Jylamvo

RSS

methotrexate

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

Overview

This is a summary of the European public assessment report (EPAR) for Jylamvo. 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 Jylamvo.

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

This EPAR was last updated on 03/04/2019

Authorisation details

Product details
Name
Jylamvo
Agency product number
EMEA/H/C/003756
Active substance
Methotrexate
International non-proprietary name (INN) or common name
methotrexate
Therapeutic area (MeSH)
  • Arthritis, Psoriatic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Psoriasis
  • Arthritis, Rheumatoid
  • Arthritis
Anatomical therapeutic chemical (ATC) code
L01BA01
Publication details
Marketing-authorisation holder
Therakind (Europe) Limited
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
29/03/2017
Contact address

3 Inn's Quay
Dublin 7
D07 PW4F
Ιreland

Product information

29/03/2019 Jylamvo - EMEA/H/C/003756 - T/0007

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

Antineoplastic agents

Therapeutic indication

In rheumatological and dermatological diseases

  • Active rheumatoid arthritis in adult patients.
  • Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate.
  • Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients.

In oncology

  • Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.

Assessment history

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