Takeda, used to prevent disease caused by dengue...
Europe – First therapy to treat transplant patients with post-transplant lymphoproliferative disease
The European Medicines Agency (EMA) has recommended a marketing authorisation in the European Union (EU) for Ebvallo (tabelecleucel) for the treatment of adult and paediatric...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
10 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its October 2022 meeting.
The CHMP recommended granting a marketing authorisation for Dengue Tetravalent...
Europe – Data Quality Framework for EU medicines regulation
As acknowledged in the recommendations of the HMA-EMA Joint Big Data Task Force (BDTF) and the workplan of the HMA-EMA Joint Big Data Steering...