SIMPONI DIN 02324784
Health Canada record
| Active ingredient(s) | GOLIMUMAB 50 MG |
|---|---|
| Dosage form | Solution |
| Route | Subcutaneous |
| Schedule | PRESCRIPTION; SCHEDULE D |
| Class | Human |
| ATC | L04AB06 GOLIMUMAB |
| Original market date | 22-Jun-2009 |
| Current status date | 20-Sep-2013 |
| Source | Health Canada DPD |
Establishment licence of the holder
Janssen Inc — licence 100239, currently licensed, last inspection rating C (2026-03-09).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing GOLIMUMAB
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02559536 | LIVMOTY | JANSSEN INC | Solution | GOLIMUMAB 100 MG | Approved |
| 02559544 | LIVMOTY | JANSSEN INC | Solution | GOLIMUMAB 100 MG | Approved |
| 02559552 | LIVMOTY | JANSSEN INC | Solution | GOLIMUMAB 50 MG | Approved |
| 02559560 | LIVMOTY | JANSSEN INC | Solution | GOLIMUMAB 50 MG | Approved |
| 02324776 | SIMPONI | JANSSEN INC | Solution | GOLIMUMAB 50 MG | Marketed |
| 02413175 | SIMPONI | JANSSEN INC | Solution | GOLIMUMAB 100 MG | Marketed |
| 02413183 | SIMPONI | JANSSEN INC | Solution | GOLIMUMAB 100 MG | Marketed |
| 02417472 | SIMPONI I.V. | JANSSEN INC | Solution | GOLIMUMAB 50 MG | Marketed |
| 02567393 | UPGOLYV | JAMP PHARMA CORPORATION | Solution | GOLIMUMAB 50 MG | Approved |
| 02567407 | UPGOLYV | JAMP PHARMA CORPORATION | Solution | GOLIMUMAB 100 MG | Approved |
| 02567415 | UPGOLYV | JAMP PHARMA CORPORATION | Solution | GOLIMUMAB 100 MG | Approved |
| 02567423 | UPGOLYV | JAMP PHARMA CORPORATION | Solution | GOLIMUMAB 50 MG | Approved |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18202 | 2016-06-23 | Supplement to a New Drug Submission (SNDS) | NEW INDICATION: SIMPONI IS INDICATED FOR THE TREATMENT OF ADULTS WITH SEVERE ACTIVE NON-RADIOGRAPHIC AXIAL SPONYLOARTHRITIS WITH OBJECTIVE SIGNS OF INFLAMMATION AS INDICATED BY ELEVATED C-REACTIVE PROTEIN (CRP) AND/OR MAGNETIC RESONANCE IMAGING (MRI) EVIDENCE WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT TO NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) |
| 14745 | 2013-09-19 | Supplement to a New Drug Submission (SNDS) | EXPANDED INDICATION: SYMPPONI IS INDICATED IN ADULT PATIENTS WITH MODERATE TO SEVERELY ACTIVE ULCERATIVE COLITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO, OR HAVE MEDICAL CONTRAINDIATIONS FOR CONVENTIONAL THERAPY INCLUDING CORTICOSTEROIDS, AMINO SALUCYLATES, AZATHIOPRINE (AZA) OR 6-MERCATOPURINE FOR: INDUCING AND MAINTAINING CLINICAL RESPONSE (REDUCTION IN SIGNS AND SYMPTOMS), INDUCING CLINICAL REMISSION, ACHIEVING SUSTAINES CLINICAL REMISSION IN INDUTION RESPONDERS, IMPROVING ENDOSCOPIC APPEARANCE OF THE MUCOSA DURING INDUTION |
| 12521 | 2011-08-05 | New Drug Submission (NDS) | Manufacturer Name Change |
| 10135 | 2009-04-07 | New Drug Submission (NDS) |