Popular allergy drug halted from marketing
Published April 28, 2025 07:37
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The Chief Pharmaceutical Inspector halts nationwide marketing of the drug product named Clatra, Bilastinum, 6 mg/ml, eye drops, solution, package 1 bottle 5 ml, GTIN 05909991503352.
The responsible entity is Menarini International Operations Luxembourg S.A., based in Luxembourg.
The decision was given the order of immediate enforceability.
The Chief Pharmaceutical Inspector received a protocol from a test conducted by the National Medicines Institute on a sample of the medicinal product (from batch number 323550A, expiration date 05.2027) provided by the responsible party, which indicated that the product did not meet the quality requirements stipulated for it due to a negative test result in the parameter of contamination with particles visible to the unaided eye.
The Chief Pharmaceutical Inspector requested the responsible entity to state its position on the results of tests conducted by the National Institute of Medicine on a representative sample for the entire medicinal product Clatra, Bilastinum, 6 mg/mL, eye drops, solution. The responsible entity did not comment on the above issue, thus not ruling out the suspicion of a quality defect in the medicinal product.
In view of the reasonable suspicion of the Chief Pharmaceutical Inspector that the medicinal product Clatra, 6 mg/ml, eye drops, solution, batch number: 323550A, expiration date: 05.2027, responsible party: Menarini International Operations Luxembourg S.A., Luxembourg, does not meet the requirements established for it, it has become necessary and justified to suspend marketing of this product.
Clatra is a drug with antihistamine activity. Bilastine is indicated for the symptomatic treatment of allergic rhinoconjunctivitis (seasonal and year-round) and urticaria.
Source: GIF
