News and Educations

Meeting highlights from the CMDh meeting in January 2017


CMDh positions following PSUSA procedure for nationally authorised products only

The CMDh, having considered the PSURs on the basis of the PRAC recommendations and the PRAC assessment reports, agreed by consensus on the variations of the marketing authorisations of medicinal products containing the following active substances:

  • budesonide
  • misoprostol (gynaecological indication - labour induction)
  • moxifloxacin (systemic use)
  • nadifloxacin
  • nefopam
  • nicardipine
  • sulprostone
  • treprostinil

For the PSUSA of budesonide, the PRAC considered that "Blurred Vision” and "Central Serous Chorioretinopathy” is a class risk effect of corticosteroids and should also be included in the product information of the fixed combinations of budesonide as well as other corticosteroids, for all routes of administration. The MAHs of affected products should take due note of the outcome of this PSUSA assessment and implement this PRAC recommendation via the appropriate regulatory procedures.

Further information regarding the above mentioned PSUSA procedures, including information on the implementation, will be published on the EMA website.

Combined hormonal contraceptives (CHCs) containing ethinylestradiol

The CMDh has agreed a common text to be included in the product information of combined hormonal contraceptives (CHCs) containing ethinylestradiol regarding the interaction concerning concomitant use with medicinal products containing ombitasvir/paritaprevir/ritonavir (Viekirax) and dasabuvir with or without ribavirin, following the inclusion of the same interaction in the product information of Viekirax.

The agreed wording will be published on the CMDh website under "Product Information, CMDh recommendations”.

Concerned MAHs are requested to implement the agreed wording via the appropriate regulatory procedure.

Implementation of Commission Decisions after Article 30 referral procedures

A link to the Commission decisions, including SmPC, package leaflet and labelling, on the finalised Article 30 referral procedures for Clenil (beclometasone dipropionate) and associated names will be published on the CMDh website.

Generic companies are encouraged to contact the Reference Member State to harmonise the product information of the medicinal products authorised via MRP/DCP to conform to the Commission Decision, through submission of a type IB variation under classification C.I.1.b, provided the conditions described in Regulation (EC) No 1234/2008 are met.

The CMDh will update the tracking table on referrals in accordance with Article 30 of Directive 2001/83/EC to include MRP procedure numbers following the referral procedures, once known. The updated tracking table will be published on the CMDh website.

More news from the CMDh January 2017 meeting are available on the CMDh/HMA website.