Is Pemetrexed registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 15 valid registrations of Pemetrexed, including ALIMTA 500MG POWDER FOR SOLUTION FOR INFUSION (500 mg, Powder for concentrate for solution for infusion, SAR 3861.45); ALMETRA (500 mg, Powder for concentrate for solution for infusion, SAR 2595.15); Alix (500 mg, Lyophilisate for solution for injection, SAR 2595.15); PEMETREXED SPC 500 mg Powder for Solution for Infusion (500 mg, Powder for solution for infusion, SAR 2384.10); PEMITRA 500 mg Vial (500 mg, Powder for concentrate for solution for infusion, SAR 3784.30).

Is Pemetrexed approved by the US FDA?

Drugs@FDA lists 30 application product lines for Pemetrexed, including ALIMTA (Prescription); ALIMTA (Prescription); PEMFEXY (Prescription); PEMETREXED (Prescription); PEMETREXED DISODIUM (Prescription).

Is Pemetrexed authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Pemetrexed: Alimta, Pemetrexed medac, Pemetrexed Fresenius Kabi.

Are there safety signals or safety updates for Pemetrexed?

EMA PRAC: 6 entries; US FDA: 5 entries (latest 2026-01-15).

Active substance

Pemetrexed

SFDA 17
US FDA 30
EMA 5
Health Canada 13
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ALIMTA 500MG POWDER FOR SOLUTION FOR INFUSION	500 mg	Powder for concentrate for solution for infusion · Parenteral use	1 Vial	SAR 3861.45	NCE · Prescription	Eli Lilly and Company	Valid
ALMETRA	500 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 2595.15	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Alix	500 mg	Lyophilisate for solution for injection · Intravenous use	1 Vial	SAR 2595.15	Generic · Prescription	Saudi Amarox	Valid
PEMETREXED SPC 500 mg Powder for Solution for Infusion	500 mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 2384.10	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
PEMITRA 500 mg Vial	500 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 3784.30	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Pemetrexed EPC	500 mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 2595.15	Generic · Prescription	Eastern Pharma Co (EPC)	Valid
Pemetrexed EPC	100 mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 519.05	Generic · Prescription	Eastern Pharma Co (EPC)	Valid
Pemetrexed EVER Pharma	25 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 2235.45	Generic · Prescription	EVER Valinject GmbH	Valid
Pemetrexed EVER Pharma	25 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 4470.90	Generic · Prescription	EVER Valinject GmbH	Valid
Pemetrexed Seacross	500 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 1873.40	Generic · Prescription	Seacross Pharmaceuticals Ltd	Valid
Pemetrexed Seacross	100 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 498.25	Generic · Prescription	Seacross Pharmaceuticals Ltd	Valid
Pemitax	500 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 1816.60	Generic · Prescription	Boston Oncology Arabia	Valid
Penmat	500 mg	Lyophilisate for solution for infusion · Intravenous use	1 Vial	SAR 2595.15	Generic · Prescription	ALTAIF PHARMACEUTICALS COMPANY	Valid
Tekspepa	500 mg	Powder for injection · Intravenous use	1 Vial	SAR 2595.15	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
jodaxed	500 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 1833.75	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
ALIMTA 500MG POWDER FOR SOLUTION FOR INFUSION	500 mg	Powder for concentrate for solution for infusion · Parenteral use	1 Vial	SAR 4657.60	NCE · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed
PREXET 500 mg Pow for Concentrate for Sol for Inf	500 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 2883.50	Generic · Prescription	GENSENTA İLAÇ SANAYI VE TICARET A.Ş	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

Cervical Cancer; MESOTHELIOMA; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); OVARIAN CANCER; VAGINAL AND VULVAR CANCERS

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

Product	Strength	Form · route	Applicant	Status	First approved
ALIMTA	EQ 500MG BASE/VIAL; EQ 100MG BASE/VIAL	powder · intravenous	LILLY	Prescription	4 Feb 2004
ALIMTA	500MG	injectable · injection	LILLY	Prescription	19 Aug 2004
PEMFEXY	500MG/20ML (25MG/ML)	solution · intravenous	EAGLE PHARMS	Prescription	8 Feb 2020
PEMETREXED	100MG/4ML (25MG/ML); 500MG/20ML (25MG/ML); 1GM/40ML (25MG/ML)	solution · intravenous	ACTAVIS	Prescription	21 Aug 2020
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 750MG BASE/VIAL; EQ 1GM BASE/VIAL	powder · intravenous	FRESENIUS KABI USA	Prescription	25 May 2022
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL	powder · intravenous	DR REDDYS	Prescription	25 May 2022
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL	powder · intravenous	ACCORD HLTHCARE	Prescription	25 May 2022
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL	powder · intravenous	APOTEX	Prescription	25 May 2022
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL	powder · intravenous	QILU PHARM HAINAN	Prescription	25 May 2022
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL	powder · intravenous	NANG KUANG PHARM CO	Prescription	25 May 2022
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL	powder · intravenous	JIANGSU HANSOH PHARM	Prescription	25 May 2022
PEMETREXED DISODIUM	EQ 750MG BASE/VIAL	powder · intravenous	APOTEX	Prescription	25 May 2022
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL	powder · intravenous	RELIANCE LIFE	Prescription	25 May 2022
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL	powder · intravenous	ZYDUS PHARMS	Prescription	25 May 2022
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL	powder · intravenous	EUGIA PHARMA	Prescription	25 May 2022
PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML); EQ 500MG BASE/20ML (EQ 25MG BASE/ML); EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	solution · intravenous	SANDOZ	Prescription	26 May 2022
PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML); EQ 500MG BASE/20ML (EQ 25MG BASE/ML); EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	solution · intravenous	HOSPIRA	Prescription	22 Jun 2022
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 750MG BASE/VIAL; EQ 1GM BASE/VIAL	powder · intravenous	MEITHEAL	Prescription	13 Dec 2022
PEMETREXED	EQ 100MG/10ML BASE (10MG/ML); EQ 500MG/50ML BASE (10MG/ML); EQ 1GM/100ML BASE (10MG/ML)	solution · intravenous	SHILPA	Prescription	22 May 2023
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	powder · intravenous	PRINSTON INC	Prescription	11 Dec 2023
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL	powder · intravenous	HETERO LABS LTD VI	Prescription	14 Jun 2024
AXTLE	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL	powder · intravenous	AVYXA HOLDINGS	Prescription	28 Jun 2024
PEMETREXED FOR INJECTION	100MG; 500MG; 1G	injectable · injection	DR REDDYS LABS INC	Prescription
PEMETREXED DISODIUM	EQ 100MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL	powder · intravenous	HOSPIRA	Discontinued	25 May 2022
PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	powder · intravenous	APOTEX	Discontinued	25 May 2022

5 more — full table

EMA European Union — centrally authorised medicines

Alimta Eli Lilly Nederland B.V. · Authorised · authorised 20 Sep 2004 · ATC L01BA04

Therapeutic indication (EMA)

Malignant pleural mesothelioma Alimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma. Non-small-cell lung cancer Alimta 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. Alimta 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. Alimta 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.

Pemetrexed medac medac Gesellschaft für klinische Spezialpräparate mbH · Authorised · authorised 26 Nov 2015 · ATC L01BA04

Therapeutic indication (EMA)

Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed medac 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. Pemetrexed medac 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. Pemetrexed medac 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.

Pemetrexed Fresenius Kabi Fresenius Kabi Deutschland GmbH · Authorised · authorised 22 Jul 2016 · ATC L01BA04

Therapeutic indication (EMA)

Malignant pleural mesothelioma Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Fresenius Kabi 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. Pemetrexed Fresenius Kabi 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. Pemetrexed Fresenius Kabi 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.

Pemetrexed Lilly Eli Lilly Netherlands · Withdrawn · authorised 14 Sep 2015 · ATC L01BA04

Therapeutic indication (EMA)

Malignant pleural mesothelioma Pemetrexed Lilly in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Lilly 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. Pemetrexed Lilly 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. Pemetrexed Lilly 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.

Pemetrexed Krka KRKA d.d. · Withdrawn · authorised 22 May 2018 · ATC L01BA04

Therapeutic indication (EMA)

Malignant pleural mesothelioma Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Krka 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. Pemetrexed Krka 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. Pemetrexed Krka 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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PEMETREXED DISODIUM FOR INJECTION	02394227	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	TEVA CANADA LIMITED
PEMETREXED DISODIUM FOR INJECTION	02438674	100 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	ACCORD HEALTHCARE INC
PEMETREXED DISODIUM FOR INJECTION	02438682	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	ACCORD HEALTHCARE INC
PEMETREXED DISODIUM FOR INJECTION	02459434	100 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	TEVA CANADA LIMITED
PEMETREXED DISODIUM FOR INJECTION	02517639	100 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	AURO PHARMA INC
PEMETREXED DISODIUM FOR INJECTION	02517647	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	AURO PHARMA INC
PEMETREXED DISODIUM FOR INJECTION	02528746	100 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	EUGIA PHARMA INC.
PEMETREXED DISODIUM FOR INJECTION	02528754	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	EUGIA PHARMA INC.
PEMETREXED FOR INJECTION, USP	02463083	100 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	DR REDDY'S LABORATORIES LTD
PEMETREXED FOR INJECTION, USP	02463091	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	DR REDDY'S LABORATORIES LTD
TARO-PEMETREXED	02429195	100 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	TARO PHARMACEUTICALS INC
TARO-PEMETREXED	02429209	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	TARO PHARMACEUTICALS INC
TARO-PEMETREXED	02480492	1000 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	TARO PHARMACEUTICALS INC

Safety signals and safety-related labeling changes

EMA PRAC 15 Jan 2026 PRAC signal: Lupus erythematosus
Action for MAH: update of the product information: No
US FDA 15 Dec 2025 PEMETREXED DISODIUM — safety-related labeling change
Labeling sections changed: Drug Interactions; Use in Specific Populations
US FDA 3 Oct 2025 AXTLE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 4 Sep 2025 PRAC signal: Lupus erythematosus
Action for MAH: update of the product information: No
US FDA 14 Dec 2022 PEMFEXY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
US FDA 22 Nov 2022 PEMETREXED — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 31 Aug 2022 ALIMTA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 6 Sep 2018 PRAC signal: Syncope
Action for MAH: update of the product information: No
EMA PRAC 11 Jan 2018 PRAC signal: Nephrogenic diabetes insipidus
Action for MAH: update of the product information: Yes
EMA PRAC 1 Sep 2017 PRAC signal: Nephrogenic diabetes insipidus
Action for MAH: update of the product information: No
EMA PRAC 10 Sep 2015 PRAC signal: Scleroderma
Action for MAH: update of the product information: No

All safety entries for pemetrexed →

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.