FOI release

Module 2 sections

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2024/00734

Received 21 November 2024

Published 17 January 2025

Request

PL 43461/0076, Carbimazole 10mg tablets, Flamingo PL 43461/0104, Carbimazole 15mg tablets, Flamingo Under the FOI I would like to request module 2 documents for the above 2 MAs. This includes 2.3.P.1-quality overall summary, 2.4.P-non clinical overview, 2.5.P- clinical overview, 2.7.P- clinical summary

Response

see attached

Documents

• Clinical Overview.pdf (285.0 KB)
• FOI2024_00734 redacted for publication.pdf (106.5 KB)
• Nonclinical Overview redacted.pdf (282.0 KB)
• Summary of Biopharmaceutic Studies and Associated Analytical Methods redacted.pdf (162.4 KB)

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