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Gina 10 : PAGB Backs Over-The-Counter Sale - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on plans to reclassify a locally-applied hormone replacement therapy product to treat the cause and relieve the symptoms of vaginal atrophy. The MHRA is proposing that Gina 10 microgram vaginal tablets, containing oestradiol, be made available over the counter as a "self care" product, under the supervision of a pharmacist. The Commission on Human Medicines too has advised that the application by Novo Nordisk, which is used to treat vaginal dryness, caused by oestrogen deficiency in postmenopausal women, can be made available as a pharmacy (P) medicine. The MHRA has been asking GPs, pharmacists and members of the public for their opinions on whether the tablets can be made available to women aged 50 and over who have not had a period for at least a year. If the reclassification goes ahead, pharmacists will be given training materials and a checklist to help them supply the medicine safely.
pharmacybiz

Gina 10 mg:MHRA reclassifies from POM to over-the-counter - 0 views

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    Women in the UK will be able to purchase Gina 10 mg vaginal tablets without prescription from September from their local pharmacies, announced the Medicines and Healthcare products Regulatory Agency (MHRA). The Hormone Replacement Therapy (HRT) product, Gina 10 microgram vaginal tablets (containing estradiol) are used for the treatment of vaginal symptoms such as dryness, soreness, itching, burning and uncomfortable sex caused by oestrogen deficiency in postmenopausal women aged 50 years and above who have not had a period for at least one year. The decision to reclassify these vaginal tablets follows a safety review by the MHRA, independent advice from the Commission on Human Medicines (CHM), and a public consultation. The UK regulator sought views from patients, pharmacists, prescribers and a wide range of stakeholders including the Royal College of Obstetricians & Gynaecologists, the Faculty of Sexual & Reproductive Healthcare, the British Pharmacopoeia Commission and the British Menopause Society.
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