HEMANGIOL Oral solution Ref.[7053] Active ingredients: Propranolol

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: PIERRE FABRE DERMATOLOGIE, 45 place Abel Gance, F-92100 Boulogne

Product name and form

HEMANGIOL 3.75 mg/mL oral solution.

Pharmaceutical Form

Oral solution.

Clear, colourless to slightly yellow oral solution, with a fruity odour.

Qualitative and quantitative composition

1 ml of solution contains 4.28 mg of propranolol hydrochloride equivalent to 3.75 mg of propranolol base.

Excipients with known effect: 1 ml of solution contains Propylene glycol 2.60 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Propranolol

Propranolol is a competitive antagonist at both beta, and beta2-adrenoceptor, but has membrane stabilising activity at concentrations exceeding 1-3mg/litre, though such concentrations are rarely achieved during oral therapy. Competitive beta-blockade has been demonstrated in man by a parallel shift to the right in the dose-heart rate response curve to beta-agonists such as isoprenaline.
List of Excipients
  • Hydroxyethylcellulose
  • Sodium saccharin
  • Strawberry flavour (contains propylene glycol)
  • Vanilla flavour (contains propylene glycol)
  • Citric acid monohydrate
  • Purified water

Pack sizes and marketing

120 mL solution, in a type III amber-glass bottle fitted with a low density polyethylene insert and a child resistant polypropylene screw cap, provided with a polypropylene oral syringe graduated in mg of propranolol base.

Pack size: carton containing 1 bottle and 1 oral syringe.

Marketing authorization holder

PIERRE FABRE DERMATOLOGIE, 45 place Abel Gance, F-92100 Boulogne

Marketing authorization dates and numbers

EU/1/14/919/001

Date of first authorisation: 23 April 2014

Drugs

Drug Countries
HEMANGIOL Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Turkey
 
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