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NE
ClosedFTS · 045808

Licence variation: spironolactone for acne in women

NHS England
Status
unsuccessful
Estimated
—
Services
Published
17 Jan 2025

Key facts

Notice ID
ocds-h6vhtk-045808
CPV code
85149000 · Health & social
Contract type
services
Source
Find a Tender

Timeline

  1. Published
    17 Jan 2025

Description

NHS England required a supplier to apply for a major (type II) MHRA Marketing Authorisation variation for spironolactone. The variation is to add a new indication to the current licence (marketing authorisation) for treating acne in women. The Successful Supplier would need to prepare a dossier for the MHRA including a Risk Management Plan, apply for the licence variation, and if granted update their licence, Summary of Product Characteristics and patient information leaflet with the new indication and related data.

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Page 11 of 8261
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