Oresund — Jylamvo EMA EPAR public assessment report (EMEA/H/C/003756, 2017)
Oresund · 2017 · EMA EPAR public assessment report
Report summary
The EMA's 2017 assessment of Jylamvo, an oral methotrexate solution, approved it for adults, adolescents, and children aged 3+ for rheumatological, dermatological, and certain oncological conditions. Developed to provide an alternative oral formulation, especially for pediatric patients unable to swallow tablets, Jylamvo ensures accurate dosing and reduces cytotoxic exposure. Bioequivalence studies (MTX001, MTX002) in healthy volunteers confirmed its pharmacokinetic equivalence to reference methotrexate tablets. The report also addresses environmental risks and emphasizes risk minimization, particularly regarding potential medication errors due to its varied indications. The CHMP concluded a favorable benefit-risk balance for Jylamvo.
Key findings — cited to the page
| Eligibility to centralised procedure agreed date | 30 May 2013 | Jylamvo · EU · p.4 |
| Procedure start date | 25 March 2015 | Jylamvo · EU · p.5 |
| Positive opinion for Marketing Authorisation date | 26 January 2017 | Jylamvo · EU · p.6 |
| Shelf life | 20 months | Jylamvo · p.11 |
| Cmax mean ratio | 103.71 % | MTX002 · p.24 |
| In-use shelf life | 3 months | Jylamvo · p.11 |
| Number of subjects | 24 | MTX001 · p.15 |
| Number of subjects planned for inclusion | 24 | MTX001 · p.16 |
| Number of subjects analyzed | 24 | MTX001 · p.16 |
| Number of subjects enrolled | 24 | MTX002 · p.21 |
| Number of subjects completed | 24 | MTX002 · p.21 |
| Application submission date | 4 December 2014 | Jylamvo · EU · p.4 |
Source: Oresund ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →