Consultation outcome

Lovima 75 microgram film-coated tablets (Desogestrel): Public Consultation

• From: Medicines and Healthcare products Regulatory Agency
• Published: 12 February 2021
• Last updated: 8 July 2021 — See all updates

This consultation has concluded

Read the full outcome

Lovima public assessment report

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Detail of outcome

The Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to reclassify Lovima (containing 75 microgram desogestrel (DSG) per tablet) from prescription only (POM) to Pharmacy (P) for the prevention of pregnancy in women of childbearing age. See the public assessment report above for more information.

Feedback received

A public consultation on reclassifying two medicines containing desogestrel from prescription only (POM) to pharmacy (P)

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Detail of feedback received

Consultation document ARM 99, which summarises the proposals on the prescription only (POM) to pharmacy (P) reclassification of Lovima 75 microgram film coated tablets and Hana 75 microgram film coated tablets both containing desogestrel for the prevention of pregnancy in women of childbearing age, was posted on the GOV.UK website on 12 February. The deadline for comments was 5 March 2021.

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Original consultation

Summary

A 3-week consultation on a proposal to make Lovima 75 microgram film-coated tablets (Desogestrel) available from pharmacies.

This consultation ran from
2pm on 12 February 2021 to 11:45pm on 5 March 2021

Consultation description

We want to know what you think

• Lovima 75 microgram film-coated tablets are an oral contraceptive used to prevent pregnancy in women of childbearing age
• Lovima 75 microgram film-coated tablets are currently licensed as a prescription only medicine.
• We propose to make it available in pharmacies
• Medicines containing desogestrel will still be available on prescription from GPs and sexual health clinics
• Women will have 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 tell us your views – please use the form below.

The deadline for comments is Friday 5 March 2021.

Other consultations

We are currently carrying out a public consultation on Hana, another desogestrel contraceptive product

Documents

Lovima public consultation document

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Annex 1: Response document for MHRA public consultation on the proposal to make Lovima available from pharmacies

MS Word Document, 221 KB

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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.

Annex 2: Lovima leaflet

PDF, 2.21 MB, 2 pages

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Annex 3: Lovima Label

PDF, 658 KB, 3 pages

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Annex 4: Lovima SPC

PDF, 299 KB, 13 pages

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Annex 5: Lovima checklist

PDF, 210 KB, 2 pages

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Data Protection and Privacy Information

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Published 12 February 2021
Last updated 8 July 2021 + show all updates

1. 8 July 2021

   Outcome of reclassification published.

2. 12 February 2021

   First published.