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

Republic of Ireland
Incyte Biosciences Distribution B.V.
Paasheuvelweg 25,
1105 BP Amsterdam, Netherlands

UNITED KINGDOM
Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Incyte by calling 00‑800‑0002‑7423.

REPUBLIC OF IRELAND
Adverse events should be reported.Reporting forms and information can be found at HPRA Pharmacovigilance: www.hpra.ie. Adverse events should also be reported to Incyte immediately by phoning the Toll-free phone number 1800‑456‑748.

^▼ 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. This means that further evidence on this medicinal product is awaited.

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