Drug information for CLIMARA PRO

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
FILM, EXTENDED RELEASE; TRANSDERMAL 0.045MG/24HR;0.015MG/24HR Prescription  (Reference Drug) ESTRADIOL; LEVONORGESTREL klimonorm BAYER HLTHCARE 21258
2006-06-07 Review
2005-06-24 Letter
2005-06-24 Label
2004-04-01 Label
2003-11-28 Letter
SYSTEM; TRANSDERMAL 0.045MG Prescription   ESTRADIOL; LEVONORGESTREL klimonorm BERLEX LABS 21885
2007-07-02 Review
2006-01-06 Letter
2006-01-05 Label

Drug Adverse Effects information for CLIMARA PRO

Role code Indications Reaction # Reports
PS HEADACHE MUSCLE SPASMS 2
PS HEADACHE PARAESTHESIA 2
PS HORMONE REPLACEMENT THERAPY APPLICATION SITE RASH 2
PS HORMONE REPLACEMENT THERAPY PRODUCT ADHESION ISSUE 1
PS HORMONE REPLACEMENT THERAPY PRURITUS 1
PS HORMONE REPLACEMENT THERAPY RASH 1
PS HOT FLUSH ALOPECIA 1
PS HOT FLUSH APPLICATION SITE RASH 3
PS HOT FLUSH DIZZINESS 3
PS HOT FLUSH DYSPNOEA 1
PS HOT FLUSH ERYTHEMA 1
PS HOT FLUSH FALL 1
PS HOT FLUSH FEELING ABNORMAL 2
PS HOT FLUSH HEADACHE 2
PS HOT FLUSH HOT FLUSH 4
PS HOT FLUSH HYPERTENSION 1
PS HOT FLUSH INCORRECT DRUG ADMINISTRATION DURATION 1
PS HOT FLUSH INSOMNIA 2
PS HOT FLUSH LOWER LIMB FRACTURE 1
PS HOT FLUSH MALAISE 1
PS HOT FLUSH METRORRHAGIA 1
PS HOT FLUSH NERVOUSNESS 1
PS HOT FLUSH NIGHT SWEATS 1
PS HOT FLUSH PAIN IN EXTREMITY 1
PS HOT FLUSH POLYMENORRHOEA 1
PS HOT FLUSH PRODUCT ADHESION ISSUE 4
PS HOT FLUSH PRODUCT DEPOSIT 1
PS HOT FLUSH RASH MACULAR 2
PS HOT FLUSH RASH PRURITIC 1
PS HOT FLUSH UTERINE SPASM 1
PS MENOPAUSAL SYMPTOMS APPLICATION SITE PUSTULES 1
PS MENOPAUSAL SYMPTOMS APPLICATION SITE RASH 1
PS MENOPAUSAL SYMPTOMS HOT FLUSH 1
PS MENOPAUSE APPLICATION SITE RASH 1
PS MENOPAUSE MUSCLE SPASMS 2
PS MENOPAUSE PARAESTHESIA 2
PS MENOPAUSE PRODUCT ADHESION ISSUE 1
PS NIGHT SWEATS HOT FLUSH 1
PS NIGHT SWEATS NIGHT SWEATS 1
PS OSTEOPENIA MUSCLE SPASMS 2
PS OSTEOPENIA PARAESTHESIA 2
PS OSTEOPOROSIS POSTMENOPAUSAL FEELING ABNORMAL 1
PS OSTEOPOROSIS POSTMENOPAUSAL HOT FLUSH 2
PS OSTEOPOROSIS POSTMENOPAUSAL POLYMENORRHOEA 1
PS OSTEOPOROSIS POSTMENOPAUSAL POSTMENOPAUSAL HAEMORRHAGE 2
PS OSTEOPOROSIS POSTMENOPAUSAL PRODUCT ADHESION ISSUE 2
PS OSTEOPOROSIS POSTMENOPAUSAL RASH 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERHIDROSIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION INSOMNIA 1
SS HEADACHE MUSCLE SPASMS 4
SS HEADACHE PARAESTHESIA 4
SS HOT FLUSH APPLICATION SITE RASH 2
SS HOT FLUSH ERYTHEMA 1
SS HOT FLUSH HOT FLUSH 1
SS HOT FLUSH INCORRECT DRUG ADMINISTRATION DURATION 1
SS HOT FLUSH NIGHT SWEATS 1
SS HOT FLUSH PRODUCT ADHESION ISSUE 1
SS HOT FLUSH PRODUCT DEPOSIT 1
SS HOT FLUSH RASH PRURITIC 1
SS MENOPAUSE APPLICATION SITE RASH 1
SS MENOPAUSE MUSCLE SPASMS 4
SS MENOPAUSE PARAESTHESIA 4
SS MENOPAUSE PRODUCT ADHESION ISSUE 1
SS NIGHT SWEATS HOT FLUSH 1
SS NIGHT SWEATS NIGHT SWEATS 1
SS OSTEOPENIA MUSCLE SPASMS 4
SS OSTEOPENIA PARAESTHESIA 4
C ANGIOGRAM ARTHRALGIA 5
C ANGIOGRAM DYSSTASIA 5
C ANGIOGRAM GAIT DISTURBANCE 5
C ANGIOGRAM JOINT CONTRACTURE 5
C ANGIOGRAM JOINT RANGE OF MOTION DECREASED 5
C ANGIOGRAM LICHENIFICATION 5
C ANGIOGRAM NEPHROGENIC SYSTEMIC FIBROSIS 5
C ANGIOGRAM OCULAR ICTERUS 5
C ANGIOGRAM OEDEMA PERIPHERAL 5
C ANGIOGRAM PAIN 5
C ANGIOGRAM PULMONARY FIBROSIS 5
C ANGIOGRAM SKIN HYPERPIGMENTATION 5
C ANGIOGRAM SKIN INDURATION 5
C ANGIOGRAM SKIN TIGHTNESS 5
C NUCLEAR MAGNETIC RESONANCE IMAGING ARTHRALGIA 5
C NUCLEAR MAGNETIC RESONANCE IMAGING DYSSTASIA 5
C NUCLEAR MAGNETIC RESONANCE IMAGING GAIT DISTURBANCE 5
C NUCLEAR MAGNETIC RESONANCE IMAGING JOINT CONTRACTURE 5
C NUCLEAR MAGNETIC RESONANCE IMAGING JOINT RANGE OF MOTION DECREASED 5
C NUCLEAR MAGNETIC RESONANCE IMAGING LICHENIFICATION 5
C NUCLEAR MAGNETIC RESONANCE IMAGING NEPHROGENIC SYSTEMIC FIBROSIS 5
C NUCLEAR MAGNETIC RESONANCE IMAGING OCULAR ICTERUS 5
C NUCLEAR MAGNETIC RESONANCE IMAGING OEDEMA PERIPHERAL 5
C NUCLEAR MAGNETIC RESONANCE IMAGING PAIN 5
C NUCLEAR MAGNETIC RESONANCE IMAGING PULMONARY FIBROSIS 5
C NUCLEAR MAGNETIC RESONANCE IMAGING SKIN HYPERPIGMENTATION 5
C NUCLEAR MAGNETIC RESONANCE IMAGING SKIN INDURATION 5
C NUCLEAR MAGNETIC RESONANCE IMAGING SKIN TIGHTNESS 5
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ARTHRALGIA 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN DYSSTASIA 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN GAIT DISTURBANCE 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN JOINT CONTRACTURE 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN JOINT RANGE OF MOTION DECREASED 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN LICHENIFICATION 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN NEPHROGENIC SYSTEMIC FIBROSIS 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN OCULAR ICTERUS 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN OEDEMA PERIPHERAL 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN PAIN 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN PULMONARY FIBROSIS 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN SKIN HYPERPIGMENTATION 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN SKIN INDURATION 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN SKIN TIGHTNESS 1
C PRODUCT USED FOR UNKNOWN INDICATION DYSGEUSIA 1
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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