Module Overseas ● ● ● ● ● ● ○ ● ● ● ● ● 1.10 Regulatory Status Summary of Module ● ● ● ● ○ ○ ● ● ○ ○ biopharmaceutic 1.11 studies References to Module ● ● ● ● ● ● ● Paediatric Dvpt 1.12 Program Information Module ○ ○ ○ ○ ○ ○ ● ● ● ● ● relating to 1.13 pharmacovigilance Module Antibiotic ○ ○ ○ ○ ○ 1 Annex Resistance Data I Module Overseas ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ 1 Annex Evaluation II Reports Module 2 Module ○ ○ ○ ○ ● ● ● ● ● ● ● ● ● ● ● Table of Contents 2.1 Module ● ● ● ● ● ● ● ● ● ● ● ○ ○ ○ ○ Introduction 2.2 Module Quality Overall ○ ○ ○ ○ ○ ● ● ● ● ● ● ● 2.3 Summary Module Non-clinical ○ ○ ○ ○ ○ ○ ○ ○ ● ● ● ● 2.4 Overview
Module 1.10 Overseas Regulatory Status ● ● ● ● ● ● ○ ● ● ● ● ● Module 1.11 Summary of biopharmaceutic studies ● ● ● ● ○ ○ ● ● ○ ○ Module 1.12 References to Paediatric Dvpt Program ● ● ● ● ● ● ● Module 1.13 Information relating to pharmacovigilance ● ● ○ ● ● ○ ○ ● ○ ○ ○ Module 1 Annex I Antibiotic Resistance Data ○ ○ ○ ○ ○ Module 1 Annex II Overseas Evaluation Reports ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Module 2 Module 2.1 Table of Contents ● ● ● ● ● ● ● ● ● ● ● ○ ○ ○ ○ Module 2.2 Introduction ● ● ● ● ● ● ● ● ● ● ● ○ ○ ○ ○ Module 2.3 Quality Overall Summary ● ● ● ● ● ● ● ○ ○ ○ ○ ○ Module 2.4 Non-clinical Overview ● ● ● ● ○ ○ ○ ○ ○ ○ ○ ○
pm-ctd-module1-1101-a.docx