Application Nr Approved Date Route Status External Links
NDA019886 None Nasal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage For Central Precocious Puberty (For Endometriosis, See Reverse Side ) Synarel Is Indicated For Treatment Of Central Precocious Puberty (Cpp) (Gonadotropin-Dependent Precocious Puberty) In Children Of Both Sexes. The Diagnosis Of Central Precocious Puberty (Cpp) Is Suspected When Premature Development Of Secondary Sexual Characteristics Occurs At Or Before The Age Of 8 Years In Girls And 9 Years In Boys, And Is Accompanied By Significant Advancement Of Bone Age And/or A Poor Adult Height Prediction. The Diagnosis Should Be Confirmed By Pubertal Gonadal Sex Steroid Levels And A Pubertal Lh Response To Stimulation By Native Gnrh. Pelvic Ultrasound Assessment In Girls Usually Reveals Enlarged Uterus And Ovaries, The Latter Often With Multiple Cystic Formations. Magnetic Resonance Imaging Or Ct-Scanning Of The Brain Is Recommended To Detect Hypothalamic Or Pituitary Tumors, Or Anatomical Changes Associated With Increased Intracranial Pressure. Other Causes Of Sexual Precocity, Such As Congenital Adrenal Hyperplasia, Testotoxicosis, Testicular Tumors And/or Other Autonomous Feminizing Or Masculinizing Disorders Must Be Excluded By Proper Clinical Hormonal And Diagnostic Imaging Examinations.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Nafarelin Acetate

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