Nilotinib Zentiva 50 mg
Nilotinib Zentiva 50 mg is a medicine authorised by Swissmedic under authorisation number 69846. The authorisation holder is Helvepharm 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 20 November 2025 and the authorisation is limited until 19 November 2030. ATC code L01EA03 places the medicine in the group Antineoplastic agents.
| Authorisation number | 69846 |
|---|---|
| Name | Nilotinib Zentiva 50 mg |
| Full name | Nilotinib Zentiva 50 mg, Hartkapseln |
| Authorisation holder | Helvepharm AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | L01EA03 |
| First authorisation | 20 November 2025 |
| Authorisation validity | 19 November 2030 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Nilotinib Zentiva 50 mg, Hartkapseln | A | 20 November 2025 |
| 2 | Nilotinib Zentiva 150 mg, Hartkapseln | A | 20 November 2025 |
| 3 | Nilotinib Zentiva 200 mg, Hartkapseln | A | 20 November 2025 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 120 | Kapsel(n) | L01EA03 | 07.16.1. | A |
| 2 | 112 | Kapsel(n) | L01EA03 | 07.16.1. | A |
| 3 | 28 | Kapsel(n) | L01EA03 | 07.16.1. | A |
| 4 | 112 | Kapsel(n) | L01EA03 | 07.16.1. | A |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Nilotinib Zentiva 50 mg authorised in Switzerland?
Yes. Nilotinib Zentiva 50 mg is authorised by Swissmedic under authorisation number 69846, data as of 01 September 2026. The authorisation is limited until 19 November 2030.
Which dispensing category does Nilotinib Zentiva 50 mg have?
Nilotinib Zentiva 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 Zentiva 50 mg?
The authorisation holder is Helvepharm 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.