FOI release

Request for Risk Management Plan – Glycopyrronium Bromide 1 mg/5 mL Oral Solution

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 FOI2026/00947

Received 25 August 2026

Published 6 October 2026

Request

Could you please provide the Risk Management Plan (RMP) for the following product: Product: Glycopyrronium Bromide 1 mg/5 mL Oral Solution PL Number: PL 41344/0010 MAH: Colonis Pharma Limited I would be grateful if you could share the RMP for our regulatory and development reference. Thank you for your assistance.

Response

See attached

Documents

• FOI2026_00947 (redacted).pdf (545.7 KB)
• FOI_RMP_Glycopyrronium_Bromide_Redacted.pdf (923.3 KB)

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