Nebenwirkungen · Evra
EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch · Abschnitt 4.8 · PDF-Seite 13–14
HOS-110324 · Präparat HOS-093363
13 Tabulated list of adverse reactions Safety was evaluated in 3 322 sexually active women who participated in three Phase III clinical trials, which were designed to evaluate contraceptive efficacy. These subjects received six or 13 cycles of contraception (EVRA or oral contraceptive comparator), took at least one dose of study medicinal product and provided safety data. Table 1 below reflects the adverse reactions reported in clinical trials and from post-marketing experience. Frequency MedDRA convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-04-22T17:22:00Z · SHA-256 08ee5b4a9562d12725bc2847cb5a881102ab4ddbaaf7c1a2e28b65b78fd2ab5d · Passage 92585fa5bc774ad0c457d3f0df82e6e5adf862d17187237b62b8d54d57c30ea4 · Zeichen 757–1466 im Abschnitt