Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Alexion Europe SAS, 103-105 rue Anatole France, 92300, Levallois-Perret, France
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. |
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 |
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.
Alexion Europe SAS, 103-105 rue Anatole France, 92300, Levallois-Perret, France
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
| Drug | Countries | |
|---|---|---|
| STRENSIQ | Austria, Brazil, Canada, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
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