Ignite Creation Date:
2024-07-17 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471088
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-17
Brief Title:
Safety and Efficacy Evaluation of Dovprela Tablets 200 mg by Post-marketing Surveillance
Sponsor:
Viatris Inc
Organization:
Viatris Inc
Study Overview
Official Title:
Safety and Efficacy Evaluation of Dovprela Tablets 200 mg by Post-marketing Surveillance
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dovprela Tablets Pretomanid is the only treatment approved for the treatment of drug-resistant tuberculosis on a wider scale
This non-interventional post-marketing surveillance PMS study is one of the obligations that must be followed under the Ministry of Food and Drug Safety MFDS In accordance with the Pharmaceutical Affairs Act and the re-examination criteria for new drugs etc notified by the MFDS this study will be conducted with the purpose to collect and review required information on the safety and efficacy of drugs requiring re-examination for appropriate use Safety and efficacy information will be provided for a minimum of 100 subjects who receive treatment in general clinical settings for a period of 4 years following approval
This survey is an open non-comparative non-interventional prospective multicenter study conducted by certified physicians ie the investigator at a Korean medical institution
This non-interventional post-marketing surveillance PMS study is one of the obligations that must be followed under the Ministry of Food and Drug Safety MFDS In accordance with the Pharmaceutical Affairs Act and the re-examination criteria for new drugs etc notified by the MFDS this study will be conducted with the purpose to collect and review required information on the safety and efficacy of drugs requiring re-examination for appropriate use Safety and efficacy information will be provided for a minimum of 100 subjects who receive treatment in general clinical settings for a period of 4 years following approval
This survey is an open non-comparative non-interventional prospective multicenter study conducted by certified physicians ie the investigator at a Korean medical institution
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None