Orencia

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abatacept

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

Overview

Authorisation details

Product details
Name
Orencia
Agency product number
EMEA/H/C/000701
Active substance
Abatacept
International non-proprietary name (INN) or common name
abatacept
Anatomical therapeutic chemical (ATC) code
L04AA24
Publication details
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
21/05/2007

Product information

25/07/2017 Orencia - EMEA/H/C/000701 - II/0105

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

Not yet assigned

Therapeutic indication

Rheumatoid arthritisORENCIA, in combination with methotrexate, is indicated for:

  • the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
  • the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.

Assessment history

Changes since initial authorisation of medicine

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