Simponi 50 mg
Simponi 50 mg is a medicine authorised by Swissmedic under authorisation number 61318. 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 29 September 2010 and the authorisation is valid without a time limit. ATC code L04AB06 places the medicine in the group Immunosuppressants.
| Authorisation number | 61318 |
|---|---|
| Name | Simponi 50 mg |
| Full name | Simponi 50 mg, Injektionslösung im Fertigpen |
| Authorisation holder | Janssen-Cilag AG |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | B · Prescription only |
| ATC code | L04AB06 |
| First authorisation | 29 September 2010 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Simponi 50 mg, Injektionslösung im Fertigpen | B | 29 September 2010 |
| 2 | Simponi 100 mg, Injektionslösung im Fertigpen | B | 27 November 2013 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 | Injektor(en), vorgefüllt/Pen | L04AB06 | 07.15.0. | B |
| 3 | 1 | Injektor(en), vorgefüllt/Pen | L04AB06 | 07.15.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Simponi 50 mg authorised in Switzerland?
Yes. Simponi 50 mg is authorised by Swissmedic under authorisation number 61318, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Simponi 50 mg have?
Simponi 50 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 Simponi 50 mg?
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.