TRACLEER
As listed in the register: TRACLEER 125 mg, comprimé pelliculé
129,082 mg · comprimé pelliculé
- Prescription only
- Active substance
- Bosentan Monohydraté
- 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
Details
| Made by | JANSSEN CILAG INTERNATIONAL NV |
|---|---|
| Active substance | Bosentan Monohydraté |
| Strength | 129,082 mg |
| Form | comprimé pelliculé |
| Route | orale |
| Dispensing (as stated by the register) | médicament nécessitant une surveillance particulière pendant le traitement · prescription réservée aux spécialistes et services MEDECINE INTERNE · prescription réservée aux spécialistes et services CARDIOLOGIE · prescription réservée aux spécialistes et services PNEUMOLOGIE · prescription réservée aux spécialistes et services RHUMATOLOGIE · prescription réservée aux spécialistes et services DERMATOLOGIE · prescription hospitalière · liste I |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/02/220 |
| Name in the register | TRACLEER 125 mg, comprimé pelliculé |
| Packs | 4 plaquette(s) thermoformée(s) PVC polyéthylène PVDC aluminium de 14 comprimé(s) |
| CIS | 61855918 |
| CIP13 | 3400956362288 |
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.