Section 4.8: Undesirable effects - Rev. 1
SmPC training presentation I. General objectives of section 4.8 ... This section should include all adverse reactions from clinical trials post-.
Section 6: Pharmaceutical particulars - Rev. 1
SmPC training presentation Section 6: Pharmaceutical particulars ... medicinal products except those mentioned in section 6.6.
Section 4.1 Therapeutic indications
Section 4.1: Therapeutic indications. Rev.1. SmPC training presentation. Note: for full information refer to the European Commission's Guideline on summary
Section 3 - Data Presentation
research questions and hypotheses through a presentation of relevant data. Presenting data The data presentation section is.
Communication from the Commission — Detailed guidance on the
11 Jun 2011 presentation of adverse event/reaction reports arising from clinical trials on ... reference is made to section 1.2 of the Detailed guidance.
Section 4.7 Effects on ability to drive and use machines
SmPC training presentation I. General objectives of section 4.7 ... This section should provide information regarding the influence.
SmPC : summary of product characteristics
Table of content of this presentation. 1. What is the summary of The therapeutic indication(s) of the medicine is given in section 4.1 in defining.
Section 1: Name of medicinal product
SmPC training presentation I. General objective of section 1 ... This section should provide the (invented) name of the product followed.
Présentation de lutilisateur [Section : Presentation of the learner]
How I use my languages [Section: Presentation of the learner]. A. Outside language classes I use/have used the languages which I am learning or already
Section 4.5 Interaction with other medicinal products and other forms
SmPC training presentation I. General objectives of section 4.5 ... In vitro data should be summarised in section 5.2 and not in section 4.5 unless.
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