Official announcements
Recall
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Medicines
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21/10/2014
The marketing authorization holder informed its supplied customers in a letter dated October 21, 2014, that the affected finished product lot 4E915 was produced with an aciclovir active ingredient lot that does not meet the specifications regarding…
Safety warnings
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messages in brief
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17/10/2014
The Federal Office provides information on recommendations of the Committee for Risk Assessment and Pharmacovigilance (PRAC) within the framework of the European risk assessment procedure according to Article 31 of Directive 2001/83/EC regarding the…
messages in brief
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17/10/2014
Status 06.09.2014: The BASG / AGES Medical Market Surveillance became aware that dubious persons were contacting by telephone in the name of AGES pharmaceutical companies, or that these persons were posing as AGES employees in order to request…
Recall
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Medicines
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15/10/2014
The distribution company informed its customers in a letter dated October 13, 2014, that after 3 years of storage at 30°C and 75% humidity and after 6 months of storage at 40°C and 75% humidity, increased levels of known and unknown impurities as…
Recall
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Medicines
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13/10/2014
In a letter dated October 8, 2014, the distribution company informed its supplied customers that there is a possibility of crystals forming if the enclosed diluent of batch AHZW/1 is stored at 2 to 8°C. The diluent was used for the production of this…
Recall
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Medicines
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08/10/2014
Gedeon Richter Austria GmbH" informed its supplied wholesalers and gynecologists in a letter dated 03.10.2014 that instabilities of the active ingredient Desogestrel were detected during periodic stability measurements, which could shorten the shelf…
Recall
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Medicines
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07/10/2014
The marketing authorization holder informed its supplied customers in a letter dated October 3, 2014, that the long-term stability of the two affected batches cannot be ensured and that a precautionary recall is therefore being carried out.
Safety warnings
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messages in brief
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25/09/2014
Auto-injectors containing adrenaline are used for emergency treatment of anaphylactic shock or allergic reaction (e.g. to insect stings or bites, food or drugs). The active substance in the auto-injector (pen) is adrenaline, a substance that…
Safety warnings
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Medicines
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17/09/2014
In addition to isolated cases of tampered Italian Herceptin distributed in parallel, tampered MabThera of Romanian origin has now emerged.
Safety warnings
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messages in brief
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17/09/2014
Situation EU: In addition to individual cases of manipulated, parallel distributed Italian Herceptin, manipulated, parallel distributed MabThera of Romanian origin has now occurred in Germany (as of 16.9.2014) The Paul Ehrlich Institute warns of…