Jylamvo

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methotrexate

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

Overview

Jylamvo is an anti-inflammatory and cancer medicine used to treat the following conditions: 

  • active rheumatoid arthritis (a disease causing inflammation in joints) in adults;
  • severe juvenile idiopathic arthritis (inflammation of joints in children) in patients from 3 years of age when NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough;
  • severe disabling psoriasis (an inflammatory disease causing red, scaly patches on the skin) in adults when other treatments have not worked well enough;
  • severe psoriatic arthritis (inflammation of joints that occurs in patients with psoriasis) in adults;
  • acute lymphoblastic leukaemia (ALL), a cancer of white blood cells, in adults and children over the age of 3

Jylamvo contains the active substance methotrexate. 

Jylamvo is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Jylamvo is given in a different way. The reference medicine for Jylamvo is Methotrexat Lederle injection.

This EPAR was last updated on 31/10/2019

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
5
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

21/10/2019 Jylamvo - EMEA/H/C/003756 - A31/0002

Contents

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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

Changes since initial authorisation of medicine

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