KALETRA DIN 02285533
Health Canada record
| Active ingredient(s) | RITONAVIR 50 MG; LOPINAVIR 200 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | J05AR10 LOPINAVIR AND RITONAVIR |
| Original market date | 08-Sep-2006 |
| Current status date | 14-Jan-2015 |
| Source | Health Canada DPD |
Establishment licence of the holder
AbbVie Corporation — licence 101988, currently licensed, last inspection rating C (2023-07-18).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing RITONAVIR
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02523620 | AURO-RITONAVIR | AURO PHARMA INC | Tablet | RITONAVIR 100 MG | Marketed |
| 02357593 | NORVIR | ABBVIE CORPORATION | Tablet | RITONAVIR 100 MG | Marketed |
| 02524031 | PAXLOVID | PFIZER CANADA ULC | Tablet | RITONAVIR 100 MG; NIRMATRELVIR 150 MG | Marketed |
| 02229137 | NORVIR | ABBVIE CORPORATION | Capsule | RITONAVIR 100 MG | Cancelled Post Market |
| 02229145 | NORVIR | ABBVIE CORPORATION | Solution | RITONAVIR 80 MG | Cancelled Post Market |
| 02241480 | NORVIR SEC | ABBVIE CORPORATION | Capsule | RITONAVIR 100 MG | Cancelled Post Market |
| 02527804 | PAXLOVID | PFIZER CANADA ULC | Tablet | RITONAVIR 100 MG; NIRMATRELVIR 150 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 13806 | 2012-11-01 | New Drug Submission (NDS) | Manufacturer name change |
| 8245 | 2006-09-06 | Supplement to a New Drug Submission (SNDS) | NEW DOSAGE FORM: 200 / 50 MG (LOPINAVIR / RITONAVIR) TABLET |
International API supply for RITONAVIR
7 valid EDQM Certificates of Suitability from 7 holders. 17 active FDA Drug Master Files.
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