🇪🇺 Vicinium in European Union

Vicinium (Vicinium) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/005730
  • Marketing authorisation holder: DLRC Pharma Services Ltd
  • Local brand name: Oportuzumab monatox DLRC Pharma Services
  • Indication: Treatment and prevention of recurrence of carcinoma-in-situ (CIS) of the urinary bladder and prevention of recurrence of high grade Ta and/or T1 papillary tumours
  • Status: withdrawn

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Other Other approved in European Union

Frequently asked questions

Is Vicinium approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for Vicinium in European Union?

DLRC Pharma Services Ltd holds the EU marketing authorisation.