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agalsidase beta (Fabrazyme®)


Reference No. 12

Publication date:
30/12/2006


Appraisal information

agalsidase beta (Fabrazyme®) 5 mg powder for concentrate for solution for infusion
agalsidase beta (Fabrazyme®) 35 mg powder for concentrate for solution for infusion


Company: Genzyme Therapeutics
BNF category: Nutrition and blood
NMG meeting date: Not scheduled
AWMSG meeting date: 02/10/2006
   
   
Submission Type: Full Submission
Status: Recommended
Advice No: Not available
Ministerial ratification: 25/10/2006

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

AWMSG advice

It was agreed (by majority) that the recommendation to the Minister for Health & Social Services with regard to agalsidase beta (Fabrazyme®) is that agalsidase beta (Fabrazyme®) should be endorsed within NHS Wales for the treatment of Fabry disease in accordance with the licensed indication with the following restrictions: AWMSG recommends that: 1. Patients receiving agalsidase beta (Fabrazyme®) will be entered into the Fabry registry. 2. Treatment will be administered under the supervision of a physician experienced in the management of Fabry disease or other inherited metabolic diseases. 3. Treatment will be administered according to agreed guidelines at appropriate centres.
Final Appraisal Recommendation (FAR)
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