Search results
This guideline aims at providing criteria to select medicinal products for which active surveillance for collecting post-authorisation data in pregnancy is necessary. It provides guidance on how to monitor accidental or intended exposure to medicinal products during pregnancy and specific requirements for
Scientific guidelines. This document describes how to assess the risk of an adverse reproductive/developmental effect in human based on reproductive toxicity studies in animals and human clinical data.
The European Medicines Agency's (EMA) provides answers to frequently asked questions on good manufacturing practice (GMP) and good distribution practice (GDP), as discussed and agreed by the GMP/GDP Inspectors Working Group.
8 paź 2003 · Part IV - GMP requirements for Advanced Therapy Medicinal Products. Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products; Other documents related to GMP and GDP. Compilation of Union Procedures on Inspections and Exchange of Information
1 sie 2021 · Introduction. Some women may experience unexplained vaginal bleeding during pregnancy. For some women an initial bleed can lead to more severe bleeding which could lead to adverse outcomes. It is therefore important that women are treated appropriately when presenting with unexplained vaginal bleeding.
16 mar 2023 · Vaginal spotting or bleeding occurs in approximately 25 percent of pregnancies in the first trimester (up to 13+6 weeks [ie, 13 weeks plus 6 days of gestation]) . It is much less common in the second trimester (14+0 to 27+6 weeks), occurring in one to two percent of pregnancies [ 2 ].
1 lut 2019 · Approximately one-fourth of pregnant women will experience bleeding in the first trimester. The differential diagnosis includes threatened abortion, early pregnancy loss, and ectopic...
