Drug information for EMSAM
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
FILM, EXTENDED RELEASE; TRANSDERMAL
12MG/24HR
Prescription
SELEGILINE
Selegiline
SOMERSET
21336
2008-02-14 Letter
2007-09-10 Review
2007-08-02 Letter
2007-07-31 Label
2007-05-09 Other Important Information from FDA
2007-02-20 Medication Guide
2006-03-03 Label
2006-03-03 Letter
FILM, EXTENDED RELEASE; TRANSDERMAL
6MG/24HR
Prescription
(Reference Drug)
SELEGILINE
Selegiline
SOMERSET
"
FILM, EXTENDED RELEASE; TRANSDERMAL
9MG/24HR
Prescription
SELEGILINE
Selegiline
SOMERSET
"
SYSTEM; TRANSDERMAL
12MG
Prescription
SELEGILINE
Selegiline
SOMERSET
21708
2007-09-10 Review
2007-05-09 Other Important Information from FDA
2007-02-20 Medication Guide
2006-03-03 Label
2006-03-03 Letter
SYSTEM; TRANSDERMAL
6MG
Prescription
SELEGILINE
Selegiline
SOMERSET
"
SYSTEM; TRANSDERMAL
9MG
Prescription
SELEGILINE
Selegiline
SOMERSET
"
Drug Adverse Effects information for EMSAM
Role code
Indications
Reaction
# Reports
PS
ANXIETY
ANGIOEDEMA
1
PS
ANXIETY
APPLICATION SITE RASH
1
PS
DEPRESSION
ANGIOEDEMA
1
PS
DEPRESSION
APPLICATION SITE RASH
1
PS
DEPRESSION
DISSOCIATIVE FUGUE
2
PS
DEPRESSION
DISTURBANCE IN ATTENTION
2
PS
DEPRESSION
RESTLESSNESS
2
SS
ANXIETY
ANGIOEDEMA
1
SS
ANXIETY
APPLICATION SITE RASH
1
SS
DEPRESSION
ANGIOEDEMA
1
SS
DEPRESSION
APPLICATION SITE RASH
1
C
BIPOLAR DISORDER
HYPOMANIA
3
C
DEPRESSION
BURNING SENSATION
2
C
DEPRESSION
CYANOSIS
2
C
DEPRESSION
DENTAL CARIES
2
C
DEPRESSION
ERYTHEMA
2
C
DEPRESSION
HYPERHIDROSIS
2
C
DEPRESSION
HYPOAESTHESIA
2
C
DEPRESSION
OEDEMA PERIPHERAL
2
C
DEPRESSION
OVERDOSE
2
C
DEPRESSION
PARAESTHESIA
2
C
DEPRESSION
PERIPHERAL COLDNESS
2
C
DEPRESSION
PRURITUS
2
C
DEPRESSION
RASH MACULAR
2
C
DEPRESSION
TEMPERATURE INTOLERANCE
2
C
PARKINSON'S DISEASE
BURNING SENSATION
4
C
PARKINSON'S DISEASE
CYANOSIS
4
C
PARKINSON'S DISEASE
DENTAL CARIES
4
C
PARKINSON'S DISEASE
ERYTHEMA
4
C
PARKINSON'S DISEASE
HYPERHIDROSIS
4
C
PARKINSON'S DISEASE
HYPOAESTHESIA
4
C
PARKINSON'S DISEASE
OEDEMA PERIPHERAL
4
C
PARKINSON'S DISEASE
OVERDOSE
4
C
PARKINSON'S DISEASE
PARAESTHESIA
4
C
PARKINSON'S DISEASE
PERIPHERAL COLDNESS
4
C
PARKINSON'S DISEASE
PRURITUS
4
C
PARKINSON'S DISEASE
RASH MACULAR
4
C
PARKINSON'S DISEASE
TEMPERATURE INTOLERANCE
4
C
PRODUCT USED FOR UNKNOWN INDICATION
DYSGEUSIA
1
C
PRODUCT USED FOR UNKNOWN INDICATION
HYPOMANIA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE ERYTHEMA
1
C
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE INDURATION
1
C
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE REACTION
1
C
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE SWELLING
1
C
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE URTICARIA
1
C
PRODUCT USED FOR UNKNOWN INDICATION
RHINORRHOEA
1
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