INHIXA 2,000 IU Solution for injection in pre-filled syringe Ref.[27648] Active ingredients: Enoxaparin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Techdow Pharma Netherlands B.V., Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Netherlands

Product name and form

Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection.

Pharmaceutical Form

Solution for injection in pre-filled syringe.

Clear, colourless to pale yellow solution.

Qualitative and quantitative composition

10,000 IU/mL (100 mg/mL) solution for injection:

Each pre-filled 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

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

0.2 mL of solution in:

  • a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a blue polypropylene plunger rod. The syringe can be additionally equipped with needle guard or manual needle guard; or
  • a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a white polycarbonate plunger rod equipped with UltraSafe Passive needle guard.

Packs of:

  • 1, 2, 6, 10 and 50 pre-filled syringe(s)
  • 2, 6, 10, 20, 50 and 90 pre-filled syringes with needle guard
  • 6 and 10 pre-filled syringes with manual needle guard
  • 2 and 6 pre-filled syringes with UltraSafe Passive needle guard

Not all pack sizes may be marketed.

Marketing authorization holder

Techdow Pharma Netherlands B.V., Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Netherlands

Marketing authorization dates and numbers

EU/1/16/1132/001
EU/1/16/1132/002
EU/1/16/1132/011
EU/1/16/1132/012
EU/1/16/1132/021
EU/1/16/1132/023
EU/1/16/1132/033
EU/1/16/1132/034
EU/1/16/1132/051
EU/1/16/1132/053
EU/1/16/1132/054
EU/1/16/1132/064
EU/1/16/1132/065
EU/1/16/1132/085
EU/1/16/1132/090

Date of first authorisation: 15/09/2016

Drugs

Drug Countries
INHIXA Albania, Austria, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom
 
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