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Gardasil 9, Human Papillomavirus 9-valent Vaccine, Recombinant
申请企业
Merck Sharp & Dohme Corp.
药品名称
Gardasil 9, Human Papillomavirus 9-valent Vaccine, Recombinant
承诺描述
To establish a pregnancy registry as described in your final protocol submitted September 16, 2014, to continue for at least 5 years, to prospectively collect data on spontaneously reported exposures to Gardasil 9 occurring within 30 days prior to the last menstrual period or at any time during pregnancy. You will submit annual reports as well as a five-year summary report, after which you will continue enrolling patients in the registry pending CBER review of the report and determination of whether the registry can be discontinued.