This brand name is authorized in Australia, Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Tunisia, UK.
The drug SPIOLTO contains a combination of these active pharmaceutical ingredients (APIs):
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UNII
L64SXO195N - TIOTROPIUM BROMIDE MONOHYDRATE
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Tiotropium is a long-acting, specific, muscarinic receptor antagonist, in clinical medicine often called an anticholinergic. By binding to the muscarinic receptors in the bronchial smooth musculature, tiotropium inhibits the cholinergic (bronchoconstrictive) effects of acetylcholine, released from parasympathetic nerve endings. |
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2
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UNII
65R445W3V9 - OLODATEROL HYDROCHLORIDE
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Olodaterol has a high affinity and high selectivity to the human beta2-adrenoceptor. The compound exerts its pharmacological effects by binding and activation of beta2-adrenoceptors after topical administration by inhalation. Activation of these receptors in the airways results in a stimulation of intracellular adenyl cyclase, an enzyme that mediates the synthesis of cyclic-3',5' adenosine monophosphate (cAMP). Elevated levels of cAMP induce bronchodilation by relaxation of airway smooth muscle cells. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| SPIOLTO RESPIMAT Inhalation solution | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| R03AL06 | Olodaterol and tiotropium 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) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 10557P |
| BR | Câmara de Regulação do Mercado de Medicamentos | 504520010021207 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 1559-MEE-1215 |
| EE | Ravimiamet | 1648481, 1648492, 1648504, 1648515 |
| ES | Centro de información online de medicamentos de la AEMPS | 79967 |
| FR | Base de données publique des médicaments | 63620349 |
| GB | Medicines & Healthcare Products Regulatory Agency | 299714, 376781 |
| HK | Department of Health Drug Office | 64356 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-852053792 |
| IE | Health Products Regulatory Authority | 46802, 46803 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7839 |
| JP | 医薬品医療機器総合機構 | 2259807G1026, 2259807G2022 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1086460, 1086461, 1086462, 1086463 |
| MT | Medicines Authority | MA211/00701 |
| NL | Z-Index G-Standaard, PRK | 127086 |
| NZ | Medicines and Medical Devices Safety Authority | 17124 |
| PL | Rejestru Produktów Leczniczych | 100346050 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W61818005, W61818006, W61818007, W61818008 |
| SG | Health Sciences Authority | 14923P |
| TN | Direction de la Pharmacie et du Médicament | 11533081 |
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