Drug information for OPTIVAR

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SOLUTION/DROPS; OPHTHALMIC 0.05% Prescription AT (Reference Drug) AZELASTINE HYDROCHLORIDE azelastine MEDA PHARMS 21127
2008-07-09 Label

2008-07-08 Letter

2004-09-03 Letter

2004-05-04 Label

2004-05-04 Label

2004-05-04 Letter

2004-05-04 Letter

2002-05-22 Review

2000-05-22 Letter

2000-05-22 Label

Drug Adverse Effects information for OPTIVAR

Role code Indications Reaction # Reports
C ASTHMA ANAPHYLACTIC REACTION 2
C COMPUTERISED TOMOGRAM ABDOMEN FLUSHING 1
C COMPUTERISED TOMOGRAM ABDOMEN NASAL CONGESTION 1
C COMPUTERISED TOMOGRAM ABDOMEN PRURITUS 1
C COMPUTERISED TOMOGRAM ABDOMEN URTICARIA 1
C HYPOGLOBULINAEMIA ORAL CANDIDIASIS 1
C HYPOGLOBULINAEMIA SINUSITIS 1
C IMMUNODEFICIENCY ORAL CANDIDIASIS 1
C IMMUNODEFICIENCY SINUSITIS 1
C INFLAMMATORY BOWEL DISEASE ABDOMINAL PAIN 4
C POST PROCEDURAL COMPLICATION FLUSHING 1
C POST PROCEDURAL COMPLICATION NASAL CONGESTION 1
C POST PROCEDURAL COMPLICATION PRURITUS 1
C POST PROCEDURAL COMPLICATION URTICARIA 1
C PREMEDICATION FLUSHING 3
C PREMEDICATION NASAL CONGESTION 3
C PREMEDICATION PRURITUS 3
C PREMEDICATION URTICARIA 3
C PRODUCT USED FOR UNKNOWN INDICATION ANAPHYLACTIC REACTION 18
C PRODUCT USED FOR UNKNOWN INDICATION HEPATIC ENZYME INCREASED 26
C PRODUCT USED FOR UNKNOWN INDICATION KIDNEY INFECTION 26
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