| Product Information |
|
| Registration Number |
DR-XY44936
|
| Generic Name |
Indacaterol (as maleate) + Glycopyrronium (as bromide)
|
| Brand Name |
Glycoair Breezhaler
|
| Dosage Strength |
110 mcg/50 mcg equivalent to 85 mcg/43 mcg delivered dose)
|
| Dosage Form |
Pre-Metered Dose Dry Powder For Inhalation
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Adrenergic - Anticholinergic Combination
|
| Packaging |
PA/Alu/PVC-Alu blister pack + 1 inhaler device (Box of 1
blister pack x 10 capsules as Physician's sample; Box of 3 blister packs x 10 capsules)
|
| Manufacturer |
Novartis Pharma Stein AG
|
| Country of Origin |
Switzerland
|
| Trader |
|
| Importer |
Novartis Healthcare Philippines, Inc.
|
| Distributor |
UNILAB, Inc.
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
31 March 2022
|
| Expiry Date |
27 November 2025
|