Drug information for ACTIVELLA
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
0.5MG;0.1MG
Prescription
AB
ESTRADIOL
;
NORETHINDRONE ACETATE
NOVO NORDISK INC
20907
2007-01-08 Letter
2007-01-08 Letter
2007-01-08 Label
2007-01-08 Label
2005-12-08 Review
2005-12-08 Review
2005-12-08 Review
2005-12-08 Review
2005-12-08 Review
2005-12-08 Review
2005-07-08 Letter
2005-07-07 Label
1998-11-18 Review
1998-11-18 Letter
1998-11-18 Label
TABLET; ORAL
1MG;0.5MG
Prescription
AB (Reference Drug)
ESTRADIOL
;
NORETHINDRONE ACETATE
NOVO NORDISK INC
"
TABLET; ORAL
1MG/0.5MG
Prescription
ESTRADIOL
;
NORETHINDRONE ACETATE
NOVO NORDISK
21103
2007-11-06 Review
2000-04-11 Letter
2000-04-11 Label
TABLET; ORAL
1MG/0.5MG
Prescription
ESTRADIOL
;
NORETHINDRONE ACETATE
NOVO NORDISK INC
22001
2008-10-03 Review
2007-01-08 Letter
2007-01-08 Label
Drug Adverse Effects information for ACTIVELLA
Role code
Indications
Reaction
# Reports
SS
HORMONE REPLACEMENT THERAPY
BREAST CANCER FEMALE
3
C
ANXIETY
ANXIETY
1
C
ANXIETY
CHOLECYSTITIS CHRONIC
1
C
ANXIETY
CHOLELITHIASIS
1
C
ANXIETY
EMOTIONAL DISTRESS
1
C
ANXIETY
INJURY
1
C
ANXIETY
PAIN
1
C
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
ANXIETY
1
C
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
CHOLECYSTITIS CHRONIC
1
C
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
CHOLELITHIASIS
1
C
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
EMOTIONAL DISTRESS
1
C
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
INJURY
1
C
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
PAIN
1
C
CHRONIC LYMPHOCYTIC LEUKAEMIA
HAEMOGLOBIN DECREASED
1
C
CHRONIC LYMPHOCYTIC LEUKAEMIA
LIP SWELLING
1
C
CHRONIC LYMPHOCYTIC LEUKAEMIA
PARAESTHESIA ORAL
1
C
CHRONIC LYMPHOCYTIC LEUKAEMIA
RASH
1
C
CHRONIC LYMPHOCYTIC LEUKAEMIA
RED BLOOD CELL COUNT DECREASED
1
C
CHRONIC LYMPHOCYTIC LEUKAEMIA
URTICARIA
1
C
CHRONIC LYMPHOCYTIC LEUKAEMIA
WHITE BLOOD CELL COUNT DECREASED
1
C
CONTRACEPTION
ANXIETY
1
C
CONTRACEPTION
CHOLECYSTITIS CHRONIC
1
C
CONTRACEPTION
CHOLELITHIASIS
1
C
CONTRACEPTION
EMOTIONAL DISTRESS
1
C
CONTRACEPTION
INJURY
1
C
CONTRACEPTION
PAIN
1
C
DEPRESSION
ANXIETY
1
C
DEPRESSION
CHOLECYSTITIS CHRONIC
1
C
DEPRESSION
CHOLELITHIASIS
1
C
DEPRESSION
EMOTIONAL DISTRESS
1
C
DEPRESSION
INJURY
1
C
DEPRESSION
PAIN
1
C
DYSPEPSIA
SQUAMOUS CELL CARCINOMA
2
C
GASTROOESOPHAGEAL REFLUX DISEASE
SQUAMOUS CELL CARCINOMA
1
C
GENERAL PHYSICAL HEALTH DETERIORATION
SQUAMOUS CELL CARCINOMA
3
C
HERPES VIRUS INFECTION
ANXIETY
1
C
HERPES VIRUS INFECTION
CHOLECYSTITIS CHRONIC
1
C
HERPES VIRUS INFECTION
CHOLELITHIASIS
1
C
HERPES VIRUS INFECTION
EMOTIONAL DISTRESS
1
C
HERPES VIRUS INFECTION
INJURY
1
C
HERPES VIRUS INFECTION
PAIN
1
C
HORMONE REPLACEMENT THERAPY
SQUAMOUS CELL CARCINOMA
1
C
HYPERLIPIDAEMIA
SQUAMOUS CELL CARCINOMA
1
C
HYPOTHYROIDISM
SQUAMOUS CELL CARCINOMA
2
C
MENOPAUSE
ANXIETY
1
C
MENOPAUSE
CHOLECYSTITIS CHRONIC
1
C
MENOPAUSE
CHOLELITHIASIS
1
C
MENOPAUSE
EMOTIONAL DISTRESS
1
C
MENOPAUSE
INJURY
1
C
MENOPAUSE
PAIN
1
C
MULTIPLE SCLEROSIS
BACK PAIN
1
C
MULTIPLE SCLEROSIS
FLUSHING
1
C
MULTIPLE SCLEROSIS
HEADACHE
1
C
MULTIPLE SCLEROSIS
PYREXIA
1
C
OSTEOPOROSIS
ARTHROPATHY
1
C
OSTEOPOROSIS
BLOOD PRESSURE FLUCTUATION
1
C
PAIN
ANXIETY
1
C
PAIN
CHOLECYSTITIS CHRONIC
1
C
PAIN
CHOLELITHIASIS
1
C
PAIN
EMOTIONAL DISTRESS
1
C
PAIN
INJURY
1
C
PAIN
PAIN
1
C
PREMENSTRUAL SYNDROME
ANXIETY
1
C
PREMENSTRUAL SYNDROME
CHOLECYSTITIS CHRONIC
1
C
PREMENSTRUAL SYNDROME
CHOLELITHIASIS
1
C
PREMENSTRUAL SYNDROME
EMOTIONAL DISTRESS
1
C
PREMENSTRUAL SYNDROME
INJURY
1
C
PREMENSTRUAL SYNDROME
PAIN
1
C
RHEUMATOID ARTHRITIS
SQUAMOUS CELL CARCINOMA
4
C
SEASONAL ALLERGY
SQUAMOUS CELL CARCINOMA
1
C
SUPPLEMENTATION THERAPY
SQUAMOUS CELL CARCINOMA
1
C
VITAMIN D DEFICIENCY
SQUAMOUS CELL CARCINOMA
1
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