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FABRAZYME Powder for concentrate solution (2018)

Active ingredients: Agalsidase beta

Product Name and Form

Fabrazyme 35 mg powder for concentrate for solution for infusion.

Fabrazyme 5 mg powder for concentrate for solution for infusion.

Pharmaceutical form

Powder for concentrate for solution for infusion.

White to off-white lyophilised cake or powder.

Qualitative and Quantitative Composition

Fabrazyme 35 mg powder for concentrate for solution for infusion: Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase beta. After reconstitution with 7.2 ml water for injections, each vial of Fabrazyme contains 5 mg/ml (35 mg/7 ml) of agalsidase beta. The reconstituted solution must be diluted further (see section 6.6).

Fabrazyme 5 mg powder for concentrate for solution for infusion: Each vial of Fabrazyme contains a nominal value of 5 mg of agalsidase beta. After reconstitution with 1.1 ml water for injections, each vial of Fabrazyme contains 5 mg/ml of agalsidase beta. The reconstituted solution must be diluted further (see section 6.6).

Agalsidase beta is a recombinant form of human α-galactosidase A and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture. The amino acid sequence of the recombinant form, as well as the nucleotide sequence which encoded it, are identical to the natural form of α-galactosidase A.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Agalsidase beta

Agalsidase beta is a recombinant form of human α-galactosidase A and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture. The amino acid sequence of the recombinant form, as well as the nucleotide sequence which encoded it, are identical to the natural form of α-galactosidase.

List of excipients

Mannitol
Sodium phosphate monobasic, monohydrate
Sodium phosphate dibasic, heptahydrate

Pack sizes and Marketing

Fabrazyme 35 mg powder for concentrate for solution for infusion:

Fabrazyme 35 mg is supplied in clear Type I glass 20 ml vials. The closure consists of a siliconised butyl stopper and an aluminium seal with a plastic flip-off cap.

Package sizes: 1, 5 and 10 vials per carton.

Not all pack sizes may be marketed.

Fabrazyme 5 mg powder for concentrate for solution for infusion:

Fabrazyme 5 mg is supplied in clear Type I glass 5 ml vials. The closure consists of a siliconised butyl stopper and an aluminium seal with a plastic flip-off cap.

Package sizes: 1, 5 and 10 vials per carton.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, The Netherlands

Date of first authorisation: 03 August 2001

Date of last renewal: 03 August 2006

Marketing authorization number:

EU/1/01/188/001 Fabrazyme 35 mg 1 vial of powder for concentrate for solution for infusion
EU/1/01/188/002 Fabrazyme 35 mg 5 vials of powder for concentrate for solution for infusion
EU/1/01/188/003 Fabrazyme 35 mg 10 vials of powder for concentrate for solution for infusion
EU/1/01/188/004 Fabrazyme 5 mg 1 vial of powder for concentrate for solution for infusion
EU/1/01/188/005 Fabrazyme 5 mg 5 vials of powder for concentrate for solution for infusion
EU/1/01/188/006 Fabrazyme 5 mg 10 vials of powder for concentrate for solution for infusion