FOI release

Details of Decentralized Procedures FI/H/1205/001/DC and NL/H/3952/001/DC

Case reference FOI2025/00545

Received 2 June 2025

Published 5 August 2025

Request

I am submitting a FOI request to obtain information related to the decentralized procedures FI/H/1205/001/DC and NL/H/3952/001/DC, which may have been relied upon for UK marketing authorizations. Please provide the following details, if available: 1. For NL/H/3952/001/DC (Ivermectin 3 mg tablets, PL 47587/0014): * The reference medicinal product used for this generic application, including its brand name, marketing authorization holder, and authorization details. 1. For FI/H/1205/001/DC: * Confirmation of whether this procedure resulted in a UK or Great Britain marketing authorization (PL or PLGB number). * The name of the medicinal product, its active substance, and pharmaceutical form. * The reference medicinal product used (if applicable), including its brand name and authorization details.

Response

see attached

Documents

• FOI2025_00545 redacted for publication.pdf (104.9 KB)

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