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