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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