FOI release

PAR for Sucralfate Oral Suspension manufactured by Roma

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 FOI2026/00822

Received 27 July 2026

Published 14 September 2026

Request

We have come across information indicating that Sucralfate Oral Suspension manufactured by Roma has been approved by the MHRA. In this regard, we would like to kindly request, if available, the following documents for reference purposes only: Public Assessment Report (PAR) Clinical Overview/Summary Non-Clinical Overview/Summary

Response

See attached

Documents

• clinical-overview (redacted).pdf (22.8 MB)
• FOI2026_00822 (redacted).pdf (704.5 KB)
• nonclinical-overview (redacted).pdf (8.3 MB)

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