Otezla
apremilast
Table of contents
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.
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List item
Otezla : EPAR - Summary for the public (PDF/82.75 KB)
First published: 16/02/2015
Last updated: 16/02/2015
EMA/727043/2014 -
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List item
Otezla : EPAR - Risk-management-plan summary (PDF/1.84 MB)
First published: 16/02/2015
Last updated: 29/03/2023
EMA/741412/2014
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) |
|
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 |
Product information
13/07/2022 Otezla - EMEA/H/C/003746 - N/0040
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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).