Drug information for OMNITROPE
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
INJECTABLE; INJECTION
1.5MG/VIAL
Prescription
BX
SOMATROPIN RECOMBINANT
Human Growth Hormone
SANDOZ
21426
2011-07-27 Letter
2011-07-25 Label
2011-04-15 Letter
2011-04-15 Label
2010-08-31 Letter
2010-08-27 Label
2010-05-03 Label
2010-05-03 Label
2010-04-28 Letter
2010-04-28 Letter
2009-03-27 Letter
2009-03-26 Label
2008-08-26 Label
2008-08-25 Letter
2008-01-18 Label
2008-01-18 Letter
2007-06-11 Review
2006-06-01 Letter
2006-05-31 Label
INJECTABLE; INJECTION
10MG/1.5ML
Prescription
BX
SOMATROPIN RECOMBINANT
Human Growth Hormone
SANDOZ
"
INJECTABLE; INJECTION
5.8MG/VIAL
Prescription
BX
SOMATROPIN RECOMBINANT
Human Growth Hormone
SANDOZ
"
INJECTABLE; INJECTION
5MG/1.5ML
Prescription
BX
SOMATROPIN RECOMBINANT
Human Growth Hormone
SANDOZ
"
Drug Adverse Effects information for OMNITROPE
Role code
Indications
Reaction
# Reports
PS
DWARFISM
RASH
1
PS
DWARFISM
URTICARIA
1
PS
GROWTH HORMONE DEFICIENCY
BENIGN INTRACRANIAL HYPERTENSION
1
PS
GROWTH HORMONE DEFICIENCY
CEREBELLAR INFARCTION
1
PS
GROWTH HORMONE DEFICIENCY
CEREBROVASCULAR ACCIDENT
1
PS
GROWTH HORMONE DEFICIENCY
HEADACHE
1
PS
GROWTH HORMONE DEFICIENCY
MUSCULOSKELETAL STIFFNESS
1
PS
GROWTH HORMONE DEFICIENCY
PAPILLOEDEMA
1
PS
HYPOTHALAMO-PITUITARY DISORDER
RASH
1
PS
HYPOTHALAMO-PITUITARY DISORDER
URTICARIA
1
PS
MICROSOMIA
ARTHRALGIA
1
PS
MICROSOMIA
BONE MARROW OEDEMA
1
SS
DWARFISM
HORMONE LEVEL ABNORMAL
3
SS
DWARFISM
HYPERSENSITIVITY
3
SS
THYROID DISORDER
HORMONE LEVEL ABNORMAL
1
SS
THYROID DISORDER
HYPERSENSITIVITY
1
C
PRECOCIOUS PUBERTY
FAT NECROSIS
2
C
PRECOCIOUS PUBERTY
IMPAIRED HEALING
2
C
PRECOCIOUS PUBERTY
INJECTION SITE ABSCESS
2
C
PRECOCIOUS PUBERTY
INJECTION SITE DISCHARGE
2
C
PRECOCIOUS PUBERTY
INJECTION SITE ERYTHEMA
2
C
PRECOCIOUS PUBERTY
INJECTION SITE INDURATION
2
C
PRECOCIOUS PUBERTY
WOUND
2
C
PRODUCT USED FOR UNKNOWN INDICATION
FAT NECROSIS
1
C
PRODUCT USED FOR UNKNOWN INDICATION
IMPAIRED HEALING
1
C
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE ABSCESS
1
C
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE DISCHARGE
1
C
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE ERYTHEMA
1
C
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE INDURATION
1
C
PRODUCT USED FOR UNKNOWN INDICATION
WOUND
1
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