Tofacitinib Sandoz 5 mg
Tofacitinib Sandoz 5 mg is a medicine authorised by Swissmedic under authorisation number 69483. The authorisation holder is Sandoz Pharmaceuticals 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 19 February 2025 and the authorisation is limited until 18 February 2030. ATC code L04AF01 places the medicine in the group Immunosuppressants.
| Authorisation number | 69483 |
|---|---|
| Name | Tofacitinib Sandoz 5 mg |
| Full name | Tofacitinib Sandoz 5 mg, Filmtabletten |
| Authorisation holder | Sandoz Pharmaceuticals AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | L04AF01 |
| First authorisation | 19 February 2025 |
| Authorisation validity | 18 February 2030 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Tofacitinib Sandoz 5 mg, Filmtabletten | B | 19 February 2025 |
| 2 | Tofacitinib Sandoz 10 mg, Filmtabletten | B | 19 February 2025 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 56 | Tablette(n) | L04AF01 | 07.15.0. | B |
| 2 | 56 | Tablette(n) | L04AF01 | 07.15.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Tofacitinib Sandoz 5 mg authorised in Switzerland?
Yes. Tofacitinib Sandoz 5 mg is authorised by Swissmedic under authorisation number 69483, data as of 01 September 2026. The authorisation is limited until 18 February 2030.
Which dispensing category does Tofacitinib Sandoz 5 mg have?
Tofacitinib Sandoz 5 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 Tofacitinib Sandoz 5 mg?
The authorisation holder is Sandoz Pharmaceuticals 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.