Macitentan AccordPharma
- Prescription status not stated
- Heart, blood pressure and circulation
- Active substance
- Macitentan
- Made by
- Accord Healthcare
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- AdultsMacitentan AccordPharma, as monotherapy or in combination, is indicated for the long-term treatmentof pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III (seesection 5.1)Paediatric populationMacitentan AccordPharma, as monotherapy or in combination, is indicated for the long-term treatmentof pulmonary arterial hypertension (PAH) in paediatric patients aged less than 18 years andbodyweight ≥ 40 kg with WHO Functional Class (FC) II to III (see section 5.1)
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (macitentan). It describes the substance, not this exact product.
Endothelin (ET)-1 and its receptors (ET A and ET B ) mediate a variety of deleterious effects, such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation.
In disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage.
Macitentan is metabolized primarily by oxidative depropylation of the sulfamide to form the pharmacologically active metabolite.
In a study in healthy subjects with radiolabeled macitentan, approximately 50% of radioactive drug material was eliminated in urine but none was in the form of unchanged drug or the active metabolite.
Macitentan may therefore be taken with or without food.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-06-11
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 by | Accord Healthcare |
|---|---|
| Active substance | Macitentan |
| Used in | Heart, blood pressure and circulation |
| Classification | C02KX04 · Heart, blood pressure and circulation |
| Generic | Yes — a generic medicine, according to the register |
| Authorised on | 2025-09-24 |
| Last updated by the regulator | 2026-07-27 |
| EMA product number | EMEA/H/C/006523 |
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).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.