Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Nyvepria 6 mg solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear, colourless, free from visible particles, solution for injection. |
Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. The concentration is 10 mg/mL based on protein only**.
* Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
** The concentration is 20 mg/mL if the PEG moiety is included.
The potency of this medicinal product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class. For more information, see section 5.1.
Excipients with known effect:
Each pre-filled syringe contains 30 mg sorbitol (E420) (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pegfilgrastim |
Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. Pegfilgrastim and filgrastim have been shown to 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 |
|---|
|
Sodium acetate trihydrate |
Pre-filled syringe (type I glass), with a rubber stopper, stainless steel needle and needle cover with an automatic needle guard. The Nyvepria syringe plunger stopper and needle cover are not made with natural rubber latex.
Each pre-filled syringe contains 0.6 mL of solution for injection.
Pack size of one pre-filled syringe, in a carton.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/20/1486/001
Date of first authorisation: 18 November 2020
| Drug | Countries | |
|---|---|---|
| NYVEPRIA | Austria, Canada, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland |
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