News and Educations

Meeting highlights from the CMDh meeting in April 2017


CMDh positions following PSUSA procedure for nationally authorised products only

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

  • finasteride

The CMDh considered that the changes recommended for finasteride 1 mg tablets, introduced as an outcome of a parallel work-sharing variation, should additionally be part of the single assessment outcome of this PSUR procedure.

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

Follow-up of CMDh position on PSUSA procedure for budesonide

In the January 2017 CMDh press release, following the adoption of the CMDh position for the PSUSA on budesonide, the CMDh requested MAHs of all corticosteroid containing medicinal products to implement the outcome of the PSUSA assessment with regard to "Blurred Vision” and "Central Serous Chorioretinopathy”, which have been identified as class risk effects of corticosteroids. However, the frequency of the adverse reactions mentioned in the PSUSA outcome is only applicable to budesonide. For other corticosteroids and/or formulations not covered by the PSUSA, the frequency "not known” should be mentioned. The MAHs should adapt the frequency for their products in the future. For the implementation, the same timelines as for the PSUSA apply.

Follow-up of PSUSA for zoledronic acid (indicated for cancer and fractures) - question to be addressed by MAHs of all other bisphosphonates

As part of the PSUSA (PSUSA/00003149/201608) for zoledronic acid, indicated for cancer and fractures (including CAPs and NAPs) the PRAC recommended, on 6 April 2017, an update to the product information to add a warning on osteonecrosis of other anatomical sites and to add this adverse reaction with a frequency very rare. These changes will be found on the Community Register maintained by the European Commission for the national medicinal products.

Consequently, the MAHs of bisphosphonates (i.e alendronic acid, clodronic acid, etidronate, neridronic acid, pamidronate, risedronate, tiludronic acid) containing medicinal products, with the requirement to submit PSURs according to the EURD list, should review the following information with a critical appraisal of all available data from clinical trials, spontaneous reports of adverse reactions and the published literature relating to osteonecrosis of hip, femur and eventually other locations (with exception of jaw and external auditory canal) in association with their bisphosphonates containing medicinal products:

  • information regarding diagnostic criteria applied and results of diagnostic tests
  • discussion regarding the potential influence of the local anatomy
  • discussion regarding the underlying pathophysiological mechanism and possible risk factors. This should include similarities and differences with the pathophysiology of osteonecrosis of the jaw or external auditory canal.

Based on the information above, the MAH should consider in the next PSUR the need for updates to the product information to inform healthcare professionals and patients and to introduce potential risk minimisation measures. If the PSUR DLP is not due in the next 6 months and updates to the product information are considered warranted, MAHs should submit the appropriate variation to the relevant competent authorities.

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