Nintedanib Zentiva 100 mg
Nintedanib Zentiva 100 mg is a medicine authorised by Swissmedic under authorisation number 70124. The authorisation holder is Helvepharm AG. The medicinal product code is Synthetic medicines and the dispensing category is B: Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly. First authorisation was granted on 14 August 2025 and the authorisation is limited until 13 August 2030. ATC code L01EX09 places the medicine in the group Antineoplastic agents.
| Authorisation number | 70124 |
|---|---|
| Name | Nintedanib Zentiva 100 mg |
| Full name | Nintedanib Zentiva 100 mg, Weichkapseln |
| Authorisation holder | Helvepharm AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | L01EX09 |
| First authorisation | 14 August 2025 |
| Authorisation validity | 13 August 2030 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Nintedanib Zentiva 100 mg, Weichkapseln | B | 14 August 2025 |
| 2 | Nintedanib Zentiva 150 mg, Weichkapseln | B | 14 August 2025 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 60 | Kapsel(n) | L01EX09 | 03.99.0. | B |
| 2 | 60 | Kapsel(n) | L01EX09 | 03.99.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Nintedanib Zentiva 100 mg authorised in Switzerland?
Yes. Nintedanib Zentiva 100 mg is authorised by Swissmedic under authorisation number 70124, data as of 01 September 2026. The authorisation is limited until 13 August 2030.
Which dispensing category does Nintedanib Zentiva 100 mg have?
Nintedanib Zentiva 100 mg is in dispensing category B. Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly.
Who is the authorisation holder of Nintedanib Zentiva 100 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.