Official announcements
Replacement
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Medicines
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18/11/2010
The marketing authorization holder has informed its supplied customers by letter dated 18.11.2010 that due to 5 complaints about visible particles after reconstitution of the product, which occurred in two batches of this medicinal speciality, the…
messages in brief
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17/11/2010
Table 1: Product on the market and new application filed (65)*. Table 2: Product not on the market, new application filed (6)** Table 3: Product on the market, no new application filed (122)* Table 4: Product not on the market, no new application…
Recall
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Medicines
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17/11/2010
Ebewe/Sandox has initiated a voluntary recall of certain lots of ebetraxate as a precautionary measure. See related file.
messages in brief
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11/11/2010
Due to a given occasion and due to inquiries regarding "innovations" in the field of traditional herbal medicinal products, the Federal Office for Safety in Health Care takes the liberty to inform about the current legal situation. The background of…
Recall
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Medicines
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17/10/2010
Ebewe/Santoz has initiated a voluntary recall of certain lots of 5-fluorouracil as a precautionary measure. See related file.
Medicines
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28/09/2010
Notice of supply difficulties for PegIntron Powder and Solvent for Solution for Injection. See related file.
messages in brief
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27/09/2010
BASG/AGES PharmMed informs about the internal changeover of the E2B transmission of individual case reports, which was previously done via WebTrader, to gateway operation. The changeover will take place in October. For notifiers who have already…
messages in brief
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01/09/2010
All eServices offered by BASG / AGES PharmMed will be available via this platform in the future. Currently, the following services can be accessed via the eServices navigation point: Non-interventional studies (NIS) : Public register of all NIS…
messages in brief
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20/08/2010
The Medicinal Products Import Act 2010, BGBl I 79/2010, came into force on 19.08.2010. Compilation of the scenarios possible according to the law and the forms to be used: AWEG 2010 scenarios import certificates.pdf AWEG 2010 scenarios marketability…
messages in brief
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19/08/2010
On 18.08.2010, the Medicinal Products Import Act 2010 was published in the Federal Law Gazette, Federal Law Gazette I No. 79/2010 and comes into force on 19.08.2010. The primary objective of the Medicinal Products Import Act is to protect the health…