Core summary of product characteristics for plasma-derived fibrin sealant/haemostatic products - Scientific guideline

This document describes the information to be included in the summary of product characteristics for plasma-derived fibrin sealant/haemostatic products.

Keywords: Fibrin sealant, haemostatics, human fibrinogen, factor XIII, antifibrinolytics, aprotinin, tranexamic acid, human thrombin, sealant, otologic, rhinologic, ophthalmic and vertebral surgery, cerebro-spinal fluid, dura mater, glueing, neurosurgery, treatment of bleeding, vascular surgery, gastrointestinal anastomoses

Current effective version

Guideline on core SmPC for plasma-derived fibrin sealant / haemostatic products

Adopted Reference Number: EMA/CHMP/BPWP/598816/2010 Rev. 1 Summary:

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for plasma-derived fibrin sealant / haemostatic products.

Document history - Revision 1

Guideline on core SmPC for plasma-derived fibrin sealant / haemostatic products

Adopted Reference Number: EMA/CHMP/BPWP/598816/2010 Rev. 1 Summary:

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for plasma-derived fibrin sealant / haemostatic products.

Overview of comments received on 'Guideline on core SmPC for plasma-derived fibrin sealant / haemostatic products'

Reference Number: EMA/CHMP/BPWP/316655/2014 Summary:

Interested parties (organisations or individuals) that commented on the draft document as released for consultation.

Draft concept paper on the need for revision of the guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products and the related core summary of product characteristics

Draft: consultation closed Consultation dates: 01/06/2014 to 31/08/2014 Reference Number: EMA/CHMP/BPWP/572810/2013 Summary:

The currently approved ‘guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products’ came into operation in January 2005. Since then, new fibrin sealant products have been authorised, new methods of application have established and applicants have sought scientific advice on the clinical development of further fibrin sealant / haemostatic products or new indications for approved fibrin sealant products. A revision of the guideline seems appropriate to reflect recent gains in clinical experience.

Draft guideline on core summary of product characteristics for plasma-derived fibrin sealant / haemostatic products

Draft: consultation closed Consultation dates: 01/01/2014 to 31/03/2014 Reference Number: EMA/CHMP/BPWP/598816/2010 Rev. 1 Summary:

This guideline describes the information to be included in the summary of product characteristics (SmPC) for plasma-derived fibrin sealant / haemostatic products.

Document history - First version

Guideline on Core SPC for plasma derived fibrin sealant/haemostatic products (CPMP/BPWG/153/00)

Adopted Reference Number: CPMP/BPWG/153/00 Legal effective date: 01/01/2005