Arimidex - referral

Current status

European Commission final decision

Overview

AstraZeneca AB submitted on 29 April 2009 an application to the European Medicines Agency (EMEA) for Arimidex (anastrozole), and triggered a procedure under Article 29 of Regulation (EC) No 1901/2006, as amended. The CHMP was requested to give its opinion on the use of Arimidex 1mg film-coated tablets in the treatment of short stature in pubertal boys with growth hormone deficiency (GHD), in combination with exogenous growth hormone (GH).

Arimidex 1 mg film-coated tablets is registered in the following EU Member States/EEA countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom.

The eligibility of the centralised procedure for this application was agreed upon by the EMEA/CHMP on 23 April 2009.

The application was composed of administrative information, non-clinical and clinical data based on the MAHs' own studies and/or bibliographic literature

Information relating to the PIP

Pursuant to Article 8 of Regulation (EC) No 1901/2006, as amended, the application included an EMEA Decision (P/20/2009):

• On the granting of a waiver for gynaecomastia and McCune-Albright syndrome.
• On the agreement of a paediatric investigation plan (PIP) for testotoxicosis and short stature due to growth hormone deficiency.

The PIP is completed. The PDCO issued a positive opinion on compliance with the PIP (EMEA-C-000283-PIP01-08).

CHMP Assessment Report for Arimidex 1 mg film-coated tablet

AdoptedReference Number: EMA/311974/2010

Key facts

About this medicine

• Approved name:
  Arimidex
• International non-proprietary name (INN) or common name:
  anastrozole

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMA/311974/2010
• Type:
  Article 29 paediatrics

  This type of procedure may be triggered by a marketing-authorisation holder when applying for a new indication, new pharmaceutical form or new route of administration for use in children for a product authorised under Directive 2001/83/EC.

Key dates and outcomes

• EC decision date:
  06/11/2009

All documents

Arimidex 1 mg film-coated tablet - Artical 29 Paediatrics referral - Annex I, II, III

Adopted

Opinion provided by Committee for Medicinal Products for human Use

CHMP Assessment Report for Arimidex 1 mg film-coated tablet

AdoptedReference Number: EMA/311974/2010

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.