This brand name is authorized in Nigeria.
The drug SALTROL contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
O2GMZ0LF5W - FLUTICASONE PROPIONATE
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Fluticasone has anti-inflammatory and vasoconstrictive features. Fluticasone given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of both symptoms and exacerbations of asthma, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically. |
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2
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UNII
6EW8Q962A5 - SALMETEROL XINAFOATE
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Salmeterol is a selective long-acting (12 hour) β2 adrenoceptor agonist. These pharmacological properties of salmeterol offer more effective protection against histamine-induced bronchoconstriction and produce a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting β2 agonists. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| B4-9409 | Pressurised inhalation | SALTROL INHALER 25MCG + 125MCG INHALANT 125 mcg; 25 mcg 1 X 120 | 18 RNW-PP-339252 SALTROL INHALER 25MCG + 125MCG SALMETEROL 25MCG + FLUTICASONE PROPIONATE 125MCG SALMETERO 25MCG, FLUTICASONE PROPIONATE PH. EUR. 125MCG ALSO CONTAINS: CFC-FREE PROPELLANT, HFA 134A B4-9409 Drugs Imported Products 1120 POM 1 7/11/2023 GETZ PHARMA NIGERIA LIMITED, PLOT 2, IJAODOLA CLOSE, OFF ADEYEMO ALAKIJA STREET, IKEJA GRA, LAGOS. 8165370750 nneka.obegolu@getzpharma.com GETZ PHARMA (PRIVATE) LIMITED, 29 – 30/27, KORANGI INDUSTRIAL AREA,KARACHI-74900 PAKISTAN , Pakistan | 31/10/2023 |
| B4-9595 | Spray, Metered-Dose | SALTROL INHALER 25MCG + 250MCG SPRAY_MET 250 mcg/Metered-Dose; 25 mcg/Metered-Dose 1 X 120 | 128 RNW-PP-354550 SALTROL INHALER 25MCG + 250MCG SALMETEROL 25MCG + FLUTICASONE PROPIONATE 250MCG SALMETERO 25MCG, FLUTICASONE PROPIONATE PH. EUR. 250MCG ALSO CONTAINS: CFC-FREE PROPELLANT, HFA 134A B4-9595 Drugs Imported Products 1120 POM 1 9/26/2023 GETZ PHARMA NIGERIA LIMITED, PLOT 2, IJAODOLA CLOSE, OFF ADEYEMO ALAKIJA STREET, IKEJA GRA, LAGOS. 8165370750 nneka.obegolu@getzpharma.com GETZ PHARMA (PRIVATE) LIMITED, 29 – 30/27, KORANGI INDUSTRIAL AREA,KARACHI-74900 PAKISTAN , Pakistan | 21/12/2023 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| R03AK06 | Salmeterol and fluticasone | R Respiratory system → R03 Drugs for obstructive airway diseases → R03A Adrenergics, inhalants → R03AK Adrenergics and other drugs for obstructive airway diseases |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| NG | Registered Drug Product Database | B4-9409, B4-9595 |
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