Estradiol-containing (0.01% w/w) medicinal products for topical use
- Procedure started
- Under evaluation
- PRAC recommendation
- CMDh final position
Table of contents
Overview
Four-week limit for use of high-strength estradiol creams confirmed
On 16 January 2020, EMA’s safety committee (PRAC) confirmed its recommendation to limit the use of high-strength creams containing 100 micrograms/gram (0.01%) of estradiol to a single treatment period of up to 4‑weeks. This followed a re-examination of its recommendation of October 2019 which was requested by one of the companies that market high-strength estradiol cream.
The PRAC reviewed available data on the safety and effectiveness of high-strength estradiol-containing creams used to treat symptoms of vaginal atrophy in women who have been through menopause. Data on these creams show that in postmenopausal women who use them, the levels of estradiol in the blood were higher than normal postmenopausal levels. The PRAC concluded that absorption of estradiol into the bloodstream is of concern and could result in similar side effects to those seen with hormone replacement therapy (HRT). The side effects of HRT taken orally or used transdermally (as patches) include venous thromboembolism (formation of blood clots in the veins), stroke, endometrial cancer (cancer of the lining of the womb) and breast cancer. In addition, there are limited safety data on long term use of high-strength estradiol creams. For these reasons, the PRAC recommended that these creams should only be used for a single treatment period of a maximum of 4 weeks.
The PRAC recommended that the prescribing information for these creams be updated with the new recommendations. A warning that the medicine is to be used for a single treatment period of up to 4 weeks only will be placed on the outer and inner packaging and the size of the tube will be limited to 25 grams to prevent use for longer than recommended.
The PRAC recommendations were 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 |
Estradiol-containing (0.01% w/w) medicinal products for topical use
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International non-proprietary name (INN) or common name |
estradiol |
Associated names |
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Class |
Hormonal
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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-31/1482
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Type | |
Decision making model |
PRAC-CMDh
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Authorisation model |
Nationally authorised product(s)
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Key dates and outcomes
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Procedure start date |
11/04/2019
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PRAC recommendation date |
16/01/2020
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CHMP opinion/CMDh position date |
30/01/2020
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Outcome |
Risk minimisation measures
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All documents
Procedure started
Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - Timetable (start of re-examination procedure) (PDF/139.88 KB)
First published: 12/07/2019
Last updated: 18/12/2019
EMA/PRAC/214200/2019 Rev. 2
Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - Notification (PDF/71.63 KB)
First published: 12/04/2019
Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - Annex I (PDF/127.58 KB)
First published: 12/04/2019
Last updated: 08/04/2020
Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - PRAC list of questions (PDF/77 KB)
First published: 12/04/2019
EMA/PRAC/214199/2019
Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - New review of risks with high-strength estradiol-containing creams (PDF/77.55 KB)
First published: 12/04/2019
EMA/215459/2019
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - PRAC confirms four-week limit for use of high-strength estradiol creams (PDF/126.91 KB)
First published: 17/01/2020
EMA/20248/2020
Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - Four-week limit for use of high-strength estradiol creams (PDF/117.88 KB)
First published: 04/10/2019
Last updated: 31/10/2019
EMA/531250/2019
Position provided by CMDh
Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - Annex II (PDF/175 KB)
First published: 08/04/2020
Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - PRAC assessment report (PDF/554.03 KB)
First published: 10/02/2020
EMA/62697/2020
Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - Timetable for the implementation of the CMDh position (PDF/48.5 KB)
First published: 04/02/2020
Last updated: 08/04/2020
Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - Annex III (PDF/369.8 KB)
First published: 31/01/2020
Last updated: 08/04/2020
Document description
- Annex I - List of the medicines affected by the referral
- Annex II - Scientific conclusions of the CHMP or CMDh
- Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
- Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
- Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
- Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
- PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
- PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
- PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated
News
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17/01/2020
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17/01/2020
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31/10/2019
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04/10/2019
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04/10/2019
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11/07/2019
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17/05/2019
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12/04/2019