Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Evive Biotechnology Ireland LTD, 20 Kildare Street, Dublin 2, D02 T3V7, Ireland
Ryzneuta 20 mg solution for injection.
| Pharmaceutical Form |
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Solution for injection (injection). Clear, colourless solution for injection. |
Each pre-filled syringe contains 20 mg of efbemalenograstim alfa* in 1 mL solution for injection. The concentration is 20 mg/mL.
* Recombinant human granulocyte colony-stimulating factor Fc fusion protein derived from mammalian cell culture.
The potency of this medicinal product should not be compared to the potency of another protein (pegylated or non-pegylated) of the same therapeutic class. For more information, see section 5.1.
Excipient with known effect: Each prefilled syringe contains 50 mg sorbitol (E420).
For the full list of excipients, see section 6.
| Active Ingredient | Description | |
|---|---|---|
| Efbemalenograstim alfa |
Human granulocyte-colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow. Efbemalenograstim alfa is a recombinant fusion protein containing G-CSF, a 16 amino-acid linker, and the Fc portion of human IgG2. Efbemalenograstim alfa is a sustained duration form of G-CSF due to decreased renal clearance. Efbemalenograstim alfa and other G-CSFs have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes. |
| List of Excipients |
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Sodium acetate trihydrate |
Pre-filled syringe (Type I glass), with a rubber stopper, stainless steel needle and needle cap.
The needle cap on the prefilled syringe contains dry natural rubber (latex) (see section 4.4).
Each pre-filled syringe contains 1 mL of solution for injection.
Pack size of one pre-filled syringe
Evive Biotechnology Ireland LTD, 20 Kildare Street, Dublin 2, D02 T3V7, Ireland
EU/1/24/1793/001
Date of first authorisation: 21 March 2024
| Drug | Countries | |
|---|---|---|
| RYZNEUTA | Lithuania, United States |
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