Baxter dialysis solutions
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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
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Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant (PDF/129.01 KB)
Adopted
First published: 23/09/2011
Last updated: 20/11/2013
EMA/CHMP/768789/2011 -
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Assessment report for Baxter dialysis solutions (3 sites) (PDF/336.97 KB)
Adopted
First published: 20/11/2013
Last updated: 20/11/2013
EMA/404194/2011 -
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Baxter dialysis solutions Article-31 referral - Annex I (3 sites) (PDF/709.25 KB)
First published: 20/11/2013
Last updated: 20/11/2013 -
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Baxter dialysis solutions Article-31 referral - Annex II (3 sites) (PDF/68.74 KB)
First published: 20/11/2013
Last updated: 20/11/2013 -
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Baxter dialysis solutions Article-31 referral - Annex III (3 sites) (PDF/79.86 KB)
First published: 20/11/2013
Last updated: 20/11/2013 -
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List item
Assessment report for Baxter dialysis solutions (US site) (PDF/202.08 KB)
Adopted
First published: 20/11/2013
Last updated: 20/11/2013
EMA/488426/2011 -
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Baxter dialysis solutions Article-31 referral - Annex I (US site) (PDF/434.16 KB)
First published: 20/11/2013
Last updated: 20/11/2013 -
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Baxter dialysis solutions Article-31 referral - Annex II (US site) (PDF/67.76 KB)
First published: 20/11/2013
Last updated: 20/11/2013 -
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Baxter dialysis solutions Article-31 referral - Annex III (US site) (PDF/84.21 KB)
First published: 20/11/2013
Last updated: 20/11/2013 -
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Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) (PDF/69.41 KB)
First published: 20/11/2013
Last updated: 20/11/2013 -
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List item
Assessment report for Baxter dialysis solutions (Castlebar site) (PDF/219.48 KB)
Adopted
First published: 20/11/2013
Last updated: 20/11/2013
EMA/973411/2011 -
List item
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) (PDF/721.14 KB)
First published: 20/11/2013
Last updated: 20/11/2013 -
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List item
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) (PDF/74.17 KB)
First published: 20/11/2013
Last updated: 20/11/2013 -
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Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) (PDF/47.25 KB)
First published: 20/11/2013
Last updated: 20/11/2013 -
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