Medicine guide

Orladeyo

·

  • Prescription status not stated
  • Blood, clotting and anaemia
Active substance
Berotralstat
Made by
BioCryst Ireland Limited

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

What it is for

  • Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older weighing at least 40 kg. Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in: children aged 2 to less than 12 years weighing at least 15 kg adolescents aged 12 and older weighing less than 40 kg

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 byBioCryst Ireland Limited
Active substanceBerotralstat
Used inBlood, clotting and anaemia
ClassificationB06AC06 · Blood, clotting and anaemia
Authorised on2021-04-30
Last updated by the regulator2026-08-31
EMA product numberEMEA/H/C/005138

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).