CRED SMPC 2024

Labelling requirements (1/3)

1. Name of medicinal product i.e. licensed product name (section 1 of SmPC) immediately followed by common name(s) of up to three active substances

2. Statement of active content (per dosage unit)

3. List of excipients (if applicable)

4. Pharmaceutical form and contents of pack

5. Method and route of administration

6. Special warning to “store out of the sight and reach of children”

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Labelling requirements (2/3)

7. Other special warnings (if necessary)

8. Expiry date

9. Special storage precautions

10. Special precautions for disposal

11. Name and address of MA holder

12. Marketing authorisation number

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