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          REBYOTAVaccines REBYOTA
  
  	
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    Print**STN:**125739**Proper Name:** fecal microbiota, live-jslm**Tradename:**REBYOTA**Manufacturer:** Ferring Pharmaceuticals Inc.**Indication:**

REBYOTA is indicated for the prevention of recurrence of *Clostridioides difficile* infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.Product Information

Package Insert - REBYOTA
	Demographic Subgroup Information – fecal microbiota, live-jslm (REBYOTA)
	Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.Supporting Documents

November 30, 2022 Approval Letter - REBYOTA
	November 30, 2022 Summary Basis for Regulatory Action - REBYOTA
	Approval History, Letters, Reviews, and Related Documents - REBYOTA

                                                                                  Content current as of:
      12/19/2022
              
              
Regulated Product(s)
		 BiologicsVaccines

          
                        Emergency Use Authorization for Vaccines Explained
          Approved Vaccine Products
          Questions about Vaccines
 
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