Macitentan Leman 10 mg
Macitentan Leman 10 mg is a medicine authorised by Swissmedic under authorisation number 69522. The authorisation holder is Leman SKL SA. 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 13 January 2026 and the authorisation is limited until 12 January 2031. ATC code C02KX04 places the medicine in the group Antihypertensives.
| Authorisation number | 69522 |
|---|---|
| Name | Macitentan Leman 10 mg |
| Full name | Macitentan Leman 10 mg, comprimés pelliculés |
| Authorisation holder | Leman SKL SA |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | C02KX04 |
| First authorisation | 13 January 2026 |
| Authorisation validity | 12 January 2031 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Macitentan Leman 10 mg, comprimés pelliculés | B | 13 January 2026 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 30 | 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 Leman 10 mg authorised in Switzerland?
Yes. Macitentan Leman 10 mg is authorised by Swissmedic under authorisation number 69522, data as of 01 September 2026. The authorisation is limited until 12 January 2031.
Which dispensing category does Macitentan Leman 10 mg have?
Macitentan Leman 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 Leman 10 mg?
The authorisation holder is Leman SKL SA. 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.