Medicine guide

Hemlibra

·

  • Prescription status not stated
  • Blood, clotting and anaemia
Active substance
Emicizumab
Made by
Roche Registration Limited

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

What it is for

  • Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency): with factor VIII inhibitors without factor VIII inhibitors who have: severe disease (FVIII < 1%) moderate disease (FVIII ? 1% and ? 5%) with severe bleeding phenotype. Hemlibra can be used in all age groups.

EMA’s data export replaced some characters it could not represent (for example “≥”) with “?”. The text is shown exactly as exported; the wording on the EMA page is authoritative.

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

SpainNo exact match for this strength and form

CanadaNo exact match for this strength and form

NetherlandsNo exact match for this strength and form

SwitzerlandNo exact match for this strength and form

Details

Made byRoche Registration Limited
Active substanceEmicizumab
Used inBlood, clotting and anaemia
ClassificationB02BX06 · Blood, clotting and anaemia
Authorised on2018-02-23
Last updated by the regulator2025-09-10
EMA product numberEMEA/H/C/004406

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).