Consultation outcome

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 2 February 2022
• Last updated: 20 July 2022 — See all updates

This consultation has concluded

Read the full outcome

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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Detail of outcome

A consultation document which summarises the proposal on the prescription only (POM) to pharmacy (P) reclassification of Gina 10 microgram vaginal tablets containing estradiol hemihydrate 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, was posted on the GOV.UK website on 2 February. The deadline for comments was 23 February 2022.

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Original consultation

Summary

Public consultation on a set of proposals to make Gina 10 microgram vaginal tablets (Estradiol) available from pharmacies.

This consultation ran from
midday on 2 February 2022 to midday on 23 February 2022

Consultation description

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

Documents

Proposal to make Gina 10 microgram vaginal tablets (Estradiol) available from pharmacies

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Gina - Patient Information Leaflet

PDF, 140 KB, 2 pages

This file may not be suitable for users of assistive technology.

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If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Gina - Pharmacy Checklist

PDF, 180 KB, 14 pages

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Gina - Carton label

PDF, 1.4 MB, 3 pages

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Gina - Summary of Product Characteristics

PDF, 244 KB, 12 pages

This file may not be suitable for users of assistive technology.

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Published 2 February 2022
Last updated 20 July 2022 + show all updates

1. 20 July 2022

   Responses to consultation published.

2. 2 February 2022

   First published.