Official announcements
Safety warnings
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messages in brief
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23/11/2018
"Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" (active ingredient: valsartan) have been approved for the treatment of hypertension since August 16, 2013. In the course of…
Recall
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Medicines
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20/11/2018
The marketing authorization holder has informed its supplied customers in a letter dated November 16, 2018, that isolated impurities or contamination of the film-coated tablets have been detected, which occurred during the packaging of the…
messages in brief
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19/11/2018
To summarize legal provisions, requirements regarding content as well as information how to submit and handle Mock-Ups a new Guidance Document was set up, which can be found under…
Recall
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Medicines
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13/11/2018
The marketing authorization holder has informed its supplied customers by letter dated Nov. 12, 2018, that due to a slightly increased exceedance of the specification for known impurities, the above batch is being recalled.
Safety warnings
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Medicines
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25/10/2018
No acute danger, recall purely as a precautionary measure
Safety warnings
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messages in brief
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25/10/2018
Situation in Austria: The Federal Office for Safety in Health Care has received information that several packages of the drug Jakavi 15 mg tablets, for which there is an urgent suspicion of counterfeiting, have entered the legal distribution chain as…
Recall
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Medicines
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11/10/2018
The marketing authorization holder informed the supplied customers via its distribution partner in a letter dated 01.10.2018 that the urology catheters of the company ConvaTec may exhibit unsterility. In tests conducted with the packaging of the…
Recall
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Medicines
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08/10/2018
The parallel distributor - "HAEMATO PHARM GmbH" - informed its supplied customers in a letter dated October 8, 2018, that for the two batches of "Jakavi 15 mg tablets" with the batch numbers SM018 and SAD42, packages were delivered in parallel trade…
messages in brief
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17/09/2018
Information is provided on the possibility of prolonged usability of certain batches of "EpiPen 300 microgram solution for injection in a ready-to-use pen" beyond the expiry date. The batches can be found in the following information letter:
Recall
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Medicines
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16/08/2018
The marketing authorization holder informed its supplied customers in a letter dated August 16, 2018, that due to quality problems with one batch of ampoules, batch D1K13 is being recalled as a precautionary measure.