CRED SMPC 2024

23/09/2024

SmPC Guidance Revision

● Guidance for Paediatric Information in many SmPC sections

Sections: 4.1; 4.2; 4.4; 4.5; 4.8; 4.9; 5.1; 5.2.

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SmPC and Risk Management Plan (RMP)

Section 4.4 For example; “Liver function should be monitored before initiation of treatment and monthly thereafter”, “Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation”, “ Women of childbearing potential should use contraception”, …)

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