in procedura PRAC
| 09:02 Apr 14, 2024 |
| Italian to English translations [PRO] Law/Patents - Law (general) | |||||||
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| 4 | in the pharmacovigilance procedure |
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| 3 | under PRAC assessment / surveillance / within PRAC procedure |
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| finding only |
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| Discussion entries: 1 | |
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Answers
34 mins confidence: 
in the pharmacovigilance procedure Explanation: https://en.wikipedia.org/wiki/Pharmacovigilance |
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43 mins confidence:
under PRAC assessment / surveillance / within PRAC procedure Explanation: Pharmacovigilance Risk Assessment Committee (PRAC) https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CEL... Under PRAC assessment https://www.ema.europa.eu/en/documents/presentation/presenta... he SSRs are under PRAC surveillance. R 4 of mRNA-1273-P903 has been assessed and discussed within PRAC procedure https://www.ema.europa.eu/en/documents/variation-report/spik... |
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Reference comments
2 hrs |
| Reference: finding only Reference information: https://www.ema.europa.eu/it/documents/other/valproate-cmdh-... 2 Conclusioni scientifiche Tenendo conto della valutazione del Comitato per la valutazione dei rischi in farmacovigilanza (Pharmacovigilance and Risk Assessment Committee, PRAC) per il report finale del PASS di tipo non interventistico per i medicinali contenenti il principio attivo valproato e interessati dal rapporto finale PASS, le conclusioni scientifiche sono le seguenti: -------------------------------------------------- Note added at 2 godz. (2024-04-14 12:00:33 GMT) -------------------------------------------------- I don't think this is right:)! -------------------------------------------------- Note added at 3 godz. (2024-04-14 12:10:35 GMT) -------------------------------------------------- maybe it is! |
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