SM sosp.
English translation: proprietary medicinal product suspended
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| 11:29 Mar 13, 2020 |
| Italian to English translations [PRO] Medical - Medical (general) / pharmacovigilance report | |||||||
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|  Selected response from: Cedric Randolph Italy Local time: 00:17 | ||||||
Grading comment
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| 4 +1 | proprietary medicinal product suspended |
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| 4 | Proprietary medicinal product suspected |
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| 4 | medicinal product suspended |
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| Discussion entries: 1 | |
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Answers
5 mins confidence: 
peer agreement (net): +1
peer agreement (net): +1proprietary medicinal product suspended Explanation: Asking for the name of the SM (specialità medicinale) suspended |
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Grading comment
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1 hr confidence:
Proprietary medicinal product suspected Explanation: In alternativa la segnalazione di sospetta reazione avversa può essere comunicata al Titolare dell’Autorizzazione all’Immissione in Commercio (AIC) del medicinale che si sospetta abbia causato la reazione avversa. Come codificare il nome dei farmaci segnalati? (Aggiornamento aprile 2018) I farmaci possono essere indicati dal segnalatore come specialità medicinali o come principi attivi. All’interno della RNF i farmaci concomitanti, in accordo alla definizione sopra riportata, vanno riportati nella sezione “S.M./P.A. Concomitante”, mentre solo quelli assunti in passato vanno riportati nella “Storia delle SM\PA Assunti” che si trova nella sezione “Paziente”. http://www.asl.vt.it/Staff/farmacovigilanza/pdf/FAQ_per_gest... Pharmacovigilange Characterization of drug role (suspect/concomitant/interacting) Effect of rechallenge (or re-exposure), for suspect drug(s) only. https://books.google.co.uk/books?id=Sp86AwAAQBAJ&pg=PT258&lp... Moreover, the adverse reaction must be related to the investigational medicinal product. In other words, it is suspected that there is a causal relationship between the use of the medicinal product and the adverse reaction that has occurred. https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials... User Guidance: Characterization of the drug as provided by primary reporter. All spontaneous reports should have at least one suspect drug (see Section 1.5). If the reporter indicates a suspected interaction, "interacting" should be selected. All interacting drugs are considered to be suspect drugs. Drug identification Proprietary medicinal product name https://books.google.co.uk/books?id=SwkuAgAAQBAJ&pg=PT31&lpg... |
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1 day 4 hrs confidence:
medicinal product suspended Explanation: medicinal product suspended as in, the information request as regards the trade name for the medicinal product is suspended - I like suspended given the first half of the source... RLFV indicated ATC V for insertion in RNF ATC code not yet assigned; information request for trade name SM susp. https://translate.google.com/?sl=en#view=home&op=translate&sl=auto&tl=en&text=RLFV%20indicata%20ATC%20V%20per%20inserimento%20in%20RNF%20cod https://www.linguee.com/english-italian/search?source=auto&query=specialit%C3%A0+medicinale |
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