The following information - or confirmation where applicable - is required from your company (refer to the attachment) in order to generate a literature PSUR:

• confirmation that the company holds a valid MedDRA licence (if not, the "reaction terms" cannot be submitted in code).
  
  
• the safety information (CCSI; e.g. in the form of updated SPCs or package leaflets) applying at the beginning of the reporting period
  
  
• a list of already known publications which are relevant fort he benefit-risk-ratio published within the period under review
  
  

The following information - or confirmation where applicable - is required from your company (refer to the attachment) in order to generate an individual PSUR:

• confirmation that the company holds a valid MedDRA licence (if not, the "reaction terms" cannot be submitted in code).
  
  
• world-wide marketing authorisation status, as well as information concerning lack or withdrawal of authorisation with details of the pertinent reasons.
  
  
• dates of marketing authorisation and subsequent renewal (where applicable) and date of launch or withdrawal from the market
  
  
• any qualifications surrounding the authorisation
  
  
• the safety information (CCSI; e.g. in the form of updated SPCs or package leaflets) applying at the beginning of the reporting period
  
  
• all change notifications (with correspondingly updated SPC or package leaflet) related to pharmacovigilance throughout the reporting period, where applicable
  
  
• world-wide sales figures, broken down according to country
  
  
• a list of all already known suspected ADR from the periodic literature search (incl. CIOMS forms)
  
  
• a list of already known publications which are relevant fort he benefit-risk-ratio published within the period under review

Please enter the requested information in the form below:

Product information (.xls)