MONOVER Solution for injection / infusion Ref.[49847] Active ingredients:

Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark

Product name and form

Monover 100 mg/ml solution for injection/infusion (vials).

Pharmaceutical Form
Solution for injection/infusion. Dark brown, non transparent solution.

Qualitative and quantitative composition

One millilitre of solution contains 100 mg iron as ferric derisomaltose.

1 ml ampoule contains 100 mg iron as ferric derisomaltose
2 ml ampoule contains 200 mg iron as ferric derisomaltose
5 ml ampoule contains 500 mg iron as ferric derisomaltose
10 ml ampoule contains 1,000 mg iron as ferric derisomaltose

For the full list of excipients, see section 6.1.

List of Excipients
Water for injections Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)

Pack sizes and marketing

Type 1 glass vial with chlorobutyle rubber stopper and aluminium cap.

Pack sizes: 1 × 1ml, 5 × 1 ml, 10 × 1 ml, 5 × 2 ml, 10 × 2 ml, 1 × 5ml, 2 × 5 ml, 5 × 5 ml, 1 × 10ml, 2 × 10 ml, 5 × 10 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark

Marketing authorization dates and numbers

PA0982/002/002

Date of first authorisation: 9^th April 2010
Date of last renewal: 26^th November 2014

Drugs

Drug	Countries
MONOVER	France, Ireland, Japan, Poland

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