Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Takeda Manufacturing Austria AG, Industriestrasse 67, 1221 Vienna, Austria, medinfoEMEA@takeda.com
ADZYNMA 500 IU powder and solvent for solution for injection.
ADZYNMA 1 500 IU powder and solvent for solution for injection.
| Pharmaceutical Form |
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Powder and solvent for solution for injection. White lyophilised powder. The solvent is a clear and colourless solution. The reconstituted solution has a pH of 6.7 - 7.3 and an osmolality of no lower than 240 mOsmol/kg. |
ADZYNMA 500 IU powder and solvent for solution for injection:
Each vial of powder contains nominally 500 international units (IU) of rADAMTS13* activity, as measured in terms of its potency.
After reconstitution with the 5 mL solvent provided, the solution has a potency of approximately 100 IU/mL.
ADZYNMA 1 500 IU powder and solvent for solution for injection:
Each vial of powder contains nominally 1 500 IU of rADAMTS13* activity, as measured in terms of its potency.
After reconstitution with the 5 mL solvent provided, the solution has a potency of approximately 300 IU/mL.
* ADZYNMA is a purified bivariant human recombinant "A disintegrin and metalloproteinase with thrombospondin motifs 13" (rADAMTS13) expressed in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology (a mixture of native rADAMTS13 Q23 and variant rADAMTS13 R23 with a controlled range of the two variants ratio), referred to as rADAMTS13.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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rADAMTS13 is a recombinant form of the endogenous ADAMTS13. ADAMTS13 is a plasma zinc metalloprotease that regulates the activity of von Willebrand factor (VWF) by cleaving large and ultra-large VWF multimers to smaller units and thereby reducing the platelet binding properties of VWF and its propensity to form microthrombi. rADAMTS13 is expected to reduce or eliminate the spontaneous formation of VWF-platelet microthrombi that leads to platelet consumption and thrombocytopenia in patients with cTTP. |
| List of Excipients |
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Powder: Sodium chloride Solvent: Water for injections |
ADZYNMA 500 IU powder and solvent for solution for injection:
Each pack contains:
ADZYNMA 1 500 IU powder and solvent for solution for injection:
Each pack contains:
Takeda Manufacturing Austria AG, Industriestrasse 67, 1221 Vienna, Austria, medinfoEMEA@takeda.com
EU/1/24/1837/001
EU/1/24/1837/002
Date of first authorisation: 01 August 2024
| Drug | Countries | |
|---|---|---|
| ADZYNMA | Austria, Estonia, France, Ireland, Italy, Lithuania, Romania, United Kingdom |
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