Vectibix

RSS

panitumumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Vectibix is a medicine for treating colorectal (bowel) cancer that has spread to other parts of the body. Vectibix is used alone or with other cancer medicines in patients with a type of tumour that has normal
(‘wild-type’) copies of a gene known as RAS.

It contains the active substance panitumumab.

This EPAR was last updated on 06/07/2022

Authorisation details

Product details
Name
Vectibix
Agency product number
EMEA/H/C/000741
Active substance
panitumumab
International non-proprietary name (INN) or common name
panitumumab
Therapeutic area (MeSH)
Colorectal Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC08
Publication details
Marketing-authorisation holder
Amgen Europe B.V.
Revision
34
Date of issue of marketing authorisation valid throughout the European Union
03/12/2007
Contact address

Minervum 7061
NL-4817 ZK Breda
The Netherlands

Product information

05/07/2022 Vectibix - EMEA/H/C/000741 - IA/0100

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):

  • in first-line in combination with Folfox or Folfiri.
  • in second-line in combination with Folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
  • as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Assessment history

Changes since initial authorisation of medicine

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