CRED SMPC 2024

23/09/2024

SmPC Content

1. Trade name of the medicinal product

2.Qualitative and quantitative composition

3.Pharmaceutical form

4.Clinical particulars

5.Pharmacological properties

6.Pharmaceutical particulars

7.Marketing authorisation holder

8.Marketing authorisation number

9.Date of first authorisation

10. Date of (partial) revision

The Organisation for Professionals in Regulatory Affairs

15

SmPC: Pharmaceutical information 2. Qualitative and quantitative composition 2. Qualitative and quantitative composition

– Active ingredient and the quantity found in the product.

– Excipients and its compositions found in the product.

(Full list of excipients in the product detailed under “Section 6.1 List of excipients”)

ingredient and the quantity found in the product.

Excipients and its compositions found in the product.

(Full list of excipients in the product detailed under “Section 6.1 List of excipients”)

The Organisation for Professionals in Regulatory Affairs

16

8