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
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
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.