Opinion on medicine for use outside EU: Dapivirine Vaginal Ring 25 mg, dapivirine, Anti-HIV Agents, 23/07/2020 Positive opinion
The organisation that markets Dapivirine Vaginal Ring 25 mg will conduct a study in women between 18 and 25 years of age to address the current uncertainty regarding effectiveness in younger women and the development of resistance in women who become HIV positive, and to confirm the overall effect of the medicine.
The company will also provide educational materials to healthcare professionals expected to prescribe and dispense the medicine and a user guide for women, with information on the safety of the medicine, the importance of compliance during treatment and how to use the medicine correctly.
Recommendations and precautions to be followed by healthcare professionals and women for the safe and effective use of Dapivirine Vaginal Ring 25 mg have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Dapivirine Vaginal Ring 25 mg are continuously monitored. Side effects reported with Dapivirine Vaginal Ring 25 mg are carefully evaluated and any necessary action taken to protect patients.
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