Drug information for NOXAFIL

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SUSPENSION; ORAL 40MG/ML Prescription  (Reference Drug) POSACONAZOLE posaconazole SCHERING 22003
2010-09-13 Letter

2010-09-10 Label

2009-02-23 Letter

2009-02-20 Label

2008-05-21 Letter

2008-05-21 Letter

2006-11-09 Review

2006-09-20 Letter

2006-09-18 Label
SUSPENSION; ORAL 40MG/ML Prescription   POSACONAZOLE posaconazole SCHERING 22027
2010-09-13 Letter

2010-09-10 Label

2008-09-05 Review

2006-10-23 Label

2006-10-23 Letter

Drug Adverse Effects information for NOXAFIL

Role code Indications Reaction # Reports
PS ANTIFUNGAL TREATMENT PANCYTOPENIA 1
PS ASPERGILLOSIS CHOLESTASIS 1
PS ASPERGILLOSIS NEUROPATHY PERIPHERAL 1
PS FUNGAL INFECTION CENTRAL NERVOUS SYSTEM INFECTION 1
PS HEPATOSPLENIC CANDIDIASIS ARRHYTHMIA 1
PS HEPATOSPLENIC CANDIDIASIS ARRHYTHMIA SUPRAVENTRICULAR 1
PS HEPATOSPLENIC CANDIDIASIS ATRIOVENTRICULAR BLOCK SECOND DEGREE 1
PS HEPATOSPLENIC CANDIDIASIS BRADYCARDIA 1
PS HEPATOSPLENIC CANDIDIASIS CARDIAC ARREST 1
PS HEPATOSPLENIC CANDIDIASIS DRUG INTERACTION 1
PS HEPATOSPLENIC CANDIDIASIS NODAL ARRHYTHMIA 1
PS HEPATOSPLENIC CANDIDIASIS SINOATRIAL BLOCK 1
PS HEPATOSPLENIC CANDIDIASIS SINUS TACHYCARDIA 1
PS LUNG INFECTION DRUG INEFFECTIVE 2
PS PNEUMONIA DRUG INEFFECTIVE 1
PS PRODUCT USED FOR UNKNOWN INDICATION ARRHYTHMIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION ARRHYTHMIA SUPRAVENTRICULAR 1
PS PRODUCT USED FOR UNKNOWN INDICATION ATRIOVENTRICULAR BLOCK SECOND DEGREE 1
PS PRODUCT USED FOR UNKNOWN INDICATION BRADYCARDIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION CARDIAC ARREST 1
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG INTERACTION 1
PS PRODUCT USED FOR UNKNOWN INDICATION NODAL ARRHYTHMIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION SINOATRIAL BLOCK 1
PS PRODUCT USED FOR UNKNOWN INDICATION SINUS TACHYCARDIA 1
PS SINUSITIS PANCYTOPENIA 1
PS VISCERAL LEISHMANIASIS CYSTITIS RADIATION 1
PS VISCERAL LEISHMANIASIS HAEMATURIA 1
PS ZYGOMYCOSIS PANCYTOPENIA 1
SS ACUTE LEUKAEMIA IN REMISSION SINOATRIAL BLOCK 2
SS CANDIDIASIS SINOATRIAL BLOCK 1
SS HEPATOSPLENIC CANDIDIASIS ARRHYTHMIA 2
SS HEPATOSPLENIC CANDIDIASIS ATRIOVENTRICULAR BLOCK SECOND DEGREE 4
SS HEPATOSPLENIC CANDIDIASIS BRADYARRHYTHMIA 2
SS HEPATOSPLENIC CANDIDIASIS BRADYCARDIA 2
SS HEPATOSPLENIC CANDIDIASIS DRUG INTERACTION 5
SS HEPATOSPLENIC CANDIDIASIS HEPATOSPLENIC CANDIDIASIS 1
SS HEPATOSPLENIC CANDIDIASIS NODAL ARRHYTHMIA 3
SS HEPATOSPLENIC CANDIDIASIS SINOATRIAL BLOCK 5
SS HEPATOSPLENIC CANDIDIASIS SINUS BRADYCARDIA 3
SS HEPATOSPLENIC CANDIDIASIS SINUS TACHYCARDIA 4
SS PRODUCT USED FOR UNKNOWN INDICATION ARRHYTHMIA 18
SS PRODUCT USED FOR UNKNOWN INDICATION ATRIOVENTRICULAR BLOCK SECOND DEGREE 41
SS PRODUCT USED FOR UNKNOWN INDICATION BRADYARRHYTHMIA 18
SS PRODUCT USED FOR UNKNOWN INDICATION BRADYCARDIA 18
SS PRODUCT USED FOR UNKNOWN INDICATION DRUG INTERACTION 49
SS PRODUCT USED FOR UNKNOWN INDICATION HEPATOSPLENIC CANDIDIASIS 8
SS PRODUCT USED FOR UNKNOWN INDICATION NODAL ARRHYTHMIA 35
SS PRODUCT USED FOR UNKNOWN INDICATION SINOATRIAL BLOCK 40
SS PRODUCT USED FOR UNKNOWN INDICATION SINUS BRADYCARDIA 35
SS PRODUCT USED FOR UNKNOWN INDICATION SINUS TACHYCARDIA 34
SS PROPHYLAXIS OF NAUSEA AND VOMITING SINOATRIAL BLOCK 1
C ABDOMINAL PAIN ADENOVIRAL HEPATITIS 1
C ABDOMINAL PAIN ANAEMIA 1
C ABDOMINAL PAIN CARDIOVASCULAR DISORDER 1
C ABDOMINAL PAIN COAGULATION FACTOR V LEVEL DECREASED 1
C ABDOMINAL PAIN CYSTITIS HAEMORRHAGIC 1
C ABDOMINAL PAIN ENCEPHALITIS 1
C ABDOMINAL PAIN GENERAL PHYSICAL HEALTH DETERIORATION 1
C ABDOMINAL PAIN HEPATIC FAILURE 1
C ABDOMINAL PAIN MULTI-ORGAN FAILURE 1
C ABDOMINAL PAIN RESPIRATORY DISORDER 1
C ACUTE GRAFT VERSUS HOST DISEASE ADENOVIRAL HEPATITIS 1
C ACUTE GRAFT VERSUS HOST DISEASE ANAEMIA 1
C ACUTE GRAFT VERSUS HOST DISEASE CARDIOVASCULAR DISORDER 1
C ACUTE GRAFT VERSUS HOST DISEASE COAGULATION FACTOR V LEVEL DECREASED 1
C ACUTE GRAFT VERSUS HOST DISEASE CYSTITIS HAEMORRHAGIC 1
C ACUTE GRAFT VERSUS HOST DISEASE ENCEPHALITIS 1
C ACUTE GRAFT VERSUS HOST DISEASE GENERAL PHYSICAL HEALTH DETERIORATION 1
C ACUTE GRAFT VERSUS HOST DISEASE HEPATIC FAILURE 1
C ACUTE GRAFT VERSUS HOST DISEASE MULTI-ORGAN FAILURE 1
C ACUTE GRAFT VERSUS HOST DISEASE RESPIRATORY DISORDER 1
C ACUTE MYELOID LEUKAEMIA ATRIAL FIBRILLATION 3
C ACUTE MYELOID LEUKAEMIA BRADYCARDIA 3
C ACUTE MYELOID LEUKAEMIA CARDIAC ARREST 9
C ACUTE MYELOID LEUKAEMIA FUSARIUM INFECTION 9
C ACUTE MYELOID LEUKAEMIA GANGRENE 3
C ACUTE MYELOID LEUKAEMIA HAEMODIALYSIS 3
C ACUTE MYELOID LEUKAEMIA METABOLIC ACIDOSIS 3
C ACUTE MYELOID LEUKAEMIA NEUTROPENIC COLITIS 9
C ACUTE MYELOID LEUKAEMIA RENAL IMPAIRMENT 3
C ACUTE MYELOID LEUKAEMIA SINUS ARREST 3
C ACUTE MYELOID LEUKAEMIA ZYGOMYCOSIS 9
C ANTIFUNGAL PROPHYLAXIS ATRIAL FIBRILLATION 1
C ANTIFUNGAL PROPHYLAXIS BRADYCARDIA 1
C ANTIFUNGAL PROPHYLAXIS CARDIAC ARREST 3
C ANTIFUNGAL PROPHYLAXIS FUSARIUM INFECTION 3
C ANTIFUNGAL PROPHYLAXIS GANGRENE 1
C ANTIFUNGAL PROPHYLAXIS HAEMODIALYSIS 1
C ANTIFUNGAL PROPHYLAXIS METABOLIC ACIDOSIS 1
C ANTIFUNGAL PROPHYLAXIS NEUTROPENIC COLITIS 3
C ANTIFUNGAL PROPHYLAXIS RENAL IMPAIRMENT 1
C ANTIFUNGAL PROPHYLAXIS SINUS ARREST 1
C ANTIFUNGAL PROPHYLAXIS ZYGOMYCOSIS 3
C BREAST CANCER ACUTE MYELOID LEUKAEMIA 1
C BREAST CANCER DEATH 1
C BREAST CANCER NEOPLASM MALIGNANT 1
C BRONCHIECTASIS BRONCHOSPASM 1
C BRONCHIECTASIS CANDIDIASIS 1
C BRONCHIECTASIS CHEST DISCOMFORT 1
C BRONCHIECTASIS DEVICE MALFUNCTION 1
C BRONCHIECTASIS EMPHYSEMA 1
C BRONCHIECTASIS OXYGEN SATURATION DECREASED 1
C BRONCHIECTASIS PULMONARY CONGESTION 1
C BRONCHIECTASIS TOOTH DISORDER 1
C DIALYSIS ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 1
C DIALYSIS BACTERIAL INFECTION 1
C DIALYSIS BRONCHOPULMONARY ASPERGILLOSIS 1
C DIALYSIS GENERAL PHYSICAL HEALTH DETERIORATION 1
C DIALYSIS INFECTION 1
C INFECTION ATRIAL FIBRILLATION 1
C INFECTION BRADYCARDIA 1
C INFECTION CARDIAC ARREST 3
C INFECTION FUSARIUM INFECTION 3
C INFECTION GANGRENE 1
C INFECTION HAEMODIALYSIS 1
C INFECTION METABOLIC ACIDOSIS 1
C INFECTION NEUTROPENIC COLITIS 3
C INFECTION RENAL IMPAIRMENT 1
C INFECTION SINUS ARREST 1
C INFECTION ZYGOMYCOSIS 3
C INFECTION PROPHYLAXIS DYSPNOEA 4
C INFECTION PROPHYLAXIS HYPERCALCAEMIA 2
C INFECTION PROPHYLAXIS PNEUMONIA 2
C INFECTION PROPHYLAXIS TUMOUR LYSIS SYNDROME 2
C INSOMNIA ADENOVIRAL HEPATITIS 1
C INSOMNIA ANAEMIA 1
C INSOMNIA CARDIOVASCULAR DISORDER 1
C INSOMNIA COAGULATION FACTOR V LEVEL DECREASED 1
C INSOMNIA CYSTITIS HAEMORRHAGIC 1
C INSOMNIA ENCEPHALITIS 1
C INSOMNIA GENERAL PHYSICAL HEALTH DETERIORATION 1
C INSOMNIA HEPATIC FAILURE 1
C INSOMNIA MULTI-ORGAN FAILURE 1
C INSOMNIA RESPIRATORY DISORDER 1
C MULTIPLE MYELOMA ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 1
C MULTIPLE MYELOMA BACTERIAL INFECTION 1
C MULTIPLE MYELOMA BRONCHOPULMONARY ASPERGILLOSIS 1
C MULTIPLE MYELOMA GENERAL PHYSICAL HEALTH DETERIORATION 1
C MULTIPLE MYELOMA INFECTION 1
C NAUSEA ADENOVIRAL HEPATITIS 1
C NAUSEA ANAEMIA 1
C NAUSEA CARDIOVASCULAR DISORDER 1
C NAUSEA COAGULATION FACTOR V LEVEL DECREASED 1
C NAUSEA CYSTITIS HAEMORRHAGIC 1
C NAUSEA ENCEPHALITIS 1
C NAUSEA GENERAL PHYSICAL HEALTH DETERIORATION 1
C NAUSEA HEPATIC FAILURE 1
C NAUSEA MULTI-ORGAN FAILURE 1
C NAUSEA RESPIRATORY DISORDER 1
C PAIN ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 1
C PAIN ADENOVIRAL HEPATITIS 1
C PAIN ANAEMIA 1
C PAIN BACTERIAL INFECTION 1
C PAIN BRONCHOPULMONARY ASPERGILLOSIS 1
C PAIN CARDIOVASCULAR DISORDER 1
C PAIN COAGULATION FACTOR V LEVEL DECREASED 1
C PAIN CYSTITIS HAEMORRHAGIC 1
C PAIN DYSPNOEA 2
C PAIN ENCEPHALITIS 1
C PAIN GENERAL PHYSICAL HEALTH DETERIORATION 2
C PAIN HEPATIC FAILURE 1
C PAIN HYPERCALCAEMIA 1
C PAIN INFECTION 1
C PAIN MULTI-ORGAN FAILURE 1
C PAIN PNEUMONIA 1
C PAIN RESPIRATORY DISORDER 1
C PAIN TUMOUR LYSIS SYNDROME 1
C PNEUMONIA DYSPNOEA 2
C PNEUMONIA HYPERCALCAEMIA 1
C PNEUMONIA PNEUMONIA 1
C PNEUMONIA TUMOUR LYSIS SYNDROME 1
C PRODUCT USED FOR UNKNOWN INDICATION ADENOVIRAL HEPATITIS 27
C PRODUCT USED FOR UNKNOWN INDICATION ANAEMIA 27
C PRODUCT USED FOR UNKNOWN INDICATION CARDIOVASCULAR DISORDER 27
C PRODUCT USED FOR UNKNOWN INDICATION COAGULATION FACTOR V LEVEL DECREASED 27
C PRODUCT USED FOR UNKNOWN INDICATION CYSTITIS HAEMORRHAGIC 27
C PRODUCT USED FOR UNKNOWN INDICATION ENCEPHALITIS 27
C PRODUCT USED FOR UNKNOWN INDICATION GENERAL PHYSICAL HEALTH DETERIORATION 27
C PRODUCT USED FOR UNKNOWN INDICATION HEPATIC FAILURE 27
C PRODUCT USED FOR UNKNOWN INDICATION MULTI-ORGAN FAILURE 27
C PRODUCT USED FOR UNKNOWN INDICATION RESPIRATORY DISORDER 27
C PROPHYLAXIS CARDIAC ARREST 1
C PROPHYLAXIS DYSPNOEA 4
C PROPHYLAXIS FUSARIUM INFECTION 1
C PROPHYLAXIS HYPERCALCAEMIA 2
C PROPHYLAXIS NEUTROPENIC COLITIS 1
C PROPHYLAXIS PNEUMONIA 2
C PROPHYLAXIS TUMOUR LYSIS SYNDROME 2
C PROPHYLAXIS ZYGOMYCOSIS 1
C PYREXIA ADENOVIRAL HEPATITIS 1
C PYREXIA ANAEMIA 1
C PYREXIA CARDIOVASCULAR DISORDER 1
C PYREXIA COAGULATION FACTOR V LEVEL DECREASED 1
C PYREXIA CYSTITIS HAEMORRHAGIC 1
C PYREXIA ENCEPHALITIS 1
C PYREXIA GENERAL PHYSICAL HEALTH DETERIORATION 1
C PYREXIA HEPATIC FAILURE 1
C PYREXIA MULTI-ORGAN FAILURE 1
C PYREXIA RESPIRATORY DISORDER 1
C THROMBOSIS PROPHYLAXIS DYSPNOEA 2
C THROMBOSIS PROPHYLAXIS HYPERCALCAEMIA 1
C THROMBOSIS PROPHYLAXIS PNEUMONIA 1
C THROMBOSIS PROPHYLAXIS TUMOUR LYSIS SYNDROME 1
I ACUTE LEUKAEMIA IN REMISSION ARRHYTHMIA 2
I ACUTE LEUKAEMIA IN REMISSION ATRIOVENTRICULAR BLOCK SECOND DEGREE 2
I ACUTE LEUKAEMIA IN REMISSION BRADYCARDIA 2
I ACUTE LEUKAEMIA IN REMISSION DRUG INTERACTION 2
I ACUTE LEUKAEMIA IN REMISSION SINOATRIAL BLOCK 2
I ACUTE LEUKAEMIA IN REMISSION SINUS TACHYCARDIA 2
I HEPATOSPLENIC CANDIDIASIS ARRHYTHMIA 3
I HEPATOSPLENIC CANDIDIASIS ATRIOVENTRICULAR BLOCK SECOND DEGREE 12
I HEPATOSPLENIC CANDIDIASIS BRADYARRHYTHMIA 4
I HEPATOSPLENIC CANDIDIASIS BRADYCARDIA 6
I HEPATOSPLENIC CANDIDIASIS DRUG INTERACTION 12
I HEPATOSPLENIC CANDIDIASIS HEPATOSPLENIC CANDIDIASIS 1
I HEPATOSPLENIC CANDIDIASIS NODAL ARRHYTHMIA 4
I HEPATOSPLENIC CANDIDIASIS SINOATRIAL BLOCK 12
I HEPATOSPLENIC CANDIDIASIS SINUS BRADYCARDIA 4
I HEPATOSPLENIC CANDIDIASIS SINUS TACHYCARDIA 6
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