Drug information for EGRIFTA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
POWDER; SUBCUTANEOUS EQ 1MG BASE/VIAL Prescription  (Reference Drug) TESAMORELIN ACETATE tesamorelin THERATECHNOLOGIES 22505
2011-12-02 Label

2011-12-02 Label

2010-12-14 Review

2010-12-14 Summary Review

2010-11-15 Letter

2010-11-12 Label

Drug Adverse Effects information for EGRIFTA

Role code Indications Reaction # Reports
PS ACQUIRED IMMUNODEFICIENCY SYNDROME HYPOTENSION 1
PS ACQUIRED IMMUNODEFICIENCY SYNDROME INJECTION SITE PAIN 1
PS ACQUIRED IMMUNODEFICIENCY SYNDROME VISION BLURRED 1
PS BARRETT'S OESOPHAGUS HEPATOMEGALY 1
PS CARDIOVASCULAR EVENT PROPHYLAXIS HYPOTENSION 1
PS CARDIOVASCULAR EVENT PROPHYLAXIS INJECTION SITE PAIN 1
PS CARDIOVASCULAR EVENT PROPHYLAXIS VISION BLURRED 1
PS DIABETES MELLITUS BLOOD GLUCOSE INCREASED 1
PS DIABETES MELLITUS GLYCOSYLATED HAEMOGLOBIN INCREASED 1
PS HIV INFECTION ABDOMINAL PAIN 1
PS HIV INFECTION AGEUSIA 1
PS HIV INFECTION ARTHRALGIA 1
PS HIV INFECTION BLOOD CHLORIDE DECREASED 1
PS HIV INFECTION BLOOD PH DECREASED 1
PS HIV INFECTION BLOOD SODIUM DECREASED 1
PS HIV INFECTION CONFUSIONAL STATE 1
PS HIV INFECTION DYSGEUSIA 1
PS HIV INFECTION GASTRIC INFECTION 1
PS HIV INFECTION HEPATOMEGALY 3
PS HIV INFECTION HYPERGLYCAEMIA 1
PS HIV INFECTION HYPERSENSITIVITY 1
PS HIV INFECTION HYPOAESTHESIA 1
PS HIV INFECTION HYPOKALAEMIA 1
PS HIV INFECTION MYALGIA 1
PS HIV INFECTION OEDEMA PERIPHERAL 1
PS HIV INFECTION PAIN IN EXTREMITY 1
PS HIV INFECTION PHARYNGITIS 1
PS HIV INFECTION RENAL FAILURE ACUTE 1
PS HIV INFECTION RENAL TUBULAR NECROSIS 1
PS LENTIVIRUS TEST POSITIVE BREAST CANCER 1
PS LENTIVIRUS TEST POSITIVE WEIGHT DECREASED 1
PS LIPODYSTROPHY ACQUIRED ABDOMINAL DISTENSION 4
PS LIPODYSTROPHY ACQUIRED ABDOMINAL PAIN 1
PS LIPODYSTROPHY ACQUIRED ABDOMINAL TENDERNESS 1
PS LIPODYSTROPHY ACQUIRED ADVERSE REACTION 1
PS LIPODYSTROPHY ACQUIRED ALOPECIA 1
PS LIPODYSTROPHY ACQUIRED ANAEMIA 1
PS LIPODYSTROPHY ACQUIRED ANGER 1
PS LIPODYSTROPHY ACQUIRED ANOGENITAL DYSPLASIA 1
PS LIPODYSTROPHY ACQUIRED ANXIETY 4
PS LIPODYSTROPHY ACQUIRED ARTHRALGIA 6
PS LIPODYSTROPHY ACQUIRED ARTHRITIS 2
PS LIPODYSTROPHY ACQUIRED ASTHENIA 4
PS LIPODYSTROPHY ACQUIRED BLOOD CHLORIDE DECREASED 1
PS LIPODYSTROPHY ACQUIRED BLOOD CHOLESTEROL INCREASED 1
PS LIPODYSTROPHY ACQUIRED BLOOD GLUCOSE ABNORMAL 2
PS LIPODYSTROPHY ACQUIRED BLOOD GLUCOSE DECREASED 1
PS LIPODYSTROPHY ACQUIRED BLOOD GLUCOSE INCREASED 5
PS LIPODYSTROPHY ACQUIRED BLOOD PH DECREASED 1
PS LIPODYSTROPHY ACQUIRED BLOOD PRESSURE INCREASED 5
PS LIPODYSTROPHY ACQUIRED BLOOD SODIUM DECREASED 1
PS LIPODYSTROPHY ACQUIRED BLOOD UREA INCREASED 1
PS LIPODYSTROPHY ACQUIRED BREAST CANCER 1
PS LIPODYSTROPHY ACQUIRED BRONCHITIS 1
PS LIPODYSTROPHY ACQUIRED BURNING SENSATION 1
PS LIPODYSTROPHY ACQUIRED CACHEXIA 1
PS LIPODYSTROPHY ACQUIRED CARPAL TUNNEL SYNDROME 3
PS LIPODYSTROPHY ACQUIRED CHEST DISCOMFORT 1
PS LIPODYSTROPHY ACQUIRED CHILLS 1
PS LIPODYSTROPHY ACQUIRED CHOLECYSTECTOMY 2
PS LIPODYSTROPHY ACQUIRED COLORECTAL CANCER STAGE IV 1
PS LIPODYSTROPHY ACQUIRED CONCUSSION 1
PS LIPODYSTROPHY ACQUIRED CONDITION AGGRAVATED 1
PS LIPODYSTROPHY ACQUIRED CONFUSIONAL STATE 1
PS LIPODYSTROPHY ACQUIRED CONSTIPATION 2
PS LIPODYSTROPHY ACQUIRED CONTUSION 2
PS LIPODYSTROPHY ACQUIRED COUGH 1
PS LIPODYSTROPHY ACQUIRED CYST 1
PS LIPODYSTROPHY ACQUIRED DECREASED APPETITE 1
PS LIPODYSTROPHY ACQUIRED DEPRESSED MOOD 1
PS LIPODYSTROPHY ACQUIRED DEPRESSION 3
PS LIPODYSTROPHY ACQUIRED DIABETES MELLITUS 4
PS LIPODYSTROPHY ACQUIRED DIARRHOEA 4
PS LIPODYSTROPHY ACQUIRED DIVERTICULITIS 1
PS LIPODYSTROPHY ACQUIRED DIZZINESS 8
PS LIPODYSTROPHY ACQUIRED DYSGEUSIA 1
PS LIPODYSTROPHY ACQUIRED DYSMORPHISM 1
PS LIPODYSTROPHY ACQUIRED DYSPEPSIA 1
PS LIPODYSTROPHY ACQUIRED DYSPNOEA 2
PS LIPODYSTROPHY ACQUIRED DYSURIA 1
PS LIPODYSTROPHY ACQUIRED EPIGASTRIC DISCOMFORT 1
PS LIPODYSTROPHY ACQUIRED EPSTEIN-BARR VIRUS INFECTION 1
PS LIPODYSTROPHY ACQUIRED ERYTHEMA 2
PS LIPODYSTROPHY ACQUIRED EUPHORIC MOOD 1
PS LIPODYSTROPHY ACQUIRED EXPIRED DRUG ADMINISTERED 1
PS LIPODYSTROPHY ACQUIRED FACIAL WASTING 1
PS LIPODYSTROPHY ACQUIRED FAECES DISCOLOURED 1
PS LIPODYSTROPHY ACQUIRED FAT TISSUE INCREASED 2
PS LIPODYSTROPHY ACQUIRED FATIGUE 7
PS LIPODYSTROPHY ACQUIRED FEELING ABNORMAL 3
PS LIPODYSTROPHY ACQUIRED FEELING HOT 2
PS LIPODYSTROPHY ACQUIRED FLUSHING 1
PS LIPODYSTROPHY ACQUIRED FREQUENT BOWEL MOVEMENTS 1
PS LIPODYSTROPHY ACQUIRED FURUNCLE 2
PS LIPODYSTROPHY ACQUIRED GASTRIC INFECTION 2
PS LIPODYSTROPHY ACQUIRED GLYCOSYLATED HAEMOGLOBIN INCREASED 3
PS LIPODYSTROPHY ACQUIRED GYNAECOMASTIA 1
PS LIPODYSTROPHY ACQUIRED HEADACHE 3
PS LIPODYSTROPHY ACQUIRED HEPATOMEGALY 1
PS LIPODYSTROPHY ACQUIRED HIP ARTHROPLASTY 1
PS LIPODYSTROPHY ACQUIRED HIP SURGERY 1
PS LIPODYSTROPHY ACQUIRED HOT FLUSH 4
PS LIPODYSTROPHY ACQUIRED HYPERGLYCAEMIA 1
PS LIPODYSTROPHY ACQUIRED HYPERHIDROSIS 3
PS LIPODYSTROPHY ACQUIRED HYPERSOMNIA 3
PS LIPODYSTROPHY ACQUIRED HYPERTENSION 1
PS LIPODYSTROPHY ACQUIRED HYPOAESTHESIA 1
PS LIPODYSTROPHY ACQUIRED HYPOGLYCAEMIA 1
PS LIPODYSTROPHY ACQUIRED HYPOKALAEMIA 1
PS LIPODYSTROPHY ACQUIRED HYPOTENSION 1
PS LIPODYSTROPHY ACQUIRED INCISION SITE PAIN 2
PS LIPODYSTROPHY ACQUIRED INCREASED APPETITE 1
PS LIPODYSTROPHY ACQUIRED INFECTION 1
PS LIPODYSTROPHY ACQUIRED INFLUENZA 1
PS LIPODYSTROPHY ACQUIRED INJECTION SITE HAEMATOMA 6
PS LIPODYSTROPHY ACQUIRED INJECTION SITE HAEMORRHAGE 3
PS LIPODYSTROPHY ACQUIRED INJECTION SITE MASS 2
PS LIPODYSTROPHY ACQUIRED INJECTION SITE PAIN 4
PS LIPODYSTROPHY ACQUIRED INSOMNIA 4
PS LIPODYSTROPHY ACQUIRED JOINT SWELLING 1
PS LIPODYSTROPHY ACQUIRED LARYNGITIS 1
PS LIPODYSTROPHY ACQUIRED LIPOSUCTION 2
PS LIPODYSTROPHY ACQUIRED MALAISE 4
PS LIPODYSTROPHY ACQUIRED MASS 1
PS LIPODYSTROPHY ACQUIRED MIGRAINE 2
PS LIPODYSTROPHY ACQUIRED MOOD SWINGS 1
PS LIPODYSTROPHY ACQUIRED MUSCLE ATROPHY 1
PS LIPODYSTROPHY ACQUIRED MUSCULAR WEAKNESS 1
PS LIPODYSTROPHY ACQUIRED MUSCULOSKELETAL CHEST PAIN 1
PS LIPODYSTROPHY ACQUIRED MYALGIA 2
PS LIPODYSTROPHY ACQUIRED MYOCARDIAL INFARCTION 1
PS LIPODYSTROPHY ACQUIRED NASOPHARYNGITIS 2
PS LIPODYSTROPHY ACQUIRED NAUSEA 4
PS LIPODYSTROPHY ACQUIRED NEURODERMATITIS 1
PS LIPODYSTROPHY ACQUIRED NEUROPATHY PERIPHERAL 1
PS LIPODYSTROPHY ACQUIRED NIGHT SWEATS 1
PS LIPODYSTROPHY ACQUIRED NO ADVERSE EVENT 1
PS LIPODYSTROPHY ACQUIRED OEDEMA PERIPHERAL 4
PS LIPODYSTROPHY ACQUIRED ORAL HERPES 1
PS LIPODYSTROPHY ACQUIRED ORAL SURGERY 2
PS LIPODYSTROPHY ACQUIRED OVERDOSE 1
PS LIPODYSTROPHY ACQUIRED PAIN 6
PS LIPODYSTROPHY ACQUIRED PAIN IN EXTREMITY 4
PS LIPODYSTROPHY ACQUIRED PALPITATIONS 4
PS LIPODYSTROPHY ACQUIRED PHARYNGEAL OEDEMA 1
PS LIPODYSTROPHY ACQUIRED POLLAKIURIA 1
PS LIPODYSTROPHY ACQUIRED PRURITUS 1
PS LIPODYSTROPHY ACQUIRED PULMONARY THROMBOSIS 2
PS LIPODYSTROPHY ACQUIRED PYREXIA 1
PS LIPODYSTROPHY ACQUIRED RENAL DISORDER 1
PS LIPODYSTROPHY ACQUIRED RENAL FAILURE 1
PS LIPODYSTROPHY ACQUIRED RENAL FAILURE ACUTE 1
PS LIPODYSTROPHY ACQUIRED RENAL TUBULAR NECROSIS 1
PS LIPODYSTROPHY ACQUIRED RESPIRATORY TRACT INFECTION 1
PS LIPODYSTROPHY ACQUIRED RHINORRHOEA 1
PS LIPODYSTROPHY ACQUIRED ROAD TRAFFIC ACCIDENT 1
PS LIPODYSTROPHY ACQUIRED SINUSITIS 1
PS LIPODYSTROPHY ACQUIRED SKIN BURNING SENSATION 1
PS LIPODYSTROPHY ACQUIRED SKIN INFECTION 2
PS LIPODYSTROPHY ACQUIRED SQUAMOUS CELL CARCINOMA 1
PS LIPODYSTROPHY ACQUIRED SUICIDAL BEHAVIOUR 1
PS LIPODYSTROPHY ACQUIRED SWELLING 2
PS LIPODYSTROPHY ACQUIRED T-LYMPHOCYTE COUNT INCREASED 1
PS LIPODYSTROPHY ACQUIRED TACHYPHRENIA 1
PS LIPODYSTROPHY ACQUIRED TENDONITIS 2
PS LIPODYSTROPHY ACQUIRED THINKING ABNORMAL 1
PS LIPODYSTROPHY ACQUIRED THROMBOSIS 2
PS LIPODYSTROPHY ACQUIRED THYROID DISORDER 1
PS LIPODYSTROPHY ACQUIRED TREMOR 2
PS LIPODYSTROPHY ACQUIRED UMBILICAL HERNIA REPAIR 1
PS LIPODYSTROPHY ACQUIRED URINE ABNORMALITY 1
PS LIPODYSTROPHY ACQUIRED URINE COLOUR ABNORMAL 1
PS LIPODYSTROPHY ACQUIRED URTICARIA 1
PS LIPODYSTROPHY ACQUIRED VERTIGO 1
PS LIPODYSTROPHY ACQUIRED VISION BLURRED 3
PS LIPODYSTROPHY ACQUIRED VISUAL IMPAIRMENT 1
PS LIPODYSTROPHY ACQUIRED VOMITING 4
PS LIPODYSTROPHY ACQUIRED WEIGHT DECREASED 1
PS LIPODYSTROPHY ACQUIRED WEIGHT INCREASED 7
PS PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISTENSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 1
PS PRODUCT USED FOR UNKNOWN INDICATION BACK PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION BLOOD GLUCOSE INCREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION BONE PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION BREAST SWELLING 1
PS PRODUCT USED FOR UNKNOWN INDICATION CHEST DISCOMFORT 1
PS PRODUCT USED FOR UNKNOWN INDICATION CHEST PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION DIABETES MELLITUS 2
PS PRODUCT USED FOR UNKNOWN INDICATION DIABETIC HYPEROSMOLAR COMA 1
PS PRODUCT USED FOR UNKNOWN INDICATION DIARRHOEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 1
PS PRODUCT USED FOR UNKNOWN INDICATION FOAMING AT MOUTH 1
PS PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 1
PS PRODUCT USED FOR UNKNOWN INDICATION HEART RATE INCREASED 2
PS PRODUCT USED FOR UNKNOWN INDICATION HEPATOMEGALY 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERHIDROSIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERTENSION 2
PS PRODUCT USED FOR UNKNOWN INDICATION INCORRECT DOSE ADMINISTERED 1
PS PRODUCT USED FOR UNKNOWN INDICATION INFLUENZA 1
PS PRODUCT USED FOR UNKNOWN INDICATION INFLUENZA LIKE ILLNESS 1
PS PRODUCT USED FOR UNKNOWN INDICATION JOINT SWELLING 1
PS PRODUCT USED FOR UNKNOWN INDICATION NEUROPATHY PERIPHERAL 1
PS PRODUCT USED FOR UNKNOWN INDICATION OEDEMA PERIPHERAL 2
PS PRODUCT USED FOR UNKNOWN INDICATION PALPITATIONS 1
PS PRODUCT USED FOR UNKNOWN INDICATION SKIN PAPILLOMA 1
PS PRODUCT USED FOR UNKNOWN INDICATION SYNCOPE 1
PS PRODUCT USED FOR UNKNOWN INDICATION UNEVALUABLE EVENT 1
PS PRODUCT USED FOR UNKNOWN INDICATION VIRAL LOAD INCREASED 1
PS SMOKING CESSATION THERAPY FATIGUE 1
PS SMOKING CESSATION THERAPY HYPOAESTHESIA 1
PS SMOKING CESSATION THERAPY THINKING ABNORMAL 1
PS TYPE 1 DIABETES MELLITUS DIABETES MELLITUS 1
PS TYPE 1 DIABETES MELLITUS DIABETIC HYPEROSMOLAR COMA 2
PS TYPE 1 DIABETES MELLITUS FOAMING AT MOUTH 1
PS TYPE 2 DIABETES MELLITUS BLOOD GLUCOSE INCREASED 2
PS TYPE 2 DIABETES MELLITUS GLYCOSYLATED HAEMOGLOBIN INCREASED 2
SS LENTIVIRUS TEST POSITIVE BREAST CANCER 1
SS LENTIVIRUS TEST POSITIVE WEIGHT DECREASED 1
SS LIPODYSTROPHY ACQUIRED BREAST CANCER 1
SS LIPODYSTROPHY ACQUIRED OVERDOSE 1
SS LIPODYSTROPHY ACQUIRED WEIGHT DECREASED 1
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