Goserelin Cell Pharm

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

Overview

The European Medicines Agency has completed a review of the clinical studies that were submitted as part of the marketing authorisation application of the hybrid (a type of generic) medicinal products Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names (goserelin, 3.6 mg implant).

The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that these medicines have not be shown to be equivalent to the reference medicine (Zoladex) and therefore the marketing authorisation should be suspended until therapeutic equivalence has been demonstrated.

Key facts

Approved name
Goserelin Cell Pharm
International non-proprietary name (INN) or common name
goserelin
Associated names
  • Novosis Goserelin
  • Goserelin Cell Pharm
  • Novimp and associated names
Reference number
EMEA/H/A-36/1297
Type
Article 36 referrals (prior to July 2012)

This type of referral applied for a marketing authorisation that were granted via the mutual-recognition or decentralised procedure. It was triggered when a Member State considered that action (variation, suspension or withdrawal) was needed on the grounds of the need to protect public health. This referral has been replaced by Articles 107i and 31.

Status
European Commission final decision
Opinion date
23/06/2011
EC decision date
16/09/2011

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

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