Official announcements
Safety warnings
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messages in brief
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23/01/2015
Measures at EU level An inspection at the research service provider GVK Biosciences in Hyderabad (India) revealed serious deficiencies in the bioequivalence studies conducted there, which serve as the basis for the approval of generic drugs. Across…
Recall
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Medicines
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20/01/2015
The distributor informed its supplied customers that during the daily sterility test control of the final products of batch 02-150115 a turbidity was detected and therefore a potential contamination had to be assumed.
messages in brief
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15/01/2015
Measures at EU level The EU Commission has released the emergency contraceptive "ellaOne" (active ingredient: Ulipristal) from prescription-only status. In doing so, the Brussels-based authority has followed the recommendation of the European…
Recall
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Medicines
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15/01/2015
The distributor informed its supplied customers that during the daily sterility test control of the final products of batch 02-150112 a turbidity was detected and therefore a potential contamination had to be assumed.
Recall
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Medicines
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13/01/2015
The marketing authorization holder informed its supplied customers in a letter dated January 13, 2015, that the package leaflet in Greek was enclosed with individual packages of batch 42053 and that a precautionary recall is therefore being carried…
Safety warnings
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Blood & Tissue
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13/01/2015
Further information on the spread of the Chikungunya virus.
Safety warnings
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messages in brief
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04/01/2015
Isotretinoin is a highly effective vitamin A analogue that has been used since the early 1980s to treat severe, therapy-resistant forms of acne. When isotretinoin is taken during pregnancy, the risk of severe congenital malformations or spontaneous…
Recall
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Veterinary Medicines
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19/12/2014
The distributor has informed its supplied customers in a letter dated 18.12.2014 that there is a possibility of incorrect labeling or batch submixing with 100 mg/ml nerfasin vials in the above batch. To date, there have only been reports of this from…
Recall
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Veterinary Medicines
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18/12/2014
The marketing authorization holder has informed its supplied customers by letter dated 16.12.2014 that a quality defect with regard to the formulation or the homogeneity of the product has been detected and therefore a recall of all batches will be…
Recall
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Medicines
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17/12/2014
The distribution company has informed its supplied customers in a letter dated December 16, 2014, that in individual cases a dosage inaccuracy (slight underdosage) has been detected in dosing pumps in the prepackages of Axura 5 mg/pump stroke, 50 ml…
