Baxter dialysis solutions

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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.

Which products are affected by the review?

The products affected by this review are some of the dialysis solutions produced at Baxter’s Castlebar plant. These include: Dianeal, Extraneal and Nutrineal solutions for peritoneal dialysis; Monosol and a sodium chloride solution for haemodialysis.

Dialysis solutions are used in patients with kidney problems to help clear waste substances (such as urea) from the blood.

What are the risks of exposure to endotoxins?

Endotoxins are harmful substances (toxins) released from bacteria after they have died. If a patient receives a medicine that contains endotoxins, there is a risk that the immune system, the body’s defence mechanism, will react against the endotoxins and cause inflammation. In particular, endotoxins in solutions used in peritoneal dialysis can cause ‘aseptic peritonitis’, an inflammation of the peritoneum that may affect the way it filters the blood. Symptoms of aseptic peritonitis include cloudy effluent (the solution in the drainage bag), abdominal pain, nausea (feeling sick), vomiting and sometimes fever. Aseptic peritonitis can force the patient to stop dialysis until it is resolved.

What is the background to the current investigation?

The Agency was made aware of the presence of endotoxins in batches of Dianeal, Extraneal and Nutrineal made in the Castlebar plant in December 2010. At the time, the company identified endotoxin-producing bacteria in two tanks as the root cause of the problem and removed the tanks from the production line. It also cleaned the other tanks and pipework involved in the production.

Despite these measures, endotoxins were still detected in new batches of solutions produced at the plant, causing the manufacture of these solutions to be shut down at the plant. It was believed that the endotoxins were being produced by ‘biofilms’ (layers of bacteria that adhere to each other), which are very resistant to cleaning processes.

Due to the lack of sufficient alternative sources for dialysis solutions, the CHMP could not recall all affected products from the Castlebar plant at that time. However the Committee aimed to reduce reliance on the plant and made recommendations in January 2011 for the use of products imported from four production sites outside the EU (in Canada, USA, Singapore and Turkey). All affected products from Castlebar were eventually recalled in stages across the EU.

The CHMP started the current review to investigate fully the issues related to the endotoxin contamination and to make recommendations to help protect public health and to prevent future supply shortages.

What are the conclusions of the CHMP?

The CHMP concluded that the root cause of the presence of endotoxins in the affected production lines was a combination of factors: undetected cracks in equipment may have allowed the growth of bacteria, while the design of the plant and the cleaning methods used may have allowed the contamination to spread.

The CHMP noted that improvements are being made to Castlebar plant to ensure future production of endotoxin-free dialysis solutions. These include changes to the design of the plant, new cleaning regimens and the introduction of improved testing methods. The Irish medicines agency will inspect the plant again in October 2011 after which it will go through a 12-month ‘requalification period’ where the plant will be carefully monitored and the products will undergo rigorous testing. The corrective measures being made at Castlebar will also be applied to Baxter’s other manufacturing sites.

As part of the future risk management plan the Committee adopted proposals for a period of intense monitoring of any reports of aseptic peritonitis during the initial months of marketing new products from CastleBar.

The Committee also adopted a strategy to ensure adequate supply of products in the EU should problems reoccur in the future. In order to facilitate this, the CHMP had earlier during the investigation made recommendations to formally include the production sites in Canada, USA, Turkey and Poland in the products’ marketing authorisations in Europe.

What are the recommendations for patients and prescribers?
  • Healthcare professionals should continue to monitor dialysis patients for any adverse events including aseptic peritonitis and report any suspected cases to the company using the reporting forms that will be provided by Baxter.
  • Patients who suspect they have aseptic peritonitis or notice any relevant symptoms (cloudy effluent in drain bag at the end of dialysis, abdominal pain, nausea, vomiting and fever) should contact their doctor.
  • Patients who have any questions should contact their doctors to discuss their treatment.

The European Commission issued a decision on 16 December 2011.

 

Name Language First published Last updated
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant BG = bălgarski 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant ES = español 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant CS = čeština 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant DA = dansk 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant DE = Deutsch 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant ET = eesti keel 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant EL = elliniká 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant EN = English 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant FR = français 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant IT = italiano 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant LV = latviešu valoda 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant LT = lietuvių kalba 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant HU = magyar 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant MT = Malti 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant NL = Nederlands 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant PL = polski 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant PT = português 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant RO = română 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant SK = slovenčina 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant SL = slovenščina 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant FI = suomi 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant SV = svenska 2011-09-23 2013-11-19

Key facts

Approved nameBaxter dialysis solutions
International non-proprietary name (INN) or common name

Baxter dialysis solutions

Associated names
Classdialysis solutions
Reference numberEMEA/H/A-31/1290
TypeArticle 31 referrals

This type of referral is triggered when the interest of the Community is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

StatusEuropean Commission final decision
Opinion date20/10/2011

All documents

Name Language First published Last updated
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant BG = bălgarski 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant ES = español 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant CS = čeština 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant DA = dansk 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant DE = Deutsch 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant ET = eesti keel 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant EL = elliniká 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant EN = English 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant FR = français 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant IT = italiano 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant LV = latviešu valoda 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant LT = lietuvių kalba 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant HU = magyar 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant MT = Malti 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant NL = Nederlands 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant PL = polski 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant PT = português 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant RO = română 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant SK = slovenčina 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant SL = slovenščina 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant FI = suomi 2011-09-23 2013-11-19
Questions and answers on endotoxins in dialysis solutions produced at Baxter manufacturing plant SV = svenska 2011-09-23 2013-11-19
Assessment report for Baxter dialysis solutions (3 sites) (English only) 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) BG = bălgarski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) ES = español 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) CS = čeština 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) DA = dansk 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) DE = Deutsch 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) ET = eesti keel 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) EL = elliniká 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) EN = English 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) FR = français 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) IT = italiano 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) LV = latviešu valoda 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) LT = lietuvių kalba 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) HU = magyar 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) MT = Malti 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) NL = Nederlands 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) PL = polski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) PT = português 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) RO = română 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) SK = slovenčina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) SL = slovenščina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) FI = suomi 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (3 sites) SV = svenska 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) BG = bălgarski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) ES = español 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) CS = čeština 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) DA = dansk 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) DE = Deutsch 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) ET = eesti keel 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) EL = elliniká 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) EN = English 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) FR = français 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) IT = italiano 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) LV = latviešu valoda 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) LT = lietuvių kalba 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) HU = magyar 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) MT = Malti 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) NL = Nederlands 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) PL = polski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) PT = português 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) RO = română 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) SK = slovenčina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) SL = slovenščina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) FI = suomi 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (3 sites) SV = svenska 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) BG = bălgarski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) ES = español 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) CS = čeština 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) DA = dansk 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) DE = Deutsch 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) ET = eesti keel 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) EL = elliniká 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) EN = English 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) FR = français 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) IT = italiano 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) LV = latviešu valoda 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) LT = lietuvių kalba 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) HU = magyar 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) MT = Malti 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) NL = Nederlands 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) PL = polski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) PT = português 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) RO = română 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) SK = slovenčina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) SL = slovenščina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) FI = suomi 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (3 sites) SV = svenska 2013-11-19  
Assessment report for Baxter dialysis solutions (US site) (English only) 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) BG = bălgarski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) ES = español 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) CS = čeština 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) DA = dansk 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) DE = Deutsch 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) ET = eesti keel 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) EL = elliniká 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) EN = English 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) FR = français 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) IT = italiano 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) LV = latviešu valoda 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) LT = lietuvių kalba 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) HU = magyar 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) MT = Malti 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) NL = Nederlands 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) PL = polski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) PT = português 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) RO = română 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) SK = slovenčina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) SL = slovenščina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) FI = suomi 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (US site) SV = svenska 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) BG = bălgarski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) ES = español 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) CS = čeština 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) DA = dansk 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) DE = Deutsch 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) ET = eesti keel 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) EL = elliniká 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) EN = English 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) FR = français 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) IT = italiano 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) LV = latviešu valoda 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) LT = lietuvių kalba 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) HU = magyar 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) MT = Malti 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) NL = Nederlands 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) PL = polski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) PT = português 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) RO = română 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) SK = slovenčina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) SL = slovenščina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) FI = suomi 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (US site) SV = svenska 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) BG = bălgarski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) ES = español 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) CS = čeština 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) DA = dansk 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) DE = Deutsch 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) ET = eesti keel 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) EL = elliniká 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) EN = English 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) FR = français 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) IT = italiano 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) LV = latviešu valoda 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) LT = lietuvių kalba 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) HU = magyar 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) MT = Malti 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) NL = Nederlands 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) PL = polski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) PT = português 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) RO = română 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) SK = slovenčina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) SL = slovenščina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) FI = suomi 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (US site) SV = svenska 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) BG = bălgarski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) ES = español 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) CS = čeština 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) DA = dansk 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) DE = Deutsch 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) ET = eesti keel 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) EL = elliniká 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) EN = English 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) FR = français 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) IT = italiano 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) LV = latviešu valoda 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) LT = lietuvių kalba 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) HU = magyar 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) MT = Malti 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) NL = Nederlands 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) PL = polski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) PT = português 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) RO = română 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) SK = slovenčina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) SL = slovenščina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) FI = suomi 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex IV (3 sites) SV = svenska 2013-11-19  
Assessment report for Baxter dialysis solutions (Castlebar site) (English only) 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) BG = bălgarski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) ES = español 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) CS = čeština 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) DA = dansk 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) DE = Deutsch 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) ET = eesti keel 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) EL = elliniká 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) EN = English 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) FR = français 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) IT = italiano 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) LV = latviešu valoda 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) LT = lietuvių kalba 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) HU = magyar 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) MT = Malti 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) NL = Nederlands 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) PL = polski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) PT = português 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) RO = română 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) SK = slovenčina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) SL = slovenščina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) FI = suomi 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site) SV = svenska 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) BG = bălgarski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) ES = español 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) CS = čeština 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) DA = dansk 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) DE = Deutsch 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) ET = eesti keel 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) EL = elliniká 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) EN = English 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) FR = français 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) IT = italiano 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) LV = latviešu valoda 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) LT = lietuvių kalba 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) HU = magyar 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) MT = Malti 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) NL = Nederlands 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) PL = polski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) PT = português 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) RO = română 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) SK = slovenčina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) SL = slovenščina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) FI = suomi 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex II (Castlebar site) SV = svenska 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) BG = bălgarski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) ES = español 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) CS = čeština 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) DA = dansk 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) DE = Deutsch 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) ET = eesti keel 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) EL = elliniká 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) EN = English 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) FR = français 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) IT = italiano 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) LV = latviešu valoda 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) LT = lietuvių kalba 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) HU = magyar 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) MT = Malti 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) NL = Nederlands 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) PL = polski 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) PT = português 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) RO = română 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) SK = slovenčina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) SL = slovenščina 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) FI = suomi 2013-11-19  
Baxter dialysis solutions Article-31 referral - Annex III (Castlebar site) SV = svenska 2013-11-19  

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 have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

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