FOI release

information supporting Aristo Marketing Authorisation

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 FOI2026/00141

Received 11 February 2026

Published 24 March 2026

Request

Please can you provide the data provided in Marketing Authorisation which supports the clinical assessment for Promazine 2.5 and 5mg/5ml (PL 40546/0178-0179) MAH Aristo Pharma GmbH. We are particularly interested in the request made from the CHM for the clinical package and how this was addressed by the MAH or Modules 2.5 in order to satisfy the WEU legal basis.

Response

See attached

Documents

• 2.5. Clinical Overview - final.pdf (4.8 MB)
• FOI2026_00141 - FOI Response (redacted).pdf (1.0 MB)

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