Consultation on proposal to make Gina 10 microgram vaginal tablets (Estradiol) available from pharmacies

Summary of responses to consultation - Gina 10 microgram vaginal tablets

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Public Assessment Report - Prescription Only Medicine to Pharmacy Reclassification - Gina 10 microgram vaginal tablets

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Gina 10 microgram vaginal tablets are 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 and are currently licensed as a prescription only medicine. We propose to make it available in pharmacies.

Gina 10 microgram vaginal tablets contain estradiol, which is a female hormone. They are a form of low dose local hormone replacement therapy. Inserted into the vagina they act locally in the vagina. Locally acting medicines containing estradiol will still be available on prescription from GPs.

Women will have a choice in where they obtain supply of this medicine from, either on prescription or from pharmacies and may opt to switch between methods of supply.

We consider that this product may be available as a Pharmacy (P) medicine.

The Commission on Human Medicines has advised that this product can be available as a Pharmacy (P) medicine.

We want to know what you think about this change.

Please use this form to tell us your views.

The deadline for comments is 23 February 2022.

Below you will find:

• A summary of the proposed change and the background
• A copy of the proposed patient information leaflet, label, and pharmacy checklist if the change goes ahead
• A form for your response

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