E-mail toelatings bevestigingsbrief
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Box 619 Rehovot, 76106 Israel Dear Dr. Horn: We have received your biologics license application (BLA) submitted under section 351 of the Public Health Service Act for the following biological product: Our Submission Tracking Number (STN): BL 125392/0 Name of Biological Product: Fibrin Pad Indication: An adjunct to hemostasis for soft tissue bleeding during retroperitoneal, intraabdominal, pelvic, and (non-cardiac) thoracic surgery when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical Date of Application: November 15, 2010 Date of Receipt: November 19, 2010 Action Due Date: September 19, 2011 US License Number and Manufacturing Site: 1603 All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred..
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