Regulatory PathRegulatory requirements compared

Active substance

Pemetrexed disodium heptahydrate

Open in the medicines table

EMA European Union — centrally authorised medicines

Pemetrexed Baxter Baxter Holding B.V. · Withdrawn · authorised 9 Dec 2022 · ATC L01BA04

Therapeutic indication (EMA)

Malignant pleural mesotheliomaPemetrexed Baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancerPemetrexed Baxter 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 section 5.1). Pemetrexed Baxter 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 section 5.1). Pemetrexed Baxter 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 section 5.1).

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
ALIMTA 100MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSIONPLGB 14895/0230ELI LILLY NEDERLAND B.V.POM
ALIMTA 500MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSIONPLGB 14895/0231ELI LILLY NEDERLAND B.V.POM
PEMETREXED 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSIONPL 20416/1003CRESCENT PHARMA LIMITEDPOM
PEMETREXED 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSIONPL 20416/0843CRESCENT PHARMA LIMITEDPOM
PEMETREXED AFT 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSIONPL 57592/0039AFT PHARMA UK LIMITEDPOM
PEMETREXED AFT 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSIONPL 57592/0040AFT PHARMA UK LIMITEDPOM
PEMETREXED SUN 10 MG/ML SOLUTION FOR INFUSIONPL 31750/0193SUN PHARMACEUTICAL INDUSTRIES EUROPE BVPOM
PEMETREXED SUN 11 MG/ML SOLUTION FOR INFUSIONPL 31750/0194SUN PHARMACEUTICAL INDUSTRIES EUROPE BVPOM
PEMETREXED SUN 5 MG/ML SOLUTION FOR INFUSIONPL 31750/0185SUN PHARMACEUTICAL INDUSTRIES EUROPE BVPOM
PEMETREXED SUN 6 MG/ML SOLUTION FOR INFUSIONPL 31750/0186SUN PHARMACEUTICAL INDUSTRIES EUROPE BVPOM
PEMETREXED SUN 6.5 MG/ML SOLUTION FOR INFUSIONPL 31750/0187SUN PHARMACEUTICAL INDUSTRIES EUROPE BVPOM
PEMETREXED SUN 7 MG/ML SOLUTION FOR INFUSIONPL 31750/0188SUN PHARMACEUTICAL INDUSTRIES EUROPE BVPOM
PEMETREXED SUN 7.5 MG/ML SOLUTION FOR INFUSIONPL 31750/0189SUN PHARMACEUTICAL INDUSTRIES EUROPE BVPOM
PEMETREXED SUN 8 MG/ML SOLUTION FOR INFUSIONPL 31750/0190SUN PHARMACEUTICAL INDUSTRIES EUROPE BVPOM
PEMETREXED SUN 8.5 MG/ML SOLUTION FOR INFUSIONPL 31750/0191SUN PHARMACEUTICAL INDUSTRIES EUROPE BVPOM
PEMETREXED SUN 9 MG/ML SOLUTION FOR INFUSIONPL 31750/0192SUN PHARMACEUTICAL INDUSTRIES EUROPE BVPOM

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.