SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| Apeto | 15 mg | powder for solution for injection · Intravenous, Intravesical | 1 Vial | SAR 843.55 | Generic · Prescription | Boston Oncology Arabia | Valid |
| Apeto | 100 mg | powder for solution for injection · Intravenous, Intravesical | 1 Vial | SAR 5623.65 | Generic · Prescription | Boston Oncology Arabia | Valid |
| TEPADINA | 15 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 748.30 | NCE · Prescription | ADIENNE SA | Valid |
| TEPADINA | 100 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 4538.20 | NCE · Prescription | ADIENNE SA | Valid |
| Tiplex | 15 mg | Lyophilisate for solution for injection · Intravenous, Intravesical | 1 Vial | SAR 1205.05 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Tiplex | 100 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 8021.10 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
Indications — CHI Daman Drug Formulary
Neuroblastoma
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| THIOTEPA | 15MG/VIAL | injectable · injection | WEST-WARD PHARMS INT | Prescription | 2 Apr 2001 |
| TEPADINA | 15MG/VIAL; 100MG/VIAL | powder · intracavitary, intravenous, intravesical | ADIENNE SA | Prescription | 26 Jan 2017 |
| TEPADINA AND SODIUM CHLORIDE | 200MG; 400MG | powder · intravenous | ADIENNE SA | Prescription | 26 Jan 2017 |
| THIOTEPA | 15MG/VIAL | injectable · injection | DR REDDYS | Prescription | 4 May 2018 |
| THIOTEPA | 15MG/VIAL | injectable · injection | PENN LIFE | Prescription | 10 Jan 2020 |
| THIOTEPA | 15MG/VIAL; 100MG/VIAL | powder · intracavitary, intravenous, intravesical | MSN | Prescription | 4 Mar 2020 |
| THIOTEPA | 15MG/VIAL; 100MG/VIAL | powder · intracavitary, intravenous, intravesical | GLAND | Prescription | 8 Mar 2021 |
| THIOTEPA | 15MG/VIAL | injectable · injection | REGCON HOLDINGS | Prescription | 8 Dec 2021 |
| THIOTEPA | 100MG/VIAL | powder · intracavitary, intravenous, intravesical | HIKMA | Prescription | 5 Sep 2023 |
| THIOTEPA | 15MG/VIAL; 100MG/VIAL | powder · intracavitary, intravenous, intravesical | MEITHEAL | Prescription | 26 Dec 2023 |
| THIOTEPA | 15MG/VIAL | powder · intracavitary, intravenous, intravesical | REGCON HOLDINGS | Prescription | 20 Aug 2024 |
| THIOTEPA | 15MG/VIAL | injectable · injection | IMMUNEX | Discontinued | 9 Mar 1959 |
| THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | IMMUNEX | Discontinued | 22 Dec 1994 |
| THIOTEPA | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | TEVA PARENTERAL | Discontinued | 20 Apr 2001 |
| THIOTEPA | 15MG/VIAL | injectable · injection | FRESENIUS KABI USA | Discontinued | 20 Sep 2001 |
| THIOTEPA | 15MG/VIAL | injectable · injection | HENGRUI PHARMA | Discontinued | 4 May 2018 |
| TEPYLUTE | 15MG/1.5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | SHORLA | Discontinued | 25 Jun 2024 |
EMA European Union — centrally authorised medicines
Tepadina · Authorised · authorised 15 Mar 2010 · ATC L01AC01
Therapeutic indication (EMA)
TEPADINA is indicated, in combination with other chemotherapy medicinal products:- with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;- when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.
Thiotepa Riemser Esteve Pharmaceuticals GmbH · Authorised · authorised 26 Mar 2021 · ATC L01AC01
Therapeutic indication (EMA)
Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients. Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients
Canada Canada — marketed products (Health Canada)
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.