Orkambi 100 mg lumacaftor / 125 mg ivacaftor
Orkambi 100 mg lumacaftor / 125 mg ivacaftor is a medicine authorised by Swissmedic under authorisation number 67395. The authorisation holder is Vertex Pharmaceuticals (CH) GmbH. The medicinal product code is Synthetic medicines and the dispensing category is A: Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly. First authorisation was granted on 23 December 2019 and the authorisation is valid without a time limit. ATC code R07AX30 places the medicine in the group Other respiratory system products.
| Authorisation number | 67395 |
|---|---|
| Name | Orkambi 100 mg lumacaftor / 125 mg ivacaftor |
| Full name | Orkambi 100 mg lumacaftor / 125 mg ivacaftor, Granulat |
| Authorisation holder | Vertex Pharmaceuticals (CH) GmbH |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | R07AX30 |
| First authorisation | 23 December 2019 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Orkambi 100 mg lumacaftor / 125 mg ivacaftor, Granulat | A | 23 December 2019 |
| 2 | Orkambi 150 mg lumacaftor / 188 mg ivacaftor, Granulat | A | 23 December 2019 |
| 3 | Orkambi 75 mg lumacaftor / 94 mg ivacaftor, Granulat | A | 31 July 2024 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 56 (4 x 14) | Beutel | R07AX30 | 03.99.0. | A |
| 2 | 56 (4 x 14) | Beutel | R07AX30 | 03.99.0. | A |
| 3 | 56 (4 x 14) | Beutel | R07AX30 | 03.99.0. | A |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Orkambi 100 mg lumacaftor / 125 mg ivacaftor authorised in Switzerland?
Yes. Orkambi 100 mg lumacaftor / 125 mg ivacaftor is authorised by Swissmedic under authorisation number 67395, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Orkambi 100 mg lumacaftor / 125 mg ivacaftor have?
Orkambi 100 mg lumacaftor / 125 mg ivacaftor is in dispensing category A. Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly.
Who is the authorisation holder of Orkambi 100 mg lumacaftor / 125 mg ivacaftor?
The authorisation holder is Vertex Pharmaceuticals (CH) GmbH. 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.