Regulatory PathRegulatory requirements compared

Active substance

Pemetrexed ditromethamine

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIALpowder · intravenousHOSPIRADiscontinued10 Jun 2022

EMA European Union — centrally authorised medicines

Pemetrexed ditromethamine Hospira · Application withdrawn · ATC L01BA04

Therapeutic indication (EMA)

Treatment of malignant pleural mesothelioma and non-small cell lung cancer

Pemetrexed Pfizer (previously Pemetrexed Hospira UK Limited) Pfizer Europe MA EEIG · Withdrawn · authorised 24 Apr 2017 · ATC L01BA04

Therapeutic indication (EMA)

Malignant pleural mesothelioma Pemetrexed Hospira UK Limited in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Hospira UK Limited in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see SmPC section 5.1). Pemetrexed Hospira UK Limited is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see SmPC section 5.1). Pemetrexed Hospira UK Limited is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see SmPC section 5.1).

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.