Vaccines, Blood & Biologics
-
Approval History, Letters, Reviews, and Related Documents - Flucelvax
-
Memorandums/Reviews
Summary Basis of Regulatory Action, November 20, 2012 - Flucelvax (PDF - 229KB)Proprietary Name Review Letter - Flucelvax Filing NDI Letter - Flucelvax Committee Memo Clinical Review Signatory Authority, November 20, 2012 - Flucelvax Product Reviewer Memo, November 9, 2012 - Flucelvax (PDF - 243KB)PNR Accepted - Flucelvax Labeling Review Memo, October 31, 2012 - Flucelvax Cell Substrate Review Memo, October 12, 2012 - Flucelvax (PDF - 166KB)Final Review Memo, October 10, 2012 - Flucelvax (PDF - 202KB)Flucelvax Clinical Review (PDF - 944KB)Statistical Review Evaluation - Flucelvax (PDF - 712KB)Novartis Marburg Review Memo – Flucelvax (PDF - 221KB)Pharmacovigilance Plan Review Memo, August 1, 2012 - Flucelvax (PDF - 181KB)Statistical Review and Evaluation Assay Only - Flucelvax Toxicology Review of Trivalent - Flucelvax (PDF - 448KB)
-
-
Correspondence
Major Amendment Letter - Flucelvax Record of Telephone Conversation, October 26, 2012 am - Flucelvax Record of Telephone Conversation, October 26, 2012 - Flucelvax Record of Telephone Conversation, October 26, 2012 pm - Flucelvax Record of Telephone Conversation, October 18, 2012 - Flucelvax Record of Telephone Conversation, October 11, 2012 - Flucelvax Record of Telephone Conversation, October 5, 2012 - Flucelvax Record of Telephone Conversation, October 5, 2012 cont - Flucelvax Record of Telephone Conversation, September 28, 2012 - Flucelvax Record of Telephone Conversation, September 17, 2012 - Flucelvax Record of Telephone Conversation, September 14, 2012 - Flucelvax Record of Telephone Conversation, September 13, 2012 - Flucelvax Record of Telephone Conversation, September 7, 2012 - Flucelvax Record of Telephone Conversation, September 7, 2012 pm - Flucelvax Record of Telephone Conversation, September 5, 2012 pm - Flucelvax Record of Telephone Conversation, August 31, 2012 - Flucelvax Record of Telephone Conversation, August 29, 2012 - Flucelvax Record of Telephone Conversation, August 28, 2012 - Flucelvax Record of Telephone Conversation, August 24, 2012 - Flucelvax Record of Telephone Conversation, August 23, 2012 - Flucelvax Record of Telephone Conversation, August 22, 2012 - Flucelvax Record of Telephone Conversation, August 21, 2012 am - Flucelvax Record of Telephone Conversation, August 21, 2012 - Flucelvax Record of Telephone Conversation, August 20, 2012 - Flucelvax Record of Telephone Conversation, August 17, 2012 - Flucelvax Monitoring residual virus Email, August 16, 2012 - Flucelvax Record of Telephone Conversation, August 15, 2012 am - Flucelvax Record of Telephone Conversation, August 15, 2012 - Flucelvax Record of Telephone Conversation, August 15, 2012, cont - Flucelvax Record of Telephone Conversation, August 10, 2012 am - Flucelvax Record of Telephone Conversation, August 10, 2012 - Flucelvax Record of Telephone Conversation, August 9, 2012 - Flucelvax Record of Telephone Conversation, August 2, 2012 - Flucelvax Record of Telephone Conversation, August 1, 2012 - Flucelvax Record of Telephone Conversation, July 31, 2012 - Flucelvax Record of Telephone Conversation, July 24, 2012 - Flucelvax Record of Telephone Conversation, July 23, 2012 - Flucelvax Record of Telephone Conversation, July 23, 2012 cont - Flucelvax Record of Telephone Conversation, July 11, 2012 - Flucelvax Record of Telephone Conversation, July 10, 2012 - Flucelvax Meeting Summary, July 9, 2012 - Flucelvax (PDF - 73KB)Record of Telephone Conversation, July 9, 2012 - Flucelvax Record of Telephone Conversation, June 27, 2012 - Flucelvax Record of Telephone Conversation, June 22, 2012 am - Flucelvax Record of Telephone Conversation, June 22, 2012 - Flucelvax Record of Telephone Conversation, June 19, 2012 - Flucelvax (PDF - 70KB)Record of Telephone Conversation, June 12, 2012 - Flucelvax Meeting Summary, June 11, 2012 - Flucelvax (PDF - 74KB)Record of Telephone Conversation, June 6, 2012 - Flucelvax Meeting Mintues, May 29, 2012 - Flucelvax Record of Telephone Conversation, May 9, 2012 - Flucelvax Meeting Summary, May 7, 2012 - Flucelvax (PDF - 70KB)- Record of Telephone Conversation, May 4, 2012 - Flucelvax
Record of Telephone Conversation, April 13, 2012 - Flucelvax Meeting Summary, April 11, 2012 - Flucelvax (PDF - 80KB)Record of Telephone Conversation, March 13, 2012 - Flucelvax Record of Telephone Conversation, March 7, 2012 - Flucelvax Record of Telephone Conversation, March 6, 2012 - Flucelvax Meeting Summary, February 29, 2012 - Flucelvax (PDF - 65KB)Record of Telephone Conversation, February 15, 2012 - Flucelvax Information Request Email, February 15, 2012 - Flucelvax Record of Telephone Conversation, January 30, 2012 - Flucelvax Record of Telephone Conversation, January 26, 2012 - Flucelvax Record of Telephone Conversation, January 19, 2012 - Flucelvax Meeting Summary, January 18, 2012 - Flucelvax (PDF - 58KB)Record of Telephone Conversation, December 23, 2011 - Flucelvax Record of Telephone Conversation, December 15, 2011 - Flucelvax Meeting Summary, December 12, 2011 - Flucelvax (PDF - 58KB)Telecon Memo, November 21, 2011 - Flucelvax First Committee Meeting Summary, November 21, 2011 - Flucelvax
-
-
-
