Zusammenfassung der Merkmale des Arzneimittels - Bilastin Urquima 10 mg Schmelztabletten
II.A List of important risks and missing information
Important risks of Bilastine are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely taken. Important risks can be regarded as identified or potential. Identified risks are concerns for which there is sufficient proof of a link with the use of Bilastine. Potential risks are concerns for which an association with the use of this medicine is possible based on available data, but this association has not been established yet and needs further evaluation. Missing information refers to information on the safety of the medicinal product that is currently missing and needs to be collected (e.g. use in children below 6 years of age).
Bilastine was authorized in Spain on 18-Nov-2010 and the risks of the product are fully characterised, appropriately managed by routine risk minimisation measures and fully integrated into standard clinical practice. There are no need of additional pharmacovigilance activities and/or risk minimisation activities to further characterise the risks of the product or to collect missing information about its use. For these reasons, no risks or important missing information are listed in this RMP.
| Safety concerns | |
| Important identified risks | – None |
| Important potential risks | – None |
| Missing information | – None |
II.B Summary of important risks
The safety information in the proposed Product Information is aligned to the reference medicinal product Bilaxten®.