Nomegestrol and chlormadinone

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status
Under evaluation

Overview

EMA starts review of meningioma risk with nomegestrol- and chlormadinone-containing medicines

EMA has started a review of medicines containing the active substance nomegestrol or chlormadinone. These medicines can be used, alone or in combination with other active substances, to treat gynaecological disorders such as amenorrhea (absence of menstrual periods) and other menstrual disorders, uterine bleeding, endometriosis (a condition in which tissue similar to the lining of the womb grows elsewhere in the body), breast tenderness, and as hormone replacement therapy or contraceptives (birth control).

The review was requested by the French medicines agency (ANSM) following new data from two epidemiological studies carried out in France in women taking these medicines to investigate the risk of meningioma, a tumour of the membranes covering the brain and spinal cord. This tumour is usually non-malignant and is not considered to be a cancer, but due to their location in and around the brain and spinal cord, meningiomas can in rare cases cause serious problems.

Cases of meningioma have been reported in women taking medicines containing nomegestrol or chlormadinone, and warnings are already included in the prescribing information for some of the medicines. However, the information for prescribers and patients may differ across EU Member States.

Data from the two studies suggest that the risk of meningioma increases with dose and duration of treatment and may be greater in women taking nomegestrol or chlormadinone for several years. The studies also showed that after women had stopped taking nomegestrol or chlormadinone for one year or more, the risk of developing these tumours was reduced and comparable to the risk in people who never used these medicines.

In light of these new data, EMA's safety committee (PRAC) will now examine the available evidence and make recommendations as to whether the marketing authorisations for nomegestrol- and chlormadinone-containing medicines should be amended across the EU.

Key facts

About this medicine
Approved name
Nomegestrol and chlormadinone
International non-proprietary name (INN) or common name
  • nomegestrol
  • chlormadinone
Associated names
Zoely
About this procedure
Current status
Under evaluation
Reference number
EMEA/H/A-31/1510
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Authorisation model
Centrally and nationally authorised products (mixed)
Decision making model
PRAC-CHMP-EC
Key dates and outcomes
Procedure start date
30/09/2021

All documents

Procedure started

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
  • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
  • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
  • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
  • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.

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