Upstelda

Application withdrawn

The application for this medicine has been withdrawn

ustekinumab

Overview

The applicant withdrew the marketing authorisation application for Upstelda (ustekinumab) on 22 March 2024. It was a duplicate of the application for another medicine, Wezenla, which EMA’s human medicines committee (CHMP) was evaluating in parallel, and which is not affected by this withdrawal.

Further details are included in the withdrawal letter.

Key facts

• Name of medicine:
  Upstelda
• Active substance:
  ustekinumab
• International non-proprietary name (INN) or common name:
  ustekinumab
• Therapeutic area (MeSH):
  • Psoriasis
  • Arthritis, Psoriatic
  • Crohn Disease
• Anatomical therapeutic chemical (ATC) code:
  L04AC05
• EMA product number:
  EMEA/H/C/006415
• Marketing authorisation applicant:
  Amgen Technology (Ireland) UC
• Withdrawal of application:
  22/03/2024

All documents

Withdrawal assessment report for Upstelda

Adopted Reference Number: EMA/250302/2024

Withdrawal letter : Upstelda