Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland, medinfoEMEA@takeda.com
TAKHZYRO 150 mg solution for injection in pre-filled syringe.
TAKHZYRO 300 mg solution for injection in pre-filled syringe.
TAKHZYRO 300 mg solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. The solution is colourless to slightly yellow, appearing either clear or slightly opalescent. The solution has a pH of approximately 6.0 and an osmolality of approximately 300 mOsm/kg. |
TAKHZYRO 150 mg solution for injection in pre-filled syringe: One unit (pre-filled syringe) contains 150 mg of lanadelumab* in 1 ml solution.
TAKHZYRO 300 mg solution for injection (pre-filled syringe or vial): One unit (pre-filled syringe or vial) contains 300 mg of lanadelumab* in 2 ml solution.
* Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lanadelumab |
Lanadelumab is a fully human, monoclonal antibody (IgG1/κ-light chain). Lanadelumab inhibits active plasma kallikrein proteolytic activity. Lanadelumab provides sustained control of plasma kallikrein activity and thereby limits bradykinin generation in patients with HAE. |
| List of Excipients |
|---|
|
Disodium phosphate dihydrate |
TAKHZYRO 150 mg solution for injection in pre-filled syringe:
1 ml of solution in pre-filed syringe with a bromobutyl stopper, 27G x 13 mm staked needle and rigid needle cap. TAKHZYRO is available as unit packs containing 1 or 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
TAKHZYRO 300 mg solution for injection in pre-filled syringe:
2 ml of solution in pre-filled syringe with a bromobutyl stopper, 27G x 13 mm staked needle and rigid needle cap. TAKHZYRO is available as unit packs containing 1 or 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
TAKHZYRO 300 mg solution for injection in vial:
2 ml of solution in a vial (type I glass) with a coated butyl rubber stopper and an aluminium seal with violet flip-off cap. TAKHZYRO is available as a single pack containing one 2 ml vial and in multipacks comprising 2 or 6 cartons, each carton containing 1 vial.
Each pack also contains the following items:
Not all pack sizes may be marketed.
Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland, medinfoEMEA@takeda.com
EU/1/18/1340/001
EU/1/18/1340/002
EU/1/18/1340/003
EU/1/18/1340/004
EU/1/18/1340/005
EU/1/18/1340/006
EU/1/18/1340/007
EU/1/18/1340/008
EU/1/18/1340/009
Date of first authorisation: 22 November 2018
Date of latest renewal: 11 August 2023
| Drug | Countries | |
|---|---|---|
| TAKHZYRO | Austria, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States |
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