Notice of Compliance Information
From Health Canada
- Notice of Compliance date :
- 2024-09-24
- Manufacturer :
- ELI LILLY CANADA INC
- Product type:
- Prescription Pharmaceutical
- NOC with conditions:
- No
- Submission type:
- Supplement to a New Drug Submission (SNDS)
- Reason for supplement:
- Addition of new dosage form: Addition of a preserved formulation in a multi-dose prefilled pen. Addition of a drug product manufacturing site and /or manufacturer involving production. New package labels
- Submission class:
- Other
Brand 1 of 1 :
MOUNJARO KWIKPEN
Product 1 of 6 :
Drug identification number:
02551969
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
| Ingredient | Strength |
|---|---|
| TIRZEPATIDE | 5 MG/0.6ML |
Product 2 of 6 :
Drug identification number:
02551993
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
| Ingredient | Strength |
|---|---|
| TIRZEPATIDE | 12.5 MG/0.6ML |
Product 3 of 6 :
Drug identification number:
02551950
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
| Ingredient | Strength |
|---|---|
| TIRZEPATIDE | 2.5 MG/0.6ML |
Product 4 of 6 :
Drug identification number:
02552000
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
| Ingredient | Strength |
|---|---|
| TIRZEPATIDE | 15 MG/0.6ML |
Product 5 of 6 :
Drug identification number:
02551985
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
| Ingredient | Strength |
|---|---|
| TIRZEPATIDE | 10 MG/0.6ML |
Product 6 of 6 :
Drug identification number:
02551977
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
| Ingredient | Strength |
|---|---|
| TIRZEPATIDE | 7.5 MG/0.6ML |