Arimidex

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
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).

Key facts

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

Status
European Commission final decision
EC decision date
06/11/2009

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