FULPHILA Solution for injection Ref.[9539] Active ingredients: Pegfilgrastim

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Mylan S.A.S., 117 allรฉe des Parcs, 69800, Saint-Priest, France

Product name and form

Fulphila 6 mg solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless solution for injection.

Qualitative and quantitative composition

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 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

Excipient with known effect: Each pre-filled syringe contains 30 mg sorbitol (E420).

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*
Sorbitol (E420)
Polysorbate 20
Water for injections

* Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.

Pack sizes and marketing

Pre-filled syringe (Type I glass), with a fluorotec-coated bromobutyl rubber stopper and a stainless steel needle with or without an automatic needle guard.

Pack size of one pre-filled syringe, in blistered packaging.

Marketing authorization holder

Mylan S.A.S., 117 allรฉe des Parcs, 69800, Saint-Priest, France

Marketing authorization dates and numbers

EU/1/18/1329/001 1 pre-filled syringe
EU/1/18/1329/002 1 pre-filled syringe with needle guard

Date of first authorisation: 20 November 2018

Drugs

Drug Countries
FULPHILA Austria, Australia, Brazil, Canada, Estonia, Finland, France, Hong Kong, Ireland, Israel, Lithuania, New Zealand, Poland, Romania, United States

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