TREMFYA
As listed in the register: TREMFYA 100 mg PUSHPEN, solution injectable en stylo prérempli
100 mg · solution injectable
- Prescription only
- Active substance
- Guselkumab
- Made by
- JANSSEN CILAG INTERNATIONAL NV
- 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 (TREMFYA). It describes the substance, not this exact product.
Guselkumab is a human monoclonal IgG1λ antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor.
IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.
The exact pathway through which guselkumab is metabolized has not been characterized.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-06-04
Safety of the active substance
From the US prescribing label for the same active substance (TREMFYA). It describes the substance, not this exact product.
- TREMFYA is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients [see Warnings and Precautions (5.1) ].
- History of serious hypersensitivity reactions to guselkumab or to any of the excipients.
The most common (≥ 1%) infections that occurred more frequently in the TREMFYA group than in the placebo group were upper respiratory infections, gastroenteritis, tinea infections, and herpes simplex infections; all cases were mild to moderate in severity and did not lead to discontinuation of TREMFYA.
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
European UnionNo exact match for this strength and form
Spain3 matching products
CanadaNo exact match for this strength and form
Details
| Made by | JANSSEN CILAG INTERNATIONAL NV |
|---|---|
| Active substance | Guselkumab |
| Strength | 100 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/1/17/1234 |
| Name in the register | TREMFYA 100 mg PUSHPEN, solution injectable en stylo prérempli |
| Packs | 1 stylo prérempli (PushPen) en verre de 1 mL |
| CIS | 63571286 |
| CIP13 | 3400930325964 |
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
5 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- solution injectable4 products
100 mg3
100 mg · 3 companies
- JANSSEN CILAG INTERNATIONAL NV · this page
- JANSSEN CILAG INTERNATIONAL NV
- JANSSEN CILAG INTERNATIONAL NV
- 200 mg
- 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.