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/179.41 KB)
First published: 16/02/2015
Last updated: 16/04/2020
EMA/741412/2014
Authorisation details
Product details | |
---|---|
Name |
Otezla
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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 B.V.
|
Revision |
14
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Date of issue of marketing authorisation valid throughout the European Union |
15/01/2015
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Contact address |
Product information
24/06/2020 Otezla - EMEA/H/C/003746 - IAIN/0033/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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).