Official announcements
Recall
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Medicines
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01/04/2016
The pharmaceutical company "Amomed Pharma GmbH" has informed its supplied customers by letter dated 11.03.2016 that in the course of stability testing a clear brown coloration of the solution was detected in some ampoules. This brown coloration…
messages in brief
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22/03/2016
Recently, pyrrolizidine alkaloids have also been detected in herbal preparations made from plants that do not biosynthesize pyrrolizidine alkaloids. Studies suggest that contamination with weeds may be responsible. Since even very few individuals of…
Recall
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Medicines
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24/02/2016
Agepha Pharma has informed its customers in a letter dated 24.02.2016 about the recall of the mentioned batch for the following reason: The composition of the eye drops has been changed (addition of povidone), but the official assessment of this…
Recall
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Medicines
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28/01/2016
The company B. Braun Austria Ges.m.b.H. informed its supplied customers in a letter dated 28.01.2016 that due to customer complaints about leaking Ecoflac® plus infusion containers of the mentioned batch a precautionary recall due to possible leakage…
Recall
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Medicines
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18/12/2015
The marketing authorization holder informed its supplied customers in a letter dated December 16, 2015, that a reduced active ingredient content was detected in the above batch in the course of routine stability tests, so that the shelf life until…
Recall
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Medicines
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17/12/2015
The marketing authorization holder and its distribution partner informed the supplied customers in a letter dated 14.12.2015 that after the introduction of a new IT system in the production facility "Stallergenes S.A." in Antony, France, difficulties…
Recall
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Medicines
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10/12/2015
The marketing authorization holder informed its supplied customers in a letter dated December 4, 2015, that a precautionary recall of the batch R09199 will be carried out due to two complaints, in which an instruction leaflet of another product in…
messages in brief
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04/12/2015
As of 1st January 2016 it will be mandatory for companies submitting applications for European and National Procedures (human and veterinary) to use the electronic application form (eAF). Please find further information at…
Safety warnings
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messages in brief
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27/11/2015
A re-examination of the safety and efficacy of human papillomavirus vaccines (HPV vaccines) has been completed. After evaluation of the current data by the Pharmacovigilance Risk Assessment Committee (PRAC), no causal association between the HPV…
Recall
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Medicines
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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…