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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