Bicalutamide 150 mg

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

Following a request from Belgium, the European Medicines Agency's (EMEA's) Committee for Medicinal Products for Human Use (CHMP) has reviewed the available information on the effectiveness and safety of medicines containing 150 mg bicalutamide, used orally (by mouth) for the treatment of locally advanced prostate cancer.

The Committee has concluded that the benefits of these products still outweigh their risks, but has recommended some changes to their prescribing information to ensure that they are prescribed only to patients who are at a high risk of disease progression.

Key facts

Approved name
Bicalutamide 150 mg
International non-proprietary name (INN) or common name
bicalutamide
Reference number
CHMP/378451/07
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
European Commission final decision
Opinion date
24/05/2007
EC decision date
03/09/2007

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

How useful was this page?

Add your rating