Bicalutamide 150 mg
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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
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About this medicine
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|---|---|
| Approved name |
Bicalutamide 150 mg
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| International non-proprietary name (INN) or common name |
bicalutamide
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About this procedure
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|---|---|
| Current status |
European Commission final decision
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| Reference number |
CHMP/378451/07
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| 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. |
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Key dates and outcomes
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|---|---|
| CHMP opinion date |
24/05/2007
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| EC decision date |
03/09/2007
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All documents
Bicalutamide - Article 31 referral - Annex I, II, III, IV (PDF/127.05 KB)
First published: 03/10/2007
Last updated: 03/10/2007
Summary information on referral opinion pursuant to Article 31 of Council Directive 2001/83/EC, as amended for Bicalutamide 150 mg-containing medicinal products (see Annex 1) International Non-Proprietary Name (INN): bic... (PDF/34.12 KB)
First published: 16/08/2007
Last updated: 16/08/2007
EMEA/378451/2007
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.