EU Regional Backbone

Introduction introduction

Introduction 23i-introduction

Drug Substance - Manufacturer 23s-substance-1-manufacturer-s1

Drug Product - Dosage - Manufacturer 23p-product-1-formstrength-1-manufacturer-p1

Appendices 23a-appendices

Regional Information 23r-regional-information

Nonclinical Overview nonclinical-overview

Clinical Overview clinical-overview

Introduction introduction

Pharmacology Written Summary pharmacol-written-summary

Pharmacology Tabulated Summary pharmacol-tabulated-summary

Pharmacokinetics Written Summary pharmkin-written-summary

Pharmacokinetics Tabulated Summary pharmkin-tabulated-summary

Toxicology Written Summary toxicology-written-summary

Toxicology Tabulated Summary toxicology-tabulated-summary

Summary of Biopharmaceutic Studies and Associated Analytical Methods summary-biopharm

Summary of Clinical Pharmacology Studies summary-clin-pharm

Summary of Clinical Efficacy summary-clin-efficacy-indication-1

Summary of Clinical Safety summary-clin-safety

Literature References literature-references

Synopses of Individual Studies synopses-indiv-studies

Nomenclature nomenclature

Structure structure

General Properties general-properties

Manufacturer(s) manufacturer

Description of Manufacturing Process and Process Controls manuf-process-and-controls

Control of Materials control-of-materials

Controls of Critical Steps and Intermediates control-critical-steps

Process Validation and/or Evaluation process-validation

Manufacturing Process Development manuf-process-development

Elucidation of Structure and Other Characteristics elucidation-of-structure

Impurities impurities

Specification specification

Analytical Procedure-1 analytical-procedure-32s42

Validation of Analytical Procedures validation-analyt-procedure-32s43

Batch Analyses batch-analyses

Justification of Specification justification-of-specification

Reference Standards or Materials reference-standards

Container Closure System container-closure-system

Stability Summary and Conclusions stability-summary

Post-approval Stability Protocol and Stability Commitment postapproval-stability

Stability Data stability-data

Description and Composition of the Drug Product description-and-composition

Pharmaceutical Development pharmaceutical-development

Manufacturer(s) manufacturers

Batch Formula batch-formula

Description of Manufacturing Process and Process Controls manuf-process-and-controls

Controls of Critical Steps and Intermediates control-critical-steps

Process Validation and/or Evaluation process-validation

Excipients of Human or Animal Origin excipients-human-animal

Novel Excipients novel-excipients

Specifications specifications

Analytical Procedures analytical-procedures

Validation of Analytical Procedures validation-analyt-procedures

Justification of Specifications justification-of-specifications

Specification(s) specifications

Analytical Procedure analytical-procedure-32p52

Validation of Analytical Procedures validation-analytical-procedures-32p53

Batch Analyses batch-analyses

Characterisation of Impurities characterisation-impurities

Justification of Specifications justification-of-specifications

Reference Standards or Materials reference-standards

Container Closure System container-closure-system

Stability Summary and Conclusion stability-summary

Post-approval Stability Protocol and Stability Commitment postapproval-stability

Stability Data stability-data

Facilities and Equipment Report facilities-and-equipment-report-32a1

Adventitious Agents Safety Evaluation Report adventitious-agents-report-32a2

Excipients - Name excip-name-1

Regional Information info

Reference reference-33

Study Reports study-report-4211

Study Reports study-report-4212

Study Reports study-report-4213

Study Reports study-report-4214

Study Reports study-report-4221

Study Reports study-report-4222

Study Reports study-report-4223

Study Reports study-report-4224

Study Reports study-report-4225

Study Reports study-report-4226

Study Reports study-report-4227

Study Reports study-report-4231

Study Reports study-report-4232

Study Reports study-report-42331

Study Reports study-report-42332

Study Reports study-report-42341

Study Reports study-report-42342

Study Reports study-report-42343

Study Reports study-report-42351

Study Reports study-report-42352

Study Reports study-report-42353

Study Reports study-report-42354

Study Reports study-report-4236

Study Reports study-report-42371

Study Reports study-report-42372

Study Reports study-report-42373

Study Reports study-report-42374

Study Reports study-report-42375

Study Reports study-report-42376

Study Reports study-report-42377

Reference reference-43

Tabular Listing of all Clinical Studies tabular-listing

Study Reports report-1

Reports of Postmarketing Experience report-536

Document/Dataset study-1

Literature References reference-54