Stelara 45 mg/0.5 ml
Stelara 45 mg/0.5 ml is a medicine authorised by Swissmedic under authorisation number 69382. The authorisation holder is Janssen-Cilag 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 14 February 2024 and the authorisation is limited until 13 February 2029. ATC code L04AC05 places the medicine in the group Immunosuppressants.
| Authorisation number | 69382 |
|---|---|
| Name | Stelara 45 mg/0.5 ml |
| Full name | Stelara 45 mg/0.5 ml, Injektionslösung im Fertigpen |
| Authorisation holder | Janssen-Cilag AG |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | B · Prescription only |
| ATC code | L04AC05 |
| First authorisation | 14 February 2024 |
| Authorisation validity | 13 February 2029 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Stelara 45 mg/0.5 ml, Injektionslösung im Fertigpen | B | 14 February 2024 |
| 2 | Stelara 90 mg/1.0 ml, Injektionslösung im Fertigpen | B | 14 February 2024 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 | Injektor(en), vorgefüllt/Pen | L04AC05 | 07.15.0. | B |
| 2 | 1 | Injektor(en), vorgefüllt/Pen | 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 Stelara 45 mg/0.5 ml authorised in Switzerland?
Yes. Stelara 45 mg/0.5 ml is authorised by Swissmedic under authorisation number 69382, data as of 01 September 2026. The authorisation is limited until 13 February 2029.
Which dispensing category does Stelara 45 mg/0.5 ml have?
Stelara 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 Stelara 45 mg/0.5 ml?
The authorisation holder is Janssen-Cilag 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.