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Dietary supplements / Beyaz / Birth control / Folic acid / Levomefolic acid / Drospirenone / Valproic acid / Neural tube defect / Antifolate / Chemistry / Medicine / Nutrition


[removed]Beyaz Clinical PREA
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City

Helsinki / /

Company

AEs / Bayer / Applicant Bayer Schering Pharma AG / /

Continent

Europe / /

Country

United States / /

Event

FDA Phase / /

Facility

Laboratory Findings / /

IndustryTerm

food items / proposed combination drug product / combination drug product / study site / Prevention of pregnancy • Treatment of symptoms / treatment of menopausal symptoms / food additive / health food stores / combination product / oral contraceptive products / /

MedicalCondition

hyperkalemia / neural tube defects / moderate acne / neural tube defect / colorectal cancer / further neural tube defects / J Cancer / premenstrual dysphoric disorder / namely renal and adrenal insufficiency / pernicious anemia / /

MedicalTreatment

contraception / /

Organization

FDA / FDA Advisory Committee / Advisory Committee / MD NDA / /

Person

Review Daniel Davis / Daniel Davis / Comment / /

Position

Division statistician / /

Product

estradiol / DRSP/EE/levomefolate tablets / folic acid / valproic acid / Dosing Regimen One / ntd / Oral tablet Dosing Regimen One tablet / Angeliq / YAZ / Yasmin / A43598 / A39814 / Beyaz / YAZ oral / /

ProgrammingLanguage

L / /

PublishedMedium

Baseline / /

Technology

Pharmacokinetics / Pharmacodynamics / /

SocialTag