Orkambi 200 mg / 125 mg
Orkambi 200 mg / 125 mg is a medicine authorised by Swissmedic under authorisation number 65981. 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 02 September 2016 and the authorisation is valid without a time limit. ATC code R07AX30 places the medicine in the group Other respiratory system products.
| Authorisation number | 65981 |
|---|---|
| Name | Orkambi 200 mg / 125 mg |
| Full name | Orkambi 200 mg / 125 mg, Filmtabletten |
| Authorisation holder | Vertex Pharmaceuticals (CH) GmbH |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | R07AX30 |
| First authorisation | 02 September 2016 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Orkambi 200 mg / 125 mg, Filmtabletten | A | 02 September 2016 |
| 2 | Orkambi 100 mg / 125 mg, Filmtabletten | A | 19 April 2018 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 112 (4 x 28) | Tablette(n) | R07AX30 | 03.99.0. | A |
| 2 | 112 (4 x 28) | Tablette(n) | 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 200 mg / 125 mg authorised in Switzerland?
Yes. Orkambi 200 mg / 125 mg is authorised by Swissmedic under authorisation number 65981, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Orkambi 200 mg / 125 mg have?
Orkambi 200 mg / 125 mg 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 200 mg / 125 mg?
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.