Drug information for COSMEGEN

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 0.5MG/VIAL Prescription AP (Reference Drug) DACTINOMYCIN Dactinomycin LUNDBECK LLC 50682
2012-02-07 Letter

2012-02-07 Letter

2012-02-06 Label

2012-02-06 Label

2009-04-03 Label

2009-03-17 Letter

2005-08-19 Letter

2004-12-06 Letter

2003-03-26 Letter

2002-10-28 Letter

Drug Adverse Effects information for COSMEGEN

Role code Indications Reaction # Reports
PS GESTATIONAL TROPHOBLASTIC TUMOUR AGITATION 2
PS GESTATIONAL TROPHOBLASTIC TUMOUR ANAPHYLACTIC REACTION 2
PS GESTATIONAL TROPHOBLASTIC TUMOUR BACK PAIN 2
PS GESTATIONAL TROPHOBLASTIC TUMOUR CHEST DISCOMFORT 2
PS GESTATIONAL TROPHOBLASTIC TUMOUR FLUSHING 2
PS GESTATIONAL TROPHOBLASTIC TUMOUR HYPERSENSITIVITY 2
PS GESTATIONAL TROPHOBLASTIC TUMOUR INFUSION RELATED REACTION 2
PS GESTATIONAL TROPHOBLASTIC TUMOUR NAUSEA 2
PS GESTATIONAL TROPHOBLASTIC TUMOUR NO THERAPEUTIC RESPONSE 2
PS GESTATIONAL TROPHOBLASTIC TUMOUR RASH MACULAR 2
PS GESTATIONAL TROPHOBLASTIC TUMOUR TACHYCARDIA 2
PS NEPHROBLASTOMA BONE MARROW TRANSPLANT 7
PS NEPHROBLASTOMA BREAST CANCER IN SITU 14
PS NEPHROBLASTOMA FIBROCYSTIC BREAST DISEASE 7
PS NEPHROBLASTOMA NEPHROBLASTOMA 7
PS NEPHROBLASTOMA RECURRENT CANCER 7
PS PRODUCT USED FOR UNKNOWN INDICATION AGITATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION ANAPHYLACTIC REACTION 1
PS PRODUCT USED FOR UNKNOWN INDICATION BACK PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION CHEST DISCOMFORT 1
PS PRODUCT USED FOR UNKNOWN INDICATION FLUSHING 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERSENSITIVITY 1
PS PRODUCT USED FOR UNKNOWN INDICATION INFUSION RELATED REACTION 1
PS PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION NO THERAPEUTIC RESPONSE 1
PS PRODUCT USED FOR UNKNOWN INDICATION RASH MACULAR 1
PS PRODUCT USED FOR UNKNOWN INDICATION TACHYCARDIA 1
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