Official announcements
Recall
|
Medicines
|
17/11/2015
The marketing authorization holder has informed its supplied customers in a letter dated 17.11.2015 that the above mentioned batch has a blue instead of green "flip-off" cap. To avoid confusion with "Propofol ratiopharm 10 mg/ml Emulsion for…
Recall
|
Medicines
|
30/10/2015
The marketing authorization holder informed its supplied customers in a letter dated October 29, 2015, that individual bags of the batches listed above may be affected by minor deviations in the content of the active ingredient ornithine aspartate.
Safety warnings
|
Blood & Tissue
|
29/10/2015
The Federal Office for Public Health Safety has been informed by the Greek authorities that two additional confirmed malaria cases have been recorded in Greece. No travel activity of the ill persons is known. The affected area is: Marathon (Ostattika).
Recall
|
Medicines
|
23/10/2015
The marketing authorization holder has informed its supplied customers in a letter dated October 22, 2015, that the stability of "Bravelle 75 I.U. Powder and Solvent for Solution for Injection" cannot be safely guaranteed until the stated expiry date…
Recall
|
Medicines
|
23/10/2015
The marketing authorization holder informed its supplied customers in a letter dated October 23, 2015, that a microbiological contamination was detected in the course of the inspection of reserve samples and that a recall of the above batch will…
Safety warnings
|
messages in brief
|
22/10/2015
The Federal Agency informs about recommendations of the Committee for Risk Assessment and Pharmacovigilance (PRAC, BASG initial notification 13.3.2015) and the subsequent decision within the European risk assessment procedure according to Article 31…
Safety warnings
|
Blood & Tissue
|
12/10/2015
The Federal Office for Public Health Safety has been informed by the French authority that the first human WNV infection has been recorded in France. There was no travel activity within 3 weeks before the onset of symptoms. The affected area is Nîmes, Gard department (southern France).
Safety warnings
|
Blood & Tissue
|
06/10/2015
The Federal Office for Public Health Safety has been informed by the Italian authority that WNV NAT testing will now be carried out in the province of Rimini in addition to the regions already announced.
Safety warnings
|
Blood & Tissue
|
05/10/2015
The Federal Office for Public Health Safety has been informed by the Romanian authority that additional human WNV (neuro-invasive disease) infections have been recorded in Romania. The affected areas are Amaru (Buzau County), Sf Gheorghe (Ialomita County), and Vidra (Ilfov County).
Recall
|
Medicines
|
01/10/2015
The marketing authorization holder informed its supplied customers in a letter dated September 17, 2015, that a slight shortfall in the protein content (PNU) was detected during internal quality control and that the affected batches of the Fusarium…