Medicine passport

Macitentan Devatis 10 mg 10 mg

The same active substance, strength and form as listed by each country’s medicines regulator. For showing a pharmacist abroad.

Active substance
Macitentan
Strength
10 mg
Form
filmomhulde tablet
ATC code
C02KX04
Registered in
Netherlands · Devatis GmbH
Prescription
Prescription only
RVG
133205

Source: Geneesmiddeleninformatiebank · 2026-09-30

Not a prescription. Not a statement that these products are interchangeable. Products are matched on active substance, strength and kind of form only. Other ingredients, release, approved uses and the dose on the box can differ. A pharmacist or doctor decides whether one can replace another.

Listed in other countries

United States 14 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Macitentan10 mg · Tablet, Film CoatedPrescription onlyMylan Pharmaceuticals Inc. (+12)0378-0606
Opsumit10 mg · Tablet, Film CoatedPrescription onlyActelion Pharmaceuticals US, Inc.66215-501

Source: NDC Directory (US Food and Drug Administration) · 2026-09-13 · Source: US Food and Drug Administration, NDC Directory.

Bulgaria 3 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Macitentan TevaМацитентан ТеваMacitentan Teva 10 mg · film - coated tabletsPrescription onlyТева Фарма ЕАД20250187
Macitentan ZentivaМацитентан ЗентиваMacitentan Zentiva 10 mg · film - coated tabletsPrescription onlyZentiva k.s.20260079
MasipahМасипах10 mg · film - coated tabletsPrescription onlyНобел Фарма ЕООД20250218

Source: Bulgarian Drug Agency register (Изпълнителна агенция по лекарствата (BDA)) · 2026-08-01

Spain 17 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
MACITENTAN ACCORD10 mg · comprimido recubierto con películaPrescription onlyAccord Healthcare S.L.U.1251970004
MACITENTAN ACCORDPHARMA10 mg · comprimido recubierto con películaPrescription onlyAccord Healthcare S.L.U.1251971004
MACITENTAN DR. REDDYS10 MG · comprimido recubierto con películaPrescription onlyReddy Pharma Iberia S.A.90500
MACITENTAN EVER PHARMA10 mg · comprimido recubierto con películaPrescription onlyEver Pharma Therapeutics Spain S.L.91216
MACITENTAN GLENMARK10 mg · comprimido recubierto con películaPrescription onlyGlenmark Arzneimittel Gmbh91092
MACITENTAN OLPHA10 mg · comprimido recubierto con películaPrescription onlyOlpha As90960

11 more names not shown. Source: CIMA — Centro de Información online de Medicamentos (Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)) · 2026-09-30 · Fuente: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), CIMA.

Canada 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
OPSUMIT10 mg · tabletPrescription onlyJanssen Inc02415690

Source: Drug Product Database (Health Canada) · 2026-09-30 · Contains information licensed under the Open Government Licence – Canada.

Same active substance, but no match for this strength and form

Countries covered: United States, Bulgaria, European Union, Spain, France, Netherlands, Canada, Switzerland. A country missing from the list may still sell this medicine: Mediclarum reads only these registers.

Register data as of 2026-09-30. Mediclarum stores nothing about you for this page. https://www.mediclarum.com/nl/en/medicines/macitentan-devatis-10-mg-10-mg-filmomhulde-tablet