| Product Information |
|
| Registration Number |
DR-XY48401
|
| Generic Name |
Indacaterol (as acetate) + Mometasone furoate
|
| Brand Name |
Atectura Breezhaler
|
| Dosage Strength |
150 mcg/ 160 mcg (equivalent to 125 mcg/ 127.5 mcg
delivered dose)
|
| Dosage Form |
Powder for Inhalation in Hard Capsule
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Adrenergic-Corticosteroid Combination
|
| Packaging |
PA/Alu/PVC-Alu Blister Pack x 10's with inhaler device (Box of 10's and 30's)
|
| Manufacturer |
Novartis Pharma Stein AG
|
| Country of Origin |
Switzerland
|
| Trader |
N/A
|
| Importer |
Novartis Healthcare Philippines, Inc.
|
| Distributor |
N/A
|
| Application Type |
Monitored Release
|
| Issuance Date |
07 October 2022
|
| Expiry Date |
07 October 2027
|