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List of medicinal products under additional monitoring

21 January 2022 EMA/245297/2013 Rev. 96*For the UK, as from 1st January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NIProduct nameActive substance (s)Reason (s) on listMarketing authorisation holder (s)Link to product informationDate of inclusionAbevmybevacizumabNew biologicalMylan IRE Healthcare vicleucelNew biological, new active substance, conditional marketing authorisation, PASS Bristol-Myers Squibb Pharma 2021 AdakveocrizanlizumabNew biological, new active substance, conditional marketing authorisationNovartis Europharm 2020 AdcetrisBrentuximab vedotin Conditional marketing authorisationTakeda Pharma A/ 2013 AdynoviRurioctocog alfa pegolNew active substance and new biological, PASS Baxalta Innovations 2018 AdtralzatralokinumabNew active substance and new biologicalLeo Pharma A/ TetraInfluenza vaccine (split virion, inactivated)

Human Medicines Division To note: All products added to the list in September 2021 are shown in red font. All products removed from the list are shown with a strikethrough for the period of one month after which they are excluded. For

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  Product, Under, Medicine, Monitoring, Medicinal, Additional, Medicinal products under additional monitoring

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