Nintedanib Spirig HC 100 mg
Nintedanib Spirig HC 100 mg is a medicine authorised by Swissmedic under authorisation number 69531. The authorisation holder is Spirig HealthCare 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 26 September 2025 and the authorisation is limited until 25 September 2030. ATC code L01EX09 places the medicine in the group Antineoplastic agents.
| Authorisation number | 69531 |
|---|---|
| Name | Nintedanib Spirig HC 100 mg |
| Full name | Nintedanib Spirig HC 100 mg, Weichkapsel |
| Authorisation holder | Spirig HealthCare AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | L01EX09 |
| First authorisation | 26 September 2025 |
| Authorisation validity | 25 September 2030 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Nintedanib Spirig HC 100 mg, Weichkapsel | B | 26 September 2025 |
| 2 | Nintedanib Spirig HC 150 mg, Weichkapsel | B | 26 September 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 Spirig HC 100 mg authorised in Switzerland?
Yes. Nintedanib Spirig HC 100 mg is authorised by Swissmedic under authorisation number 69531, data as of 01 September 2026. The authorisation is limited until 25 September 2030.
Which dispensing category does Nintedanib Spirig HC 100 mg have?
Nintedanib Spirig HC 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 Spirig HC 100 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.