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Prescribing Information Summary of Product Characteristics (SmPC) – Great Britain Summary of Product Characteristics (SmPC) – Northern Ireland Report an adverse event
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Prescribing Information Summary of Product Characteristics (SmPC) – Great Britain Summary of Product Characteristics (SmPC) – Northern Ireland Report an adverse event

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions

This medicinal product has been authorised under a 'conditional approval' scheme

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Marketing authorisation holder:
Great Britain:
Incyte Biosciences UK Ltd,
First Floor Q1, The Square,
Randalls Way, Leatherhead,
KT22 7TW, UK

Northern Ireland:
Incyte Biosciences Distribution B.V.
Paasheuvelweg 25,
1105 BP Amsterdam, Netherlands

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. Adverse events should also be reported to Incyte immediately by phoning 0330‑100‑3677 (Great Britain) or 00‑800‑0002‑7423 (United Kingdom [Northern Ireland]).

This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited. The Medicines and Healthcare products Regulatory Agency will review new information on this medicinal product at least every year and the Summary of Product Characteristics will be updated as necessary.

UK/PEMA/P/23/0039
Date of preparation: November 2023
Developed and funded by Incyte Biosciences International Sàrl.
© 2023, Incyte. All rights reserved.
PEMAZYRE, the PEMAZYRE logo and the Incyte logo are registered trademarks of Incyte.

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