
Prilocaine + Lidocaine Creams and Ointments
Form: Creams and Ointments
Strength: 2.5%, 5%, 7% (prilocaine); 2.5% lidocaine
Reference Brands: EMLA, Oraqix, Ametop(US & EU)
Category: Analgesic
Prilocaine + lidocaine creams and ointments are approved in the EU and US for topical anesthesia in dermatological, dental, and minor surgical procedures. In the EU, brands like EMLA are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is based on comprehensive clinical data, with many generic formulations available. Both regions require detailed dossiers for approval and ongoing pharmacovigilance. For regulatory support, dossier preparation, and compliance, visit PharmaTradz. We facilitate seamless market access for prilocaine + lidocaine formulations, ensuring adherence to European and American standards for safe, effective topical anesthesia, navigating complex regulatory landscapes seamlessly.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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