This brand name is authorized in Austria, Croatia, Cyprus, Ecuador, Estonia, Finland, Hong Kong SAR China, Ireland, Lithuania, Malta, Poland, Romania, Singapore, South Africa, UK.
The drug SKUDEXA contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
9N7R477WCK - TRAMADOL HYDROCHLORIDE
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Tramadol is a centrally acting opioid analgesic. It is a non selective pure agonist at μ-, δ- and κ-opioid receptors with a higher affinity for the μ-receptor. Other mechanisms which may contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release. Tramadol has an antitussive effect. In contrast to morphine, analgesic doses of tramadol over a wide range have no respiratory depressant effect. |
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2
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UNII
6KD9E78X68 - DEXKETOPROFEN
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Dexketoprofen belongs to the non-steroidal anti-inflammatory group of drugs. The mechanism of action of Dexketoprofen is related to the reduction of prostaglandin synthesis by the inhibition of cyclooxygenase pathway. Furthermore, the inhibition of the synthesis of prostaglandins could affect other inflammation mediators such as kinins, causing an indirect action which would be additional to the direct action. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| SKUDEXA Film-coated tablet | 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 | |
|---|---|---|
| N02AJ14 | Tramadol and dexketoprofen | N Nervous system → N02 Analgesics → N02A Opioids → N02AJ Opioids in combination with non-opioid analgesics |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 7461-MEE-0822 |
| EE | Ravimiamet | 1674042, 1674064, 1674075, 1674086, 1674109, 1674110, 1674121, 1727063, 1732687, 1740192, 1740204, 1740215, 1740226, 1740237, 1740248, 1740259, 1740260 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 093126 |
| GB | Medicines & Healthcare Products Regulatory Agency | 350291, 350292 |
| HK | Department of Health Drug Office | 65491 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-561072688, HR-H-649118396 |
| IE | Health Products Regulatory Authority | 69801, 69802 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1075389, 1080167, 1080168, 1080169, 1080170, 1080171, 1080172, 1080789, 1081165, 1085265, 1085266, 1085267, 1085268, 1085269, 1085270, 1085271, 1085272 |
| MT | Medicines Authority | MA204/00701, MA204/00703 |
| PL | Rejestru Produktów Leczniczych | 100336412, 100389101 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W63725001, W63725002, W63725003, W63725004, W63725005, W63725006, W63725007, W63725008, W63725009, W63725010, W63725011, W63725012, W63725013, W63725014, W63725015, W63725016, W63725017, W63725018, W63725019, W63725020, W63725021, W63725022, W63725023, W63725024, W63725025, W63725026, W63725027, W65395001, W65395002, W65395003, W65395004, W65395005, W65395006, W65395007, W65395008 |
| SG | Health Sciences Authority | 15394P |
| ZA | Health Products Regulatory Authority | 54/2.8/0538 |
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