Baxter dialysis solutions

Current status:
European Commission final decision

Overview

The European Medicines Agency has completed an investigation into the production processes at Baxter's manufacturing plant in Castlebar, Ireland. The investigation follows the detection in December 2010 of endotoxins in dialysis solutions produced at the plant. The Agency's Committee for Medicinal Products for Human Use (CHMP) has finalised recommendations to ensure the adequate supply of these dialysis solutions in the EU while measures are being put in place at Castlebar to enable the production of endotoxin-free solutions.

Key facts

Approved name
Baxter dialysis solutions
International non-proprietary name (INN) or common name
Baxter dialysis solutions
Class
dialysis solutions
Reference number
EMEA/H/A-31/1290
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.

Status
European Commission final decision
Opinion date
20/10/2011
EC decision date
16/12/2011

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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