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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS11.NAME OF THE MEDICINAL PRODUCTMyocet lysosomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion.2.QUALITATIVE AND QUANTITATIVE
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Myocet INN-EPAR refers to the European Public Assessment Report for the medicinal product Myocet, which includes information about its efficacy, safety, and quality.
Manufacturers or marketing authorization holders of Myocet are required to file the INN-EPAR.
To fill out the Myocet INN-EPAR, one should provide detailed information regarding the drug's components, clinical data, manufacturing details, and safety information in accordance with the guidelines set by the European Medicines Agency.
The purpose of Myocet INN-EPAR is to provide comprehensive data to regulatory authorities, healthcare professionals, and the public regarding the medicine's profile to assess its value and safety in use.
Information that must be reported includes pharmacological data, clinical trial results, safety profiles, manufacturing processes, risk management plans, and post-marketing surveillance.
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