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2024-12-19 11:06:52 · Revision 1

Class 4 Medicines Notification: Argenx BV, Vyvgart 1000 mg solution for injection, EL (24)A/63

Argenx BV have informed MHRA that the Patient Information Leaflet (PIL) in the affected packs incorrectly contains reference to two subcutaneous injection sites. Only subcutaneous injection to the abdomen is permitted.

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Source: Medicines and Healthcare products Regulatory Agency (MHRA). Read the full notice, including its required actions and deadlines, before recording your response.

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