Active substance
Gemcitabine
- SFDA 19
- US FDA 35
- Health Canada 2
- WHO EML 1
- Safety 6
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| CITABOL 1000 mg powder for solution for infusion | 1000 mg | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 260.85 | Generic · Prescription | VENUS REMEDIES LIMITED | Valid |
| CITABOL 200 mg powder for solution for infusion | 200 mg | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 52.15 | Generic · Prescription | VENUS REMEDIES LIMITED | Valid |
| CITAROX 1000MG VIAL | 1000 mg | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 147.85 | Generic · Prescription | Boston Oncology Arabia | Valid |
| CITAROX 200 mg VIAL | 40 mg/ml | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 29.55 | Generic · Prescription | Boston Oncology Arabia | Valid |
| GEBTIN | 200 mg | Powder for injection · Intravenous use | 1 Vial | SAR 29.60 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
| GEBTIN | 1 g | Powder for injection · Intravenous use | 1 Vial | SAR 211.25 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
| GEMCITABIN EBEWE 1000MG-100ML VAIL | 1000 mg | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 321.95 | Generic · Prescription | EBEWE PHARMA | Valid |
| GEMCITABIN EBEWE 200MG-20ML VAIL | 200 mg | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 74.30 | Generic · Prescription | EBEWE PHARMA | Valid |
| GEMCITABINE GLENMARK 1000MG VIAL | 1000 mg | Powder for injection · Intravenous use | 1 Vial | SAR 94.35 | Generic · Prescription | GLENMARK GENERIC SA | Valid |
| GEMCITABINE GLENMARK 200MG VIAL | 200 mg | Powder for injection · Intravenous use | 1 Vial | SAR 42.25 | Generic · Prescription | GLENMARK GENERIC SA | Valid |
| GEMCITABINE JAZEERA 40 mg/ml Lyophilisate For solution For infusion | 40 mg/ml | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 234.75 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| GEMCITABINE JAZEERA 40 mg/ml Lyophilisate For solution For infusion | 40 mg/ml | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 46.95 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| GEMZAR 200MG LYPH.VIAL 5ML | 40 mg/ml | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 142.60 | NCE · Prescription | LILLY FRANCE | Valid |
| Gemcitabine BOS | 1000 mg | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 169.75 | Generic · Prescription | Boston Oncology Arabia | Valid |
| Gemcitabine Neapolis | 1000 mg | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 179.70 | Generic · Prescription | LES LABORATORIES NEAPOLIS PHARMA | Valid |
| GEMCITABIN EBEWE 500MG-50ML VAIL | 500 mg | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 234.95 | Generic · Prescription | EBEWE PHARMA | Withdrawn by MAH · Not Marketed |
| GEMCITABINE ACTAVIS 1 GM | 1 g | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 289.85 | NCE · Prescription | ACTAVIS | Withdrawn by MAH · Not Marketed |
| GEMCITABINE ACTAVIS 200MG | 200 mg | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 65.40 | NCE · Prescription | ACTAVIS | Withdrawn by MAH · Not Marketed |
| GEMZAR 200MG LYPH.VIAL 5ML | 40 mg/ml | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 142.60 | NCE · Prescription | Eli Lilly and Company | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
BILIARY TRACT CANCER; BLADDER CANCER; BONE SARCOMAS; BREAST CANCER MET.HER-2 -VE; BURKITT`S LYMPHOMA; Cervical Cancer; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HODGKIN'S LYMPHOMA; MALIGNANT NEOPLASM OF THE PANCREAS; MESOTHELIOMA; NASOPHARYNGEL CARCINOMA SALIVARY GLAND TUMORS; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); OVARIAN CANCER; RENAL CELL CARCINOMA (RCC)-COLLECTING DUCT, MEDULLARY NON-CC RCC; SMALL CELL LUNG CANCER (SCLC); SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA; T-CELL LYMPHOMA; TESTICULAR CANCER; VAGINAL AND VULVAR CANCERS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | injectable · injection | HOSPIRA INC | Prescription | 15 Nov 2010 |
| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | FRESENIUS KABI USA | Prescription | 16 May 2011 |
| GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | injectable · injection | FRESENIUS KABI USA | Prescription | 17 May 2011 |
| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL; EQ 1GM BASE/VIAL | injectable · injection | HOSPIRA | Prescription | 25 Jul 2011 |
| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL; EQ 1GM BASE/VIAL | injectable · injection | SUN PHARM | Prescription | 25 Jul 2011 |
| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL; EQ 1GM BASE/VIAL | injectable · injection | TEYRO LABS | Prescription | 25 Jul 2011 |
| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL; EQ 1GM BASE/VIAL | injectable · injection | DR REDDYS LABS LTD | Prescription | 25 Jul 2011 |
| GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML); 1GM/26.3ML (38MG/ML); 2GM/52.6ML (38MG/ML) | injectable · injection | HOSPIRA INC | Prescription | 4 Aug 2011 |
| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL; EQ 1GM BASE/VIAL | injectable · injection | JIANGSU HANSOH PHARM | Prescription | 7 May 2013 |
| GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | injectable · injection | DR REDDYS LABS LTD | Prescription | 7 May 2013 |
| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL; EQ 1GM BASE/VIAL | injectable · injection | GLAND | Prescription | 5 Jan 2016 |
| GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML); 1GM/26.3ML (38MG/ML); 2GM/52.6ML (38MG/ML) | injectable · injection | MYLAN LABS LTD | Prescription | 6 Dec 2017 |
| GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML); 1GM/26.3ML (38MG/ML); 2GM/52.6ML (38MG/ML) | injectable · injection | SAGENT PHARMS INC | Prescription | 20 Jul 2018 |
| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL; EQ 1GM BASE/VIAL | injectable · injection | ADAPTIS | Prescription | 22 Feb 2019 |
| GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML); 1GM/26.3ML (38MG/ML); 2GM/52.6ML (38MG/ML) | injectable · injection | ADAPTIS | Prescription | 4 Oct 2019 |
| GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML); 1GM/26.3ML (38MG/ML); 2GM/52.6ML (38MG/ML) | injectable · injection | MEITHEAL | Prescription | 11 Dec 2020 |
| GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML); 1GM/26.3ML (38MG/ML); 2GM/52.6ML (38MG/ML) | injectable · injection | HIKMA | Prescription | 7 Mar 2023 |
| AVGEMSI | EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML); EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) | solution · intravenous | AVYXA HOLDINGS | Prescription | 27 Jun 2025 |
| INLEXZO | EQ 225MG BASE | system · intravesical | JANSSEN BIOTECH | Prescription | 9 Sep 2025 |
| GEMZAR | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | LILLY | Discontinued | 15 May 1996 |
| GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL; EQ 200MG BASE/VIAL | injectable · injection | TEVA PHARMS | Discontinued | 25 Jan 2011 |
| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | ACTAVIS TOTOWA | Discontinued | 25 Jul 2011 |
| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | ACCORD HLTHCARE | Discontinued | 25 Jul 2011 |
| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | PHARMOBEDIENT | Discontinued | 25 Jul 2011 |
| GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL; EQ 1GM BASE/VIAL | injectable · injection | HAMELN RDS GMBH | Discontinued | 10 Sep 2012 |
10 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| GEMCITABINE INJECTION | 02402831 | 38 MG / ML | SOLUTION · INTRAVENOUS | PFIZER CANADA ULC |
| GEMCITABINE INJECTION | 02412292 | 40 MG / ML | SOLUTION · INTRAVENOUS | SANDOZ CANADA INCORPORATED |
WHO WHO Model List of Essential Medicines (2025)
- 8.2.1. Cytotoxic medicines · complementary
Other specified carcinomas of ovary; Other specified malignant neoplasms of bronchus or lung
Parenteral > General injections > IV: 200 mg in vial powder for injection; 1 g in vial powder for injection
Safety signals and safety-related labeling changes
- EMA PRAC 11 Jun 2026 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: Yes - EMA PRAC 12 Mar 2026 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No - US FDA 24 Sep 2024 GEMCITABINE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 24 Sep 2024 INFUGEM — 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 May 2024 GEMCITABINE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 14 May 2019 GEMZAR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
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.