MABTHERA
As listed in the register: MABTHERA 1400 mg, solution pour injection sous-cutanée
1400 mg · solution injectable
- Prescription only
- Active substance
- Rituximab
- Made by
- ROCHE REGISTRATION (ALLEMAGNE)
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Rituxan). It describes the substance, not this exact product.
Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes.
Upon binding to CD20, rituximab mediates B-cell lysis.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-01-06
Safety of the active substance
From the US prescribing label for the same active substance (Rituxan). It describes the substance, not this exact product.
WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning.
The most common adverse reactions of RITUXAN (incidence greater than or equal to 25%) observed in clinical trials of patients with NHL were infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
European UnionNo exact match for this strength and form
CanadaNo exact match for this strength and form
Netherlands1 matching products
Details
| Made by | ROCHE REGISTRATION (ALLEMAGNE) |
|---|---|
| Active substance | Rituximab |
| Strength | 1400 mg |
| Form | solution injectable |
| Route | sous-cutanée |
| Dispensing (as stated by the register) | médicament nécessitant une surveillance particulière pendant le traitement · prescription réservée aux spécialistes et services HEMATOLOGIE · prescription hospitalière · liste I · la première administration doit être effectuée en milieu hospitalier · prescription réservée aux médecins compétents en maladie du sang |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/98/067 |
| Name in the register | MABTHERA 1400 mg, solution pour injection sous-cutanée |
| Packs | 1 flacon(s) en verre |
| CIS | 65314657 |
| CIP13 | 3400958659928 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.