Medicine guide

Hemgenix

·

  • Prescription status not stated
  • Blood, clotting and anaemia
Made by
CSL Behring GmbH

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

  • Treatment of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors.

From the official label · 2026-09-30 · European Medicines Agency

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

United StatesNo exact match for this strength and form

CanadaNo exact match for this strength and form

Details

Made byCSL Behring GmbH
Active substanceEtranacogene dezaparvovec
Used inBlood, clotting and anaemia
ClassificationB02BD · Blood, clotting and anaemia
Orphan medicineYes — designated for a rare disease, according to the register
Additional monitoring ▼Yes — under additional monitoring (black triangle). Report suspected side effects.
Authorised on2023-02-20
Last updated by the regulator2026-08-27
EMA product numberEMEA/H/C/004827

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).