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Thursday, June 13, 2024

Furniture. GIF stops the sale of the drug

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The Main Pharmaceutical Inspectorate informed about the suspension of the sale of Mebelin. The reason is the lowered values ​​of the active substance release in the product, compared to the requirements, therefore a risk to the patient’s health cannot be excluded. The drug is used to treat irritable bowel syndrome in adults.

The Main Pharmaceutical Inspectorate informed about the suspension of the Mebelin drug, which was recently introduced to the market for the first time. For this reason, the product has been subjected to a research expertise performed by the National Medicines Institute (NIL).

According to GIF, “in the course of testing the quality of the medicinal product, a result outside the specification was obtained for the parameter: release of mebeverine hydrochloride”.

A health risk cannot be excluded

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Due to the reduced, in relation to the requirements, release of the active substance in the product, the risk to the patient’s health resulting from the reduced effectiveness of the drug cannot be excluded.

The drug withheld is Mebelin (Mebeverini hydrochloridum) modified-release hard capsules, 200 mg: pack of 30 capsules GTIN No. 05909991425289, pack of 60 capsules GTIN No. 05909991425296, all series, Marketing Authorization Holder: Aristo Pharma Sp. z o. o., ul. Baletowa 30, 02-867 Warsaw.

The product is used in the symptomatic treatment of irritable bowel syndrome (IBS) in adults. Mebeverine relaxes the smooth muscles of the gastrointestinal tract and at the same time does not disturb the normal peristalsis of the intestines.

Main photo source: Shutterstock



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