FOI release

Public assessment report for Urospir™ 50 mg/5 ml Oral Solution

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

Case reference FOI2026/00209

Received 27 February 2026

Published 14 April 2026

Request

We are developing generic formulation for Spironolactone 50mg/ 5 ml oral solution.SPC and PIL information is available for Urospir™ 50 mg/5 ml Oral Solution on MHRA website. We would like to know basis for approval for Urospir™ 50 mg/5 ml Oral Solution hence requesting you to share public assessment of Urospir™ 50 mg/5 ml Oral Solution.

Response

See attached

Documents

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