Vivaglobin

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
Opinion provided by Committee for Medicinal Products for Human Use

Overview

The European Medicines Agency (EMA) has completed a review of Vivaglobin, following the detection of impurities in the medicine which could cause thromboembolic events (problems due to formation of blood clots in blood vessels). The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended changes to the manufacturing process to prevent the presence of these impurities and thus reduce the risk of thromboembolic events.

Key facts

Approved name
Vivaglobin
International non-proprietary name (INN) or common name
Human normal immunoglobulin
Class
-
Reference number
EMEA/H/A-36/1296
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 This referral has been replaced by Articles 107i and 31.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
Opinion provided by Committee for Medicinal Products for Human Use
Opinion date
16/02/2012
EC decision date
07/05/2012

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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