WebOct 28, 2024 · Pregnancy: Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to MOTEGRITY during pregnancy [see Use in Specific Populations (8.1)]. Storage. Advise patients to keep MOTEGRITY in the original container to protect from moisture. Distributed by: Takeda Pharmaceuticals America, Inc. … Webfor Pregnancy Safety Concerns Drug Name: Prucalopride (Motegrity®) Application Type/#: NDA 210166 Applicant/Sponsor: Shire Pharmaceuticals OSE RCM #: 2024-622 Reference ID: 4363358. Page 2 of 5 Expedited ARIA Sufficiency Template for Pregnancy Safety Concerns 1. BACKGROUND INFORMATION
Clinical Efficacy and Safety Profile of Prucalopride in Chronic ...
WebWebMD provides important information about Abilify oral such as if you can you take Abilify oral when you are pregnant or nursing or If Motegrity dangerous for children or adults over 60. WebMotegrity: - Protect from moisture - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F - Store in original container. ... There is a pregnancy exposure registry that monitors pregnancy outcomes in women … dallas mavericks season tickets 2023
Motegrity (prucalopride) dose, indications, adverse effects ... - PDR
WebExposure Information Service 866.626.6847. Pregnancy Studies 877.311.8972. Media Inquiries 619.368.3259 [email protected] WebOct 28, 2024 · The safety and effectiveness of MOTEGRITY have not been established in pediatric patients. 8.5 Geriatric Use. Of the 2484 patients treated with MOTEGRITY 1 mg or 2 mg once daily in 6 controlled trials of at least 12-week duration in patients with CIC, 15% were 65 years of age and over, and 5% were 75 years of age and over [see Clinical … WebFeb 15, 2024 · Motegrity may interact with erythromycin or ketoconazole. Tell your doctor all medications and supplements you use. Motegrity During Pregnancy and Breastfeeding. Tell your doctor if you are pregnant or plan to become pregnant before using Motegrity; it is unknown how it would affect a fetus. Motegrity passes into breast milk. birch run building department