Pv Flashcards
Banned drugs in india
Anal-gin, pi-oglita-zone,dextropropoxyphene
Labelling for the patient/caregiver(USA)
Medication guides,patient package inserts,instructions for use
In Europe, document for end users is called
Patient information leaflet, package leaflet
In Europe the technical document is called
Summary of product characteristics
In the US, labelling for the HCP is called
Prescribing information
Recently banned drugs
Kavakava,vio-xx,bextra
CIOMS
Founded by WHO,UNESCO,United nations educational, scientific, and cultural organization in 1949
Triage
Perform preliminary assessment of safety report WRT reportability
Signal
Reported info on a possible causal relationship between an adverse event and the drug relationship being previously unknown or incompletely documented previously
medDRA hierarchy
The five levels of the dictionary are System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT).