Safety advice on particular drugs or classes of drugs
|
| |
| European Union: Estradiol-containing creams Linoladiol N and Linoladiol HN – benefits continue to outweigh risks with new restrictions |
| |
The European Medicines Agency (EMA) has announced that Linoladiol N and Linoladiol HN, two high-strength estradiol-containing creams used for topical treatment of diseases of the genital area in women who have been through the menopause, may continue to be used with certain restrictions. The EMA’s recommendations are as follow:
- Linoladiol N may continue to be used for the short-term treatment of vaginal atrophy. However, Linoladiol N should only be used when at least one topical, lower dose oestrogen treatment has failed.
- Linoladiol HN may continue to be used for the short-term treatment of acute, mild inflammatory skin diseases of the external genital area.
- Linoladiol HN should no longer be used to treat lichen sclerosus.
- For both Linoladiol N and Linoladiol HN, application beyond four weeks is not recommended due to possible systemic exposure to estradiol during treatment.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002001.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Saturday, December 21, 2013
Issued at HKT 13:00
|
| |
|
