AROVI 2,000 IU Solution for injection in pre-filled syringe Ref.[7544] Active ingredients: Enoxaparin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Laboratorios Farmacéuticos ROVI, S.A., Julián Camarillo, 35, 2803, Madrid, Spain

Product name and form

Arovi 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection in pre-filled syringe (Injection).

Clear, colourless to pale yellow solution.

Qualitative and quantitative composition

2,000 IU (20 mg)/0.2 mL: Each prefilled syringe contains enoxaparin sodium 2,000 IU anti-Xa activity (equivalent to 20 mg) in 0.2 mL water for injections.

For the full list of excipients, see section 6.1.

Enoxaparin sodium is a biological substance obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa.

Active Ingredient Description

Enoxaparin is a LMWH with a mean molecular weight of approximately 4,500 daltons, in which the antithrombotic and anticoagulant activities of standard heparin have been dissociated. The drug substance is the sodium salt and has a high anti-Xa activity.

List of Excipients

Water for injections

Pack sizes and marketing

Solution for injection in Type I glass pre-filled syringes with chlorobutyl rubber stopper fitted with injection needle and with or without an automatic safety device. Prefilled syringes are stored in plastic trays and carton boxes.

Arovi 2,000 IU (20 mg)/0.2mL solution for injection in pre-filled syringe: 0.2 mL solution for injection in a 0.5 mL pre-filled syringe without scale. Pack sizes of 2, 6, 10, 20 and 50 syringes.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios Farmacéuticos ROVI, S.A., Julián Camarillo, 35, 2803, Madrid, Spain

Marketing authorization dates and numbers

PL 15406/0007



Drug Countries
AROVI Ireland, United Kingdom

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