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EXEMBOL Solution for infusion (2017)

Product Name and Form

Exembol 1 mg/ml Solution for Infusion.

Pharmaceutical form

Solution for Infusion.

Clear colourless to pale yellow solution.

The pH of the intravenous solution is 5.0–8.0.

Qualitative and Quantitative Composition

One ml solution for infusion contains 1 mg argatroban monohydrate.

One vial with 50 ml solution for infusion contains 50 mg argatroban monohydrate.

Excipients: 1 ml of solution for infusion contains 4 mg ethanol (0.5% by volume), 3 mg sorbitol (E420 i) and 9 mg sodium chloride.

For a full list of excipients, see section 6.1.

List of excipients

Sorbitol (E420i)
Sodium chloride
Anhydrous ethanol
Water for injections

Pack sizes and Marketing

Clear 50 ml glass vial sealed with an ethylene tetrafluorethylene (ETFE)-coated chlorobutyl rubber stopper and aluminium crimp-seal with a polypropylene flip-off cap. Each vial contains 50 ml of solution for infusion.

Vials are supplied in cardboard cartons of 4 or 12 vials. Not all pack-sizes may be marketed.

Marketing authorization holder
Authorization dates

Mitsubishi Tanabe Pharma Europe Ltd, Dashwood House, 69 Old Broad Street, London EC2M 1QS, United Kingdom

2015-12-31

Marketing authorization number:

PL 20012/0011