Active substance
Irinotecan
- SFDA 16
- US FDA 31
- Health Canada 8
- WHO EML 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| CAMPTO 100MG-5ML VIAL FOR I.V INFUSION | 20 mg/ml | concentrate for solution for injection · Intravenous use | 1 Vial | SAR 291.05 | NCE · Prescription | PFIZER PERTH PTY LIMITED | Valid |
| IMTUS 20MG/ML SOL. FOR INFUSION | 20 mg/ml | Solution for infusion · Intravenous use | 1 Vial | SAR 247.40 | Generic · Prescription | Emcure Pharmaceuticals Ltd. | Valid |
| IMTUS 20MG/ML SOL. FOR INFUSION | 20 mg/ml | Solution for infusion · Intravenous use | 1 Vial | SAR 179.35 | Generic · Prescription | Emcure Pharmaceuticals Ltd. | Valid |
| IRINOTECAN JAZEERA 20 mg/ml concentrate for solution for infusion | 20 mg/ml | concentrate for solution for injection · Intravenous use | 1 Vial | SAR 98.95 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| IRINOTECAN JAZEERA 20 mg/ml concentrate for solution for infusion | 20 mg/ml | concentrate for solution for injection · Intravenous use | 1 Vial | SAR 247.40 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Ircan 100 mg per 5 ml | 20 mg/ml | Lyophilisate for solution for injection · Intravenous use | 1 Vial | SAR 169.05 | Generic · Prescription | ALTAIF PHARMACEUTICALS COMPANY | Valid |
| Irinotecan BOS | 20 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 169.05 | Generic · Prescription | Boston Oncology Arabia | Valid |
| Onivyde pegylated liposomal | 4.3 mg/ml | Dispersion for infusion · Intravenous use | 1 Vial | SAR 4171.55 | NCE · Prescription | LES LABORATORIES SERVIER | Valid |
| TECANA 20MG/ML VIAL | 20 mg/ml | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 118.35 | Generic · Prescription | Boston Oncology Arabia | Valid |
| CAMPTO 100MG-5ML VIAL FOR I.V INFUSION | 20 mg/ml | concentrate for solution for injection · Intravenous use | 1 Vial | SAR 700.90 | NCE · Prescription | sanofi-aventis | Withdrawn by MAH · Not Marketed |
| IRINOTECAN HCL 40MG/2ML CONC. FOR SOLU. FOR INF | 20 mg/ml | concentrate for solution for injection · Intravenous use | 1 Vial | SAR 246.50 | Generic · Prescription | HOSPIRA UK LIMITED | Withdrawn by MAH · Not Marketed |
| IRINOTECAN HCL 40MG/2ML CONC. FOR SOLU. FOR INF | 20 mg/ml | concentrate for solution for injection · Intravenous use | 1 Vial | SAR 1232.50 | Generic · Prescription | HOSPIRA UK LIMITED | Withdrawn by MAH · Not Marketed |
| IRINOTECAN HCL 40MG/2ML CONC. FOR SOLU. FOR INF | 20 mg/ml | concentrate for solution for injection · Intravenous use | 1 Vial | SAR 123.20 | Generic · Prescription | HOSPIRA UK LIMITED | Withdrawn by MAH · Not Marketed |
| IRINOTICAN EBEWE 20 mg/ml concentrate for solution for infusion | 20 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 247.40 | Generic · Prescription | EBEWE PHARMA | Withdrawn by MAH · Not Marketed |
| IRINOTICAN EBEWE 20 mg/ml concentrate for solution for infusion | 20 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 1237.00 | Generic · Prescription | EBEWE PHARMA | Withdrawn by MAH · Not Marketed |
| IRINOTICAN EBEWE 20 mg/ml concentrate for solution for infusion | 20 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 98.95 | Generic · Prescription | EBEWE PHARMA | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
BILIARY TRACT CANCER; BONE SARCOMAS; Cervical Cancer; COLORECTAL CANCER-ADVANCED/ METASTATIC; ESOPHAGEAL CANCER; GASTRIC CANCER; MALIGNANT NEOPLASM OF THE PANCREAS; Neuroblastoma; NEUROENDOCRINE TUMORS; OVARIAN CANCER; SMALL CELL LUNG CANCER (SCLC); SOFT TISSUE SARCOMA - RHABDOMYOSARCOMA; VAGINAL AND VULVAR CANCERS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CAMPTOSAR | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML); 300MG/15ML (20MG/ML) | injectable · injection | PFIZER INC | Prescription | 14 Jun 1996 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | TEVA PARENTERAL | Prescription | 27 Feb 2008 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | FRESENIUS KABI USA | Prescription | 27 Feb 2008 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | HOSPIRA | Prescription | 27 Feb 2008 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML); 500MG/25ML (20MG/ML) | injectable · injection | ACTAVIS TOTOWA | Prescription | 27 Feb 2008 |
| IRINOTECAN HYDROCHLORIDE | 500MG/25ML (20MG/ML) | injectable · injection | HOSPIRA | Prescription | 27 Feb 2008 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | ACCORD HLTHCARE | Prescription | 21 Nov 2008 |
| IRINOTECAN HYDROCHLORIDE | 500MG/25ML (20MG/ML) | injectable · injection | TEVA PHARMS USA | Prescription | 26 Nov 2008 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | HIKMA PHARMS | Prescription | 24 Dec 2008 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | EPIC PHARMA LLC | Prescription | 16 Sep 2009 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | HIKMA FARMACEUTICA | Prescription | 20 Dec 2010 |
| IRINOTECAN HYDROCHLORIDE | 20MG/ML; 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | PHARMOBEDIENT | Prescription | 13 May 2011 |
| IRINOTECAN HYDROCHLORIDE | 100MG/5ML | injectable · injection | EMCURE PHARMS LTD | Prescription | 14 Feb 2012 |
| ONIVYDE | EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | injectable, liposomal · intravenous | IPSEN | Prescription | 22 Oct 2015 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML); 300MG/15ML (20MG/ML) | injectable · injection | QILU PHARM HAINAN | Prescription | 3 May 2016 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | INTAS PHARMS USA | Prescription | 31 Aug 2017 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML); 300MG/15ML (20MG/ML) | injectable · injection | ADAPTIS | Prescription | 28 Dec 2018 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | GLAND | Prescription | 18 Nov 2019 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML); 300MG/15ML (20MG/ML); 500MG/25ML (20MG/ML) | injectable · injection | EUGIA PHARMA | Prescription | 2 Nov 2020 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | CIPLA LTD | Discontinued | 20 Feb 2008 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | SANDOZ | Discontinued | 27 Feb 2008 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | FRESENIUS KABI USA | Discontinued | 27 Feb 2008 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | SUN PHARMA GLOBAL | Discontinued | 21 Apr 2008 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | PLIVA LACHEMA | Discontinued | 31 Oct 2008 |
| IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML); 100MG/5ML (20MG/ML) | injectable · injection | TEVA PHARMS USA | Discontinued | 26 Nov 2008 |
6 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| IRINOTECAN FOR INJECTION | 02312409 | 20 MG / ML | SOLUTION · INTRAVENOUS | TEVA CANADA LIMITED |
| IRINOTECAN HYDROCHLORIDE INJECTION | 02501279 | 100 MG / 5 ML | SOLUTION · INTRAVENOUS | AURO PHARMA INC |
| IRINOTECAN HYDROCHLORIDE INJECTION | 02501295 | 500 MG / 25 ML | SOLUTION · INTRAVENOUS | AURO PHARMA INC |
| IRINOTECAN HYDROCHLORIDE INJECTION | 02528789 | 500 MG / 25 ML | SOLUTION · INTRAVENOUS | EUGIA PHARMA INC. |
| IRINOTECAN HYDROCHLORIDE INJECTION | 02528800 | 100 MG / 5 ML | SOLUTION · INTRAVENOUS | EUGIA PHARMA INC. |
| IRINOTECAN HYDROCHLORIDE INJECTION USP | 02258218 | 20 MG / ML | SOLUTION · INTRAVENOUS | PFIZER CANADA ULC |
| IRINOTECAN HYDROCHLORIDE INJECTION USP | 02357585 | 20 MG / ML | SOLUTION · INTRAVENOUS | ACCORD HEALTHCARE INC |
| IRINOTECAN HYDROCHLORIDE INJECTION, USP | 02452421 | 20 MG / ML | SOLUTION · INTRAVENOUS | GENERIC MEDICAL PARTNERS INC |
WHO WHO Model List of Essential Medicines (2025)
- 8.2.1. Cytotoxic medicines · complementary
Rhabdomyosarcoma primary site; Malignant neoplasm metastasis in large intestine; Malignant neoplasms of kidney, except renal pelvis
Parenteral > General injections > IV: 40 mg per 2 mL in 2 mL vial; 100 mg per 5 mL in 5 mL vial; 500 mg per 25 mL in 25 mL vial
Safety signals and safety-related labeling changes
- US FDA 27 Jan 2022 CAMPTOSAR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.