Dexketoprofen + Tramadol tablets
Form: Tablets
Strength: 25 mg dexketoprofen + 37.5 mg tramadol
Reference Brands: Enantyum(EU)
Category: Analgesic
Dexketoprofen + Tramadol tablets are approved in the EU for managing moderate to severe acute pain, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, this combination is currently not approved or marketed. In the EU, regulatory approval requires comprehensive clinical data and pharmacovigilance plans. Both regions enforce strict prescribing regulations due to the opioid component. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We facilitate seamless market access for dexketoprofen + tramadol formulations, ensuring adherence to European standards for safe, effective analgesic therapy while navigating complex regulatory pathways effectively.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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