| Product Information |
DR-XY48771_PI_01.pdf
|
| Registration Number |
DR-XY48771
|
| Generic Name |
Budesonide/Glycopyrronium (as bromide)/
Formoterol fumarate (as dihydrate)
|
| Brand Name |
Breztri Aerosphere
|
| Dosage Strength |
160 mcg/7.2 mcg/4.8 mcg per actuation
|
| Dosage Form |
Pressurized Metered-Dose Suspension for Inhalation
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Fluorinated ethylene propylene coated aluminum can
sealed with metering valve dessicated flow path yellow plastic actuator with grey plastic dust cap and shield- style dose indicator x 120 actuations
(Box of 1 canister overwrapped in foil laminated pouch with dessicant)
|
| Manufacturer |
AstraZeneca Dunkerque Production.
|
| Country of Origin |
France
|
| Trader |
|
| Importer |
AstraZeneca Pharmaceuticals (Phils.), Inc.
|
| Distributor |
AstraZeneca Pharmaceuticals (Phils.), Inc.
|
| Application Type |
Monitored Release
|
| Issuance Date |
09 June 2023
|
| Expiry Date |
09 June 2028
|