| Product Information |
|
| Registration Number |
DRP-11896
|
| Generic Name |
Budesonide + Formoterol Fumarate Dihydrate
|
| Brand Name |
Rolastym Combi
|
| Dosage Strength |
400 mcg / 12 mcg
|
| Dosage Form |
Dry Powder for Inhalation in Capsule
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Adrenergic-Corticosteroid Combination
|
| Packaging |
OPA/Alu/PVC-Alu blister pack x 10's (Box of 60's) + One
(1) plastic monodose (aerolizer) inhaler device.
|
| Manufacturer |
Deva Holding A.Ş Çerkezköy I
|
| Country of Origin |
Turkey
|
| Trader |
N/A
|
| Importer |
Ambicare Pharmaceuticals Inc.
|
| Distributor |
Ambicare Pharmaceuticals Inc.
|
| Application Type |
Monitored Release
|
| Issuance Date |
17 May 2022
|
| Expiry Date |
17 May 2027
|