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
|