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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