Messages in brief
Clinical Trials Information System (CTIS): Virtual information day – 26.10.2021
messages in brief
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06/10/2021
The aim of this event is to help future CTIS users prepare for submitting and evaluating clinical trial applications in CTIS after its go-live on 31 January 2022.
Clinical Trials Information System (CTIS): Virtual information day – 26.10.2021
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Current issue of “RMS NEWS”
messages in brief
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30/09/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Current issue of “RMS NEWS”
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Shelf-life of Comirnaty extended
messages in brief
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20/09/2021
The Product Information has been updated with the new shelf-life for the frozen vial, that has been extended from 6 months to 9 months. The storage conditions remain unchanged (-90 °C to -60 °C).
Shelf-life of Comirnaty extended
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SARS-CoV-2 rapid antigen test registry
messages in brief
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19/07/2021
The registry lists in a new form - with search and filter options - those SARS-CoV-2 rapid antigen tests that can be placed on the Austrian market for self-testing.
SARS-CoV-2 rapid antigen test registry
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CHMP Meeting Highlights June 2021
messages in brief
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07/07/2021
Up-to-date information from the 21.06.-24.06.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
CHMP Meeting Highlights June 2021
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Current issue of “RMS NEWS”
messages in brief
|
30/06/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Current issue of “RMS NEWS”
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CHMP Meeting Highlights May 2021
messages in brief
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17/06/2021
Up-to-date information from the 17.05.-20.05.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
CHMP Meeting Highlights May 2021
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Comirnaty (COVID-19-mRNA-Vaccine)
messages in brief
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02/06/2021
On May 28, 2021, the use "for active immunization of individuals 12 years of age and older" was extended by the EMA.
Comirnaty (COVID-19-mRNA-Vaccine)
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Innovation in the eService Marketing Authorisation and Lifecycle
messages in brief
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25/05/2021
As of 22.5.2021, the function "Withdrawal according to §23 AMG" will be available in the area "Overview Medicinal Products".
Innovation in the eService Marketing Authorisation and Lifecycle
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EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2021/2022
messages in brief
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10/05/2021
The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2021/2022 (published 30 March 2021)
EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2021/2022
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