What was the reason for the decision?
Irritable bowel syndrome drug halted from marketing
Published June 28, 2023 09:00
Źródło: GIF
The Chief Pharmaceutical Inspector has decided to suspend nationwide marketing of the drug Mebelin (Mebeverini hydrochloridum), modified-release capsules, hard, 200 mg, pack of 30 capsules GTIN No. 05909991425289, pack of 60 capsules GTIN No. 05909991425296, all lots.
The responsible entity is Aristo Pharma Sp. z o.o., 30 Baletowa St., 02-867 Warsaw.
The decision was given the order of immediate enforceability.
The reason for this was information from the National Institute of Medicine (NIL Research Protocol No. NI-0742-21), performing an expert examination of the medicinal product Mebelin (Mebeverini hydrochloridum), modified-release capsules, hard, 200 mg, introduced into the market for the first time, which was carried out on the basis of a sample of the above-mentioned medicinal product submitted by the responsible entity. of the medicinal product with batch number EMBCD1002A, expiration date 12.2023. In the content of the above-mentioned test protocol, NIL indicated that in the course of testing the quality of the medicinal product, an out-of-specification result was obtained for the parameter: mebeverine hydrochloride release.
Mebelin is a drug used to treat irritable bowel syndrome (IBS).
