Official announcements
messages in brief
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04/02/2019
In December 2018 the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a guideline on the assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products. The calculated threshold values are intended to…
messages in brief
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04/02/2019
The EMA published a revision of the “Guideline on the environmental risk assessment (ERA) of human medicines” on 30 November 2018. The guideline is now open for public consultation until 30 June 2019. The purpose of the ‚Guideline on Environmental…
Safety warnings
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Blood & Tissue
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25/01/2019
Only available in German
Safety warnings
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Blood & Tissue
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25/01/2019
Only available in German
Safety warnings
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Blood & Tissue
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24/01/2019
Only available in German
Safety warnings
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Blood & Tissue
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24/01/2019
Only available in German
Safety warnings
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Blood & Tissue
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24/01/2019
Only available in German
Safety warnings
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Medical devices
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22/01/2019
The product "Raindrop Near Vision Inlay" is a medical device for the treatment of presbyopia.
(presbyopia). It is implanted into the cornea of an eye and causes a change in the shape of the cornea.
Cornea, which is intended to improve sharp near vision.
messages in brief
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22/01/2019
A team from the Austrian Federal Office for Safety in Health Care (BASG) was a guest at the Paul Ehrlich Institute (PEI) on Jan. 14, 2019. The aim was to cooperate more closely in the future in the regulation of medicinal products for the diagnosis…
Recall
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Medicines
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28/12/2018
The marketing authorization holder has informed its supplied customers in a letter dated December 27, 2018, that the above-mentioned batch occasionally shows a yellow coloration of the infusion solution concentrate outside the approved color…
