Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Hympavzi 150 mg solution for injection in pre-filled syringe.
Hympavzi 150 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear, colourless to light yellow solution with pH of 5.8. |
Hympavzi 150 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 150 mg marstacimab in 1 mL of solution.
Hympavzi 150 mg solution for injection in pre-filled pen: Each pre-filled pen contains 150 mg marstacimab in 1 mL of solution.
Marstacimab is a human monoclonal immunoglobulin G Type 1 (IgG1) antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipients with known effect: Hympavzi contains 0.2 mg polysorbate 80 in each mL of solution.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Marstacimab |
Marstacimab is a human monoclonal IgG1 antibody directed against the Kunitz domain 2 (K2) of tissue factor pathway inhibitor (TFPI), the primary inhibitor of the extrinsic coagulation cascade. TFPI initially binds to and inhibits the factor Xa active site via its second Kunitz inhibitor domain (K2). The action of marstacimab to neutralise the inhibitory activity of TFPI may serve to enhance the extrinsic pathway and bypass deficiencies in the intrinsic pathway of coagulation by increasing free factor Xa available to increase thrombin generation and promote haemostasis. |
| List of Excipients |
|---|
|
Disodium edetate |
Hympavzi 150 mg solution for injection in pre-filled syringe:
Each carton contains one single-dose pre-filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer) and a stainless steel 27 gauge, ½ inch staked needle with a needle shield (thermoplastic elastomer).
Each pre-filled syringe contains 1 mL solution for injection.
Hympavzi 150 mg solution for injection in pre-filled pen:
Each carton contains one single-dose pre-filled pen.
The syringe inside the pen is made from Type I glass with a plunger stopper (chlorobutyl elastomer) and a stainless steel 27 gauge, ½ inch staked needle with a needle shield (thermoplastic elastomer).
Each pre-filled pen contains 1 mL solution for injection.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/24/1874/001
EU/1/24/1874/002
| Drug | Countries | |
|---|---|---|
| HYMPAVZI | Lithuania, United States |
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