| US
|
2.01
|
m1-us
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| US
|
3.3
|
m1-us
|
3.3
|
Folder
|
| m1-us-meta-data-application
|
3.3
|
PublisherMetaData
|
| m1-us-admin-form
|
3.3
|
Folder
|
| m1-us-form
|
3.3
|
Folder
|
| m1-15-promotional-material
|
3.3
|
Folder
|
| m1-15-2-materials
|
3.3
|
Folder
|
| m1-15-2-1-material
|
3.3
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| EAEU
|
1.0
|
envelope-eaeu
|
1.0
|
Folder
|
| eaeu-envelope
|
1.0
|
Leaf
|
| eaeu_leaf
|
1.0
|
Leaf
|
| m2-3-quality-overall-summary
|
1.0
|
Folder
|
| drug_substance
|
1.0
|
Folder
|
| drug_solvent
|
1.0
|
Folder
|
| EU
|
1.0
|
envelope
|
1.0
|
Folder
|
| eu_module_1_country_specific_information
|
1.0
|
Folder
|
| eu-envelope
|
1.0
|
Leaf
|
| m1-3-1-pim
|
1.0
|
Folder
|
| m1-3-1-spc-label-pl
|
1.0
|
Folder
|
| m1-additional
|
1.0
|
Folder
|
| m1-eu
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| EU
|
1.1
|
envelope
|
1.1
|
Folder
|
| eu_module_1_country_specific_information
|
1.0
|
Folder
|
| eu-envelope
|
1.0
|
Leaf
|
| m1-3-1-pim
|
1.0
|
Folder
|
| eu_pim_additional_documents
|
1.0
|
Folder
|
| m1-3-1-spc-label-pl
|
1.1
|
Folder
|
| m1-additional
|
1.0
|
Folder
|
| m1-eu
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| EU
|
1.2.1
|
envelope
|
1.2.1
|
Folder
|
| eu_module_1_country_specific_information
|
1.2.1
|
Folder
|
| m1-3-1-spc-label-pl
|
1.2.1
|
Folder
|
| m1-3-1-pim
|
1.0
|
Folder
|
| m1-additional
|
1.2.1
|
Folder
|
| m1-responses
|
1.2.1
|
Folder
|
| m1-eu
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| eu-envelope
|
1.0
|
Leaf
|
| EU
|
1.3
|
envelope
|
1.3
|
Folder
|
| eu_module_1_country_specific_information
|
1.2.1
|
Folder
|
| m1-3-1-spc-label-pl
|
1.2.1
|
Folder
|
| m1-3-1-pim
|
1.0
|
Folder
|
| m1-additional
|
1.2.1
|
Folder
|
| m1-responses
|
1.2.1
|
Folder
|
| m1-eu
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| eu-envelope
|
1.0
|
Leaf
|
| EU
|
1.4
|
envelope
|
1.4
|
Folder
|
| eu_module_1_country_specific_information
|
1.2.1
|
Folder
|
| m1-3-1-spc-label-pl
|
1.2.1
|
Folder
|
| m1-3-1-pim
|
1.0
|
Folder
|
| m1-additional
|
1.2.1
|
Folder
|
| m1-responses
|
1.2.1
|
Folder
|
| m1-eu
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| eu-envelope
|
1.0
|
Leaf
|
| EU
|
2.0
|
envelope
|
2.0
|
Folder
|
| eu_module_1_country_specific_information
|
2.0
|
Folder
|
| m1-3-1-spc-label-pl
|
2.0
|
Folder
|
| m1-additional
|
2.0
|
Folder
|
| m1-responses
|
2.0
|
Folder
|
| m1-eu
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| eu-envelope
|
1.0
|
Leaf
|
| EU
|
3.0
|
envelope
|
3.0
|
Folder
|
| eu_module_1_country_specific_information
|
3.0
|
Folder
|
| m1-3-1-spc-label-pl
|
3.0
|
Folder
|
| m1-additional
|
3.0
|
Folder
|
| m1-responses
|
3.0
|
Folder
|
| m1-eu
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| eu-envelope
|
1.0
|
Leaf
|
| EU
|
3.0.1
|
envelope
|
3.0.1
|
Folder
|
| eu_module_1_country_specific_information
|
3.0
|
Folder
|
| m1-3-1-spc-label-pl
|
3.0
|
Folder
|
| m1-additional
|
3.0
|
Folder
|
| m1-responses
|
3.0
|
Folder
|
| m1-eu
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| eu-envelope
|
1.0
|
Leaf
|
| HR
|
1.4
|
envelope-hr
|
1.4
|
Folder
|
| hr_module_1_country_specific_information
|
1.2.1
|
Folder
|
| hr-m1-3-1-spc-label-pl
|
1.2.1
|
Folder
|
| m1-3-1-pim
|
1.0
|
Folder
|
| hr-m1-additional
|
1.2.1
|
Folder
|
| hr-m1-responses
|
1.2.1
|
Folder
|
| m1-hr
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| eu-envelope
|
1.0
|
Leaf
|
| GC
|
1.2
|
envelope-gc
|
1.2
|
Folder
|
| m1-gc
|
1.2
|
Folder
|
| gc-envelope
|
1.2
|
Leaf
|
| gc-m1-responses
|
1.2
|
Folder
|
| gc-m1-additional
|
1.2
|
Folder
|
| gc_module_1_label
|
1.2
|
Folder
|
| gc_module_1_country_specific_information
|
1.2
|
Folder
|
| GC
|
1.5
|
envelope-gc
|
1.5
|
Folder
|
| m1-gc
|
1.2
|
Folder
|
| gc-envelope
|
1.2
|
Leaf
|
| gc-m1-responses
|
1.2
|
Folder
|
| gc-m1-additional
|
1.2
|
Folder
|
| gc_module_1_label
|
1.2
|
Folder
|
| gc_module_1_country_specific_information
|
1.2
|
Folder
|
| CH
|
1.0
|
m1-ch
|
1.0
|
Folder
|
| m1-ch-galenic-form
|
1.0
|
Folder
|
| m1-ch-responses
|
1.0
|
Folder
|
| m1-ch-additional
|
1.0
|
Folder
|
| m1-ch-common-form
|
1.0
|
Folder
|
| CH
|
1.0.1
|
m1-ch
|
1.0
|
Folder
|
| m1-ch-galenic-form
|
1.0
|
Folder
|
| m1-ch-responses
|
1.0
|
Folder
|
| m1-ch-additional
|
1.0
|
Folder
|
| m1-ch-common-form
|
1.0
|
Folder
|
| CH
|
1.1
|
m1-ch
|
1.1
|
Folder
|
| m1-ch-galenic-form
|
1.1
|
Folder
|
| m1-ch-responses
|
1.0
|
Folder
|
| m1-ch-additional
|
1.0
|
Folder
|
| m1-ch-common-form
|
1.0
|
Folder
|
| CH
|
1.2
|
m1-ch
|
1.2
|
Folder
|
| m1-ch-galenic-form
|
1.1
|
Folder
|
| m1-ch-responses
|
1.0
|
Folder
|
| m1-ch-additional
|
1.0
|
Folder
|
| m1-ch-common-form
|
1.0
|
Folder
|
| CH
|
1.3
|
m1-ch
|
1.3
|
Folder
|
| m1-ch-galenic-form
|
1.1
|
Folder
|
| m1-ch-responses
|
1.0
|
Folder
|
| m1-ch-additional
|
1.0
|
Folder
|
| m1-ch-common-form
|
1.0
|
Folder
|
| CH
|
1.4
|
m1-ch
|
1.4
|
Folder
|
| m1-ch-galenic-form
|
1.1
|
Folder
|
| m1-ch-responses
|
1.0
|
Folder
|
| m1-ch-additional
|
1.0
|
Folder
|
| m1-ch-common-form
|
1.0
|
Folder
|
| CH
|
1.5
|
m1-ch
|
1.5
|
Folder
|
| m1-ch-galenic-form
|
1.1
|
Folder
|
| m1-ch-responses
|
1.0
|
Folder
|
| m1-ch-additional
|
1.0
|
Folder
|
| m1-ch-common-form
|
1.0
|
Folder
|
| CN
|
1.0
|
m1-cn
|
1.0
|
Folder
|
| JP
|
1.0
|
m1-jp
|
1.1
|
Folder
|
| japanese_leaf
|
1.0
|
Leaf
|
| JO
|
1.0
|
m1-jo
|
1.0
|
Folder
|
| jo-envelope
|
1.0
|
Leaf
|
| envelope-jo
|
1.0
|
Folder
|
| jo_pic_doc
|
1.0
|
Folder
|
| jo-additional
|
1.0
|
Folder
|
| JO
|
1.1
|
m1-jo
|
1.1
|
Folder
|
| envelope-jo
|
1.1
|
Folder
|
| jo_pil_doc
|
1.0
|
Folder
|
| jo_label_doc
|
1.0
|
Folder
|
| jo_spc_doc
|
1.0
|
Folder
|
| jo-additional
|
1.0
|
Folder
|
| jo-envelope
|
1.0
|
Leaf
|
| ZA
|
1.0
|
m1-za
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| ZA
|
2.1
|
m1-za
|
2.1
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| TH
|
0.92
|
m1-th
|
0.92
|
Folder
|
| m1-th-responses
|
1.0
|
Folder
|
| m1-th-additional
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| TH
|
1.0
|
m1-th
|
1.0
|
Folder
|
| m1-th-responses
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| TW
|
1.0
|
m1-tw
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| AU
|
0.9
|
m1-au
|
0.9
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| AU
|
3.0
|
m1-au
|
3.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| AU
|
3.1
|
au-3-1
|
3.1
|
Folder
|
| AU
|
AU 2.0 NeeS
|
au-2-0-nees
|
2.0
|
Folder
|
| CDN
|
1.0
|
m1-ca
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| CDN
|
2.2
|
m1-ca
|
2.2
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| STF
|
2.2
|
stf
|
1.1
|
Folder
|
| study_data_folder
|
1.0
|
Folder
|
| study_report_leaf
|
1.1
|
Leaf
|
| study_patient_information_leaf
|
1.0
|
Leaf
|
| STF
|
2.2.3.0
|
stf
|
3.0
|
Folder
|
| study_data_folder
|
3.0
|
Folder
|
| study_patient_information_folder
|
3.0
|
Folder
|
| module_studies
|
3.0
|
Folder
|
| study_report_leaf
|
3.0
|
Leaf
|
| study_patient_information_leaf
|
1.0
|
Leaf
|
| STF
|
2.2.5.0
|
stf
|
5.0
|
Folder
|
| study_data_folder
|
5.0
|
Folder
|
| study_patient_information_folder
|
5.0
|
Folder
|
| module_studies
|
5.0
|
Folder
|
| study_report_leaf
|
5.0
|
Leaf
|
| study_report_folder
|
5.0
|
Folder
|
| ICH
|
3.2
|
study_patient_information_leaf
|
1.0
|
Folder
|
| drug_product
|
1.0
|
Folder
|
| quality_appendix
|
1.1
|
Folder
|
| excipient
|
1.1
|
Folder
|
| clinical_indication
|
1.0
|
Folder
|
| module_studies
|
1.0
|
Folder
|
| m2-3-quality-overall-summary
|
1.0
|
Folder
|
| m2-3-introduction
|
1.0
|
Folder
|
| node-extension
|
1.0
|
Folder
|
| PIM
|
2.1
|
m1-3-1-pim
|
1.0
|
Folder
|
| eu_pim_additional_documents
|
1.0
|
Folder
|
| m1-eu
|
1.0
|
Folder
|
| FORM
|
1.1
|
eu_xml_application_form
|
1.0
|
Folder
|
| m1-eu
|
1.0
|
Folder
|