STRENSIQ Solution for injection Ref.[7579] Active ingredients: Asfotase alfa

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Alexion Europe SAS, 103-105 rue Anatole France, 92300, Levallois-Perret, France

Product name and form

Strensiq 40 mg/ml solution for injection.

Strensiq 100 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless to slightly yellow, aqueous solution; pH 7.4.

Qualitative and quantitative composition

Strensiq 40 mg/ml solution for injection:

Each ml of solution contains 40 mg of asfotase alfa*.

Each vial contains 0.3 ml solution and 12 mg of asfotase alfa (40 mg/ml).
Each vial contains 0.45 ml solution and 18 mg of asfotase alfa (40 mg/ml).
Each vial contains 0.7 ml solution and 28 mg of asfotase alfa (40 mg/ml).
Each vial contains 1.0 ml solution and 40 mg of asfotase alfa (40 mg/ml).

Strensiq 100 mg/ml solution for injection:

Each ml of solution contains 100 mg of asfotase alfa*.

Each vial contains 0.8 ml solution and 80 mg of asfotase alfa (100 mg/ml).

* produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Asfotase alfa

Asfotase alfa, a human recombinant tissue-nonspecific alkaline phosphatase-Fc-deca-aspartate fusion protein with enzymatic activity, promotes mineralisation of the skeleton in patients with hypophosphatasia.

List of Excipients

Sodium chloride
Sodium phosphate dibasic heptahydrate
Sodium phosphate monobasic monohydrate
Water for injections

Pack sizes and marketing

Type I glass vial with a stopper (butyl rubber) and a seal (aluminium) with a flip-off cap
(polypropylene).

Strensiq 40 mg/ml solution for injection: Filled volumes of the vials are: 0.3 ml, 0.45 ml, 0.7 ml and 1.0 ml

Strensiq 100 mg/ml solution for injection: Filled volumes of the vials are: 0.8 ml

Pack sizes of 1 or 12 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Alexion Europe SAS, 103-105 rue Anatole France, 92300, Levallois-Perret, France

Marketing authorization dates and numbers

Strensiq 40 mg/ml solution for injection:

EU/1/15/1015/001
EU/1/15/1015/002
EU/1/15/1015/005
EU/1/15/1015/006
EU/1/15/1015/007
EU/1/15/1015/008
EU/1/15/1015/009
EU/1/15/1015/010

Strensiq 100 mg/ml solution for injection:

EU/1/15/1015/003
EU/1/15/1015/004

28/08/2015

Drugs

Drug Countries
STRENSIQ Austria, Brazil, Canada, Estonia, Finland, France, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States

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