Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Clinigen Healthcare B.V., Schiphol Boulevard 359, WTC Schiphol Airport, D Tower 11th floor, 1118BJ Schiphol, Netherlands
Rybrila 160 micrograms/ml Oral Solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Rybrila is a clear, colourless, strawberry flavoured liquid. The oral solution has a pH between 3.5 and 4.5. |
Each ml oral solution contains 200 micrograms of glycopyrronium bromide equivalent to 160 micrograms of glycopyrronium.
Excipient(s) with known effect:
Sorbitol (E420)
Sodium methyl parahydroxybenzoate (E219)
Sodium propyl parahydroxybenzoate (E217)
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 |
|---|
|
Glycerol Strawberry flavour: Flavouring substance |
150 ml amber type III glass bottle with a tamper evident child resistant HDPE/PP screw cap.
Each 150 ml bottle is provided in a cardboard carton with a 15 ml graduated LDPE oral syringe and a PE syringe adaptor to allow the correct dose to be measured.
Rybrila is also available in multipacks of 2 × 150 ml, 3 × 150 ml, 4 × 150 ml, and 5 × 150 ml.
Not all pack sizes may be marketed.
Clinigen Healthcare B.V., Schiphol Boulevard 359, WTC Schiphol Airport, D Tower 11th floor, 1118BJ Schiphol, Netherlands
PA22701/001/001
Date of first authorisation: 23rd July 2021
| Drug | Countries | |
|---|---|---|
| RYBRILA | Finland, Ireland |
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