CRED SMPC 2024

18/09/2024

Solution – Section 4.8

4.8 Undesirable effects [MedDRA frequency convention and system organ class database, see Appendix II.]

Summary of the safety profile The most commonly reported adverse reactions possibly related to toprexate were constipation and nausea.

Tabulated list of adverse reactions The incidences of the Adverse Drug Reactions (ADRs) associated with toprexate are tabulated below. The table is based on adverse events reported during clinical trials and/or post-marketing use. All ADRs are listed by system organ class (SOC) and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

The Organisation for Professionals in Regulatory Affairs

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Solution – Section 4.8 (continued)

The Organisation for Professionals in Regulatory Affairs

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