EYLEA DIN 02415992
Status: Marketed
Holder: BAYER INC
Health Canada record
| Active ingredient(s) | AFLIBERCEPT 2 MG |
|---|
| Dosage form | Solution |
|---|
| Route | Intravitreal |
|---|
| Schedule | PRESCRIPTION; SCHEDULE D |
|---|
| Class | Human |
|---|
| ATC | S01LA05 AFLIBERCEPT |
|---|
| Original market date | 23-Dec-2013 |
|---|
| Current status date | 23-Dec-2013 |
|---|
| Source | Health Canada DPD |
|---|
Establishment licence of the holder
Bayer Inc — licence 101029, currently licensed, last inspection rating C (2023-02-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing AFLIBERCEPT
| DIN | Product | Company | Form | Strength | Status |
|---|
| 02554194 | AFLIVU | APOTEX INC | Solution | AFLIBERCEPT 2 MG | Marketed |
| 02554178 | AFLIVU | APOTEX INC | Solution | AFLIBERCEPT 2 MG | Marketed |
| 02562928 | AHZANTIVE | VALORUM BIOLOGICS LLC | Solution | AFLIBERCEPT 2 MG | Approved |
| 02562529 | ENZEEVU | SANDOZ CANADA INCORPORATED | Solution | AFLIBERCEPT 2 MG | Approved |
| 02562510 | ENZEEVU | SANDOZ CANADA INCORPORATED | Solution | AFLIBERCEPT 2 MG | Marketed |
| 02563037 | EYDENZELT | CELLTRION INC. | Solution | AFLIBERCEPT 2 MG | Marketed |
| 02563045 | EYDENZELT | CELLTRION INC. | Solution | AFLIBERCEPT 2 MG | Marketed |
| 02505355 | EYLEA | BAYER INC | Solution | AFLIBERCEPT 2 MG | Marketed |
| 02554798 | EYLEA HD | BAYER INC | Solution | AFLIBERCEPT 8 MG | Marketed |
| 02545004 | EYLEA HD | BAYER INC | Solution | AFLIBERCEPT 8 MG | Marketed |
| 02561883 | OPUVIZ | SAMSUNG BIOEPIS CO., LTD | Solution | AFLIBERCEPT 2 MG | Approved |
| 02561891 | OPUVIZ | SAMSUNG BIOEPIS CO., LTD | Solution | AFLIBERCEPT 2 MG | Approved |
| 02550636 | PAVBLU | AMGEN CANADA INC | Solution | AFLIBERCEPT 2 MG | Marketed |
| 02550628 | PAVBLU | AMGEN CANADA INC | Solution | AFLIBERCEPT 2 MG | Approved |
| 02558238 | YESAFILI | BIOCON BIOLOGICS CANADA INC | Solution | AFLIBERCEPT 2 MG | Marketed |
| 02535858 | YESAFILI | BIOCON BIOLOGICS CANADA INC | Solution | AFLIBERCEPT 2 MG | Marketed |
| 02421089 | ZALTRAP | SANOFI-AVENTIS CANADA INC | Solution | AFLIBERCEPT 200 MG | Cancelled Post Market |
| 02421070 | ZALTRAP | SANOFI-AVENTIS CANADA INC | Solution | AFLIBERCEPT 100 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|
| 16368 | 2014-11-28 | Supplement to a New Drug Submission (SNDS) | NEW INDICATION: EYLEA IS INDICATED FOR THE TREATMENT OF DIABETIC MACULAR EDEMA (DME) |
| 16179 | 2014-10-16 | New Drug Submission (NDS) | |
| 14893 | 2013-11-08 | New Drug Submission (NDS) | |
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