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Parvolex 200 mg/ml Concentrate for Solution for Infusion (2014)

Product Name and Form

Parvolex 200 mg/ml Concentrate for Solution for Infusion.

Pharmaceutical form

Solution for infusion.

Clear colourless solution contained in a 10 ml clear colourless Type I glass ampoule.

Qualitative and Quantitative Composition

Each ml contains Acetylcysteine 200mg.

Each 10 ml contains 322.6 mg of sodium.

For a full list of excipients, see section 6.1.

List of excipients

Disodium edetate
Sodium hydroxide
Water for injections

Pack sizes and Marketing

Clear, Type I glass, 10ml snap ring ampoules. 10 × 10ml ampoules are packed in cartons.

Marketing authorization holder
Authorization dates

Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Co. Meath, Ireland

14/10/1992 / 14/01/2003

Marketing authorization number:

PL 35104/0011