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...

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.