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REPLAGAL Concentrate solution for infusion (2018)

Active ingredients: Agalsidase alfa

Product Name and Form

Replagal 1 mg/ml concentrate for solution for infusion.

Pharmaceutical form

Concentrate for solution for infusion.

A clear and colourless solution.

Qualitative and Quantitative Composition

1 ml of concentrate for solution for infusion contains 1 mg of agalsidase alfa*.

Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa.

* agalsidase alfa is the human protein α-galactosidase A produced in a human cell line by genetic engineering technology.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Agalsidase alfa

Agalsidase alfa catalyses the hydrolysis of Gb3, cleaving a terminal galactose residue from the molecule. Treatment with the enzyme has been shown to reduce accumulation of Gb3 in many cell types including endothelial and parenchymal cells. Agalsidase alfa has been produced in a human cell line to provide for a human glycosylation profile that can influence uptake by mannose-6-phosphate receptors on the surface of target cells.

List of excipients

Sodium phosphate monobasic, monohydrate
Polysorbate 20
Sodium chloride
Sodium hydroxide
Water for injections

Pack sizes and Marketing

3.5 ml of concentrate for solution for infusion in a 5 ml vial (Type I glass) with a stopper (fluoro-resin coated butyl rubber), a one piece seal (aluminium) and flip-off cap. Pack sizes of 1, 4 or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Shire Human Genetic Therapies AB, Vasagatan 7, 111 20, Stockholm, Sweden

Date of first authorisation: 03/08/2001
Date of last renewal: 03/08/2006

Marketing authorization number:

EU/1/01/189/001-003