CRED SMPC 2024

[General storage conditions of the finished medicinal product should appear here, together with a cross-reference to section 6.3 where appropriate:] of the medicinal product, see section 6.3.> 6.5 Nature and contents of container [The proposed optional heading “and special equipment for use, administration or implantation” is for advanced therapy medicinal products only. Explanatory illustrations may be included, if necessary.] [Multipack presentations should also be listed in this section, e.g. “multipacks containing 180 (2 packs of 90) film-coated tablets”.] 6.6 Special precautions for disposal [Include practical instructions for preparation and handling of the medicinal product, where applicable, including disposal of the medicinal product, and waste materials derived from the used medicinal product. Presentation of practical information using pictograms in addition to text may be considered, if necessary.] < Use in the paediatric population > .>

7.

MARKETING AUTHORISATION HOLDER

[Country name in the language of the text.] {Name and address}

<{tel}> <{fax}> <{e-mail}>

8.

MARKETING AUTHORISATION NUMBER(S)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [As per SmPC guideline, the date should be stated in the following format:]

[For the initial authorisation, the date should correspond to the initial date of the Commission Decision on the marketing authorisation of the medicinal product concerned. It should not reflect individual strength/presentation approvals introduced via subsequent variations and/or extensions.

8