Otulfi 45 mg/0.5 ml
Otulfi 45 mg/0.5 ml is a medicine authorised by Swissmedic under authorisation number 70296. The authorisation holder is Fresenius Kabi (Schweiz) 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 24 April 2026 and the authorisation is limited until 23 April 2031. ATC code L04AC05 places the medicine in the group Immunosuppressants.
| Authorisation number | 70296 |
|---|---|
| Name | Otulfi 45 mg/0.5 ml |
| Full name | Otulfi 45 mg/0.5 ml, Injektionslösung in einer Fertigspritze |
| Authorisation holder | Fresenius Kabi (Schweiz) AG |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | B · Prescription only |
| ATC code | L04AC05 |
| First authorisation | 24 April 2026 |
| Authorisation validity | 23 April 2031 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Otulfi 45 mg/0.5 ml, Injektionslösung in einer Fertigspritze | B | 24 April 2026 |
| 2 | Otulfi 90 mg/1 ml, Injektionslösung in einer Fertigspritze | B | 24 April 2026 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 | Fertigspritze(n) | L04AC05 | 07.15.0. | B |
| 2 | 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 Otulfi 45 mg/0.5 ml authorised in Switzerland?
Yes. Otulfi 45 mg/0.5 ml is authorised by Swissmedic under authorisation number 70296, data as of 01 September 2026. The authorisation is limited until 23 April 2031.
Which dispensing category does Otulfi 45 mg/0.5 ml have?
Otulfi 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 Otulfi 45 mg/0.5 ml?
The authorisation holder is Fresenius Kabi (Schweiz) 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.