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- European Medicines Agency (EMA)
EMA starts review of sodium oxybate in alcohol dependence Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse
- Medicines | European Medicines Agency (EMA)
The European Medicines Agency (EMA) facilitates development and access to medicines for countries within the European Union (EU) EMA evaluates applications for marketing authorisation submitted via the centralised procedure, monitors the safety of medicines across their lifecycle and provides information to healthcare professionals and patients
- About us - European Medicines Agency (EMA)
The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) It is responsible for the scientific evaluation, supervision and safety monitoring of medicines
- Human regulatory: overview - European Medicines Agency (EMA)
Information on the regulation of medicines for human use in the European Union (EU), with a focus on the centralised procedure The European Medicines Agency (EMA) plays a key role in this procedure
- Marketing authorisation | European Medicines Agency (EMA)
The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA) Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein
- Guidance on the application of the revised variations framework
The revised Variations Regulation applies since 1 January 2025 for variation applications implemented and submitted to the European Medicines Agency (EMA) from 1 January 2025
- What’s new - European Medicines Agency (EMA)
Find all new and updated information published on our website in one place below Filters are available to narrow results down based on your interests, such as whether it relates to human or veterinary medicines or specific topics This overview covers up to two months back
- Human Medicines | European Medicines Agency (EMA)
The European Medicines Agency's (EMA) Human Medicines Division oversees human medicines throughout their lifecycle This includes the provision of guidance and advice during medicine development, the marketing authorisation process and the safety monitoring of medicines on the market
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