Exembol 100 mg/ml concentrate for solution for infusion

Product name and form

Exembol 100 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for Solution for Infusion.

Clear colourless to pale yellow solution.

Qualitative and quantitative composition

1 ml concentrate for solution for infusion contains argatroban as 100 mg argatroban monohydrate.

1 Vial with 2.5 ml concentrate for solution for infusion contains argatroban as 250 mg argatroban monohydrate. Final concentration after dilution as recommended is 1 mg/ml (see section 6.6).

Excipients: 1 ml solution contains 400 mg ethanol (50% by volume) and 300 mg sorbitol.

For a full list of excipients, see section 6.1.

List of Excipients

Sorbitol (E 420i)
Anhydrous ethanol
Water for injections

Pack sizes and marketing

Clear 5 mL type I glass vial sealed with a teflon-coated chlorobutylrubber stopper and an aluminium crimp-seal with a polypropylene flip-off cap. Each vial contains 2.5 ml of concentrate for solution for infusion.

Vials are supplied in cardboard cartons of 1 or 6 vials. Not all pack-sizes may be marketed.

Marketing Authorization Holder
Authorization Dates

Mitsubishi Pharma Europe Ltd
6 th Floor Dashwood House
69 Old Broad Street
London EC2M 1QS
United Kingdom

11/05/2012

Marketing authorization number:

PL 20012/0008