Official announcements
messages in brief
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13/06/2016
For detailed information, please contact us and EMA .
Recall
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Medicines
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09/05/2016
The marketing authorization holder has informed its supplied customers in a letter dated 09.05.2016 that due to a technical error during production, there are residues of corrosive agents in the dry substance. Therefore, the two above mentioned…
messages in brief
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26/04/2016
Please note the changed BIC for transfers to the accounts of the Federal Office for Safety in Health Care (BASG) / AGES Medizinmarktaufsicht. (The IBAN numbers do not change). Account details for fee advances: BAWAG P.S.K. AG IBAN: AT59 6000 0000…
Recall
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Medicines
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25/04/2016
The marketing authorization holder has informed its supplied customers by letter dated April 20, 2016, that an internal quality control has detected an undercutting of the phenol content and therefore the affected batches of the Prick Test Solution…
Recall
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Medicines
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21/04/2016
The marketing authorization holder informed its supplied customers in a letter dated 19.04.2016 that an error in the filling process was detected at the manufacturer. The error results in a few vials possibly containing a too high concentration. The…
Recall
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Medicines
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21/04/2016
The marketing authorization holder has informed its supplied customers in a letter dated 20.04.2016 that the marketing authorizations of medicinal products containing fusafungin (Locabiosol / Bioparox / Locabiotal / Fusaloyos as oral spray, nasal…
Recall
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Medicines
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18/04/2016
The marketing authorization holder has informed its supplied customers in a letter dated April 15, 2016, that a possible non-sterility cannot be excluded and therefore a precautionary recall is being carried out. This recall results from an…
Recall
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Medicines
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14/04/2016
In a letter dated April 13, 2016, the marketing authorization holder informed its customers that the above-mentioned batch of "Curatoderm - Ointment" was found to be mixed with "Amciderm - Cream" and is therefore being recalled. "Amciderm - Creme" is…
messages in brief
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04/04/2016
Due to legal requirements (Reg. (EC) 726/2004, Article 25a), EMA is obliged to set up a database for periodic safety update reports (PSUR) and the associated opinions. All PSUR procedures must be submitted electronically (according to Reg. 726/2004,…
Recall
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Medicines
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01/04/2016
The pharmaceutical company "Amomed Pharma GmbH" has informed its supplied customers by letter dated 11.03.2016 that in the course of stability testing a clear brown coloration of the solution was detected in some ampoules. This brown coloration…
