MEPRON DIN 02217422
Health Canada record
| Active ingredient(s) | ATOVAQUONE 750 MG |
|---|---|
| Dosage form | Suspension |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | P01AX06 ATOVAQUONE |
| Original market date | 10-Sep-1996 |
| Current status date | 25-Feb-2002 |
| Source | Health Canada DPD |
Establishment licence of the holder
GlaxoSmithKline Inc. — licence 100630, currently licensed, last inspection rating C (2025-09-15).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ATOVAQUONE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02471949 | APO-ATOVAQUONE | APOTEX INC | Suspension | ATOVAQUONE 750 MG | Approved |
| 02466783 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS | GLENMARK PHARMACEUTICALS CANADA INC. | Tablet | ATOVAQUONE 250 MG; PROGUANIL HYDROCHLORIDE 100 MG | Marketed |
| 02421429 | ATOVAQUONE PROGUANIL | SANIS HEALTH INC | Tablet | ATOVAQUONE 250 MG; PROGUANIL HYDROCHLORIDE 100 MG | Marketed |
| 02556618 | AURO-ATOVAQUONE | AURO PHARMA INC | Suspension | ATOVAQUONE 750 MG | Marketed |
| 02528495 | GLN-ATOVAQUONE | GLENMARK PHARMACEUTICALS CANADA INC. | Suspension | ATOVAQUONE 750 MG | Marketed |
| 02264935 | MALARONE PEDIATRIC | GLAXOSMITHKLINE INC | Tablet | ATOVAQUONE 62.5 MG; PROGUANIL HYDROCHLORIDE 25.0 MG | Marketed |
| 02402165 | MYLAN-ATOVAQUONE/PROGUANIL | MYLAN PHARMACEUTICALS ULC | Tablet | ATOVAQUONE 250 MG; PROGUANIL HYDROCHLORIDE 100 MG | Marketed |
| 02380927 | TEVA-ATOVAQUONE PROGUANIL | TEVA CANADA LIMITED | Tablet | ATOVAQUONE 250 MG; PROGUANIL HYDROCHLORIDE 100 MG | Marketed |
| 02009358 | MEPRON TAB 250MG | GLAXO WELLCOME INC. | Tablet | ATOVAQUONE 250 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 881 | 2001-08-07 | New Drug Submission (NDS) | CHANGE IN MANUFACTURER NAME |
| 4219 | 1996-04-04 | Supplement to a New Drug Submission (SNDS) | NEW DOSAGE FORM: ORAL SUSPENSION |
International API supply for ATOVAQUONE
4 valid EDQM Certificates of Suitability from 4 holders. 12 active FDA Drug Master Files.
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