Official announcements
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Medicines
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10/08/2016
CSL Behring as distributor of the product Helixate®NexGen has, in coordination with the marketing authorization holder Bayer Pharma AG, informed its supplied customers by letter dated August 8, 2016, that above mentioned batches of Helixate®NexGen…
Recall
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Medicines
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05/08/2016
The marketing authorization holder has informed its supplied customers in a letter dated August 4, 2016, that after the application of "Nutriflex Lipid special Emulsion for Infusion " of the batch 160338052 individual cases of fever and chills have…
Recall
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Medicines
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21/07/2016
The distribution company has informed its supplied customers in a letter dated 21.07.2016 that in the instructions for use of this batch the wrong daily maximum dose of ten capsules is indicated. The correct maximum is five capsules per day. This…
Recall
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Medicines
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15/07/2016
The marketing authorization holder has informed its supplied customers in a letter dated 14.07.2016 that the title of the leaflet is incorrect. The active strength is listed as 5 mg instead of 10 mg and therefore the affected batches of "Amlodipine…
Recall
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Medicines
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14/07/2016
The distributor of the marketing authorization holder has informed the customers supplied in the period 04.05.2016 to 19.05.2016 that due to a wrong delivery of batch 117 a batch of "Dorzo-Vision 20 mg/ml Eye Drops" in the presentation of the German…
Recall
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Medicines
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23/06/2016
The marketing authorization holder informed its supplied customers in a letter dated June 20, 2016, that a precautionary recall is being carried out due to the potential risk of glass particles in the vials.
Recall
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Medicines
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09/05/2016
The marketing authorization holder has informed its supplied customers in a letter dated 09.05.2016 that due to a technical error during production, there are residues of corrosive agents in the dry substance. Therefore, the two above mentioned…
Recall
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Medicines
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25/04/2016
The marketing authorization holder has informed its supplied customers by letter dated April 20, 2016, that an internal quality control has detected an undercutting of the phenol content and therefore the affected batches of the Prick Test Solution…
Recall
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Medicines
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21/04/2016
The marketing authorization holder informed its supplied customers in a letter dated 19.04.2016 that an error in the filling process was detected at the manufacturer. The error results in a few vials possibly containing a too high concentration. The…
Recall
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Medicines
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21/04/2016
The marketing authorization holder has informed its supplied customers in a letter dated 20.04.2016 that the marketing authorizations of medicinal products containing fusafungin (Locabiosol / Bioparox / Locabiotal / Fusaloyos as oral spray, nasal…