Kalydeco 50 mg
Kalydeco 50 mg is a medicine authorised by Swissmedic under authorisation number 66169. 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 December 2016 and the authorisation is valid without a time limit. ATC code R07AX02 places the medicine in the group Other respiratory system products.
| Authorisation number | 66169 |
|---|---|
| Name | Kalydeco 50 mg |
| Full name | Kalydeco 50 mg, Granulat |
| Authorisation holder | Vertex Pharmaceuticals (CH) GmbH |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | R07AX02 |
| First authorisation | 02 December 2016 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Kalydeco 50 mg, Granulat | A | 02 December 2016 |
| 2 | Kalydeco 75 mg, Granulat | A | 02 December 2016 |
| 3 | Kalydeco 25 mg, Granulat | A | 18 January 2021 |
| 4 | Kalydeco 13.4 mg, Granulat | A | 03 June 2026 |
Scroll the table sideways
| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 56 (4 x 14) | Sachet(s) | R07AX02 | 03.99.0. | A |
| 2 | 56 (4 x 14) | Sachet(s) | R07AX02 | 03.99.0. | A |
| 3 | 56 (4 x 14) | Beutel | R07AX02 | 03.99.0. | A |
| 4 | 28 | Beutel | R07AX02 | 03.99.0. | A |
| 5 | 56 | Beutel | R07AX02 | 03.99.0. | A |
Scroll the table sideways
Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Kalydeco 50 mg authorised in Switzerland?
Yes. Kalydeco 50 mg is authorised by Swissmedic under authorisation number 66169, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Kalydeco 50 mg have?
Kalydeco 50 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 Kalydeco 50 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.