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Information to MAHs for new combined hormonal contraceptives

29 January 2014

After the most recent EU review of a number of new combined contraceptives under Article 31 of Directive 2001/83/EC, it was decided that marketing authorisation holder (MAHs) for these products must send out DHPCs and guidance material to doctors.

The guidance material to doctors must include:

  • a checklist to doctors to support consultations before prescribing the products
  • a card with information about the products and symptoms of blood clots to the users.

MAHs in Denmark should not send out DHPCs

The Danish Health and Medicines Authority has decided that we will send out the DHPCs. Consequently, MAHs in Denmark should not send out this information.

On 23 January 2014, the Danish Health and Medicines Authority sent out a DHPC via the relevant partners. A copy of the letter sent out is available on our website: Direct Healthcare Professional Communication (DHPC) sent to healthcare professionals

Translation of other material to doctors and users

In the coming month, the Danish Health and Medicines Authority will make translations of other material to doctors and users. The translations will be published on this website and the involved MAHs are expected to download, print and distribute the material.

Link

PRAC confirms that benefits of all combined hormonal contraceptives (CHCs) continue to outweigh risks