Haloperidol injection

Form: Injection (IM/IV)

Strength: 5 mg/mL

Reference Brands: Haldol®(US)

Category: Antipsychotropic Drugs

Haloperidol injection, available in both immediate- and long-acting (decanoate) forms, is FDA-approved in the U.S. for treating schizophrenia and acute psychotic agitation. In the EU, it is authorized under national procedures for similar psychiatric indications. Regulatory requirements include GMP-compliant sterile manufacturing, validated parenteral dosing, and safety data addressing extrapyramidal effects, QT prolongation, and neuroleptic malignant syndrome. U.S. submissions must include REMS (Risk Evaluation and Mitigation Strategy) when applicable. EU approvals require full pharmacovigilance systems and may involve risk minimization measures. To explore dossier-ready Haloperidol injections and alternative formulations, visit Pharmatradz.com — your trusted B2B pharma platform.