Cyproterone-containing medicinal products
- Procedure started
- Under evaluation
- PRAC recommendation
- CMDh final position
Table of contents
Overview
Restrictions in use of cyproterone due to meningioma risk
On 13 February 2020, EMA’s safety committee (PRAC) recommended that medicines with daily doses of 10 mg or more of cyproterone should only be used for androgen-dependent conditions such as hirsutism (excessive hair growth), alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed. Once higher doses have started working, the dose should be gradually reduced to the lowest effective dose.
The medicines should only be used for reduction of sex drive in sexual deviations in men when other treatment options are not suitable.
There is no change in use of the medicines in men for prostate cancer.
The recommendations follow a review of the risk of the rare tumour meningioma with cyproterone. Overall, this side effect is rare: it may affect between 1 and 10 in 10,000 people, depending on the dose and duration of treatment. The risk increases with increasing cumulative doses (the total amount of medicine a patient has taken over time).
Available data do not indicate a risk for low-dose cyproterone medicines containing 1 or 2 milligrams cyproterone in combination with ethinylestradiol or estradiol valerate and used for acne, hirsutism, contraception, or hormone replacement therapy. However, as a precaution, they should not be used in people who have or have had a meningioma. This restriction is already in place for the higher dose medicines.
Doctors should monitor patients for symptoms of meningioma, which can include changes in vision, hearing loss or ringing in the ears, loss of smell, headaches, memory loss, seizures or weakness in arms and legs. If a patient is diagnosed with meningioma, treatment with cyproterone medicines must be stopped permanently.
As part of the ongoing surveillance of the safety of the medicines, companies marketing medicines containing 10 mg or more of cyproterone will be required to carry out a study to assess doctors’ awareness of the risk of meningioma and how to avoid it.
Meningioma is a rare tumour of the membranes covering the brain and spinal cord. It 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 cause serious problems.
The PRAC recommendation was adopted by the CMDh by consensus and will be implemented directly at national level.
Key facts
About this medicine
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Approved name |
Cyproterone-containing medicinal products
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International non-proprietary name (INN) or common name |
cyproterone
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Class |
antiandrogens
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About this procedure
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Current status |
CMDh final position
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Reference number |
EMEA/H/A-31/1488
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Type | |
Authorisation model |
Nationally authorised product(s)
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Decision making model |
PRAC-CMDh
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Key dates and outcomes
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Procedure start date |
11/07/2019
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PRAC recommendation date |
13/02/2020
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CHMP opinion/CMDh position date |
25/03/2020
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Outcome |
Variation
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All documents
Procedure started
Cyproterone Article-31 referral - Notification (PDF/2.52 MB)
First published: 12/07/2019
Cyproterone Article-31 referral - Timetable for the procedure (PDF/116.62 KB)
First published: 12/07/2019
Last updated: 12/11/2019
EMA/PRAC/371761/2019
Cyproterone Article-31 referral - PRAC list of questions (PDF/112.51 KB)
First published: 12/07/2019
EMA/PRAC/371762/2019
Cyproterone Article-31 referral - Draft Annex I (PDF/253.38 KB)
First published: 12/07/2019
Last updated: 06/08/2019
EMA/398686/2019 Rev. 1
Cyproterone Article-31 referral - Review started (PDF/77.83 KB)
First published: 12/07/2019
EMA/384708/2019
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Position provided by CMDh
Cyproterone Article-31 referral - Annex I (PDF/421.76 KB)
First published: 20/05/2020
Cyproterone Article-31 referral - Annex II (PDF/181.09 KB)
First published: 20/05/2020
Cyproterone Article-31 referral - Annex IV (PDF/84.48 KB)
First published: 20/05/2020
Cyproterone Article-31 referral - PRAC assessment report (PDF/493.5 KB)
First published: 01/04/2020
EMA/134740/2020
Cyproterone Article-31 referral - Annex III (PDF/201.16 KB)
First published: 27/03/2020
Last updated: 20/05/2020
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.
News
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27/03/2020
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14/02/2020
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14/02/2020
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17/01/2020
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31/10/2019
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11/07/2019