Otezla

RSS

apremilast

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Otezla. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Otezla.

For practical information about using Otezla, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 14/08/2018

Authorisation details

Product details
Name
Otezla
Agency product number
EMEA/H/C/003746
Active substance
apremilast
International non-proprietary name (INN) or common name
apremilast
Therapeutic area (MeSH)
  • Arthritis, Psoriatic
  • Psoriasis
Anatomical therapeutic chemical (ATC) code
L04AA32
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Celgene Europe BV
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
15/01/2015
Contact address
Winthontlaan 6 N
3526KV Utrecht
The Netherlands

Product information

02/08/2018 Otezla - EMEA/H/C/003746 - T/0020

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Psoriatic arthritis
Otezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.

Psoriasis
Otezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).

Assessment history

How useful was this page?

Add your rating
Average
1 rating