▼ 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.
EU/PEMA/P/23/0004
UK/PEMA/P/23/0039
Date of preparation: November 2023
Developed and funded by Incyte Biosciences International Sàrl.
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Intended for licensed healthcare professionals located in the United Kingdom only.
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