Macitentan-Mepha 10 mg
Macitentan-Mepha 10 mg is a medicine authorised by Swissmedic under authorisation number 69796. The authorisation holder is Mepha Pharma AG. The medicinal product code is Synthetic medicines and the dispensing category is B: Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly. First authorisation was granted on 15 September 2025 and the authorisation is limited until 14 September 2030. ATC code C02KX04 places the medicine in the group Antihypertensives.
| Authorisation number | 69796 |
|---|---|
| Name | Macitentan-Mepha 10 mg |
| Full name | Macitentan-Mepha 10 mg, Filmtabletten |
| Authorisation holder | Mepha Pharma AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | C02KX04 |
| First authorisation | 15 September 2025 |
| Authorisation validity | 14 September 2030 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Macitentan-Mepha 10 mg, Filmtabletten | B | 15 September 2025 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 30 | Tablette(n) | C02KX04 | 02.07.1. | B |
| 2 | 60 | Tablette(n) | C02KX04 | 02.07.1. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Macitentan-Mepha 10 mg authorised in Switzerland?
Yes. Macitentan-Mepha 10 mg is authorised by Swissmedic under authorisation number 69796, data as of 01 September 2026. The authorisation is limited until 14 September 2030.
Which dispensing category does Macitentan-Mepha 10 mg have?
Macitentan-Mepha 10 mg is in dispensing category B. Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly.
Who is the authorisation holder of Macitentan-Mepha 10 mg?
The authorisation holder is Mepha Pharma AG. The holder carries the legal responsibility for quality, safety and product information of the medicine in Switzerland.
Sources
Swissmedic data as of 01 September 2026. No medical advice. Independent directory, not affiliated with Swissmedic or the FOPH.