Vectibix
panitumumab
Table of contents
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 |
Product information
23/09/2019 Vectibix - EMEA/H/C/000741 - R/0094
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
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.