TEPADINA DIN 02523906
Health Canada record
| Active ingredient(s) | THIOTEPA 400 MG |
|---|---|
| Dosage form | Powder For Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01AC01 THIOTEPA |
| Original market date | 25-Jun-2025 |
| Current status date | 31-Jul-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Adienne S.r.l. — licence , not currently licensed, last inspection rating C (2023-01-20).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing THIOTEPA
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02462702 | TEPADINA | ADIENNE SA | Powder For Solution | THIOTEPA 100 MG | Marketed |
| 02567059 | TEPADINA | ADIENNE SA | Powder For Solution | THIOTEPA 200 MG | Approved |
| 02462680 | TEPADINA | ADIENNE SA | Powder For Solution | THIOTEPA 15 MG | Marketed |
| 02526417 | THIOTEPA FOR INJECTION USP | STERIMAX INC | Powder For Solution | THIOTEPA 15 MG | Marketed |
| 02526425 | THIOTEPA FOR INJECTION USP | STERIMAX INC | Powder For Solution | THIOTEPA 100 MG | Marketed |
| 02536862 | THIOTEPA FOR INJECTION, BP | HIKMA CANADA LIMITED | Powder For Solution | THIOTEPA 15 MG | Marketed |
| 02536870 | THIOTEPA FOR INJECTION, BP | HIKMA CANADA LIMITED | Powder For Solution | THIOTEPA 100 MG | Marketed |
| 00237035 | THIO TEPA INJ 15MG/VIAL | LEDERLE CYANAMID CANADA INC. | Powder For Solution | THIOTEPA 15 MG | Cancelled Post Market |
| 02174391 | THIOTEPA - (PWS 15 MG/VIAL) | WYETH CANADA | Powder For Solution | THIOTEPA 15 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 27316 | 2021-12-30 | Supplement to a New Drug Submission (SNDS) | NWE STRENGTH. NEW CONTAINER CLOSURE SYSTEM.CONVERT PRODUCT MONOGRAPH TO 2020 FORMAT. UPDATE TO PACKAGE INSERT AND LABELS |
International API supply for THIOTEPA
7 active FDA Drug Master Files.
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