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Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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Searched for "active".
11/03/2020
contact person: Address: Phone: E-mail address: Date: Nr. MRP/DCP number (former RMS)* ATC Code/active substance(s) Proposed NEW RMS Legal Basis Product name in proposed new RMS MA number in proposed
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Recall
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Medicines
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26/02/2020
Recall due to reduced active ingredient content
Safety warnings
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Medicines
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11/02/2020
The all-clear can be given, because samples of the active substance noscapine from manufacturer and affected pharmacies have been examined in the meantime.
13/01/2020
Gemäß § 8. (2) Gewebeviglianzverordnung ist das BASG dazu verpflichtet, die von der Europäischen Kommission verfasste Zusammenfassung der von den Mitgliedstaaten eingegangenen Berichte zu veröffentlichen (Bericht nur auf englisch verfügbar).
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13/01/2020
Zusammenfassung der jährlichen Berichterstattung über ernste unerwünschte Reaktionen und Zwischenfälle bei Blut und Blutbestandteilen (2018) - Bericht nur auf englisch verfügbar
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17/12/2019
The fees valid on the date of application at BASG after 01.01.2020.
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17/12/2019
Advice) V.3.a bei im EWR neuen Wirkstoffen (new active substances), sowie Biosimilars 9405 EURO V.3.b bei im EWR bekannten Wirkstoffen (existing active substances) 5878 EURO V.4 Labortechnische Analysen
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06/12/2019
The manufacturer informed its customers on 04 December, 2019, that the stated value of the active pharmaceutical ingredient content was too high.
Referenced at:
Recall
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Medicines
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06/12/2019
The manufacturer informed its customers on 04 December, 2019, that the stated value of the active pharmaceutical ingredient content was too high.
Recall
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Medicines
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06/12/2019
The manufacturer informed its customers on 03 December, 2019, that the listed batches of active pharmaceutical ingredients are recalled as a precautionary measure due to the withdrawal of the manufacturer's certificate of the Indian original manufacturer "Mehta API Pvt. Ltd.".