ROACTEMRA
As listed in the register: ROACTEMRA 162 mg, solution injectable en seringue préremplie
162 mg · solution injectable
- Prescription only
- Active substance
- Tocilizumab
- 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 (AVTOZMA). It describes the substance, not this exact product.
Tocilizumab products bind to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and have been shown to inhibit IL-6-mediated signaling through these receptors.
IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts.
Accordingly, inhibition of IL-6 signaling in RA patients treated with tocilizumab may restore CYP450 activities to higher levels than those in the absence of tocilizumab leading to increased metabolism of drugs that are CYP450 substrates.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-27
Safety of the active substance
From the US prescribing label for the same active substance (AVTOZMA). It describes the substance, not this exact product.
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including AVTOZMA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1), Adverse Reactions (6.1) ].
- AVTOZMA is contraindicated in patients with known hypersensitivity to tocilizumab products [see Warnings and Precautions (5.6) ].
- Known hypersensitivity to tocilizumab products.
Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions.
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
Spain8 matching products
CanadaNo exact match for this strength and form
Netherlands6 matching products
- Tuyory 162 mg · oplossing voor injectie2 makers
- Avtozma 162 mg · oplossing voor injectie
- RoActemra 162 mg oplossing voor injectie in een voorgevulde spuit 162 mg · oplossing voor injectie
- Tyenne 162 mg oplossing voor injectie in voorgevulde pen 162 mg · oplossing voor injectie
- Tyenne 162 mg oplossing voor injectie in voorgevulde spuit 162 mg · oplossing voor injectie
Details
| Made by | ROCHE REGISTRATION (ALLEMAGNE) |
|---|---|
| Active substance | Tocilizumab |
| Strength | 162 mg |
| Form | solution injectable |
| Route | sous-cutanée |
| Dispensing (as stated by the register) | prescription réservée aux spécialistes et services PEDIATRIE · médicament nécessitant une surveillance particulière pendant le traitement · prescription réservée aux spécialistes et services MEDECINE INTERNE · prescription réservée aux spécialistes et services RHUMATOLOGIE · liste I |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/08/492 |
| Name in the register | ROACTEMRA 162 mg, solution injectable en seringue préremplie |
| Packs | 4 seringue(s) préremplie(s) en verre de 0,9 ml |
| CIS | 69107620 |
| CIP13 | 3400927824845 |
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.
- solution injectable2 products
162 mg2
162 mg · 2 companies
- ROCHE REGISTRATION (ALLEMAGNE) · this page
- ROCHE REGISTRATION (ALLEMAGNE)
- solution à diluer pour perfusion1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.