News and Educations

Meeting highlights from the CMDh meeting in February 2017


Falsified Medicines Directive

Following the receipt of several queries on the implementation of the Directive 2011/62/EU of the European Parliament and the Council on falsified medicinal products over the last year, the CMDh has agreed to publish, for transparency reasons, the feedback given to those queries. The new document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive” will be published on the CMDh website under "Falsified Medicines”.

Update of product information of medicinal products containing dexamethasone and other corticosteroids (excluding cutaneous formulations)

On 29 September 2016, the PRAC finalised the PSUSA for dexamethasone (apart from centrally authorised products) (PSUSA/00000973/201601) and recommended to update the product information for ocular use to add a warning on the risk of Cushing syndrome and/or adrenal suppression, and inform on the interaction with CYP3A4 inhibitors, which may increase this risk.

On 27 October 2016, the PRAC adopted a signal recommendation for cobicistat containing products, with regards to drug interaction with corticosteroids leading to adrenal suppression. This signal recommendation provided a wording for all corticosteroid products (excluding cutaneous formulations). The recommendation is available here.

While the two recommendations are similar, the PSUSA wording includes information specific to dexamethasone ocular formulations only.

The CMDh discussed the specificities of the wordings and agreed that for ocular formulations of dexamethasone containing products, the PSUSA wording should be implemented. With regard to all other corticosteroid containing products (excluding cutaneous formulations), the wording included in the signal recommendation should be implemented.

Revision of Core SmPC and Package Leaflet for Hormonal Replacement Therapy (HRT) products

The CMDh has agreed a new version of the core SmPC and package leaflet for hormonal replacement therapy products. The updated documents contain additional information for vaginal estrogen preparations for the treatment of symptoms of vaginal atrophy due to estrogen deficiency in postmenopausal women. An annex for vaginal estrogen products for which the systemic exposure to estrogen remains within the normal postmenopausal range has been created. The core document is applicable to all HRT preparations and vaginally applied estrogen products with systemic exposure higher than postmenopausal range.
The updated Core SmPC and Package Leaflet will be published under "Product information, Core SmPC/PL”.

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