Jylamvo
methotrexate
Table of contents
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.
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Jylamvo : EPAR - Medicine overview (PDF/83.1 KB)
First published: 19/04/2017
Last updated: 31/10/2019 -
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Jylamvo : EPAR - Risk-management-plan summary (PDF/197.75 KB)
First published: 31/10/2019
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) |
|
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 |
Product information
21/10/2019 Jylamvo - EMEA/H/C/003756 - A31/0002
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
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.