MabThera subkutan 1400 mg/11.7 ml
MabThera subkutan 1400 mg/11.7 ml is a medicine authorised by Swissmedic under authorisation number 65813. The authorisation holder is Roche Pharma (Schweiz) AG. The medicinal product code is Biotechnological medicines and the dispensing category is A: Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly. First authorisation was granted on 28 June 2016 and the authorisation is valid without a time limit. ATC code L01FA01 places the medicine in the group Antineoplastic agents.
| Authorisation number | 65813 |
|---|---|
| Name | MabThera subkutan 1400 mg/11.7 ml |
| Full name | MabThera subkutan 1400 mg/11.7 ml, Lösung zur subkutanen Injektion |
| Authorisation holder | Roche Pharma (Schweiz) AG |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | L01FA01 |
| First authorisation | 28 June 2016 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | MabThera subkutan 1400 mg/11.7 ml, Lösung zur subkutanen Injektion | A | 28 June 2016 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 | Durchstechflasche(n) | L01FA01 | 07.16.1. | A |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is MabThera subkutan 1400 mg/11.7 ml authorised in Switzerland?
Yes. MabThera subkutan 1400 mg/11.7 ml is authorised by Swissmedic under authorisation number 65813, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does MabThera subkutan 1400 mg/11.7 ml have?
MabThera subkutan 1400 mg/11.7 ml is in dispensing category A. Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly.
Who is the authorisation holder of MabThera subkutan 1400 mg/11.7 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.