Imuldosa is a medicine used to treat: - moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin). It is used in adults and children above the age of 6 years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A). PUVA is a type of treatment where the patient receives a medicine called psoralen, before being exposed to ultraviolet light; - active psoriatic arthritis (inflammation of the joints associated with psoriasis) in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs). Imuldosa may be used alone or combined with methotrexate (a DMARD); - moderately to severely active Crohn’s disease (a disease-causing inflammation of the gut) in adults and children weighing at least 40 kg whose condition has not improved enough with other treatments for Crohn’s disease or who cannot receive such treatments. Imuldosa contains the active substance ustekinumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Imuldosa is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Imuldosa is Stelara. For more information on biosimilar medicines, see [here](https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines).
Therapeutic Indication
### Therapeutic indication Adult Crohn’s Disease Imuldosa is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Paediatric Crohn’s Disease Imuldosa is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Plaque psoriasis Imuldosa is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A). Paediatric plaque psoriasis Imuldosa is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Imuldosa, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease- modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
Therapeutic Area (MeSH)
ATC Code
L04AC05
ATC Item
ustekinumab
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| ustekinumab | N/A | 乌司奴单抗 |
EMA Name
Imuldosa
Medicine Name
Imuldosa
Aliases
N/ANo risk management plan link.
