Sunitinib Accord

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sunitinib

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

Overview

Sunitinib Accord is a medicine used to treat adults with the following cancers:

  • gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel where there is uncontrolled growth of cells in the supporting tissues of these organs. Sunitinib Accord is used in patients with GISTs that cannot be removed with surgery or have spread to other parts of the body. It is used after treatment with imatinib (another cancer medicine) has failed;
  • metastatic renal cell carcinoma, a type of kidney cancer, that has spread to other parts of the body;
  • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) that have spread or cannot be removed with surgery. Sunitinib Accord is used if the disease is getting worse and the tumour cells are well-differentiated (similar to normal cells in the pancreas). 

Sunitinib Accord contains the active substance sunitinib and is a ‘generic medicine’. This means that Sunitinib Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Sutent.

This EPAR was last updated on 06/04/2021

Authorisation details

Product details
Name
Sunitinib Accord
Agency product number
EMEA/H/C/005419
Active substance
sunitinib
International non-proprietary name (INN) or common name
sunitinib
Therapeutic area (MeSH)
  • Gastrointestinal Stromal Tumors
  • Carcinoma, Renal Cell
  • Neuroendocrine Tumors
Anatomical therapeutic chemical (ATC) code
L01XE04
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
11/02/2021
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

11/02/2021 Sunitinib Accord - EMEA/H/C/005419 -

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Gastrointestinal stromal tumour (GIST)

Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.

Metastatic renal cell carcinoma (MRCC)

Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.

Pancreatic neuroendocrine tumours (pNET)

Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.

Assessment history

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