Biznes Fakty
Clatra eye drops suspended in circulation in the country
The Chief Pharmaceutical Inspector has halted the nationwide sale of a medicinal product known as Clatra due to a quality defect. This decision is effective immediately.
The Chief Pharmaceutical Inspector has suspended the nationwide sale of the medicinal product named: Clatra, Bilastinum, 6 mg/ml, eye drops, solution, packaging: 1 bottle of 5 ml, GTIN 05909991503352, across all batches.
The entity responsible is Menarini International Operations Luxembourg SA, located in Luxembourg.
The GIF has made this decision immediately enforceable.
Quality defect
The rationale behind the GIF’s decision stems from the test results obtained from the National Institute of Medicines. The report indicates that „this product fails to meet the prescribed quality standards due to a negative test outcome concerning the parameter of contamination with particles visible to the naked eye.”
Clatra is a prescription antihistamine designed for topical use in the eye. It is aimed at individuals suffering from allergic conjunctivitis and perennial conjunctivitis linked to allergies from fur and dust mites.
