This brand name is authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, UK.
The drug ULTIBRO contains a combination of these active pharmaceutical ingredients (APIs):
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UNII
2JEC1ITX7R - INDACATEROL MALEATE
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Indacaterol is a partial agonist at the human beta2-adrenergic receptor with nanomolar potency. When inhaled, indacaterol acts locally in the lung as a bronchodilator. In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action. |
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UNII
V92SO9WP2I - GLYCOPYRROLATE
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Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anticholinergic) for once-daily maintenance bronchodilator treatment of COPD. Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways. |
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This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| R03AL04 | Indacaterol and glycopyrronium bromide | R Respiratory system → R03 Drugs for obstructive airway diseases → R03A Adrenergics, inhalants → R03AL Adrenergics in combination with anticholinergics |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 526516050086605, 526516050086705 |
| CA | Health Products and Food Branch | 02418282 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 257-MEE-0414, 5331-MEE-0720 |
| EE | Ravimiamet | 1626533, 1626544, 1626555, 1626566, 1626577, 1626588, 1747571 |
| ES | Centro de información online de medicamentos de la AEMPS | 113862003 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 169596, 473807 |
| FR | Base de données publique des médicaments | 62553246 |
| GB | Medicines & Healthcare Products Regulatory Agency | 280074, 335704 |
| HK | Department of Health Drug Office | 63009, 66270 |
| IE | Health Products Regulatory Authority | 37690 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7421 |
| IT | Agenzia del Farmaco | 043031018, 043031020, 043031032, 043031044, 043031057, 043031069, 043031071, 043031083 |
| JP | 医薬品医療機器総合機構 | 2259805G1027 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1071501, 1071502, 1071503, 1071504, 1071505, 1071506, 1080632, 1080633 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 076M2014 |
| NL | Z-Index G-Standaard, PRK | 107506 |
| NZ | Medicines and Medical Devices Safety Authority | 16633 |
| PL | Rejestru Produktów Leczniczych | 100302590 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W64767001 |
| SG | Health Sciences Authority | 14539P |
| TN | Direction de la Pharmacie et du Médicament | 20833061 |
| ZA | Health Products Regulatory Authority | 47/10.2.1/1183 |
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