Annex II: Format of the electronic periodic safety update reports
The periodic safety update report shall consist of the following modules:
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Part I |
Title page including signature |
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Part II |
Executive Summary |
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Part III |
Table of contents |
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1. |
Introduction |
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2. |
Worldwide marketing authorisation status |
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3. |
Actions taken in the reporting interval for safety reasons |
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4. |
Changes to reference safety information |
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5. |
Estimated exposure and use patterns |
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5.1. |
Cumulative subject exposure in clinical trials |
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5.2. |
Cumulative and interval patient exposure from marketing experience |
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6. |
Data in summary tabulations |
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6.1. |
Reference information |
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6.2. |
Cumulative summary tabulations of serious adverse events from clinical trials |
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6.3. |
Cumulative and interval summary tabulations from post-marketing data sources |
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7. |
Summaries of significant findings from clinical trials during the reporting interval |
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7.1. |
Completed clinical trials |
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7.2. |
Ongoing clinical trials |
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7.3. |
Long-term follow-up |
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7.4. |
Other therapeutic use of medicinal product |
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7.5. |
New safety data related to fixed combination therapies |
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8. |
Findings from non-interventional studies |
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9. |
Information from other clinical trials and sources |
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10. |
Non-clinical data |
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11. |
Literature |
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12. |
Other periodic reports |
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13. |
Lack of efficacy in controlled clinical trials |
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14. |
Late-breaking information |
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15. |
Overview on signals: New, ongoing or closed |
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16. |
Signal and risk evaluation |
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16.1. |
Summaries of safety concerns |
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16.2. |
Signal evaluation |
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16.3. |
Evaluation of risks and new information |
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16.4. |
Characterisation of risks |
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16.5. |
Effectiveness of risk minimisation (if applicable) |
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17. |
Benefit evaluation |
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17.1. |
Important baseline efficacy and effectiveness information |
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17.2. |
Newly identified information on efficacy and effectiveness |
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17.3. |
Characterisation of benefits |
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18. |
Integrated benefit-risk analysis for authorised indications |
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18.1. |
Benefit-risk context — Medical need and important alternatives |
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18.2. |
Benefit-risk analysis evaluation |
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19. |
Conclusions and actions |
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20. |
Appendices to the periodic safety update report |