The drug for women has been withdrawn from the market. Check if you have it in your medicine cabinet

The drug for women has been withdrawn from the market.  Check if you have it in your medicine cabinet

A batch of Oekopl forte withdrawn from the market. The Chief Pharmaceutical Inspectorate indicated the reason for this decision.

The Chief Pharmaceutical Inspectorate decided to withdraw from the market throughout the country the medicinal product Oekolp forte, Estriolum, 0.5 mg, globules, GTIN 05909997211268, lot number 23000333, expiry date: February 28, 2026.

The drug series for women has been withdrawn. The GIF showed the reason

The responsible entity in the country of export is: Besins Healthcare Germany GmbH, Mariendorfer Damm 3, 12099 Berlin, Germany; and the parallel importer is: InPharm sp. z o. o., ul. Strumykowa 28/11, 03-138 Warsaw. Pursuant to the decision of the Chief Pharmaceutical Inspectorate, the marketing of the above-mentioned product series was also prohibited.

“The reason for withdrawing the above-mentioned series was the finding of an out-of-specification (OOS) result for an unknown impurity during the stability test of the drug in question at the 12-month time point,” the Chief Pharmaceutical Inspectorate reported.

The series of Oekolp forte has been withdrawn. What is the use of the product?

Oekolp forte are vaginal globules containing the female sex hormone estriol, i.e. estrogen. The indications in the product description indicate that it is used to treat the symptoms of atrophic vaginal changes caused by estrogen deficiency in postmenopausal women, as well as, among others, as a diagnostic aid in the case of questionable cytological results of a cervical smear.

Oekolp forte is used in postmenopausal women, at least 12 months after the cessation of natural periods. Estriol can be used as a substitute administered due to the inhibition of estrogen production. In the case of atrophic changes in the lower urogenital tract, estriol normalizes the epithelium of the urogenital tract and helps restore normal microflora and physiological pH of the vagina.

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