CRED SMPC 2024

23/09/2024

6. Pharmaceutical particulars

6.4 Special precautions for storage

Description of the product if sensitive to light moisture or any particular temperature

6.5 Nature and contents of container

Information on the pack size and material of the container such as glass vials PVC dash aluminium blister

6.6 Special Precautions for disposal and other handling

Information on product needs to be disposed of in accordance with local requirements.

The Organisation for Professionals in Regulatory Affairs

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SmPC Postion

● Legal document ● Document addressed to HCPs

leaflet Labelling SmPC

• Distillation of >10 years R&D

NC Overvi ew NC Summ ary

Clinical Overview

EPAR

Clinical Summary

• MAH asset

• Interface with RAs

Module 5 Clinical

Module 3 Quality

Module 4 Non-clinical

• HCP communication

The Organisation for Professionals in Regulatory Affairs

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