SALAMOL Pressurised inhalation, suspension Ref.[27689] Active ingredients: Salbutamol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Norton Healthcare Ltd., T/A IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom

Product name and form

Salamol Easi-Breathe CFC-Free Inhaler.

100 micrograms Pressurised Inhalation, suspension.

Pharmaceutical Form

Pressurised Inhalation, suspension.

Qualitative and quantitative composition

One metered dose contains salbutamol sulfate equivalent to 100 micrograms salbutamol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Salbutamol

Salbutamol is a selective β2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. At therapeutic doses it acts on the β2-adrenoceptors of bronchial muscle. Salbutamol is administered for the symptomatic relief of bronchospasm associated with chronic or acute asthma, bronchitis or other obstructive pulmonary diseases.

List of Excipients

Ethanol, anhydrous
Norflurane (Propellant HFA-134a)

Salamol Easi-Breathe CFC-Free Inhaler contains a new propellant (HFA-134a) and does not contain any chlorofluorocarbon (CFC) propellants.

Pack sizes and marketing

A pressurised aluminium container with a metering valve and breath-operated actuator.

Each pack contains either:

Single pack with one Easi-Breathe MDI with 200 metered doses.

Twin pack with one Easi-Breathe MDI and one refill canister, each containing 200 metered doses (2 × 200, for Germany only).

Not all pack sizes may be marketed.

Marketing authorization holder

Norton Healthcare Ltd., T/A IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom

Marketing authorization dates and numbers

PL 00530/0556

Date of first authorisation: 14 April 2000
Date of latest renewal: 14 April 2010

Drugs

Drug Countries
SALAMOL Cyprus, Hong Kong, Ireland, Malta, Netherlands, New Zealand, United Kingdom

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