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 24/01/2020

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
31
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

23/09/2019 Vectibix - EMEA/H/C/000741 - R/0094

Contents

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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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