Please note that information provided by the State Agency of Medicines (SAM) for marketing authorisation holders has been updated on 1 March 2019.
Changes have been made to the documents issued on 20 February 2017:
- Submission and agreement of educational materials stipulated by the risk management plan with the State Agency of Medicines
- Submission and agreement of Direct Healthcare Professional Communications with the State Agency of Medicines
Please note that clarifying amendments have been made throughout the text.