Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom
Soprobec 50 micrograms per actuation pressurised inhalation solution.
| Pharmaceutical Form |
|---|
|
Pressurised inhalation solution. The solution is clear and colourless. |
Each metered dose (the dose leaving the valve) contains 50 micrograms of beclometasone dipropionate.
Excipients with known effect: 7.47 mg ethanol per actuation.
For full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Beclometasone |
Beclometasone is a pro-drug with weak glucocorticoid receptor binding affinity. It is extensively hydrolysed via esterase enzymes to the active metabolite beclometasone-17-monopropionate (B-17-MP), which has potent topical anti-inflammatory activity. |
| List of Excipients |
|---|
|
Norflurane (HFA-134a) |
50mcg:
Soprobec is supplied in an aluminium canister fitted with a metering valve, cream coloured actuator and dark brown colour dust cap.
Each pack contains either a single inhaler, or two inhalers.
Each inhaler delivers 200 actuations.
Not all pack sizes may be marketed.
Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom
PL 25258/0278
20/12/2018
| Drug | Countries | |
|---|---|---|
| SOPROBEC | Spain, Malta, Poland, Romania, United Kingdom |
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