| Product Information |
DR-XY43865_PI_01.pdf
|
| Registration Number |
DR-XY43865
|
| Generic Name |
Indacaterol (as maleate) + Glycopyrronium (as bromide)
|
| Brand Name |
Ultibro Breezhaler
|
| Dosage Strength |
110 mcg/50 mcg
|
| Dosage Form |
Powder for Inhalation in Hard Capsule
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
Alu/Alu Blister Pack x 6's (Box of 6's and 30's) with
inhaler device
|
| Pharmacologic Category |
-
|
| Manufacturer |
Siegfried Barbera, S.L.
|
| Country of Origin |
Spain
|
| Trader |
|
| Importer |
Novartis Healthcare Philippines, Inc.
|
| Distributor |
|
| Application Type |
Initial (Variation)
|
| Issuance Date |
27 May 2022
|
| Expiry Date |
27 May 2027
|