Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Lonquex 6 mg solution for injection in pre-filled syringe.
Lonquex 6 mg/0.6 ml solution for injection.
| Pharmaceutical Form |
|---|
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Solution for injection (injection). Clear, colourless solution. |
Pre-filled syringe:
Each pre-filled syringe contains 6 mg of lipegfilgrastim* in 0.6 ml solution.
Vial:
Each vial contains 6 mg of lipegfilgrastim* in 0.6 ml solution.
Each ml of solution for injection contains 10 mg of lipegfilgrastim. The active substance is a covalent conjugate of filgrastim** with methoxy polyethylene glycol (PEG) via a carbohydrate linker.
* This is based on protein content only. The concentration is 20.9 mg/ml (i.e. 12.6 mg per pre-filled syringe or vial) if the PEG moiety and the carbohydrate linker are included.
** Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor [G-CSF]) is produced in Escherichia coli cells by recombinant DNA technology.
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 or vial contains 30 mg sorbitol.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Lipegfilgrastim is a covalent conjugate of filgrastim with a single methoxy polyethylene glycol (PEG) molecule via a carbohydrate linker consisting of glycine, N-acetylneuraminic acid and N-acetylgalactosamine. Human G-CSF is a glycoprotein that regulates the production and release of functional neutrophils from the bone marrow. Filgrastim is an un-glycosylated recombinant methionyl human G-CSF. Lipegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. Lipegfilgrastim binds to human the G-CSF receptor like filgrastim and pegfilgrastim. |
| List of Excipients |
|---|
|
Glacial acetic acid |
Pre-filled syringe:
Pre-filled syringe (type I glass) with a plunger stopper [poly(ethylene-co-tetrafluoroethylene)-coated bromobutyl rubber] and a fixed injection needle (stainless steel, 29G [0.34 mm] or 27G [0.4 mm] x 0.5 inch [12.7 mm]).
Each pre-filled syringe contains 0.6 ml of solution.
Pack sizes of 1 and 4 pre-filled syringes with safety device (which prevents needle stick injury and re-use) or 1 pre-filled syringe without safety device.
Not all pack sizes may be marketed.
Vial:
Type I clear, borosilicate glass vial with a bromobutyl rubber stopper and an aluminium crimp seal with polypropylene flip-off cap.
Each vial contains 0.6 ml of solution.
Pack sizes of 1 or 6 vials.
Not all pack sizes may be marketed.
Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Pre-filled syringe:
EU/1/13/856/001
EU/1/13/856/002
EU/1/13/856/003
Vial:
EU/1/13/856/004
EU/1/13/856/005
Date of first authorisation: 25 July 2013
Date of latest renewal: 19 April 2023
| Drug | Countries | |
|---|---|---|
| LONQUEX | Austria, Australia, Brazil, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom |
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