Drug information for INVIRASE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL EQ 200MG BASE Prescription  (Reference Drug) SAQUINAVIR MESYLATE Saquinavir HOFFMANN LA ROCHE 20628
2012-02-27 Letter
2012-02-22 Label
2011-05-31 Letter
2010-11-03 Other
2010-10-13 Medication Guide
2010-10-12 Letter
2010-10-12 Label
2010-08-09 Other Important Information from FDA
2010-05-07 Label
2010-04-29 Letter
2010-01-26 Letter
2010-01-24 Label
2007-11-19 Review
2007-09-26 Review
2007-08-06 Review
2007-07-16 Label
2007-07-16 Letter
2007-04-09 Letter
2007-04-06 Label
2005-11-04 Patient Package Insert
2005-11-04 Patient Package Insert
2005-09-14 Label
2005-09-14 Letter
2005-09-14 Letter
2005-09-14 Label
2005-04-27 Review
2004-02-03 Patient Package Insert
2004-01-15 Label
2004-01-14 Letter
2002-06-24 Label
2002-06-24 Letter
1997-02-27 Review
TABLET; ORAL EQ 500MG BASE Prescription  (Reference Drug) SAQUINAVIR MESYLATE Saquinavir ROCHE 21785
2012-02-27 Letter
2012-02-22 Label
2011-05-31 Letter
2010-11-03 Other
2010-10-13 Medication Guide
2010-10-12 Letter
2010-10-12 Label
2010-08-09 Other Important Information from FDA
2010-05-07 Label
2010-04-29 Letter
2010-01-26 Letter
2010-01-24 Label
2007-07-27 Review
2007-07-16 Label
2007-07-16 Letter
2007-04-09 Letter
2007-04-06 Label
2006-09-27 Review
2005-11-04 Patient Package Insert
2005-11-04 Patient Package Insert
2005-09-14 Label
2005-09-14 Label
2005-09-14 Letter
2005-09-14 Letter
2004-12-30 Label
2004-12-30 Letter

Drug Adverse Effects information for INVIRASE

Role code Indications Reaction # Reports
PS HIV INFECTION BACTERIAL SEPSIS 3
PS HIV INFECTION CARDIOVASCULAR DISORDER 4
PS HIV INFECTION DIARRHOEA INFECTIOUS 3
PS HIV INFECTION GASTROENTERITIS 3
PS HIV INFECTION HAEMOPTYSIS 3
PS HIV INFECTION HYPERBILIRUBINAEMIA 2
PS HIV INFECTION PULMONARY TUBERCULOSIS 3
PS HIV INFECTION RASH 2
PS PRODUCT USED FOR UNKNOWN INDICATION HOSPITALISATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOSPADIAS 8
PS PRODUCT USED FOR UNKNOWN INDICATION MATERNAL EXPOSURE TIMING UNSPECIFIED 8
SS CORONARY ARTERY DISEASE AIDS ENCEPHALOPATHY 1
SS HAEMARTHROSIS ALANINE AMINOTRANSFERASE INCREASED 1
SS HAEMARTHROSIS ASPARTATE AMINOTRANSFERASE INCREASED 1
SS HAEMARTHROSIS DIZZINESS 1
SS HAEMARTHROSIS PALPITATIONS 1
SS HAEMARTHROSIS PULMONARY HYPERTENSION 1
SS HIV INFECTION ALANINE AMINOTRANSFERASE INCREASED 8
SS HIV INFECTION APPARENT LIFE THREATENING EVENT 10
SS HIV INFECTION ASPARTATE AMINOTRANSFERASE INCREASED 8
SS HIV INFECTION DIZZINESS 18
SS HIV INFECTION PALPITATIONS 18
SS HIV INFECTION PULMONARY HYPERTENSION 18
SS MATERNAL EXPOSURE DURING PREGNANCY FOETAL EXPOSURE DURING PREGNANCY 4
SS MATERNAL EXPOSURE DURING PREGNANCY HYPOSPADIAS 8
SS MATERNAL EXPOSURE DURING PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY 8
SS MATERNAL EXPOSURE DURING PREGNANCY PENILE CURVATURE 8
SS MATERNAL EXPOSURE TIMING UNSPECIFIED FOETAL EXPOSURE DURING PREGNANCY 4
SS MATERNAL EXPOSURE TIMING UNSPECIFIED HYPOSPADIAS 4
SS MATERNAL EXPOSURE TIMING UNSPECIFIED PENILE CURVATURE 4
C HIV INFECTION ENLARGED CLITORIS 1
C HIV INFECTION FLATULENCE 5
C HIV INFECTION HYPOSPADIAS 2
C HIV INFECTION NAUSEA 5
C HIV INFECTION OCULAR ICTERUS 5
C HIV INFECTION PENILE CURVATURE 2
C HIV INFECTION ROTATOR CUFF SYNDROME 4
C HIV INFECTION SLEEP DISORDER 5
C HIV INFECTION TENOSYNOVITIS 4
C HIV INFECTION VERTIGO 5
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