Macitentan Zentiva Macitentan Zentiva 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
- Macitentan Zentiva 10 mg
- Form
- film - coated tablets
- ATC code
- C02KX04
- Registered in
- Bulgaria · Zentiva k.s.
- Prescription
- Prescription only
- Reg. no.
- 20260079
Source: Bulgarian Drug Agency register · 2026-08-01
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 box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| Macitentan | 10 mg · Tablet, Film Coated | Prescription only | Mylan Pharmaceuticals Inc. (+12) | 0378-0606 |
| Opsumit | 10 mg · Tablet, Film Coated | Prescription only | Actelion Pharmaceuticals US, Inc. | 66215-501 |
Source: NDC Directory (US Food and Drug Administration) · 2026-09-13 · Source: US Food and Drug Administration, NDC Directory.
Spain 17 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| MACITENTAN ACCORD | 10 mg · comprimido recubierto con película | Prescription only | Accord Healthcare S.L.U. | 1251970004 |
| MACITENTAN ACCORDPHARMA | 10 mg · comprimido recubierto con película | Prescription only | Accord Healthcare S.L.U. | 1251971004 |
| MACITENTAN DR. REDDYS | 10 MG · comprimido recubierto con película | Prescription only | Reddy Pharma Iberia S.A. | 90500 |
| MACITENTAN EVER PHARMA | 10 mg · comprimido recubierto con película | Prescription only | Ever Pharma Therapeutics Spain S.L. | 91216 |
| MACITENTAN GLENMARK | 10 mg · comprimido recubierto con película | Prescription only | Glenmark Arzneimittel Gmbh | 91092 |
| MACITENTAN OLPHA | 10 mg · comprimido recubierto con película | Prescription only | Olpha As | 90960 |
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 box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| OPSUMIT | 10 mg · tablet | Prescription only | Janssen Inc | 02415690 |
Source: Drug Product Database (Health Canada) · 2026-09-30 · Contains information licensed under the Open Government Licence – Canada.
Netherlands 12 matching products
| Name on the box | Strength and form | Prescription | Holder | Official record |
|---|---|---|---|---|
| Macitentan Accord 10 mg filmomhulde tabletten | 10 mg · filmomhulde tablet | Prescription only | Accord Healthcare S.L.U. | EU/1/25/1970 |
| Macitentan AccordPharma 10 mg filmomhulde tabletten | 10 mg · filmomhulde tablet | Prescription only | Accord Healthcare S.L.U. | EU/1/25/1971 |
| Macitentan Aurobindo 10 mg | 10 mg · filmomhulde tablet | Prescription only | Aurobindo Pharma B.V. | 134248 |
| Macitentan CF 10 mg | 10 mg · filmomhulde tablet | Prescription only | Centrafarm B.V. | 132854 |
| Macitentan Devatis 10 mg | 10 mg · filmomhulde tablet | Prescription only | Devatis GmbH | 133205 |
| Macitentan Glenmark 10 mg filmomhulde tabletten | 10 mg · filmomhulde tablet | Prescription only | Glenmark Arzneimittel GmbH | 132794 |
6 more names not shown. Source: Geneesmiddeleninformatiebank (College ter Beoordeling van Geneesmiddelen (CBG-MEB)) · 2026-09-30 · Bron: College ter Beoordeling van Geneesmiddelen (CBG). De Rijksoverheid is het niet automatisch eens met de inhoud van deze site.
Same active substance, but no match for this strength and form
- European Union: 3 products · Every strength and form
- Switzerland: 7 products · Every strength and form