其 他 安 全 警 示
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| European Union: PRAC confirms four-week limit for use of high-strength estradiol creams (English only) |
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The European Medicines Agency (EMA) announced that EMA’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC), has 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 follows 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 recommends that the prescribing information for these creams will 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.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/prac-confirms-four-week-limit-use-high-strength-estradiol-creams
In Hong Kong, there is no registered pharmaceutical product as high-strength estradiol cream for vaginal use. Related news has been released by the EMA and was posted on the Drug Office website on 21 December 2013, 26 April 2014, 13 April 2019 and 5 October 2019.
Ends/ Saturday, January 18, 2020
Issued at HKT 13:00
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