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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