
Get the free Guideline on core SmPC and Package Leaflet for sodium 4 fluoride (18F). EMA/CHMP/465...
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1 2 3 24 July 2014 EMA/CHMP/465616/2014 Committee for Medicinal Products for Human Use (CHMP) 5 Guideline on core DMPC and package leaflet for sodium fluoride (18F) 6 Draft 4 Draft Agreed by Radio
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What is guideline on core smpc?
Guideline on core smpc is a set of instructions and requirements for the core summary of product characteristics.
Who is required to file guideline on core smpc?
Manufacturers or marketing authorization holders of medicinal products are required to file guideline on core smpc.
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Guideline on core smpc can be filled out by following the specific format and structure provided by the regulatory authorities.
What is the purpose of guideline on core smpc?
The purpose of guideline on core smpc is to ensure standardized and clear information about the medicinal product for healthcare professionals and patients.
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Information such as indications, dosage, contraindications, side effects, and precautions must be reported on guideline on core smpc.
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