Official announcements
Replacement
|
Medicines
|
10/02/2011
The marketing authorization holder has informed its supplied customers that results from stability data indicate a possible shortfall of the required active ingredient content by the end of the shelf life. The affected batch currently meets all…
Safety warnings
|
Blood & Tissue
|
04/02/2011
Increased caution should be exercised in travelers with compatible symptomatology.
Replacement
|
Medicines
|
03/02/2011
The marketing authorization holder informed its supplied customers in a letter dated February 3, 2011, that empty or almost empty prefilled syringes had been discovered in individual packages of the above batch and that the batch would therefore be…
messages in brief
|
02/02/2011
AGES PharmMed is receiving a high number of requests to act as Reference Member State for the Mutual Recognition and Decentralised Procedure. The routine of allocating time slots for DC procedures allows better scheduling of applications and…
Safety warnings
|
Blood & Tissue
|
02/02/2011
A forwarding regarding derived measures for the blood donation system.
Recall
|
Medicines
|
26/01/2011
The marketing authorization holder has informed its supplied customers in a letter dated January 25, 2011, that cracks have been detected in the cone of some prefilled syringes. At present, there is no indication that sterility is impaired by this…
Replacement
|
Medicines
|
26/01/2011
The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed the wholesalers supplied that all batches with the old product name "Ebixa 10mg/g Oral, Solution" will be recalled and replaced by goods with the…
Recall
|
Medicines
|
05/01/2011
Two batches of the product Dianeal have been identified that may contain endotoxins. Therefore, the marketing authorization holder has decided to recall the above mentioned batches from a dialysis center supplied in Austria.
messages in brief
|
29/12/2010
At the end of 2010, the following deadlines will expire according to the Medicines Act BGBl Nr 185/1983 as amended: Inclusion of doping warning until 31.12.2010 All medicinal products concerned must contain the doping warning by 31.12.2010 (according…
Recall
|
Medicines
|
23/12/2010
The marketing authorization holder has received increased adverse reactions (aseptic peritonitis) to the above batch. Therefore, Baxter Healthcare has decided to recall this batch from those dialysis centers that were supplied with this product.
