CRED SMPC 2024

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}

1. NAME OF THE MEDICINAL PRODUCT {(Invented) name strength pharmaceutical form} {active substance(s)} [Active substance – see guidance in section 1 of the outer packaging.]

[Pharmaceutical form patient-friendly terms according to the current version of the “Standard terms” published by the Council of Europe may be used in case of space limitation, if consistently used in all language versions.]

2. NAME OF THE MARKETING AUTHORISATION HOLDER {Name} [Full/short name of the MAH.]

3.

EXPIRY DATE

[For terms on batch number and expiry date, see Appendix IV.]

4. 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.] OTHER [Space permitting, any other information necessary for the correct use and administration of the medicinal product can be included here, e.g. calendar days may be included if the product is taken as a single dose and that is packaged in blister strips that comprise multiples of seven.] [In the case of advanced therapy medicinal products for autologous use, the unique patient identifier and the statement “For autologous use only” shall be included.] 5.

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