REMSIMA
As listed in the register: REMSIMA 120 mg, solution injectable en seringue préremplie
120 mg · solution injectable
- Prescription only
- Active substance
- Infliximab
- Made by
- CELLTRION HEALTHCARE HUNGARY (HONGRIE)
- 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 (Renflexis). It describes the substance, not this exact product.
Infliximab products neutralize the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit binding of TNFα with its receptors.
Infliximab products do not neutralize TNFβ (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-28
Safety of the active substance
From the US prescribing label for the same active substance (Renflexis). It describes the substance, not this exact product.
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning.
- The use of RENFLEXIS at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ].
- RENFLEXIS is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab products or any of the inactive ingredients of RENFLEXIS or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness] [see Warnings and Precautions (5.7) and Adverse Reactions (6.1) ].
- RENFLEXIS doses >5 mg/kg in moderate or severe heart failure.
- ( 4 ) Previous severe hypersensitivity reaction to infliximab products or any inactive ingredients of RENFLEXIS or to any murine proteins.
Most common adverse reactions (>10%) – infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
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
Spain2 matching products
CanadaNo exact match for this strength and form
Details
| Made by | CELLTRION HEALTHCARE HUNGARY (HONGRIE) |
|---|---|
| Active substance | Infliximab |
| Strength | 120 mg |
| Form | solution injectable |
| Route | sous-cutanée |
| Dispensing (as stated by the register) | prescription réservée aux spécialistes et services HEPATO/GASTRO-ENTEROLOGIE · prescription réservée aux spécialistes et services MEDECINE INTERNE · prescription réservée aux spécialistes et services RHUMATOLOGIE · prescription réservée aux spécialistes et services DERMATOLOGIE · liste I |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/13/853 |
| Name in the register | REMSIMA 120 mg, solution injectable en seringue préremplie |
| Packs | 1 seringue préremplie en verre de 1 mL avec protège-aiguille automatique et 2 tampons alcoolisés · 2 seringues préremplies en verre de 1 mL avec protège-aiguille automatique et 2 tampons alcoolisés |
| CIS | 68279040 |
| CIP13 | 3400930199336 |
| CIP13 | 3400930199343 |
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
120 mg2
120 mg · 2 companies
- CELLTRION HEALTHCARE HUNGARY (HONGRIE) · this page
- CELLTRION HEALTHCARE HUNGARY (HONGRIE)
- poudre pour 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.