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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

3/17/2008 Telecon 1 - Rotarix

Communication - Telecon

Printed Date: March 17

Appl Type: BLA       STN: L 125265/0.0

Subm Type: Original Application     Lic #: 1617

Status: Filed     Status Date:02-AUG-2007

Applicant: GlaxoSmithKline Biologicals

Type: TELECON
Author Henchal, Laraine S

Date/Time: 17-MAR-2008
Originated By: 13:55:00 FDA

Send to DCC Date:
Outside Phone#: 610-787-3767

Communication Categories: Information Request

Related STNs:

Related PMCs:

Summary: Requested timeline for post-market study

 

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Food and Drug Administration

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