Drug information for KUVAN
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
100MG
Prescription
(Reference Drug)
SAPROPTERIN DIHYDROCHLORIDE
5,6,7,8-tetrahydrobiopterin
BIOMARIN PHARM
22181
2008-07-22 Summary Review
2008-06-24 Letter
2008-03-24 Review
2007-12-13 Label
2007-12-13 Questions and Answers
2007-12-13 Letter
Drug Adverse Effects information for KUVAN
Role code
Indications
Reaction
# Reports
PS
ARTHRITIS
GASTROOESOPHAGEAL REFLUX DISEASE
2
PS
ASTHMA
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
BLOOD CHOLESTEROL INCREASED
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
DYSTONIA
SUICIDAL IDEATION
2
PS
FOETAL EXPOSURE DURING PREGNANCY
DUODENAL ATRESIA
1
PS
FOETAL EXPOSURE DURING PREGNANCY
PREMATURE BABY
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
MATERNAL DRUGS AFFECTING FOETUS
CAESAREAN SECTION
2
PS
MATERNAL DRUGS AFFECTING FOETUS
HYPERBILIRUBINAEMIA
2
PS
MATERNAL DRUGS AFFECTING FOETUS
HYPERBILIRUBINAEMIA NEONATAL
2
PS
MATERNAL DRUGS AFFECTING FOETUS
MATERNAL DRUGS AFFECTING FOETUS
2
PS
MATERNAL DRUGS AFFECTING FOETUS
PREMATURE BABY
2
PS
MATERNAL DRUGS AFFECTING FOETUS
RESPIRATORY DISTRESS
2
PS
MATERNAL EXPOSURE DURING PREGNANCY
HYPERBILIRUBINAEMIA
2
PS
MATERNAL EXPOSURE DURING PREGNANCY
RESPIRATORY DISTRESS
2
PS
MULTIPLE ALLERGIES
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
PHENYLKETONURIA
ASPIRATION
1
PS
PHENYLKETONURIA
CAESAREAN SECTION
1
PS
PHENYLKETONURIA
DEPRESSION
1
PS
PHENYLKETONURIA
FIBROADENOMA OF BREAST
1
PS
PHENYLKETONURIA
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
PHENYLKETONURIA
GESTATIONAL DIABETES
1
PS
PHENYLKETONURIA
HYPERBILIRUBINAEMIA
2
PS
PHENYLKETONURIA
HYPERBILIRUBINAEMIA NEONATAL
1
PS
PHENYLKETONURIA
KNEE OPERATION
1
PS
PHENYLKETONURIA
MATERNAL DRUGS AFFECTING FOETUS
1
PS
PHENYLKETONURIA
MATERNAL EXPOSURE DURING PREGNANCY
1
PS
PHENYLKETONURIA
NEONATAL RESPIRATORY DISTRESS SYNDROME
2
PS
PHENYLKETONURIA
PREMATURE BABY
1
PS
PHENYLKETONURIA
RESPIRATORY DISTRESS
2
PS
PHENYLKETONURIA
SPORTS INJURY
1
PS
PHENYLKETONURIA
SUICIDAL IDEATION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
GESTATIONAL DIABETES
4
PS
PRODUCT USED FOR UNKNOWN INDICATION
HAEMATEMESIS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
MATERNAL EXPOSURE DURING PREGNANCY
4
PS
VITAMIN SUPPLEMENTATION
GASTROOESOPHAGEAL REFLUX DISEASE
1
SS
DYSTONIA
SUICIDAL IDEATION
4
SS
FOETAL EXPOSURE DURING PREGNANCY
DUODENAL ATRESIA
1
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