This brand name is authorized in Nigeria. It is also authorized in Australia, Canada, Croatia, Cyprus, Estonia, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK, United States.
The drug VENTOLIN contains one active pharmaceutical ingredient (API):
1
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UNII
021SEF3731 - ALBUTEROL SULFATE
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Salbutamol is a selective β2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. At therapeutic doses it acts on the β2-adrenoceptors of bronchial muscle. Salbutamol is administered for the symptomatic relief of bronchospasm associated with chronic or acute asthma, bronchitis or other obstructive pulmonary diseases. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| 04-0519 | Inhalation gas | Ventolin 100 mcg Inhaler_ GAS 100 mcg 1 x 200 actuations (in aluminium alloy can) | Pressurised inhalation, solution Pressurised metered-dose inhaler 29 VENTOLIN 100MCG INHALER VENTOLIN SABUTAMOL SULPHATE SABUTAMOL SULPHATE 100MCG PRESCRIPTION ONLY MEDICINE INHALER 1 X 200 METERED DOSES BRONCHODILATOR GLAXOSMITHKLINE PHARMACEUTICAL NIGERIA LTD GSK HOUSE 1, INDUSTRIAL AVENUE, ILUPEJU LAGOS GLAXO WELLCOME PRODUCTION 23, RUE LAVOISIER 2700, EVREUX, FRANCE 04-0519 FOR THE MANAGEMENT OF ASTHMA, EMPHYSEMA 06/24/2021 06/23/2026 | 24/06/2021 |
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| VENTOLIN Solution for injection | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) | |
| VENTOLIN Solution for inhalation via a nebuliser | MPI, EU: SmPC | Υπουργείο Υγείας (CY) | |
| VENTOLIN Syrup | MPI, EU: SmPC | Υπουργείο Υγείας (CY) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| R03AC02 | Salbutamol | R Respiratory system → R03 Drugs for obstructive airway diseases → R03A Adrenergics, inhalants → R03AC Selective beta-2-adrenoreceptor agonists |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 1103C, 11088N, 11095Y, 11125M, 11130T, 12108G, 12109H, 3495Y, 8288F |
| CA | Health Products and Food Branch | 02213419, 02213427, 02213451, 02213486, 02241497, 02243115 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 24.376-03-02, 24.641-08-02, 24.828-11-02, 25.592-03-04, 497-MEE-1014, 6931-MEE-0122 |
| EE | Ravimiamet | 1004319, 1004948, 1005512, 1006423, 1031308 |
| ES | Centro de información online de medicamentos de la AEMPS | 53010, 53931, 53932, 55147, 55148 |
| GB | Medicines & Healthcare Products Regulatory Agency | 139675, 139690, 147510, 14794, 19076, 200311, 24712, 33820, 33832, 33873, 381729, 39270, 48441 |
| HK | Department of Health Drug Office | 02796, 07007, 26476, 42389 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-659347356 |
| IE | Health Products Regulatory Authority | 52005, 52060, 52074, 52221, 53899, 55778, 68152, 68160, 74126, 74135 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 290, 292, 4151, 4350, 4351 |
| IT | Agenzia del Farmaco | 022984052 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1001947, 1002425, 1006578, 1012096, 1012097, 1078750, 1080799, 1086182, 1088354, 1088456, 1089751 |
| MT | Medicines Authority | AA565/26305, MA192/03301, MA192/03302, MA192/03303, MA192/03304, PI1438/08301A, PI1438/08302A, PI521/00401C, PI565/26306A, PI908/01603A, PI908/01604A, PI908/01605A |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 72948, 77849, 80307, 86514, 88021 |
| NG | Registered Drug Product Database | 04-0519 |
| NL | Z-Index G-Standaard | 12304131, 12309605, 13488066, 14039354, 14127199, 14127202, 14162644, 14172348 |
| NL | Z-Index G-Standaard, PRK | 15067, 15539, 22098, 43281, 47708, 75124, 75272, 82465 |
| NZ | Medicines and Medical Devices Safety Authority | 1142, 1145, 1146, 1147, 1152, 1153 |
| PL | Rejestru Produktów Leczniczych | 100089356, 100090603, 100090610, 100256305, 100261996, 100436579 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W64944001, W64944002, W65178001, W65179001 |
| SG | Health Sciences Authority | 02539P, 02988P, 05334P, 08211P, 08240P, 09425P, 11359P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699522019281, 8699522521456, 8699522521494, 8699522571413 |
| US | FDA, National Drug Code | 0173-0682, 35356-166, 63187-026, 68071-1670, 68071-1890, 70518-1237, 72189-016 |
| ZA | Health Products Regulatory Authority | 31/10.2.1/0120, 32/10.2.1/0344, D/10.2.1/203, H/10.2.2/118, H/10.2.2/119 |
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