Official announcements
Replacement
|
Medicines
|
28/04/2011
The marketing authorization holder has informed its supplied customers by letter dated April 28, 2011, that a small piece of glass has been detected in a vial of the above mentioned batch. As a precaution, Mallinckrodt/Covidien (NL) is recalling the…
Replacement
|
Medicines
|
27/04/2011
Baxter Healthcare has identified elevated levels of endotoxin in some batches of the above peritoneal dialysis solutions at its manufacturing facility in Castlebar, Ireland, posing a risk of aseptic peritonitis. Since December 2010, five batches have…
messages in brief
|
26/04/2011
The background to the recent discussions is not a 'new' document from the European Commission, but the 2004 Directive 2004/24 EC, which defines traditional herbal medicinal products and sets the regulatory framework for them across the EU. This…
Replacement
|
Medicines
|
14/04/2011
The licensee informed its supplied customers by telephone from April 12 to 14, 2011, that the valves of the affected gas cylinders are malfunctioning, so that there is a risk of under/overdosing of oxygen. The affected gas cylinders will be replaced.
Replacement
|
Medicines
|
13/04/2011
In a letter dated April 12, 2011, the marketing authorization holder informed its customers that visible particles had been detected in two batches after the expiry date of 18 months had been exceeded. As a precautionary measure, all batches that…
Recall
|
Medicines
|
01/04/2011
In a letter dated March 30, 2011, the marketing authorization holder informed its supplied customers of a precautionary recall, as isolated precipitations of the active ingredient within the shelf life of the prepared infusion solution specified in…
messages in brief
|
08/03/2011
Prevenar (active ingredient: pneumococcal polysaccharides of serotype 4, 6B, 9V, 14, 18C, 19F and 23F, conjugated to CRM197 carrier protein, adsorbed) has been licensed since 2001 under the centralized procedure in all EU member states for children…
messages in brief
|
03/03/2011
[Translate to english:] EudraCT - Umstellung auf Version 8
Replacement
|
Medicines
|
21/02/2011
The marketing authorization holder informed its supplied customers by letter dated Feb. 21, 2011, that information for use in Norwegian language was enclosed in this batch, which is intended for the drug Sarotex tablets.
