France · Source-listed medicine information

France / CIS 60418716

OTEZLA 10 mg, comprimé pelliculé, OTEZLA 20 mg, comprimé pelliculé, OTEZLA 30 mg, comprimé pelliculé

comprimé pelliculé et comprimé pelliculé et comprimé pelliculé · orale

Directory source checks passedOriginal source language: French

Source data retrieved: 2026-09-17. Clinical review is not yet available.

Formcomprimé pelliculé et comprimé pelliculé et comprimé pelliculé
Routeorale
Ingredient entries1
CountryFrance

Product identity

At a glance

Authorisation holder
AMGEN EUROPE
Authorisation status
Autorisation active
Market status
Commercialisée
Country
France
Source reference
CIS 60418716

Reported market status does not confirm current pharmacy stock.

From the official composition record

Ingredients & strength

Source entries are shown individually. An active substance (SA) and its reference moiety (FT) may describe the same ingredient; do not add their strengths together.

Source composition entries for OTEZLA 10 mg, comprimé pelliculé, OTEZLA 20 mg, comprimé pelliculé, OTEZLA 30 mg, comprimé pelliculé
IngredientStrength / referenceSource role
APRÉMILASTcomprimé 10 mg10 mgun compriméSAGroup 1
APRÉMILASTcomprimé 20 mg20 mgun compriméSAGroup 11
APRÉMILASTcomprimé 30 mg30 mgun compriméSAGroup 22

Pack references

Presentations (1)

plaquette(s) thermoformée(s) PVC-Aluminium de 4 comprimé(s) de 10 mg - 4 comprimé(s) de 20 mg - 19 comprimé(s) de 30 mg. Etui d'initiation de 27 comprimés

CIP13 3400930008881

Présentation active · Déclaration de commercialisation

From the French medicines authority

Official documents

The official product entry provides access to the patient leaflet and professional product information when available. Documents are in French and availability varies by medicine.

Open the official product entryBDPM · CIS 60418716 · Opens in a new tab

Check the medicine name, strength and form against your pack. The authority’s current documents may be newer than the catalogue snapshot shown here.

Where this information comes from

Sources & dates

Base de données publique des médicaments (BDPM), France. Retrieval dates record when we obtained the source files; they are not clinical review dates or a guarantee of current stock.

Source files and their retrieval dates
Source fileRetrievedSource file modified
fr_products.txtNot supplied
fr_composition.txtNot supplied
fr_packs.txtNot supplied

Directory source checks cover the factual catalogue record.Molindra clinical guidance has not yet been reviewed or published for this medicine.

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