Approval · Notice of Compliance 16894 · 2015
OMNITROPE: Notice of Compliance 16894
Issued May 8, 2015
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 16894
- Date
- May 8, 2015
- Company
- Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indications for children: small for gestational age (sga) omnitrope is indicated for the treatment of growth failure (current height standard deviation score [sds] , -2) in short children born sga (nirth weight and/or lenngth below -2 sd) and who fail to achieve catch-up growth (hieght velocity sds , 0 during the last year) by 2 to 4 years or later. turner syndrome the treatment of short stature associated with turner syndrome in patients whose epiphysis are not closed. idiopathic short stature (iss) the long-term treatment of idiopathic short stature (iss) also called nonn-growth hormone-deficient short stature, defined by height standard deviation score (sds) ,-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means. omnitrope treatment for iss should be prescribed only for those patients whose epiphyses are not closed. revised indication for adults: omnitrope is indicated for replacement of endogenous growth hormone in audlts with growth hormone dficiency who meet either of the following tweo criteria: adult onset (ao): patients who have growth hormone deficieny, wither alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalmic disease, surgery, radiation therapy or trauma; or childhood onset (co): patients who were growth hormone deficient during childhood as a result of congenital, genetic required or idiopathic causes.
- Therapeutic class
- Human growth hormone
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OMNITROPE | Not yet assigned | — |
Medicinal ingredients
- WATER 1.13 ML per CART
- SOMATROPIN 5.8 MG per VIAL
- SOMATROPIN 5 MG per CART
- SOMATROPIN 10 MG per CART