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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS1This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are
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Cablivi inn-caplacizumab EPAR is typically prescribed for individuals who are diagnosed with acquired thrombotic thrombocytopenic purpura (aTTP).
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Cablivi (inn-caplacizumab) is a medicinal product approved in the European Union, utilized for the treatment of thrombocytopenic purpura. The European Public Assessment Report (EPAR) provides comprehensive information on the drug's evaluation, approval, and usage.
Pharmaceutical companies that hold the marketing authorization for cablivi (inn-caplacizumab) are required to file the European Public Assessment Report (EPAR) to ensure compliance with regulatory standards.
To fill out the EPAR for cablivi, the marketing authorization holder must include relevant clinical trial data, proposed labeling, safety data, and an assessment of the benefits versus risks associated with the drug's use.
The purpose of the cablivi EPAR is to provide transparency and comprehensive information regarding the evaluation of the drug's efficacy, safety, and quality to healthcare professionals and the public.
The EPAR must report clinical trial results, patient populations studied, indications for use, side effects, and any additional relevant data that informs healthcare decisions regarding cablivi.
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