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Core Safety Profile Active substance: Pharmaceutical form(s)/strength: P-RMS: Date of FAR: Powder for solution for infusion 10 & 50 mg BE/H/POUR/00018/001 18.01.2011 1. NAME OF THE MEDICINAL PRODUCT
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Indicate any previous experience or employment history related to safety or risk management.
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What is core safety profile active?
Core safety profile active is a document that summarizes the safety information of a medicinal product.
Who is required to file core safety profile active?
The marketing authorization holder is required to file core safety profile active.
How to fill out core safety profile active?
Core safety profile active is filled out according to the guidelines provided by regulatory authorities.
What is the purpose of core safety profile active?
The purpose of core safety profile active is to monitor and evaluate the safety profile of a medicinal product.
What information must be reported on core safety profile active?
Information on adverse reactions, drug interactions, contraindications, and precautions must be reported on core safety profile active.
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