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Bilastine: CMDh scientific conclusions and grounds for variation, amendments to the Product Informat

Taking into account the PRAC Assessment Report on the PSUR(s) for bilastine, the scientific conclusions are as follows:

The results of a non-clinical study of the excretion of 14C-bilastine in the milk of lactating rats following a single oral administration at 20 mg/kg (PBC040-105) became available during this PSUR. In this study the radiolabelled bilastine was rapidly absorbed and radioactivity was transferred to milk. The radioactivity in milk decreased in parallel with plasma. The Cmax and AUC0-t values in milk were 0.407 and 0.536-fold lower than those in plasma, respectively. In line with the “guideline on risk assessment of medicinal

products on human reproduction and lactation: from data to labelling” (EMEA/CHMP/203927/2005), as no data are available in humans, the PRAC considered that the product information (PI) should be updated to reflect the results of this study.

Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing bilastine, were warranted.

The CMDh agrees with the scientific conclusions made by the PRAC.


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