Drug information for SAIZEN

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 4MG/VIAL Discontinued   SOMATROPIN RECOMBINANT Human Growth Hormone EMD SERONO 19764
2012-04-06 Label
2012-04-05 Letter
2009-01-12 Review
2007-11-08 Letter
2007-11-07 Label
2007-08-30 Label
2007-08-30 Letter
2007-08-27 Letter
2007-08-23 Label
2007-03-15 Letter
2007-03-07 Label
2007-01-25 Letter
2007-01-18 Label
2004-11-15 Letter
2004-11-15 Label
2004-07-14 Letter
2004-07-14 Label
2003-07-08 Label
2003-07-08 Letter
INJECTABLE; INJECTION 5MG/VIAL Prescription BX  SOMATROPIN RECOMBINANT Human Growth Hormone EMD SERONO   "
INJECTABLE; INJECTION 6MG/VIAL Discontinued   SOMATROPIN RECOMBINANT Human Growth Hormone EMD SERONO   "
INJECTABLE; INJECTION 8.8MG/VIAL Prescription  (Reference Drug) SOMATROPIN RECOMBINANT Human Growth Hormone EMD SERONO   "

Drug Adverse Effects information for SAIZEN

Role code Indications Reaction # Reports
PS ADRENAL DISORDER SKIN PAPILLOMA 1
PS ASTHMA DIZZINESS 1
PS ASTHMA EAR DISORDER 1
PS ASTHMA HYPERTENSION 1
PS ASTHMA INCORRECT STORAGE OF DRUG 1
PS ASTHMA MALAISE 1
PS ASTHMA PANCREATITIS ACUTE 6
PS ASTHMA TREMOR 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER SUICIDAL IDEATION 2
PS BODY HEIGHT BELOW NORMAL CHRONIC MYELOID LEUKAEMIA 1
PS DEPRESSION DIZZINESS 1
PS DEPRESSION EAR DISORDER 1
PS DEPRESSION HYPERTENSION 1
PS DEPRESSION INCORRECT STORAGE OF DRUG 1
PS DEPRESSION MALAISE 1
PS DEPRESSION TREMOR 1
PS EPILEPSY CONVULSION 1
PS EPILEPSY FATIGUE 1
PS EPILEPSY HEADACHE 1
PS EPILEPSY JOINT SWELLING 1
PS GROWTH HORMONE DEFICIENCY ABDOMINAL PAIN 1
PS GROWTH HORMONE DEFICIENCY ANAPHYLACTIC REACTION 1
PS GROWTH HORMONE DEFICIENCY ASTROCYTOMA 1
PS GROWTH HORMONE DEFICIENCY BODY TEMPERATURE FLUCTUATION 2
PS GROWTH HORMONE DEFICIENCY BONE CYST 1
PS GROWTH HORMONE DEFICIENCY BONE LESION 1
PS GROWTH HORMONE DEFICIENCY CHEST WALL MASS 1
PS GROWTH HORMONE DEFICIENCY CRANIOPHARYNGIOMA 1
PS GROWTH HORMONE DEFICIENCY DIZZINESS 2
PS GROWTH HORMONE DEFICIENCY FATIGUE 2
PS GROWTH HORMONE DEFICIENCY GLIOMA 2
PS GROWTH HORMONE DEFICIENCY HIP FRACTURE 1
PS GROWTH HORMONE DEFICIENCY HYPOKALAEMIA 2
PS GROWTH HORMONE DEFICIENCY INCREASED UPPER AIRWAY SECRETION 2
PS GROWTH HORMONE DEFICIENCY LOWER RESPIRATORY TRACT INFECTION 1
PS GROWTH HORMONE DEFICIENCY MYALGIA 2
PS GROWTH HORMONE DEFICIENCY NASOPHARYNGITIS 2
PS GROWTH HORMONE DEFICIENCY NAUSEA 2
PS GROWTH HORMONE DEFICIENCY NEOPLASM MALIGNANT 1
PS GROWTH HORMONE DEFICIENCY NEOPLASM PROGRESSION 2
PS GROWTH HORMONE DEFICIENCY PAIN 2
PS GROWTH HORMONE DEFICIENCY PANCREATITIS 1
PS GROWTH HORMONE DEFICIENCY PANCREATITIS ACUTE 2
PS GROWTH HORMONE DEFICIENCY PHARYNGITIS 1
PS GROWTH HORMONE DEFICIENCY PRODUCTIVE COUGH 2
PS GROWTH HORMONE DEFICIENCY SKIN PAPILLOMA 1
PS GROWTH HORMONE DEFICIENCY SOMNOLENCE 2
PS GROWTH HORMONE DEFICIENCY THYROID CANCER 1
PS GROWTH HORMONE DEFICIENCY VISUAL IMPAIRMENT 1
PS GROWTH RETARDATION ASTHMA 1
PS GROWTH RETARDATION PNEUMONIA 1
PS GROWTH RETARDATION SURGERY 2
PS HYPERSENSITIVITY GLIOMA 1
PS HYPERSENSITIVITY VISUAL IMPAIRMENT 1
PS MEDULLOBLASTOMA BLINDNESS 1
PS MEDULLOBLASTOMA FALL 1
PS MEDULLOBLASTOMA HEAD INJURY 1
PS MEDULLOBLASTOMA HEADACHE 1
PS MEDULLOBLASTOMA OFF LABEL USE 1
PS MEDULLOBLASTOMA VISUAL IMPAIRMENT 1
PS MEDULLOBLASTOMA VOMITING 1
PS PERIPHERAL VASCULAR DISORDER BONE CYST 1
PS PITUITARY TUMOUR CONVULSION 2
PS PITUITARY TUMOUR FATIGUE 2
PS PITUITARY TUMOUR HEADACHE 2
PS PITUITARY TUMOUR JOINT SWELLING 2
PS PRADER-WILLI SYNDROME MYALGIA 1
PS PRADER-WILLI SYNDROME OVERDOSE 1
PS PRODUCT USED FOR UNKNOWN INDICATION ANGINA PECTORIS 2
PS PRODUCT USED FOR UNKNOWN INDICATION CEREBROVASCULAR ACCIDENT 2
PS PRODUCT USED FOR UNKNOWN INDICATION CONVULSION 2
PS PRODUCT USED FOR UNKNOWN INDICATION DEATH 1
PS PRODUCT USED FOR UNKNOWN INDICATION DIZZINESS 2
PS PRODUCT USED FOR UNKNOWN INDICATION EAR DISORDER 2
PS PRODUCT USED FOR UNKNOWN INDICATION EPILEPSY 1
PS PRODUCT USED FOR UNKNOWN INDICATION EPSTEIN-BARR VIRUS INFECTION 3
PS PRODUCT USED FOR UNKNOWN INDICATION FALL 1
PS PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 2
PS PRODUCT USED FOR UNKNOWN INDICATION FURUNCLE 1
PS PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 2
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERTENSION 2
PS PRODUCT USED FOR UNKNOWN INDICATION INCORRECT STORAGE OF DRUG 1
PS PRODUCT USED FOR UNKNOWN INDICATION JOINT SWELLING 2
PS PRODUCT USED FOR UNKNOWN INDICATION LYMPHOMA 1
PS PRODUCT USED FOR UNKNOWN INDICATION LYMPHOPROLIFERATIVE DISORDER 3
PS PRODUCT USED FOR UNKNOWN INDICATION MALAISE 2
PS PRODUCT USED FOR UNKNOWN INDICATION NEOPLASM 1
PS PRODUCT USED FOR UNKNOWN INDICATION NEOPLASM MALIGNANT 1
PS PRODUCT USED FOR UNKNOWN INDICATION OSTEOMYELITIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION PROGNATHISM 1
PS PRODUCT USED FOR UNKNOWN INDICATION TREMOR 3
PS SMALL FOR DATES BABY ADENOTONSILLECTOMY 1
PS SMALL FOR DATES BABY DIARRHOEA INFECTIOUS 1
PS SMALL FOR DATES BABY EAR INFECTION 1
PS SMALL FOR DATES BABY PYREXIA 1
PS SMALL FOR DATES BABY TONSILLECTOMY 1
PS SMALL FOR DATES BABY VOMITING 1
PS SMALL FOR DATES BABY WEIGHT DECREASED 1
PS TURNER'S SYNDROME ACROMEGALY 3
PS TURNER'S SYNDROME SUICIDAL IDEATION 3
PS TURNER'S SYNDROME URTICARIA 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER SUICIDAL IDEATION 1
SS EPILEPSY CONVULSION 1
SS EPILEPSY FATIGUE 1
SS EPILEPSY HEADACHE 1
SS EPILEPSY JOINT SWELLING 1
SS GROWTH HORMONE DEFICIENCY BODY TEMPERATURE FLUCTUATION 2
SS GROWTH HORMONE DEFICIENCY DIZZINESS 2
SS GROWTH HORMONE DEFICIENCY FATIGUE 2
SS GROWTH HORMONE DEFICIENCY GLIOMA 1
SS GROWTH HORMONE DEFICIENCY HYPOKALAEMIA 2
SS GROWTH HORMONE DEFICIENCY INCREASED UPPER AIRWAY SECRETION 2
SS GROWTH HORMONE DEFICIENCY MYALGIA 2
SS GROWTH HORMONE DEFICIENCY NASOPHARYNGITIS 2
SS GROWTH HORMONE DEFICIENCY NAUSEA 2
SS GROWTH HORMONE DEFICIENCY PAIN 2
SS GROWTH HORMONE DEFICIENCY PANCREATITIS 1
SS GROWTH HORMONE DEFICIENCY PRODUCTIVE COUGH 2
SS GROWTH HORMONE DEFICIENCY SOMNOLENCE 2
SS GROWTH RETARDATION SURGERY 4
SS PITUITARY TUMOUR CONVULSION 2
SS PITUITARY TUMOUR FATIGUE 2
SS PITUITARY TUMOUR HEADACHE 2
SS PITUITARY TUMOUR JOINT SWELLING 2
SS PRODUCT USED FOR UNKNOWN INDICATION CEREBROVASCULAR ACCIDENT 1
SS PRODUCT USED FOR UNKNOWN INDICATION CONVULSION 2
SS PRODUCT USED FOR UNKNOWN INDICATION EPILEPSY 1
SS PRODUCT USED FOR UNKNOWN INDICATION FALL 1
SS PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 2
SS PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 2
SS PRODUCT USED FOR UNKNOWN INDICATION JOINT SWELLING 2
SS TURNER'S SYNDROME SUICIDAL IDEATION 1
SS TURNER'S SYNDROME URTICARIA 1
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