In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
Having considered the responses to the list of questions (LoQ) on the Roland et al. study provided by the registration certificate holder (RCH), the PRAC decided that the RCH of the medicinal product Jaydess (Bayer) should submit an application for an amendment to the instructions for medical use, as described below (new text underlined, text to be deleted struck through):
- “Special precautions for use” section
Ectopic pregnancy
In clinical trials, the overall incidence of ectopic pregnancy in women using the Jaydess® system is approximately 0,11 per 100 women per year. Approximately half of the pregnancies that occur in women with an inserted Jaydess® system may be ectopic. Data from post-registration observational studies indicate higher rates of ectopic pregnancy with the use of the medicinal product Jaydess (13,5 mg) compared with other intrauterine systems (IUSs) and copper-containing intrauterine contraceptives (see the “Adverse reactions” section, subsection “Description of selected adverse reactions”).
Women who plan to use the Jaydess® system should be counseled about the signs, symptoms, and risks of ectopic pregnancy. In women who become pregnant while using the Jaydess® system, the possibility of ectopic pregnancy should be considered and evaluated.
Women with a history of ectopic pregnancy, tubal surgery, or pelvic inflammatory disease have an increased risk of ectopic pregnancy. The possibility of ectopic pregnancy should be considered if lower abdominal pain occurs, especially in the absence of menstruation, or if bleeding appears in a woman with amenorrhea.
Since ectopic pregnancy may affect and compromise future fertility, the benefit/risk ratio of using the Jaydess® system should be carefully assessed on an individual basis, in particular for women who have not yet given birth. In doing so, other intrauterine systems / intrauterine contraceptives (IUDs) should be considered, especially in women who may wish to become pregnant in the future.
Use in women who have not given birth.
Jaydess® system is not a first-choice contraceptive method for nulliparous women, since clinical experience with the use of the system in this group of women is limited.
- “Adverse reactions” section
[…]
Description of selected adverse reactions
If a woman becomes pregnant while using the Jaydess system®, the relative risk of ectopic pregnancy increases (see the section “Special warnings and precautions for use,” subsection “Ectopic pregnancy”).
Based on the results of a nationwide cohort study using data from the French National Healthcare Data System, which compared hormonal intrauterine systems and copper-containing intrauterine contraceptives. Over 1 year, the rates of ectopic pregnancy were 0,18 (95% confidence interval [CI] 0,14–0,23), 0,10 (95% CI 0,08–0,11), 0,04 (95% CI 0,03–0,05) and 0,07 (95% CI 0,07–0,08) per 100 person-years for levonorgestrel IUSs at a dose of 13,5 mg, 19,5 mg, 52 mg and for copper IUDs, respectively. Compared with copper IUDs, the hazard ratios for ectopic pregnancy were 2,57 (95% CI 1,92–3,43), 1,37 (95% CI 1,15–1.62) and 0,62 (95% CI 0,49–0,80) for levonorgestrel IUSs at a dose of 13,5 mg, 19,5 mg and 52 mg, respectively.
List of medicinal products containing levonorgestrel (levonorgestrel) (intrauterine system 13,5 mg) and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 31.07.2026). (10 KB) (Downloaded: 11.08.2026 10:22:34)
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE RELEVANT APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT AVAILABLE AT THE FOLLOWING LINKS:
