SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| MAACY | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 6272.45 | Generic · Prescription | SUDAIR PHARMA COMPANY | Valid |
| MACITRIN | 10 mg | Film-coated tablet · Oral use | 28 Blister | SAR 5017.95 | Generic · Prescription | Abdi Ibrahim Ilac San ve Tic A.S. | Valid |
| Macimit | 10 mg | Film-coated tablet · Oral use | 30 Bottle | SAR 5824.40 | Generic · Prescription | Pharma Pharmaceutical Industries & Biological Products | Valid |
| Opsumit | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 6720.50 | NCE · Prescription | ACTELTION PHARMACEUTICALS LTD | Valid |
| Opsutin | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 5376.40 | Generic · Prescription | Saudi Amarox | Valid |
| Recitan | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 5376.40 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
Indications — CHI Daman Drug Formulary
PULMONARY ARTERIAL HYPERTENSION
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| OPSUMIT | 10MG | tablet · oral | ACTELION | Prescription | 18 Oct 2013 |
| MACITENTAN | 10MG | tablet · oral | ZYDUS LIFESCIENCES | Prescription | 6 Apr 2021 |
| MACITENTAN | 10MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 18 Apr 2023 |
| MACITENTAN | 10MG | tablet · oral | APOTEX | Prescription | 9 Jan 2024 |
| MACITENTAN | 10MG | tablet · oral | TORRENT | Prescription | 5 Aug 2024 |
| MACITENTAN | 10MG | tablet · oral | ALEMBIC | Prescription | 18 Aug 2025 |
| MACITENTAN | 10MG | tablet · oral | MSN | Prescription | 20 Aug 2025 |
| MACITENTAN | 10MG | tablet · oral | SUN PHARM | Prescription | 26 Aug 2025 |
| MACITENTAN | 10MG | tablet · oral | LAURUS | Prescription | 5 Nov 2025 |
| MACITENTAN | 10MG | tablet · oral | LEPU PHARM | Prescription | 3 Dec 2025 |
| MACITENTAN | 10MG | tablet · oral | MYLAN | Prescription | 3 Dec 2025 |
| MACITENTAN | 10MG | tablet · oral | AMNEAL | Prescription | 8 Jun 2026 |
| MACITENTAN | 10MG | tablet · oral | TEVA PHARMS USA INC | Prescription | 8 Jun 2026 |
EMA European Union — centrally authorised medicines
Opsumit · Authorised · authorised 20 Dec 2013 · ATC C02KX04
Therapeutic indication (EMA)
Adults Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. Paediatric populationOpsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥ 40 kg with WHO Functional Class (FC) II to III. Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 2 years to less than 18 years with WHO Functional Class (FC) II to III.
Macitentan AccordPharma Accord Healthcare · Authorised · authorised 24 Sep 2025 · ATC C02KX04
Therapeutic indication (EMA)
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)
Macitentan Accord Accord Healthcare · Authorised · authorised 24 Sep 2025 · ATC C02KX04
Therapeutic indication (EMA)
AdultsMacitentan Accord as monotherapy is indicated for the long-term treatment of pulmonary arterialhypertension (PAH) in adult patients of WHO Functional Class (FC) II to III (see section 5.1). Paediatric populationMacitentan Accord as monotherapy is indicated for the long-term treatment of pulmonary arterialhypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥ 40 kg with WHOFunctional Class (FC) II to III (see section 5.1).
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| OPSUMIT | 02415690 | 10 MG | TABLET · ORAL | JANSSEN INC |
| OPSUMIT | 02561069 | 2.5 MG | TABLET FOR SUSPENSION · ORAL | JANSSEN INC |
Safety signals and safety-related labeling changes
- US FDA 2 Apr 2025 OPSUMIT — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 2 Apr 2025 OPSYNVI — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
All safety entries for macitentan →
Combinations containing Macitentan
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.