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Recommended updates of the product information

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Updated:

Changes

  • : Changed according to the Norwegian site.

The Marketing Authorisation holder (MAH) for a medicinal product is responsible for updating the product information in accordance with new knowledge about the medicinal product. Here you will find recommendations for updating the product information.

The NOMA publishes requirements for updates to the product information that must be implemented for individual active substances or groups of active substances, based on joint recommendations for countries in the European Economic Area (EEA). The NOMA publishes information on regulatory actions and requirements for updating product information following recommendations from European medicinal authorities.

 

Change to Norwegian version of this page to find the Norwegian translations of the recommended updates.