European Index
2.2 Introduction
2.3 Introduction
2.3.S Drug Substance - eurotriptan maleate - Big Factory
2.3.P Drug Product - 5mg Tablets - Big Factory
2.3.A Appendices
2.3.R Regional Information
2.4 Nonclinical Overview
2.5 Clinical Overview
2.6.1 Introduction
2.6.2 Pharmacology Written Summary
2.6.3 Pharmacology Tabulated Summary
2.6.4 Pharmacokinetics Written Summary
2.6.5 Pharmacokinetics Tabulated Summary
2.6.6 Toxicology Written Summary
2.6.7 Toxicology Tabulated Summary
2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods
2.7.2 Summary of Clinical Pharmacology Studies
2.7.3 Summary of Clinical Efficacy - Treatment of Confusion
2.7.4 Summary of Clinical Safety
2.7.5 Literature References
2.7.6 Synopses of Individual Studies
3.2.S.1.1 nomenclature.pdf
3.2.S.1.2 structure.pdf
3.2.S.1.3 general-properties.pdf
3.2.S.2.1 manufacturer.pdf
3.2.S.2.2 manuf-process-and-controls.pdf
3.2.S.2.3 control-material-1.pdf
3.2.S.2.3 control-material-2.pdf
3.2.S.2.3 control-material-3.pdf
3.2.S.2.3 control-material-4.pdf
3.2.S.2.3 control-material-5.pdf
3.2.S.2.4 control-critical-steps-1.pdf
3.2.S.2.4 control-critical-steps-2.pdf
3.2.S.2.4 control-critical-steps-3.pdf
3.2.S.2.4 control-critical-steps-4.pdf
3.2.S.2.4 control-critical-steps-5.pdf
3.2.S.2.5 process-validation-1.pdf
3.2.S.2.5 process-validation-2.pdf
3.2.S.2.5 process-validation-3.pdf
3.2.S.2.5 process-validation-4.pdf
3.2.S.2.5 process-validation-5.pdf
3.2.S.2.6 manuf-process-development-1.pdf
3.2.S.2.6 manuf-process-development-2.pdf
3.2.S.2.6 manuf-process-development-3.pdf
3.2.S.2.6 manuf-process-development-4.pdf
3.2.S.2.6 manuf-process-development-5.pdf
3.2.S.3.1 elucidation-of-structure.pdf
3.2.S.3.2 impurities.pdf
3.2.S.4.1 specification.pdf
3.2.S.4.2.1 analytical-procedure-1.pdf
3.2.S.4.2.2 analytical-procedure-2.pdf
3.2.S.4.2.3 analytical-procedure-3.pdf
3.2.S.4.2.4 analytical-procedure-4.pdf
3.2.S.4.2.5 analytical-procedure-5.pdf
3.2.S.4.3.1 validation-analyt-procedure-1.pdf
3.2.S.4.3.2 validation-analyt-procedure-2.pdf
3.2.S.4.3.3 validation-analyt-procedure-3.pdf
3.2.S.4.3.4 validation-analyt-procedure-4.pdf
3.2.S.4.3.5 validation-analyt-procedure-5.pdf
3.2.S.4.4 batch-analyses.pdf
3.2.S.4.5 justification-of-specification.pdf
3.2.S.5.1 reference-standard-1.pdf
3.2.S.5.2 reference-standard-2.pdf
3.2.S.5.3 reference-standard-3.pdf
3.2.S.5.4 reference-standard-4.pdf
3.2.S.5.5 reference-standard-5.pdf
3.2.S.6 container-closure-system.pdf
3.2.S.7.1 stability-summary.pdf
3.2.S.7.2 postapproval-stability.pdf
3.2.S.7.3 stability-data.pdf
3.2.P.1 Description and Composition of the Drug Product
3.2.P.2 Pharmaceutical Development
3.2.P.3.1 Manufacturer(s)
3.2.P.3.2 Batch Formula
3.2.P.3.3 Description of Manufacturing Process and Process Controls
3.2.P.3.4 Controls of Critical Steps and Intermediates
3.2.P.3.5 process-validation-1.pdf
3.2.P.3.5 process-validation-2.pdf
3.2.P.3.5 process-validation-3.pdf
3.2.P.3.5 process-validation-4.pdf
3.2.P.3.5 process-validation-5.pdf
3.2.P.4.1 Specifications for Crosscarmallose Sodium
3.2.P.4.2 Analytical Procedures for Crosscarmallose Sodium
3.2.P.4.3 Validation of Analytical Procedures for Crosscarmallose Sodium
3.2.P.4.4 Justification of Specifications for Crosscarmallose Sodium
3.2.P.4.5 Excipients of Human and Animal Origin
3.2.P.4.6 Novel Excipients
3.2.P.4.1 Specifications for Magnesium Stearate
3.2.P.4.2 Analytical Procedures for Magnesium Stearate
3.2.P.4.3 Validation of Analytical Procedures for Magnesium Stearate
3.2.P.4.4 Justification of Specifications for Magnesium Stearate
3.2 P.4.5 Excipients of Human and Animal Origin
3.2.P.4.6 Novel Excipients
3.2.P.4.1 Specifications for Purified Water
3.2.P.4.2 Analytical Procedures for Purified Water
3.2.P.4.3 Validation of Analytical Procedures for Purified Water
3.2.P.4.4 Justification of Specifications for Purified Water
3.2.P.4.5 Excipients of Human and Animal Origin
3.2.P.4.6 Novel Excipients
3.2.P.4.1 Specifications for Sodium Chloride
3.2.P.4.2 Analytical Procedures for Sodium Chloride
3.2.P.4.3 Validation of Analytical Procedures for Sodium Chloride
3.2.P.4.4 Justification of Specifications for Sodium Chloride
3.2.P.4.5 Excipients of Human and Animal Origin
3.2.P.4.6 Novel Excipients
3.2.P.4.1 Specifications for Titanium Dioxide
3.2.P.4.2 Analytical Procedures for Titanium Dioxide
3.2.P.4.3 Validation of Analytical Procedures for Titanium Dioxide
3.2.P.4.4 Justification of Specifications for Titanium Dioxide
3.2.P.4.5 Excipients of Human and Animal Origin
3.2.P.4.6 Novel Excipients
3.2.P.5.1 Specification(s)
3.2.P.5.2.1 analytical-procedure-appearance.pdf
3.2.P.5.2.2 analytical-procedure-colorants.pdf
3.2.P.5.2.3 analytical-procedure-dissolution.pdf
3.2.P.5.2.4 analytical-procedure-content-uniformity.pdf
3.2.P.5.2.5 analytical-procedure-microbial-limits.pdf
3.2.P.5.2.6 analytical-procedure-identification-efpiate.pdf
3.2.P.5.3.1 validation-analytical-procedures-identification.pdf
3.2.P.5.3.2 validation-analytical-procedures-dissolution.pdf
3.2.P.5.3.3 validation-analytical-procedures-content-uniformity.pdf
3.2.P.5.4 Batch Analyses
3.2.P.5.5 Characterisation of Impurities
3.2.P.5.6 Justification of Specifications
3.2.P.6.1 reference-standards-1.pdf
3.2.P.6.2 reference-standards-2.pdf
3.2.P.6.3 reference-standards-3.pdf
3.2.P.6.4 reference-standards-4.pdf
3.2.P.6.5 reference-standards-5.pdf
3.2.P.7 Container Closure System
3.2.P.8.1 Stability Summary and Conclusion
3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment
3.2.P.8.3 Stability Data
3.2.A.1.1 facilities-and-equipment-report-1.pdf
3.2.A.1.2 facilities-and-equipment-report-2.pdf
3.2.A.1.3 facilities-and-equipment-report-3.pdf
3.2.A.1.4 facilities-and-equipment-report-4.pdf
3.2.A.1.5 facilities-and-equipment-report-5.pdf
3.2.A.2.1 adventitious-agents-report-1.pdf
3.2.A.2.2 adventitious-agents-report-2.pdf
3.2.A.2.3 adventitious-agents-report-3.pdf
3.2.A.2.4 adventitious-agents-report-4.pdf
3.2.A.2.5 adventitious-agents-report-5.pdf
3.2.A.3.1 novel-excipient-report-1.pdf
3.2.R.1 process-validation-scheme.pdf
3.2.R.2 certificates-suitability.pdf
3.3.1 reference-1.pdf
3.3.2 reference-2.pdf
3.3.3 reference-3.pdf
3.3.4 reference-4.pdf
3.3.5 reference-5.pdf
4.2.1.1.1 efpia-4211-1.pdf
4.2.1.2.1 efpia-4212-1.pdf
4.2.1.3.1 efpia-4213-1.pdf
4.2.1.4.1 efpia-4214-1.pdf
4.2.2.1.1 efpia-4221-1.pdf
4.2.2.2.1 efpia-4222-1.pdf
4.2.2.3.1 efpia-4223-1.pdf
4.2.2.4.1 efpia-4224-1.pdf
4.2.2.5.1 efpia-4225-1.pdf
4.2.2.6.1 efpia-4226-1.pdf
4.2.2.7.1 efpia-4227-1.pdf
4.2.3.1.1 efpia-4231-1.pdf
4.2.3.1.1 cd00001.pdf
4.2.3.2.1 efpia-4232-1.pdf
4.2.3.3.1.1 efpia-42331-1.pdf
4.2.3.3.2.1 efpia-42332-1.pdf
4.2.3.4.1.1 efpia-42341-1.pdf
4.2.3.4.2.1 efpia-42342-1.pdf
4.2.3.4.3.1 efpia-42343-1.pdf
4.2.3.5.1.1 efpia-42351-1.pdf
4.2.3.5.2.1 efpia-42352-1.pdf
4.2.3.5.3.1 efpia-42353-1.pdf
4.2.3.5.4.1 efpia-42354-1.pdf
4.2.3.6.1 efpia-4236-1.pdf
4.2.3.7.1.1 efpia-42371-1.pdf
4.2.3.7.2.1 efpia-42372-1.pdf
4.2.3.7.3.1 efpia-42373-1.pdf
4.2.3.7.4.1 efpia-42374-1.pdf
4.2.3.7.5.1 efpia-42375-1.pdf
4.2.3.7.6.1 efpia-42376-1.pdf
4.2.3.7.7.1 efpia-42377-1.pdf
4.3.1 reference-1.pdf
4.3.2 reference-2.pdf
4.3.3 reference-3.pdf
5.2 tabular-listing.pdf
5.3.1.1.1 efpia5001.pdf
5.3.1.1.2 efpia5001a.pdf
5.3.1.1.3 efpia5002.pdf
5.3.1.2.1 efpia5003.pdf
5.3.1.2.2 efpia5004.pdf
5.3.1.3.1 efpia5005.pdf
5.3.1.3.2 efpia5006.pdf
5.3.1.3.3 efpia5007.pdf
5.3.1.4.1 efpia5008.pdf
5.3.2.1.1 efpia5009.pdf
5.3.2.1.2 efpia5010.pdf
5.3.2.2.1 efpia5011.pdf
5.3.2.3.1 efpia5012.pdf
5.3.2.3.2 efpia5013.pdf
5.3.3.1.1 efpia5014.pdf
5.3.3.2.1 efpia5015.pdf
5.3.3.3.1 efpia5016.pdf
5.3.3.4.1 efpia5017.pdf
5.3.3.4.2 efpia5018.pdf
5.3.3.5.1 efpia5019.pdf
5.3.4.1.1 efpia5020.pdf
5.3.4.2.1 efpia5021.pdf
5.3.5.4.1.1 efpia5022.pdf
5.3.5.4.1.2 efpia5023.pdf
5.3.5.4.1.3 efpia5024.pdf
5.3.5.4.2.1 efpia5025.pdf
5.3.5.4.2.2 efpia5026.pdf
5.3.5.4.3.1 efpia5027.pdf
5.3.5.4.3.2 efpia5028.pdf
5.3.5.4.4.1 efpia5029.pdf
5.3.5.4.4.2 efpia5030.pdf
study-efpia5001.
5.3.7.1.1 crf-study-efpia5001-site002-pid-efpia5001-002-001.pdf
study-efpia5002.
5.3.7.2.1 crf-study-efpia5002-site002-pid-efpia5002-002-002.pdf
study-efpia5003.
5.3.7.3.1 crf-study-efpia5003-site002-pid-efpia5003-002-001.pdf
study-efpia5004.
5.3.7.4.1 crf-study-efpia5004-site002-pid-efpia5004-002-001.pdf
study-efpia5005.
5.3.7.5.1 crf-study-efpia5005-site002-pid-efpia5005-002-001.pdf
study-efpia5006.
5.3.7.6.1 crf-study-efpia5006-site002-pid-efpia5006-002-001.pdf
study-efpia5007.
5.3.7.7.1 crf-study-efpia5007-site002-pid-efpia5007-002-001.pdf
study-efpia5008.
5.3.7.8.1 crf-study-efpia5008-site002-pid-efpia5008-002-001.pdf
study-efpia5009.
5.3.7.9.1 crf-study-efpia5009-site002-pid-efpia5009-002-001.pdf
study-efpia5010.
5.3.7.10.1 crf-study-efpia5010-site002-pid-efpia5010-002-001.pdf
study-efpia5011.
5.3.7.11.1 crf-study-efpia5011-site002-pid-efpia5011-002-001.pdf
study-efpia5012.
5.3.7.12.1 crf-study-efpia5012-site002-pid-efpia5012-002-001.pdf
study-efpia5013.
5.3.7.13.1 crf-study-efpia5013-site002-pid-efpia5013-002-001.pdf
study-efpia5014.
5.3.7.14.1 crf-study-efpia5014-site002-pid-efpia5014-002-001.pdf
study-efpia5015.
5.3.7.15.1 crf-study-efpia5015-site002-pid-efpia5015-002-001.pdf
study-efpia5016.
5.3.7.16.1 crf-study-efpia5016-site002-pid-efpia5016-002-001.pdf
study-efpia5017.
5.3.7.17.1 crf-study-efpia5017-site002-pid-efpia5017-002-001.pdf
study-efpia5018.
5.3.7.18.1 crf-study-efpia5018-site002-pid-efpia5018-002-001.pdf
study-efpia5019.
5.3.7.19.1 crf-study-efpia5019-site002-pid-efpia5019-002-001.pdf
study-efpia5020.
5.3.7.20.1 crf-study-efpia5020-site002-pid-efpia5020-002-001.pdf
study-efpia5021.
5.3.7.21.1 crf-study-efpia5021-site002-pid-efpia5021-002-001.pdf
study-efpia5022.
5.3.7.22.1 crf-study-efpia5022-site002-pid-efpia5022-002-001.pdf
study-efpia5023.
5.3.7.23.1 crf-study-efpia5023-site002-pid-efpia5023-002-001.pdf
study-efpia5024.
5.3.7.24.1 crf-study-efpia5024-site002-pid-efpia5024-002-001.pdf
study-efpia5025.
5.3.7.25.1 crf-study-efpia5025-site002-pid-efpia5025-002-001.pdf
study-efpia5026.
5.3.7.26.1 crf-study-efpia5026-site002-pid-efpia5026-002-001.pdf
study-efpia5027.
5.3.7.27.1 crf-study-efpia5027-site002-pid-efpia5027-002-001.pdf
study-efpia5028.
5.3.7.28.1 crf-study-efpia5028-site002-pid-efpia5028-002-001.pdf
study-efpia5029.
5.3.7.29.1 crf-study-efpia5029-site002-pid-efpia5029-002-001.pdf
study-efpia5030.
5.3.7.30.1 crf-study-efpia5030-site002-pid-efpia5030-002-001.pdf
5.4.1 reference-1.pdf
5.4.2 reference-2.pdf
5.4.3 reference-3.pdf
5.4.4 reference-4.pdf
5.4.5 reference-5.pdf
5.4.6 reference-6.pdf