This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Singapore, South Africa, Spain, UK.
The drug STALEVO contains a combination of these active pharmaceutical ingredients (APIs):
1
|
UNII
46627O600J - LEVODOPA
|
|
According to the current understanding, the symptoms of Parkinson’s disease are related to depletion of dopamine in the corpus striatum. Dopamine does not cross the blood-brain barrier. Levodopa, the precursor of dopamine, crosses the blood brain barrier and relieves the symptoms of the disease. |
|
2
|
UNII
MNX7R8C5VO - CARBIDOPA
|
|
Carbidopa is a peripheral aromatic amino acid decarboxylase inhibitor. It prevents metabolism of levodopa to dopamine in the peripheral circulation, ensuring that a higher proportion of the dose reaches the brain, where dopamine exerts its therapeutic effects. A lower dose of levodopa can be used when it is coadministered with carbidopa, reducing the incidence and severity of peripheral side effects. |
|
3
|
UNII
4975G9NM6T - ENTACAPONE
|
|
Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors. It is a reversible, specific, and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa preparations. Entacapone prolongs the clinical response to levodopa. |
|
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| STALEVO Film-coated tablet | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| N04BA03 | Levodopa, decarboxylase inhibitor and COMT inhibitor | N Nervous system → N04 Anti-parkinson drugs → N04B Dopaminergic agents → N04BA Dopa and dopa derivatives |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 8797B, 8798C, 8799D, 9292C, 9344T, 9345W |
| BR | Câmara de Regulação do Mercado de Medicamentos | 511521010072617, 511521010072717, 511521010072817 |
| CA | Health Products and Food Branch | 02305933, 02305941, 02305968, 02337827, 02337835 |
| DE | Bundesinstitut für Arzneimittel und Medizinprodukte | 00003056, 00159947, 00206380, 00206411, 00209697, 00209705, 00215410, 00215427, 00325328, 00363441, 00363470, 00996175, 00996181, 01043514, 01055569, 01433126, 01437791, 01682668, 01682728, 01682757, 01897274, 02031654, 02031660, 02034279, 02208785, 02208839, 02208897, 02731222, 02733296, 02847479, 03070337, 03116602, 03445990, 03446239, 03450838, 04551062, 04551079, 04551116, 04866920, 04866995, 04867055, 04871619, 04871708, 06140067, 06140073, 06309626, 06407808, 06468974, 06492091, 06492116, 06888943, 06907310, 06908261, 06908284, 07238733, 07238756, 07404841, 09339059, 09339065, 09481946, 09485743, 09485766, 09508680, 09616642, 09632776, 09637354, 09775783, 09938073, 10000254, 10000260, 10000277, 10000283, 10070823, 16124017, 16124023, 16124046, 16802210, 17526491, 17927020, 17927037 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 26.082-12-04, 26.083-12-04, 26.084-12-04, 29299-07-10, 29591-01-11, 30305-10-12 |
| EE | Ravimiamet | 1172797, 1172809, 1172810, 1172821, 1172832, 1172843, 1172854, 1172865, 1172876, 1172887, 1172898, 1172900, 1265150, 1265161, 1265172, 1367973, 1367984, 1367995, 1368008, 1368019, 1368020, 1368042, 1368053, 1472206, 1472217, 1472228, 1472240, 1472251, 1472262, 1472273, 1472284, 1472295, 1472307, 1538568, 1538579, 1538580, 1538603, 1538614, 1843635 |
| ES | Centro de información online de medicamentos de la AEMPS | 03260003, 03260007, 03260011, 03260021, 03260026, 03260031 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 015605, 015652, 015655, 015663, 015707, 015718, 032112, 032124, 032146, 032157, 140974, 491775 |
| FR | Base de données publique des médicaments | 61186758, 62892111, 65247735, 65927172, 66851724, 68232927, 69044807 |
| GB | Medicines & Healthcare Products Regulatory Agency | 136449, 136450, 139545, 139555, 154404, 154405, 154409, 154410, 162489, 162491, 162493, 181928, 181930, 181934, 197016, 197017, 368960, 368965, 368970, 368973, 368975, 375345, 375348, 375351, 377034, 377303, 381680, 391758, 52989, 52992, 52997, 52999, 53023, 53028 |
| HK | Department of Health Drug Office | 52081, 59640, 59652, 60086, 60104, 60105 |
| IE | Health Products Regulatory Authority | 13206, 13207, 13208, 45401, 45433, 45482, 45730, 45762, 45782, 45794, 61530, 62440, 62441, 62442, 62443, 62464, 62475, 62501, 62505, 62534, 62580, 62622, 62654, 62680, 70415, 71596, 72581, 73147, 74802 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 4844, 4845, 4846, 6454, 6457, 6458 |
| IT | Agenzia del Farmaco | 036825038, 036825077, 036825115, 036825216, 036825242, 036825255 |
| JP | 医薬品医療機器総合機構 | 1169102F1027, 1169102F2023 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1004403, 1004404, 1004405, 1004912, 1005015, 1005016, 1005017, 1005018, 1005544, 1005545, 1005546, 1005547, 1030854, 1030855, 1030856, 1030857, 1030858, 1030859, 1030860, 1030861, 1030862, 1030863, 1030864, 1030865, 1032125, 1032126, 1032127, 1037732, 1037735, 1037736, 1037737, 1037740, 1037741, 1063134, 1063135, 1063136, 1063137, 1063138 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 499M2004 |
| NL | Z-Index G-Standaard, PRK | 119938, 119946, 119954, 86703, 89680, 89699 |
| NZ | Medicines and Medical Devices Safety Authority | 11072, 11073, 11074, 13337, 13825, 13826 |
| PL | Rejestru Produktów Leczniczych | 100129802, 100129819, 100129825, 100196425, 100209955, 100209961, 100261915 |
| SG | Health Sciences Authority | 13141P, 13142P, 13143P, 13566P |
| US | FDA, National Drug Code | 0078-0407, 0078-0408, 0078-0409, 0078-0527, 0078-0544, 0078-0545, 52427-805, 52427-809, 52427-816, 52427-827, 52427-834, 52427-842 |
| ZA | Health Products Regulatory Authority | 38/5.4.1/0138 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.