OTEZLA
As listed in the register: OTEZLA 10 mg, comprimé pelliculé, OTEZLA 20 mg, comprimé pelliculé
10 mg · comprimé pelliculé et comprimé pelliculé
- Prescription only
- Active substance
- Aprémilast
- Made by
- AMGEN EUROPE
- 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 | AMGEN EUROPE |
|---|---|
| Active substance | Aprémilast |
| Strength | 10 mg |
| Form | comprimé pelliculé et comprimé pelliculé |
| Route | orale |
| Dispensing (as stated by the register) | prescription réservée aux spécialistes et services PEDIATRIE · 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/1/14/981 |
| Name in the register | OTEZLA 10 mg, comprimé pelliculé, OTEZLA 20 mg, comprimé pelliculé |
| Packs | plaquette(s) thermoformée(s) PVC-Aluminium 4 comprimés de 10 mg - plaquette(s) thermoformée(s) PVC-Aluminium 23 comprimés de 20 mg |
| CIS | 62999138 |
| CIP13 | 3400930305737 |
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
4 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.