NUTROPIN - KIT PWS(5MG) & LIQ(10ML) IM SC DIN 02216183
Health Canada record
| Active ingredient(s) | SOMATROPIN 5 MG; WATER 10 ML |
|---|---|
| Dosage form | Powder For Solution; Kit |
| Route | Intramuscular; Subcutaneous |
| Schedule | SCHEDULE D; PRESCRIPTION |
| Class | Human |
| ATC | H01AC01 SOMATROPIN |
| Original market date | 20-Jan-1997 |
| Current status date | 19-Jul-2011 |
| Source | Health Canada DPD |
Establishment licence of the holder
Hoffmann-La Roche Limited — licence 100006, currently licensed, last inspection rating C (2024-06-25).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing SOMATROPIN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02401711 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 12 MG | Marketed |
| 02401681 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 5 MG | Approved |
| 02401789 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 1 MG | Marketed |
| 02401770 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 0.8 MG | Marketed |
| 02401762 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 0.6 MG | Marketed |
| 02401746 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 0.2 MG | Marketed |
| 02401703 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 5.3 MG | Marketed |
| 02401835 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 2 MG | Marketed |
| 02401827 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 1.8 MG | Marketed |
| 02401819 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 1.6 MG | Marketed |
| 02401754 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 0.4 MG | Marketed |
| 02401800 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 1.4 MG | Marketed |
| 02401797 | GENOTROPIN | PFIZER CANADA ULC | Powder For Solution | SOMATROPIN 1.2 MG | Marketed |
| 02529211 | NORDITROPIN FLEXPRO | NOVO NORDISK CANADA INC | Solution | SOMATROPIN 15 MG | Marketed |
| 02529203 | NORDITROPIN FLEXPRO | NOVO NORDISK CANADA INC | Solution | SOMATROPIN 10 MG | Marketed |
| 02459647 | OMNITROPE | SANDOZ CANADA INCORPORATED | Solution | SOMATROPIN 15 MG | Marketed |
| 02325063 | OMNITROPE | SANDOZ CANADA INCORPORATED | Solution | SOMATROPIN 5 MG | Marketed |
| 02325071 | OMNITROPE | SANDOZ CANADA INCORPORATED | Solution | SOMATROPIN 10 MG | Marketed |
| 02350149 | SAIZEN | EMD SERONO, A DIVISION OF EMD INC., CANADA | Solution | SOMATROPIN 8 MG | Marketed |
| 02237971 | SAIZEN | EMD SERONO, A DIVISION OF EMD INC., CANADA | Powder For Solution | SOMATROPIN 5 MG | Marketed |
| 02350122 | SAIZEN | EMD SERONO, A DIVISION OF EMD INC., CANADA | Solution | SOMATROPIN 5.83 MG | Marketed |
| 02350130 | SAIZEN | EMD SERONO, A DIVISION OF EMD INC., CANADA | Solution | SOMATROPIN 8 MG | Marketed |
| 02239046 | SEROSTIM | EMD SERONO, A DIVISION OF EMD INC., CANADA | Powder For Solution | SOMATROPIN 5 MG; WATER 1 ML | Marketed |
| 02231516 | BIO-TROPIN | NOVOPHARM LIMITED | Powder For Solution; Liquid | SOMATROPIN 4.8 MG; SODIUM CHLORIDE 10 ML | Cancelled Pre Market |
| 02231515 | BIO-TROPIN | NOVOPHARM LIMITED | Liquid; Powder For Solution | SOMATROPIN 1.8 MG; SODIUM CHLORIDE 10 ML | Cancelled Pre Market |
| 02243078 | HUMATROPE | ELI LILLY CANADA INC | Powder For Solution; Liquid | SOMATROPIN 12 MG; DILUENT 3.15 ML | Cancelled Post Market |
| 00745626 | HUMATROPE | ELI LILLY CANADA INC | Powder For Solution | SOMATROPIN 5 MG | Cancelled Post Market |
| 02243077 | HUMATROPE | ELI LILLY CANADA INC | Powder For Solution; Liquid | SOMATROPIN 6 MG; DILUENT 3.15 ML | Cancelled Post Market |
| 02243079 | HUMATROPE | ELI LILLY CANADA INC | Powder For Solution; Liquid | SOMATROPIN 24 MG; DILUENT 3.15 ML | Cancelled Post Market |
| 02229693 | HUMATROPE - 13.3MG | ELI LILLY CANADA INC | Powder For Solution; Liquid | SOMATROPIN 13.3 MG; DILUENT 3.15 ML | Cancelled Post Market |
| 02229694 | HUMATROPE - 26.6MG | ELI LILLY CANADA INC | Powder For Solution; Liquid | SOMATROPIN 26.6 MG; DILUENT 3.15 ML | Cancelled Post Market |
| 02229692 | HUMATROPE - 6.7MG | ELI LILLY CANADA INC | Liquid; Powder For Solution | SOMATROPIN 6.7 MG; DILUENT 3.15 ML | Cancelled Post Market |
| 02529181 | NORDITROPIN FLEXPRO | NOVO NORDISK CANADA INC | Solution | SOMATROPIN 5 MG | Dormant |
| 02334860 | NORDITROPIN NORDIFLEX | NOVO NORDISK CANADA INC | Solution | SOMATROPIN 10 MG | Cancelled Post Market |
| 02334852 | NORDITROPIN NORDIFLEX | NOVO NORDISK CANADA INC | Solution | SOMATROPIN 5 MG | Cancelled Post Market |
| 02334879 | NORDITROPIN NORDIFLEX | NOVO NORDISK CANADA INC | Solution | SOMATROPIN 15 MG | Cancelled Post Market |
| 02334968 | NORDITROPIN SIMPLEXX | NOVO NORDISK CANADA INC | Solution | SOMATROPIN 15 MG | Cancelled Post Market |
| 02334925 | NORDITROPIN SIMPLEXX | NOVO NORDISK CANADA INC | Solution | SOMATROPIN 5 MG | Cancelled Post Market |
| 02334941 | NORDITROPIN SIMPLEXX | NOVO NORDISK CANADA INC | Solution | SOMATROPIN 10 MG | Cancelled Post Market |
| 02216191 | NUTROPIN - KIT PWS(10MG) & LIQ(10ML) IM SC | HOFFMANN-LA ROCHE LIMITED | Kit; Powder For Solution | SOMATROPIN 10 MG; WATER 10 ML | Cancelled Post Market |
| 02229722 | NUTROPIN AQ - SC 5MG/ML | HOFFMANN-LA ROCHE LIMITED | Liquid | SOMATROPIN 5 MG | Cancelled Post Market |
| 02376393 | NUTROPIN AQ NUSPIN 10 | HOFFMANN-LA ROCHE LIMITED | Solution | SOMATROPIN 10 MG | Cancelled Post Market |
| 02399083 | NUTROPIN AQ NUSPIN 20 | HOFFMANN-LA ROCHE LIMITED | Solution | SOMATROPIN 20 MG | Cancelled Post Market |
| 02399091 | NUTROPIN AQ NUSPIN 5 | HOFFMANN-LA ROCHE LIMITED | Solution | SOMATROPIN 5 MG | Cancelled Post Market |
| 02249002 | NUTROPIN AQ PEN CARTRIDGE | HOFFMANN-LA ROCHE LIMITED | Solution | SOMATROPIN 10 MG | Cancelled Post Market |
| 02325055 | OMNITROPE | SANDOZ CANADA INCORPORATED | Kit; Powder For Solution | SOMATROPIN 5.8 MG; WATER 1.14 ML | Cancelled Pre Market |
| 02237970 | SAIZEN | EMD SERONO, A DIVISION OF EMD INC., CANADA | Powder For Solution | SOMATROPIN 1.33 MG; SODIUM CHLORIDE 1 ML | Cancelled Pre Market |
| 02215136 | SAIZEN 10IU - KIT | EMD SERONO, A DIVISION OF EMD INC., CANADA | Powder For Solution | SOMATROPIN 3.3 MG; SODIUM CHLORIDE 5 ML | Cancelled Post Market |
| 02272083 | SAIZEN 8.8MG (5.83MG/ML) | EMD SERONO, A DIVISION OF EMD INC., CANADA | Powder For Solution | SOMATROPIN 8.8 MG | Cancelled Post Market |
| 02239047 | SEROSTIM | EMD SERONO, A DIVISION OF EMD INC., CANADA | Powder For Solution | SOMATROPIN 6 MG; WATER 1 ML | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 4667 | 1996-07-24 | New Drug Submission (NDS) |
International API supply for SOMATROPIN
2 active FDA Drug Master Files.
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