MabThera 100 mg/10 ml

MabThera 100 mg/10 ml is a medicine authorised by Swissmedic under authorisation number 54378. 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 27 November 1997 and the authorisation is valid without a time limit. ATC code L01FA01 places the medicine in the group Antineoplastic agents.

Dispensing category A
Authorisation number 54378
ATC L01FA01
Biotechnological medicines

Authorisation data
Authorisation number	54378
Name	MabThera 100 mg/10 ml
Full name	MabThera 100 mg/10 ml, Konzentrat zur Herstellung einer Infusionslösung
Authorisation holder	Roche Pharma (Schweiz) AG
Medicinal product code	Biotechnological medicines
Dispensing category	A · Prescription, not repeatable
ATC code	L01FA01
First authorisation	27 November 1997
Authorisation validity	unlimited

Strengths
No.	Name	Dispensing category	Authorisation date
1	MabThera 100 mg/10 ml, Konzentrat zur Herstellung einer Infusionslösung	A	27 November 1997
2	MabThera 500 mg/50 ml, Konzentrat zur Herstellung einer Infusionslösung	A	27 November 1997

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Pack sizes
Pack code	Quantity	Unit	ATC	IT code	Dispensing category
17	2	Durchstechflasche(n)	L01FA01	07.16.1.	A
25	1	Durchstechflasche(n)	L01FA01	07.16.1.	A

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Medicines in the same ATC group

Ituxredi 100 mg/ 10 mlAuthorisation number 70350 · Dr. Reddy's Laboratories SA · ATC L01FA01A MabThera subkutan 1400 mg/11.7 mlAuthorisation number 65813 · Roche Pharma (Schweiz) AG · ATC L01FA01A Rixathon 100 mg/10 mlAuthorisation number 66435 · Sandoz Pharmaceuticals AG · ATC L01FA01A Ruxience 100 mg/10 mlAuthorisation number 69701 · Pfizer AG · ATC L01FA01A Truxima 100 mg/10 mlAuthorisation number 66648 · IQONE HEALTHCARE SWITZERLAND SA · ATC L01FA01A

Other medicines from this authorisation holder

Actemra 162 mg/0.9 mlAuthorisation number 63166 · ATC L04AC07A Actemra 162 mg/0.9 mlAuthorisation number 66931 · ATC L04AC07A Actemra 80 mg/4 mlAuthorisation number 58868 · ATC L04AC07A Alecensa 150 mgAuthorisation number 65970 · ATC L01ED03A Avastin 100 mg/4 mlAuthorisation number 56922 · ATC L01FG01A CellceptAuthorisation number 54701 · ATC L04AA06B Cellcept 250 mgAuthorisation number 53337 · ATC L04AA06B Cellcept 500 mgAuthorisation number 53338 · ATC L04AA06B

Frequently asked questions

Is MabThera 100 mg/10 ml authorised in Switzerland?

Yes. MabThera 100 mg/10 ml is authorised by Swissmedic under authorisation number 54378, data as of 01 September 2026. The authorisation is valid without a time limit.

Which dispensing category does MabThera 100 mg/10 ml have?

MabThera 100 mg/10 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 100 mg/10 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.