Official announcements
Safety warnings
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Medicines
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17/09/2019
Information on NDMA contamination in ranitidine medicines and recalls
Safety warnings
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messages in brief
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17/09/2019
Measures at EU level At the request of the European Commission, the European Medicines Agency (EMA) has begun reviewing medicines containing ranitidine after investigations found contamination with N-nitrosodimethylamine (NDMA). NDMA is classified as…
Recall
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Medicines
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17/09/2019
The marketing authorisation holder informed its customers on September 16, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).
Recall
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Medicines
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13/09/2019
The marketing authorisation holder informed its customers on September 13, 2019 that below mentioned batch is recalled because of a incorrect package leaflet.
Recall
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Medicines
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23/08/2019
The marketing authorisation holder informed its customers on August 23, 2019 that below mentioned batch is recalled because the content of the active substance is below specification limits.
Recall
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Medicines
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01/08/2019
The marketing authorisation holder informed its customers on August 1, 2019 that the outer packaging may leak.
messages in brief
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26/07/2019
Situation in Austria Imurek-50 mg Film-Coated Tablets are currently temporarily unavailable due to increased demand beyond national borders, and associated capacity constraints at the manufacturer. This information is publicly available on the…
messages in brief
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18/07/2019
Please find new and updated FAQ's regarding "Accessible Patient Information Leaflet" at https://www.basg.gv.at/en/medicines/faqs-about-medicinal-products/accessible-patient-information-leaflet/ .
messages in brief
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18/07/2019
The concept of parallel submission in official control authority batch release means that the applicant sends samples to the BASG-OMCL (Official Medicines Control Laboratory) while he is still testing them himself. Complete documentation is not…
messages in brief
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17/07/2019
Manufacturers of an implantable device shall provide information for identification of the device on an implant card in accordance with Article 18 MDR. More detailed guidance on a uniform format of an implant card have now been published on the…