Drug information for ZYCLARA
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
CREAM; TOPICAL
3.75%
Prescription
IMIQUIMOD
imiquimod
GRACEWAY
201153
2011-10-03 Review
2011-10-03 Summary Review
2011-03-28 Label
2011-03-25 Letter
CREAM; TOPICAL
2.5%
Prescription
(Reference Drug)
IMIQUIMOD
imiquimod
MEDICIS
22483
2012-02-17 Letter
2012-02-17 Label
2011-10-03 Letter
2011-09-30 Label
2011-07-19 Letter
2011-07-18 Label
2011-03-28 Label
2011-03-25 Letter
2011-02-18 Label
2011-02-17 Summary Review
2010-12-01 Review
2010-03-29 Letter
CREAM; TOPICAL
3.75%
Prescription
(Reference Drug)
IMIQUIMOD
imiquimod
MEDICIS
"
Drug Adverse Effects information for ZYCLARA
Role code
Indications
Reaction
# Reports
PS
ACTINIC KERATOSIS
APPLICATION SITE DISCOLOURATION
1
PS
ACTINIC KERATOSIS
APPLICATION SITE INFLAMMATION
1
PS
ACTINIC KERATOSIS
APPLICATION SITE SCAB
1
PS
ACTINIC KERATOSIS
APPLICATION SITE SCAR
1
PS
ACTINIC KERATOSIS
APPLICATION SITE SWELLING
1
PS
ACTINIC KERATOSIS
APPLICATION SITE VESICLES
1
PS
ACTINIC KERATOSIS
ARRHYTHMIA
1
PS
ACTINIC KERATOSIS
BLEPHAROSPASM
1
PS
ACTINIC KERATOSIS
DIPLOPIA
1
PS
ACTINIC KERATOSIS
INFLUENZA LIKE ILLNESS
1
PS
ACTINIC KERATOSIS
MALAISE
1
PS
ACTINIC KERATOSIS
MULTIPLE SCLEROSIS
1
PS
ACTINIC KERATOSIS
TRIGEMINAL NEURALGIA
1
PS
ACTINIC KERATOSIS
VASCULAR HEADACHE
1
PS
ACTINIC KERATOSIS
VISION BLURRED
1
PS
ACTINIC KERATOSIS
VISUAL FIELD DEFECT
1
PS
MOLLUSCUM CONTAGIOSUM
RENAL FAILURE
1
PS
PRECANCEROUS CELLS PRESENT
EYELID OEDEMA
1
PS
PRECANCEROUS CELLS PRESENT
PERIORBITAL DISORDER
1
PS
PRECANCEROUS CELLS PRESENT
SKIN DISCOLOURATION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ALVEOLITIS ALLERGIC
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
FATIGUE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INFLUENZA LIKE ILLNESS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INTERSTITIAL LUNG DISEASE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
NAUSEA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
OXYGEN SATURATION DECREASED
1
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