SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| HYCAMTIN 4MG I.V. VIAL | 4 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 489.85 | NCE · Prescription | Sandoz Pharmaceuticals | Valid |
| HYCAMTIN 4MG I.V. VIAL | 4 mg | Powder for concentrate for solution for infusion · Intravenous use | 5 Vial | SAR 2449.35 | NCE · Prescription | NOVARTIS PHARMA AG | Withdrawn by MAH · Not Marketed |
| TOPOTECAN HOSPIRA | 1 mg/ml | Concentrate for solution for infusion · Intravenous use | 5 Vial | SAR 2333.25 | Generic · Prescription | HOSPIRA UK LIMITED | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
BONE SARCOMAS; Cervical Cancer; Neuroblastoma; OVARIAN CANCER; RETINOBLASTOMA; 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 |
|---|
| HYCAMTIN | EQ 4MG BASE/VIAL | injectable · injection | SANDOZ | Prescription | 28 May 1996 |
| HYCAMTIN | EQ 0.25MG BASE; EQ 1MG BASE | capsule · oral | SANDOZ | Prescription | 11 Oct 2007 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | injectable · injection | FRESENIUS KABI USA | Prescription | 29 Nov 2010 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | injectable · injection | TEYRO LABS | Prescription | 1 Dec 2010 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | injectable · injection | ACTAVIS TOTOWA | Prescription | 2 Dec 2010 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | injectable · injection | SAGENT PHARMS | Prescription | 26 Jan 2011 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | solution · intravenous | HOSPIRA INC | Prescription | 2 Feb 2011 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | injectable · injection | DR REDDYS LABS LTD | Prescription | 9 Mar 2011 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | injectable · injection | ACCORD HLTHCARE | Prescription | 26 Jun 2013 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | injectable · injection | INGENUS PHARMS LLC | Prescription | 30 Nov 2016 |
| TOPOTECAN HYDROCHLORIDE | EQ 1MG BASE/ML (EQ 1MG BASE/ML); EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | solution · intravenous | ACCORD HLTHCARE | Prescription | 6 Jul 2017 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | injectable · injection | FRESENIUS KABI USA | Discontinued | 29 Nov 2010 |
| TOPOTECAN | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · intravenous | SANDOZ INC | Discontinued | 25 Feb 2011 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | injectable · injection | MEITHEAL | Discontinued | 8 Aug 2012 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | injectable · injection | RISING | Discontinued | 28 Aug 2012 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | solution · intravenous | MEITHEAL | Discontinued | 20 Dec 2012 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | injectable · injection | SUN PHARM INDS LTD | Discontinued | 29 Aug 2013 |
| TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | solution · intravenous | NATCO PHARMA USA | Discontinued | 24 Nov 2017 |
EMA European Union — centrally authorised medicines
Hycamtin Sandoz Pharmaceuticals d.d. · Authorised · authorised 12 Nov 1996 · ATC L01CE01
Therapeutic indication (EMA)
Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.
Topotecan Hospira Pfizer Europe MA EEIG · Authorised · authorised 9 Jun 2010 · ATC L01CE01
Therapeutic indication (EMA)
Topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination.
Potactasol Actavis Group PTC ehf · Authorised · authorised 6 Jan 2011 · ATC L01CE01
Therapeutic indication (EMA)
Topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy- patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Topotecan SUN Sun Pharmaceutical Industries Europe B.V. · Application withdrawn · ATC L01CE01
Evotopin Beecham Group plc · Withdrawn · authorised 15 Apr 1997 · ATC L01CE01
Therapeutic indication (EMA)
Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.
Topotecan Actavis Actavis Group PTC ehf · Withdrawn · authorised 24 Jul 2009 · ATC L01CE01
Therapeutic indication (EMA)
Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.
Topotecan Teva Teva B.V. · Withdrawn · authorised 21 Sep 2009 · ATC L01CE01
Therapeutic indication (EMA)
Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy; patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.
Topotecan Eagle Eagle Laboratories Ltd. · Withdrawn · authorised 22 Dec 2011 · ATC L01CE01
Therapeutic indication (EMA)
Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.
Canada Canada — marketed products (Health Canada)
Safety signals and safety-related labeling changes
- US FDA 16 Dec 2019 TOPOTECAN HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 24 Jun 2019 TOPOTECAN HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 5 Sep 2018 HYCAMTIN — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 5 Sep 2018 HYCAMTIN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
All safety entries for topotecan →
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.