Drug information for HUMATROPE
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
INJECTABLE; INJECTION
12MG/VIAL
Prescription
(Reference Drug)
SOMATROPIN RECOMBINANT
Human Growth Hormone
LILLY
19640
2011-08-26 Letter
2011-08-22 Label
2011-03-04 Label
2011-02-28 Letter
2010-07-31 Label
2010-07-30 Letter
2009-03-17 Label
2009-03-17 Letter
2009-01-14 Letter
2009-01-12 Review
2008-08-11 Review
2007-07-06 Review
2007-04-09 Review
2006-11-06 Label
2006-11-06 Letter
2006-10-27 Label
2006-10-27 Letter
2006-10-27 Letter
2006-10-27 Label
2006-07-03 Letter
2005-10-25 Letter
2005-10-25 Label
2004-09-29 Label
2004-09-29 Letter
2004-06-07 Letter
2003-08-14 Label
2003-03-26 Letter
2002-12-04 Letter
2002-06-10 Letter
1997-03-11 Review
1997-03-11 Review
INJECTABLE; INJECTION
24MG/VIAL
Prescription
(Reference Drug)
SOMATROPIN RECOMBINANT
Human Growth Hormone
LILLY
"
INJECTABLE; INJECTION
2MG/VIAL
Discontinued
SOMATROPIN RECOMBINANT
Human Growth Hormone
LILLY
"
INJECTABLE; INJECTION
5MG/VIAL
Prescription
BX (Reference Drug)
SOMATROPIN RECOMBINANT
Human Growth Hormone
LILLY
"
INJECTABLE; INJECTION
6MG/VIAL
Prescription
BX
SOMATROPIN RECOMBINANT
Human Growth Hormone
LILLY
"
Drug Adverse Effects information for HUMATROPE
Role code
Indications
Reaction
# Reports
PS
BLOOD GROWTH HORMONE
DYSPNOEA
1
PS
BLOOD GROWTH HORMONE
HEADACHE
1
PS
BLOOD GROWTH HORMONE
MUSCULOSKELETAL PAIN
1
PS
BLOOD GROWTH HORMONE
PAIN IN EXTREMITY
1
PS
BLOOD GROWTH HORMONE ABNORMAL
BRAIN NEOPLASM
1
PS
BODY HEIGHT BELOW NORMAL
RETINAL DETACHMENT
2
PS
CUSHING'S SYNDROME
CARDIAC DISORDER
1
PS
CUSHING'S SYNDROME
CORONARY ARTERY EMBOLISM
1
PS
CUSHING'S SYNDROME
CUSHING'S SYNDROME
1
PS
CUSHING'S SYNDROME
EMPHYSEMA
1
PS
CUSHING'S SYNDROME
ENDOCRINE DISORDER
1
PS
CUSHING'S SYNDROME
HYPOPITUITARISM
1
PS
CUSHING'S SYNDROME
OFF LABEL USE
1
PS
CUSHING'S SYNDROME
PULMONARY EMBOLISM
1
PS
CUSHING'S SYNDROME
SPINAL COMPRESSION FRACTURE
1
PS
DUCHENNE MUSCULAR DYSTROPHY
BENIGN INTRACRANIAL HYPERTENSION
1
PS
DWARFISM
EPIPHYSIOLYSIS
3
PS
DWARFISM
FALL
1
PS
DWARFISM
FEMUR FRACTURE
3
PS
DWARFISM
HEADACHE
1
PS
DWARFISM
TENDON RUPTURE
1
PS
GROWTH HORMONE DEFICIENCY
ADRENAL DISORDER
2
PS
GROWTH HORMONE DEFICIENCY
ANAEMIA
2
PS
GROWTH HORMONE DEFICIENCY
ANAL FISSURE
2
PS
GROWTH HORMONE DEFICIENCY
ARTHRITIS
1
PS
GROWTH HORMONE DEFICIENCY
ARTHROSCOPY
1
PS
GROWTH HORMONE DEFICIENCY
BASAL CELL CARCINOMA
1
PS
GROWTH HORMONE DEFICIENCY
BLINDNESS
1
PS
GROWTH HORMONE DEFICIENCY
BLOOD GLUCOSE ABNORMAL
1
PS
GROWTH HORMONE DEFICIENCY
BREAST CANCER
1
PS
GROWTH HORMONE DEFICIENCY
CARDIAC FAILURE CONGESTIVE
1
PS
GROWTH HORMONE DEFICIENCY
CEREBROVASCULAR ACCIDENT
1
PS
GROWTH HORMONE DEFICIENCY
COUGH
1
PS
GROWTH HORMONE DEFICIENCY
CUSHING'S SYNDROME
2
PS
GROWTH HORMONE DEFICIENCY
CYSTITIS HAEMORRHAGIC
1
PS
GROWTH HORMONE DEFICIENCY
DEHYDRATION
2
PS
GROWTH HORMONE DEFICIENCY
DIARRHOEA
3
PS
GROWTH HORMONE DEFICIENCY
DRUG DOSE OMISSION
1
PS
GROWTH HORMONE DEFICIENCY
GASTROENTERITIS VIRAL
2
PS
GROWTH HORMONE DEFICIENCY
GASTROINTESTINAL MOTILITY DISORDER
2
PS
GROWTH HORMONE DEFICIENCY
GASTROINTESTINAL VIRAL INFECTION
1
PS
GROWTH HORMONE DEFICIENCY
GENERAL PHYSICAL HEALTH DETERIORATION
1
PS
GROWTH HORMONE DEFICIENCY
HOSPITALISATION
1
PS
GROWTH HORMONE DEFICIENCY
HYPOACUSIS
1
PS
GROWTH HORMONE DEFICIENCY
HYPOAESTHESIA
2
PS
GROWTH HORMONE DEFICIENCY
IMMUNE SYSTEM DISORDER
2
PS
GROWTH HORMONE DEFICIENCY
INCORRECT DOSE ADMINISTERED
2
PS
GROWTH HORMONE DEFICIENCY
INTERNATIONAL NORMALISED RATIO INCREASED
1
PS
GROWTH HORMONE DEFICIENCY
JOINT DISLOCATION
2
PS
GROWTH HORMONE DEFICIENCY
KERATECTOMY
2
PS
GROWTH HORMONE DEFICIENCY
MEMORY IMPAIRMENT
1
PS
GROWTH HORMONE DEFICIENCY
MENINGITIS
1
PS
GROWTH HORMONE DEFICIENCY
MENISCUS LESION
1
PS
GROWTH HORMONE DEFICIENCY
MENTAL DISORDER
1
PS
GROWTH HORMONE DEFICIENCY
MIDDLE LOBE SYNDROME
1
PS
GROWTH HORMONE DEFICIENCY
MOBILITY DECREASED
1
PS
GROWTH HORMONE DEFICIENCY
MUSCULOSKELETAL PAIN
1
PS
GROWTH HORMONE DEFICIENCY
NASOPHARYNGITIS
1
PS
GROWTH HORMONE DEFICIENCY
NEOPLASM
2
PS
GROWTH HORMONE DEFICIENCY
PITUITARY TUMOUR BENIGN
1
PS
GROWTH HORMONE DEFICIENCY
PRURITUS
1
PS
GROWTH HORMONE DEFICIENCY
RECTAL TENESMUS
2
PS
GROWTH HORMONE DEFICIENCY
RECTOCELE
2
PS
GROWTH HORMONE DEFICIENCY
STAPHYLOCOCCAL INFECTION
1
PS
GROWTH HORMONE DEFICIENCY
VISUAL IMPAIRMENT
1
PS
GROWTH HORMONE DEFICIENCY
VOMITING
2
PS
GROWTH RETARDATION
BENIGN INTRACRANIAL HYPERTENSION
1
PS
HYPOPITUITARISM
ASTHENIA
1
PS
HYPOPITUITARISM
BENIGN NEOPLASM OF PROSTATE
1
PS
HYPOPITUITARISM
BLOOD GLUCOSE ABNORMAL
1
PS
HYPOPITUITARISM
BRONCHITIS
1
PS
HYPOPITUITARISM
CEREBROVASCULAR ACCIDENT
1
PS
HYPOPITUITARISM
COLONIC POLYP
1
PS
HYPOPITUITARISM
CONSTIPATION
1
PS
HYPOPITUITARISM
DIZZINESS
1
PS
HYPOPITUITARISM
ELECTROCARDIOGRAM ABNORMAL
1
PS
HYPOPITUITARISM
GASTROENTERITIS VIRAL
1
PS
HYPOPITUITARISM
HEPATIC NEOPLASM MALIGNANT
1
PS
HYPOPITUITARISM
INSULIN-LIKE GROWTH FACTOR INCREASED
1
PS
HYPOPITUITARISM
INTENTIONAL OVERDOSE
1
PS
HYPOPITUITARISM
MALAISE
2
PS
HYPOPITUITARISM
NASOPHARYNGITIS
1
PS
HYPOPITUITARISM
PITUITARY TUMOUR
1
PS
HYPOPITUITARISM
PITUITARY TUMOUR RECURRENT
1
PS
HYPOPITUITARISM
PNEUMONIA
1
PS
HYPOPITUITARISM
SELF-MEDICATION
1
PS
HYPOPITUITARISM
TACHYCARDIA
1
PS
HYPOTHALAMO-PITUITARY DISORDER
DYSURIA
1
PS
HYPOTHALAMO-PITUITARY DISORDER
PROSTATE CANCER
1
PS
NOONAN SYNDROME
DRUG DOSE OMISSION
1
PS
NOONAN SYNDROME
HYPERTROPHIC CARDIOMYOPATHY
1
PS
PITUITARY TUMOUR
AMNESIA
1
PS
PITUITARY TUMOUR
APNOEA
1
PS
PITUITARY TUMOUR
ASTHENIA
1
PS
PITUITARY TUMOUR
CONFUSIONAL STATE
1
PS
PITUITARY TUMOUR
DRUG DOSE OMISSION
1
PS
PITUITARY TUMOUR
FALL
1
PS
PITUITARY TUMOUR
HIP ARTHROPLASTY
1
PS
PITUITARY TUMOUR
HORMONE LEVEL ABNORMAL
1
PS
PITUITARY TUMOUR
HYPERTENSION
1
PS
PITUITARY TUMOUR
INSOMNIA
1
PS
PITUITARY TUMOUR
INTERVERTEBRAL DISC PROTRUSION
1
PS
PITUITARY TUMOUR
MALAISE
1
PS
PITUITARY TUMOUR
MOBILITY DECREASED
1
PS
PITUITARY TUMOUR
ORAL SURGERY
1
PS
PITUITARY TUMOUR
PAIN
1
PS
PITUITARY TUMOUR
PAIN IN EXTREMITY
1
PS
PITUITARY TUMOUR
PITUITARY TUMOUR
1
PS
PITUITARY TUMOUR
PROCEDURAL PAIN
1
PS
PITUITARY TUMOUR
ROAD TRAFFIC ACCIDENT
1
PS
PITUITARY TUMOUR
SLEEP APNOEA SYNDROME
1
PS
PITUITARY TUMOUR
SLEEP DISORDER
1
PS
PITUITARY TUMOUR
SOMNOLENCE
1
PS
PITUITARY TUMOUR
WEIGHT DECREASED
1
PS
POSTPARTUM HYPOPITUITARISM
NO ADVERSE EVENT
1
PS
POSTPARTUM HYPOPITUITARISM
URTICARIA
1
PS
THYROID DISORDER
DRUG DOSE OMISSION
1
PS
THYROID DISORDER
MALAISE
1
PS
THYROID DISORDER
MYOCARDIAL INFARCTION
1
PS
THYROID DISORDER
PITUITARY TUMOUR
1
SS
BLOOD GROWTH HORMONE ABNORMAL
BRAIN NEOPLASM
2
SS
BODY HEIGHT BELOW NORMAL
RETINAL DETACHMENT
2
SS
DUCHENNE MUSCULAR DYSTROPHY
BENIGN INTRACRANIAL HYPERTENSION
1
SS
DWARFISM
EPIPHYSIOLYSIS
3
SS
DWARFISM
FEMUR FRACTURE
3
SS
DWARFISM
HORMONE LEVEL ABNORMAL
3
SS
DWARFISM
HYPERSENSITIVITY
3
SS
GROWTH HORMONE DEFICIENCY
ANAEMIA
3
SS
GROWTH HORMONE DEFICIENCY
DIARRHOEA
3
SS
GROWTH HORMONE DEFICIENCY
GASTROENTERITIS VIRAL
3
SS
GROWTH HORMONE DEFICIENCY
HYPOAESTHESIA
3
SS
GROWTH HORMONE DEFICIENCY
INCORRECT DOSE ADMINISTERED
3
SS
GROWTH HORMONE DEFICIENCY
JOINT DISLOCATION
3
SS
GROWTH HORMONE DEFICIENCY
MUSCULOSKELETAL PAIN
3
SS
GROWTH HORMONE DEFICIENCY
VISUAL IMPAIRMENT
3
SS
GROWTH HORMONE DEFICIENCY
VOMITING
3
SS
GROWTH RETARDATION
BENIGN INTRACRANIAL HYPERTENSION
1
SS
HYPOPITUITARISM
BENIGN NEOPLASM OF PROSTATE
1
SS
HYPOPITUITARISM
COLONIC POLYP
1
SS
HYPOPITUITARISM
INSULIN-LIKE GROWTH FACTOR INCREASED
1
SS
HYPOPITUITARISM
INTENTIONAL OVERDOSE
1
SS
HYPOPITUITARISM
PITUITARY TUMOUR RECURRENT
1
SS
HYPOPITUITARISM
SELF-MEDICATION
1
SS
OSTEOPOROSIS
BLOOD GROWTH HORMONE DECREASED
2
SS
OSTEOPOROSIS
BONE DENSITY DECREASED
2
SS
OSTEOPOROSIS
GLUCOCORTICOIDS DECREASED
1
SS
OSTEOPOROSIS
HIP FRACTURE
2
SS
OSTEOPOROSIS
MEDICATION ERROR
1
SS
OSTEOPOROSIS
THYROXINE DECREASED
1
SS
OSTEOPOROSIS
UPPER LIMB FRACTURE
2
SS
THYROID DISORDER
HORMONE LEVEL ABNORMAL
1
SS
THYROID DISORDER
HYPERSENSITIVITY
1
C
PSORIASIS
EPISTAXIS
1
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