Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Proveca Pharma Limited, Marine House, Clanwilliam Place, Dublin 2, Ireland
Sialanar 320 micrograms /ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear, colourless solution. |
Each ml contains 400 micrograms glycopyrronium bromide equivalent to 320 micrograms of glycopyrronium.
Each ml contains 2.3 mg sodium benzoate (E211).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Glycopyrronium |
Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anticholinergic) for once-daily maintenance bronchodilator treatment of COPD. Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways. |
| List of Excipients |
|---|
|
Sodium benzoate (E211) |
Amber coloured glass bottle with a high density polyethylene tamper evident child resistant closure with expanded low density polyethylene liner. The bottle contains 60 ml or 250 ml of oral solution.
Pack size of one bottle, one 8 ml low density polyethylene oral syringe (0.1 ml graduations) and one syringe adaptor.
Not all pack sizes may be marketed.
Proveca Pharma Limited, Marine House, Clanwilliam Place, Dublin 2, Ireland
EU/1/16/1135/001 (250 ml bottle)
EU/1/16/1135/002 (60 ml bottle)
Date of first authorisation: 15 September 2016
| Drug | Countries | |
|---|---|---|
| SIALANAR | Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
