Xofluza 2 mg / ml
Xofluza 2 mg / ml is a medicine authorised by Swissmedic under authorisation number 68068. The authorisation holder is Roche Pharma (Schweiz) 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 November 2021 and the authorisation is valid without a time limit. ATC code J05AX25 places the medicine in the group Antivirals for systemic use.
| Authorisation number | 68068 |
|---|---|
| Name | Xofluza 2 mg / ml |
| Full name | Xofluza 2 mg / ml, Granulat zur Herstellung einer Suspension zum Einnehmen (Flasche) |
| Authorisation holder | Roche Pharma (Schweiz) AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | J05AX25 |
| First authorisation | 19 November 2021 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Xofluza 2 mg / ml, Granulat zur Herstellung einer Suspension zum Einnehmen (Flasche) | B | 19 November 2021 |
| 2 | Xofluza 10 mg, Granulat zur Herstellung einer Suspension zum Einnehmen (Beutel) | B | 05 August 2026 |
| 3 | Xofluza 30 mg, Granulat zur Herstellung einer Suspension zum Einnehmen (Beutel) | B | 05 August 2026 |
| 4 | Xofluza 40 mg, Granulat zur Herstellung einer Suspension zum Einnehmen (Beutel) | B | 05 August 2026 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 | Flasche(n) | J05AX25 | 08.03.0. | B |
| 2 | 2 | Beutel | J05AX25 | 08.03.0. | B |
| 3 | 1 | Beutel | J05AX25 | 08.03.0. | B |
| 4 | 1 | Beutel | J05AX25 | 08.03.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Xofluza 2 mg / ml authorised in Switzerland?
Yes. Xofluza 2 mg / ml is authorised by Swissmedic under authorisation number 68068, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Xofluza 2 mg / ml have?
Xofluza 2 mg / 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 Xofluza 2 mg / ml?
The authorisation holder is Roche Pharma (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.