Product Details
Aeroline Inhaler**
Salbutamol (Salbutamol Sulfate)100 mcg/Metered-Dose
Aerosol, Metered-Dose
ROA
Inhalation, Oral
Applicant Name
Jubilee & Associate Industries Ltd
NRN
04-8112
Status
Active
Composition
Salbutamol 100 mcg/actuation as Salbutamol Sulfate BP. Each actuation contains: Salbutamol Sulfate, micronized 120.5 mcg (equiv. to Salbutamol base 100 mcg), Ethanol 4.165 mg, Oleic acid 11.25 mcg, Norflurane 71.54 mg. Each canister contains at least 200 metered actuations providing 100 micrograms of salbutamol (as salbutamol sulfate BP). No overages are used for this product. But considering when the product is close to use up, the residual liquid in the container cannot be delivered out, we overfill about 40 deliveries in addition to the labeled 200 deliveries per container, so as to ensure the labeled number of the product can be realized. The concentration of drug substance in each actuation won’t be affected though the number of delivers per inhaler is designed as 240 doses
ATC Code
R03AC02
Product Category
Drugs
Marketing Category
Prescription-only Medicine (POM)
Packsize
1 x 200 Metered Doses (in Aluminium canister with a metered-dose valve system)
Product Description
Oral Inhalation, Aerosol
Manufacturer Name
Jewim Pharmaceutical (Shandong) Co. Ltd
Manufacturer Country
CHINA
Approval Date
2021-06-24
Expiry Date
2026-06-23