CRED SMPC 2024

[Including town, postal code (if available) and country name of the MAH in the language of the text (Telephone, fax numbers or e-mail addresses may be included (no MAH websites, no e-mails linking to MAH websites)). Local representatives of the MAH, if mentioned in the leaflet, may be included in the Blue box on the outer packaging.] {Name and address}

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

12. MARKETING AUTHORISATION NUMBER(S) [Item to be completed by the MAH once the marketing authorisation has been granted.] [In case of a combined labelling text covering different pack sizes of the same strength, the respective pack size should be included in grey-shading after the corresponding EU Sub-number and listed on a separate line, e.g. EU/0/00/000/001 28 film-coated tablets EU/0/00/000/002 56 film-coated tablets EU/0/00/000/003 100 film-coated tablets] For multipacks, clearly indicate the pack content for each marketing authorisation number, e.g. EU/X/XX/XXX/XXX 180 film-coated tablets (2 packs of 90).] EU/0/00/000/000 13. BATCH NUMBER<, DONATION AND PRODUCT CODES> [For terms on batch number and expiry date, see Appendix IV.] [The proposed optional heading “DONATION AND PRODUCT CODES” is for advanced therapy medicinal products only.] [For advanced therapy medicinal products, donation and product codes should be included.]

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE [Only for medicinal products not subject to medical prescription, include: - Indication(s).

- Dose recommendations, contraindication(s) and warnings; if full details cannot be printed, a reference to the package leaflet should be made, e.g. “Read the package leaflet before use”. - General warnings and overdose warnings are not routinely required, but for certain medicinal products such warnings may be added during the procedure at the request of the CHMP.]

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