Nilotinib Spirig HC 50 mg
Nilotinib Spirig HC 50 mg is a medicine authorised by Swissmedic under authorisation number 69771. The authorisation holder is Spirig HealthCare AG. 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 16 April 2025 and the authorisation is limited until 15 April 2030. ATC code L01X places the medicine in the group Antineoplastic agents.
| Authorisation number | 69771 |
|---|---|
| Name | Nilotinib Spirig HC 50 mg |
| Full name | Nilotinib Spirig HC 50 mg, Hartkapseln |
| Authorisation holder | Spirig HealthCare AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | L01X |
| First authorisation | 16 April 2025 |
| Authorisation validity | 15 April 2030 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Nilotinib Spirig HC 50 mg, Hartkapseln | A | 16 April 2025 |
| 2 | Nilotinib Spirig HC 150 mg, Hartkapseln | A | 16 April 2025 |
| 3 | Nilotinib Spirig HC 200 mg, Hartkapseln | A | 16 April 2025 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 120 | Kapsel(n) | L01X | 07.16.1. | A |
| 2 | 112 | Kapsel(n) | L01X | 07.16.1. | A |
| 3 | 28 | Kapsel(n) | L01X | 07.16.1. | A |
| 4 | 112 | Kapsel(n) | L01X | 07.16.1. | A |
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Frequently asked questions
Is Nilotinib Spirig HC 50 mg authorised in Switzerland?
Yes. Nilotinib Spirig HC 50 mg is authorised by Swissmedic under authorisation number 69771, data as of 01 September 2026. The authorisation is limited until 15 April 2030.
Which dispensing category does Nilotinib Spirig HC 50 mg have?
Nilotinib Spirig HC 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 Nilotinib Spirig HC 50 mg?
The authorisation holder is Spirig HealthCare 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.