FOI release

Need Generic product related information

Some or all of the information requested may not have been provided because we determined that the request was vexatious.

Case reference FOI2026/00819

Received 24 July 2026

Published 14 September 2026

Request

Dear Sir/Ma'am, Zydus Lifesciences requests MHRA to provide below information for our reference purpose: 1. Quality assessment report 2. Non-Clinical and Clinical Overview for below product 3. Major objection letters and corresponding responses 4. Device assessment and human factors/usability assessment FOR Product Name: SUGAMMADEX 10 mg/ml solution for injection in pre-filled syringe. MAH: LABORATOIRE AGUETTANT MA No: PL 14434/0059

Response

See attached

Documents

• FOI2026_00819 (redacted).pdf (936.4 KB)

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