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 29/03/2023

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
Publication details
Marketing-authorisation holder
Amgen Europe BV
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
15/01/2015
Contact address

Minervum 7061
4817ZK Breda
The Netherlands

Product information

13/07/2022 Otezla - EMEA/H/C/003746 - N/0040

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

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