LamotriginevDispersible tablets

Form: Tablets(IR & ER)

Strength: XR: 25 mg, 50 mg, 100 mg, 200 mg; IR: 25 mg, 100 mg, 200 mg, 300 mg

Reference Brands: Lamictal, Lamictal XR(EU & US)

Category: Multiple sclerosis

Lamotrigine dispersible tablets, available as immediate-release (IR) and extended-release (ER), are approved in the US by the FDA and in the EU via EMA for epilepsy and bipolar disorder management. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial data and manufacturing processes, while the EMA ensures compliance with regional safety and quality regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance facilitates timely approvals, supports safe use, and promotes worldwide availability of lamotrigine dispersible tablets, improving long-term patient care globally.