🇪🇺 Delayed treatment in European Union

EMA authorised Delayed treatment on 18 August 2016

Marketing authorisations

Application: EMEA/H/C/003983
Marketing authorisation holder: Nordic Group B.V.
Local brand name: Nordimet
Indication: Nordimet is indicated for the treatment of: active rheumatoid arthritis in adult patients, polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate, moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients,  induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who ha
Status: approved

Application: EMEA/H/C/003756
Marketing authorisation holder: Oresund Pharma ApS
Local brand name: Jylamvo
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
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Delayed treatment approved in European Union?

Yes. EMA authorised it on 18 August 2016; EMA authorised it on 29 March 2017.

Who is the marketing authorisation holder for Delayed treatment in European Union?

Nordic Group B.V. holds the EU marketing authorisation.