FOI release

Request for information _ FOI

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 FOI2026/00026

Received 13 January 2026

Published 24 March 2026

Request

I would like to request for Module 2.4, Module 2.5, Module 2.6 and Module 2.7 submitted for Ketoconazole 2% Shampoo, MAH: Curagenix Life Sciences Limited, (PL 59154/0004).

Response

See attached

Documents

• FOI2026_00026 Module 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods_RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (159.8 KB)
• FOI2026_00026-Final response (redacted).pdf (1.2 MB)
• FOI2026_00026_ Mod 2.7.3_Sum of Clinical Efficacy_Prev. & treat. alassezia yeast infn_treat. tinea versicolor_RdFxd_Ketoconazole 2_ Shampoo PL 59154_0004.pdf (2.9 MB)
• FOI2026_00026_ Module 2.4_Nonclinical Overview__RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (4.0 MB)
• FOI2026_00026_ Module 2.5_Clinical Overview_RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (3.4 MB)
• FOI2026_00026_ Module 2.6.1_Introduction_RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (140.3 KB)
• FOI2026_00026_ Module 2.6.4_Pharmacokinetics Written Summary_RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (177.1 KB)
• FOI2026_00026_ Module 2.7.2_Summary of Clinical Pharmacology Studies__RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (158.1 KB)
• FOI2026_00026_ Module 2.7.4_Summary of Clinical Safety__RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (1.8 MB)
• FOI2026_00026_Module 2.6.2_Pharmacology Written Summary_RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (659.2 KB)
• FOI2026_00026_Module 2.6.3_RdFxd Pharmacology Tabulated Summary_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (945.7 KB)
• FOI2026_00026_Module 2.6.5_Pharmacokinetics Tabulated Summary_RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (609.5 KB)
• FOI2026_00026_Module 2.6.6_Toxicology Written Summary__RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (1.3 MB)
• FOI2026_00026_Module 2.6.7_Toxicology Tabulated Summary__RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (158.0 KB)
• FOI2026_00026_Module 2.7.5_Literature References_RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (546.1 KB)
• FOI2026_00026_Module 2.7.5_Synopses of Individual Studies__RdFxd_Ketoconazole 2_ Shampoo (PL 59154_0004).pdf (140.7 KB)

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