The MHRA has launched a public consultation on a set of proposals to make Gina 10 microgram vaginal tablets (oestradiol) available from pharmacies without prescription
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on the reclassification of a hormone replacement therapy (HRT) product for self-care that would see it switch from prescription only (POM) to a pharmacy (P) medicine. This is the first time that an HRT treatment is under consideration for such a change.
Gina is used for the treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women aged 50 years and above, who have not had a period for at least 1 year.
The vaginal tablets contain oestradiol hemihydrate, which is gradually released directly into the vaginal tissue and helps to restore the integrity of the vaginal wall, relieving vaginal symptoms of dryness, soreness, itching, burning, and painful intercourse.
Low-dose vaginal oestrogens have been used for a number of years to treat vaginal atrophy that can arise due to diminished oestrogen production following the menopause.
Every response received ‘will be vital’
Millions of women in the UK go through the menopause every year, with the majority experiencing some symptoms that can be severe and have a negative impact on everyday life.
Dr Laura Squire, Chief Healthcare Quality and Access Officer at the MHRA, said: ‘Every response we receive will be vital in helping us gain a better picture of whether people think this form of vaginal HRT should be available over the counter.
‘The menopause can cause unpleasant symptoms, and HRT-based medications form an important part of alleviating them. This is why it’s so important for us to hear what women think about this possible reclassification.
‘We want to hear from as many people, healthcare professionals, and women’s groups as possible.’
Should this product be reclassified, topical HRT products containing oestradiol will still be available on prescription from GPs.
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