CRED SMPC 2024

23/09/2024

SmPC Guideline

5.3: Preclinical safety data

Information of relevance for the prescriber in recognising the safety profile of the medicinal product.

The Organisation for Professionals in Regulatory Affairs

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Section 6.3: Pharmaceutical Particulars

6.1 List of Excipients excipients

A) Tablet core: Mannitol, Cellulose microcrystalline, Crospovidone, Sodium carbonate, Povidone, Methionine, Magnesium stearate b) Coating: Hypromellose 6 cP, Macrogol 6000, Titanium dioxide (E 171), Talc

6.2 Incompatibilities

Information on physical and chemical incompatibilities with other medicinal products.

6.3 Shelf life

Information on the finished product shelf life and on the in-use stability after 1 st opening and/or reconstitution/dilution.

The Organisation for Professionals in Regulatory Affairs

24

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