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2023-05-22 13:00:14 · Revision 1

Class 4 Medicines Defect Information: Orifarm UK Ltd, Buccolam 10mg Oromucosal solution, EL (23)A/18

Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use.

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Source: Medicines and Healthcare products Regulatory Agency (MHRA). Read the full notice, including its required actions and deadlines, before recording your response.

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