| Product Information |
|
| Registration Number |
DR-XY45684
|
| Generic Name |
Tiotropium (as bromide) + Olodaterol (as hydrochloride)
|
| Brand Name |
Spiolto Respimat
|
| Dosage Strength |
2.5 mcg/ 2.5 mcg per puff
|
| Dosage Form |
Solution for Oral
Inhalation
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Bronchodilator (Adrenergic in combination with
Anticholinergic)
|
| Packaging |
Aluminum cylinder (cartridge) container x 4 mL (60 puffs equivalent to 30 medicinal doses) + reusable inhaler device in a box.
|
| Manufacturer |
Boehringer Ingelheim Pharma GmbH & Co. KG
|
| Country of Origin |
Germany
|
| Trader |
N/A
|
| Importer |
Boehringer Ingelheim (Phil.), Inc.
|
| Distributor |
N/A
|
| Application Type |
Initial (from Monitored Release (MR) status)
|
| Issuance Date |
19 May 2022
|
| Expiry Date |
25 November 2026
|