United States Resources
Organizations that rejected interchangeability for biologics in legislative debate:
Outside United States (EU and Other)
European Medicines Agency (EMA) Guidelines — Including Draft & Adopted Guidelines
Once a medicine has been granted a European Community marketing authorization by the European Commission, the European Medicines Agency publishes a full scientific assessment report called a European Public Assessment Report (EPAR). In the EPAR, you will find key information for a medicine including a Q&A on the medicine and the patient leaflet. You will also find information on medicines which were refused a marketing authorization or have been suspended or withdrawn post-approval. Please be aware that the Agency does not evaluate all medicines currently in use in Europe, therefore no EPAR will be available for medicines approved prior to 2004.
Each EPAR record provides information on individual medicines including: general information about the medicine, a summary of the EPAR, authorization details, product information (including clinical trial summaries) and an assessment history. An example of how the information available for each medicine is displayed can be viewed here.
|International Non-proprietary Name (INN)||Trade Name||Owner||Approval Date||Ref. Product|
Epoetin Alfa Hexal
|International Non-proprietary Name (INN)||Trade Name||Owner||Refusal Date||Ref. Product|
|International Non-proprietary Name (INN)||Trade Name||Owner||Withdrawn Date||Ref. Product|
|Insulin – Human||Insulin Rapid||Marvel LifeSciences||6-16-08||Humulin|
|Insulin – Human||Insulin 30/70 Mix||Marvel LifeSciences||6-16-08||Humulin|
|Insulin – Human||Insulin Long Acting||Marvel LifeSciences||6-16-08||Humulin|