The summary of product characteristics, the SPC, is the major annex document of Marketing Authorisation (MA) dossier for a medicine. This document is the reference document for health care professionnals since it contains all necessary and opposable information for its therapeutic use. The SPC is initially submitted by the MA applicant and deeply revised in details by regulatory authorities, the national agencies for national MA, and the European Medicine Agency (EMA) for the european centralized procedures. The SPC presents with 12 sections each one being divided into several paragraphs. Sections 1-3 present the name, dosage, qualitative and quantitative composition, the pharmaceutical form of the medicine. Section 4 contains all the clinical particulars : Therapeutic indications, posology and methods of administration, contra-indications, special warnings and precautions for use, interactions, impact on fertility, contraception, pregnancy, lactation, effects on ability to drive and use machines, undesirable effects and risk associated with overdose. Section 5 describes pharmacological properties (pharmacodynamics and pharmacokinetics) and preclinical safety data.

 

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