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European Medicines Agency
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13
E-mail: mail@emea.europa.eu http://www.emea.europa.eu
London, 28 October 2009
Doc. Ref: EMEA/CHMP/631070/2009
ASSESSMENT REPORT
FOR
Myozyme®
International Nonproprietary Name:
alglucosidase alfa
Procedure No. EMEA/H/C/000636/II/0007
Variation Assessment

Considering the above assessment and the discussion that followed, the CHMP agreed on the following amended wording regarding the late-onset patients for section 4.1 of the SPC:
In patients with late-onset Pompe disease the evidence of efficacy is limited (see section 5.1).”
Following the acceptance by the MAH of the proposed amendments in the Product Information the CHMP concluded that the benefit risk balance for Myozyme remains positive.

III.4 Product Information
Summary of Product Characteristics
The section 4.1 of the Therapeutic Indication has been amended. The new full indication for Myozyme is as follows:
“Myozyme is indicated for long-term enzyme replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid -glucosidase deficiency).
In patients with late-onset Pompe disease the evidence of efficacy is limited (see section 5.1).”

---Er wordt hier geen griep behandeld en het middel is geen paracetammolletje. Update is bijzonder genuanceerd en prikt door vele claims en statistisch gegoochel van de fabrikant.

Conclusie blijft staan. Benefit risk balance blijft positief.