Reasons for adding or updating:

• Change to section 1 - Name of the medicinal product
• Change to section 2 - Qualitative and quantitative composition
• Change to section 4.2 - Posology and method of administration
• Change to section 4.3 - Contraindications
• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.6 - Fertility, pregnancy and lactation
• Change to section 4.7 - Effects on ability to drive and use machines
• Change to section 4.8 - Undesirable effects - how to report a side effect
• Change to section 4.9 - Overdose
• Change to section 5.3 - Preclinical safety data
• Change to section 6.2 - Incompatibilities
• Change to section 6.3 - Shelf life
• Change to section 6.4 - Special precautions for storage
• Change to section 6.5 - Nature and contents of container
• Change to section 9 - Date of first authorisation/renewal of the authorisation
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-Jul-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 1: expressed the strength of the presentation from XXXIU FVIII/XXXIU VWF to XXXIU VWF/XXXIU FVIII Section 2: expressed the strength of the presentation from XXXIU FVIII/XXXIU VWF to XXXIU VWF/XXXIU FVIII. General wording changes Section 4.2: expressed the strength of the presentation from XXXIU FVIII/XXXIU VWF to XXXIU VWF/XXXIU FVIII. New warning for lack of data in under 6's.  New PUP data statement added, General wording changes. Section 4.3: General wording changes Section 4.4: New Hypersensitivity warning. Extended inhibitor warning, expressed the strength of the presentation from XXXIU FVIII/XXXIU VWF to XXXIU VWF/XXXIU FVIII. General wording changes Section 4.6: expressed the strength of the presentation from XXXIU FVIII/XXXIU VWF to XXXIU VWF/XXXIU FVIII. Section 4.7: General wording changes Section 4.8: New tabulated list of ADRs added. New ADR reporting statement, general wording changes Section 4.9: expressed the strength of the presentation from XXXIU FVIII/XXXIU VWF to XXXIU VWF/XXXIU FVIII. Section 5.3: expressed the strength of the presentation from XXXIU FVIII/XXXIU VWF to XXXIU VWF/XXXIU FVIII. Section 6.2: General wording changes Section 6.3: Changed the shelf life of reconstituted solution from 12 hours to 4 hours Section 6.4: General wording changes Section 6.5: expressed the strength of the presentation from XXXIU FVIII/XXXIU VWF to XXXIU VWF/XXXIU FVIII. Section 9: Date of Renewal of Licence has been updated Section 10: Date of revision of text updated

Reasons for adding or updating:

• Correction of spelling/typing errors

Date of revision of text on the SPC: 14-Nov-2011

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

• Removal of black triangle

Date of revision of text on the SPC: 31-Oct-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Removal of Black Triangle.

Reasons for adding or updating:

• New SPC for new product
• New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:POM

Black Triangle (CHM): YES