BUDESONIDE Nebuliser Suspension

Product name and form

Budesonide 0.5mg Nebuliser Suspension.

Pharmaceutical Form

Nebuliser suspension.

White to off-white suspension.

Qualitative and quantitative composition

One ml of suspension contains 0.25mg budesonide.

One ampoule of 2ml suspension contains 0.5mg budesonide.

For the full list of excipients, see section 6.1.

List of Excipients

Disodium edetate
Sodium chloride
Polysorbate 80
Citric acid
Sodium citrate
Water for injection

Pack sizes and marketing

Low density polyethylene ampoule containing 2ml nebuliser suspension.

Pack sizes: Tri-laminate foil sachets containing 5, 20, 24, 40 (2 × 20) and 60 ampoules (in strips of 4, 5, 8, 10 or 12 ampoules).

Not all pack sizes may be marketed.

Marketing Authorization Holder
Authorization Dates

Breath Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom

26-10-2005 / 24-02-2009

Marketing authorization number:

PL: 18023/0007