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For Summary of Product Characteristics (SPCs) of new products that have been granted a marketing authorisation since February 2022 in accordance with Regulation 2019/6, the format and content of the SPC has changed compared to those issued beforehand. In particular sections 7, 8, 9 and 10 (specifying information on the marketing authorisation holder, marketing authorisation number, date of first authorisation and date of revision of the text) are not included in the SPC document itself (these fields appear blank), as this information is provided on the national-specific product information landing page of the website (from which you click through to the SPC document itself).
The HPRA advises healthcare professionals not to retain printed versions of SPC documents, as these documents are subject to change and updating, including changes to safety and dose related information. We recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about the SPCs on our website e-mail email@example.com