CRED SMPC 2024

For the (conditional) renewal, the date should correspond to the actual date of the Commission Decision on the (conditional) renewal of the marketing authorisation.]

10. DATE OF REVISION OF THE TEXT [Item to be completed by the Marketing Authorisation Holder (MAH) at time of printing once a change to the SmPC has been notified or printed. For type IA variations affecting the product information, the date of revision of the text should be the date of implementation of the change by the MAH. For type II variations listed in Article 23(1a)(a), the date of revision of the text should be the date of the Commission Decision amending the marketing authorisation. For type II variations not listed in Article 23(1a)(a), which follow a yearly timeframe for update of the respective Commission Decision, the date of revision of the text should be the date of the adoption of the positive CHMP opinion on the variation to the terms of the marketing authorisation. For more details, please consult the post-authorisation Q&A guidance.] <{MM/YYYY}>

<{DD/MM/YYYY}> <{DD month YYYY}>

<11. DOSIMETRY>

<12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS> Detailed information on this medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu<, and on the website of {name of Member State Agency (link)}>.* [*The last part of the statement is optional, and it is only to be displayed on the final printed materials . It will not be included in the product information annexes as applicants may choose to include it for one or more Member States but not for all of them.]

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