Ustekinumab Spirig HC 45 mg / 0.5 ml
Ustekinumab Spirig HC 45 mg / 0.5 ml is a medicine authorised by Swissmedic under authorisation number 69304. The authorisation holder is Spirig HealthCare AG. The medicinal product code is Biotechnological 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 06 November 2024 and the authorisation is limited until 05 November 2029. ATC code L04AC05 places the medicine in the group Immunosuppressants.
| Authorisation number | 69304 |
|---|---|
| Name | Ustekinumab Spirig HC 45 mg / 0.5 ml |
| Full name | Ustekinumab Spirig HC 45 mg / 0.5 ml, Injektionslösung in einer Fertigspritze |
| Authorisation holder | Spirig HealthCare AG |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | B · Prescription only |
| ATC code | L04AC05 |
| First authorisation | 06 November 2024 |
| Authorisation validity | 05 November 2029 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Ustekinumab Spirig HC 45 mg / 0.5 ml, Injektionslösung in einer Fertigspritze | B | 06 November 2024 |
| 2 | Ustekinumab Spirig HC 90 mg / 1 ml, Injektionslösung in einer Fertigspritze | B | 06 November 2024 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 3 | 1 | Fertigspritze(n) | L04AC05 | 07.15.0. | B |
| 4 | 1 | Fertigspritze(n) | L04AC05 | 07.15.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Ustekinumab Spirig HC 45 mg / 0.5 ml authorised in Switzerland?
Yes. Ustekinumab Spirig HC 45 mg / 0.5 ml is authorised by Swissmedic under authorisation number 69304, data as of 01 September 2026. The authorisation is limited until 05 November 2029.
Which dispensing category does Ustekinumab Spirig HC 45 mg / 0.5 ml have?
Ustekinumab Spirig HC 45 mg / 0.5 ml 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 Ustekinumab Spirig HC 45 mg / 0.5 ml?
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.