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4 days ago · EMA’s human medicines committee (CHMP) has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta (voxelotor); this measure is taken as a precaution while a review of emerging data is ongoing. The recommendation follows emerging safety data from two registry-based studies, which indicate that patients ...
- List of medicines under additional monitoring
The list of medicines under additional monitoring includes...
- Joint HMA/EMA multi-stakeholder workshop on submission ...
Assuring the EU regulatory network’s sustainability is key...
- List of medicines under additional monitoring
5 days ago · The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities.
22 hours ago · On 19 September 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product mirvetuximab soravtansine (Elahere), intended for the treatment of adults with folate receptor-alpha (FRα)-positive epithelial ovarian, Fallopian tube and primary peritoneal cancer.
5 days ago · Assuring the EU regulatory network’s sustainability is key to the functioning of the EU regulatory system. This workshop brings together representatives from the national competent authorities, industry, and EMA, to focus on submission predictability and how it can be improved.
4 days ago · Singapore aims to peak carbon emissions by 2030 and achieve net-zero emissions by 2050. To reach this goal, the power sector continues to push forward in decarbonising its energy supply and transforming its fuel mix through multiple pathways, including exploring hydrogen as a promising low-carbon alternative. Hydrogen is considered a clean fuel ...
4 days ago · The European Medicines Agency (EMA) recommended suspending the marketing authorization for Pfizer's sickle cell disease drug Oxbryta on Thursday. The European Medicines Agency (EMA) recommended ...
3 days ago · Public Health - Union Register of medicinal products. Adopted Commission Decisions of the last six months. Last updated on 27/09/2024. Public Health. Follow us: Twitter. DG Health and Food Safety. European Commission. Commission and its priorities. Policies, information and services. Follow the European Commission. Facebook. Twitter.
