INNOHEP 10,000 anti-Factor Xa IU/ml Solution for injection Ref.[7477] Active ingredients: Tinzaparin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Product name and form

innohep 10,000 IU/ml.

Pharmaceutical Form

Solution for injection.

Vials of 2 ml filled with a colourless to straw coloured liquid, free from turbidity and from matter that deposits on standing.

Qualitative and quantitative composition

Tinzaparin sodium 10,000 anti-Factor Xa IU/ml.

Excipients with known effect: Benzyl alcohol (10 mg/ml) and sodium (in total <23 mg/dose).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tinzaparin

Tinzaparin is an antithrombotic agent. It potentiates the inhibition of several activated coagulation factors, especially Factor Xa, its activity being mediated via antithrombin III.

List of Excipients

Benzyl alcohol
Sodium acetate
Sodium hydroxide
Water for injections

Pack sizes and marketing

2 ml multi-dose glass vial containing 10,000 anti-Factor Xa IU/ml.

Pack sizes: 1, 2, 5 or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Marketing authorization dates and numbers

PL 00043/0205

Date of first authorisation: 30 September 1998

Date of latest renewal: 26 April 2004

Drugs

Drug Countries
INNOHEP Austria, Canada, Germany, Spain, Finland, France, Hong Kong, Ireland, Netherlands, Romania, Singapore, United Kingdom, South Africa

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