Vaccines, Blood & Biologics
?
-
Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC)
Proper Name: Influenza A (H1N1) 2009 Monovalent Vaccine
Tradename: None
Manufacturer: MedImmune LLC
Indication:
- Active immunization of individuals 2-49 years of age against influenza disease caused by pandemic (H1N1) 2009 virus.
-
-
-
Supporting Documents
February 3, 2010 Approval Letter - Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC)
Changes to the Adverse Reaction reporting information in the Highlights section of the package insert for Influenza A (H1N1) 2009 Monovalent Vaccine, Live formulation, to accommodate the distribution of vaccine outside of United States by the WHO.September 15, 2009 Approval Letter - Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC)
-
-
Related Information
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Questions and Answers Recall: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Influenza A (H1N1) 2009 Monovalent Influenza A (H1N1) 2009 Monovalent Vaccines Questions and Answers Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release Influenza A (H1N1) 2009 Monovalent Vaccine Safety Monitoring 2009 H1N1 (Swine) Flu Virus (Biologics) FDA 2009 H1N1 (Swine) Flu Page
-
Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
-
-