Fri-22-05-2015, 15:13 PM
Stelara is soon to be made available for adolescent psoriasis patients after the committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Stelara.
Source: ema.europa.eu
Quote:
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Stelara. The marketing authorisation holder for this medicinal product is Janssen-Cilag International N.V.
The CHMP adopted a new indication as follows
Paediatric plaque psoriasis:
Stelara is indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Source: ema.europa.eu