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Summary Public Assessment Report

Generics

Etonogestrel/Ethinylestradiol Mylan 0.120 mg/0.015 mg per 24 hours, vaginal delivery system

(etonogestrel/ethinylestradiol)

NL/H/3721/001/DC

Date: 10 October 2017

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E B M Summary Public Assessment Report

Generics

Etonogestrel/Ethinylestradiol Mylan 0.120 mg/0.015 mg per 24 hours, vaginal delivery system

Active substance: etonogestrel and ethinylestradiol

This is a summary of the public assessment report (PAR) for Etonogestrel/Ethinylestradiol Mylan 0.120 mg/0.015 mg per 24 hours, vaginal delivery system. It explains how this medicine was assessed and its authorisation recommended as well as its conditions of use. It is not intended to provide practical advice on how to use Etonogestrel/Ethinylestradiol Mylan.

For practical information about using this medicine, patients should read the package leaflet or contact their doctor or pharmacist.

What is Etonogestrel/Ethinylestradiol Mylan and what is it used for? Etonogestrel/Ethinylestradiol Mylan is a ‘generic medicine’. This means that it is similar to a ‘reference medicine’ already authorised in the European Union (EU) called NuvaRing.

Etonogestrel/Ethinylestradiol Mylan is a contraceptive vaginal ring used to prevent pregnancy.

How does this medicine work? Etonogestrel/Ethinylestradiol Mylan works just like a combined contraceptive pill (the Pill) but instead of taking a pill every day, the ring is used for three weeks in a row. This medicine releases two female sex hormones, etonogestrel and ethinylestradiol, that prevent the release of an egg cell from the ovaries. If no egg cell is released a woman cannot become pregnant.

How is this medicine used? The pharmaceutical form of Etonogestrel/Ethinylestradiol Mylan is a vaginal ring. The vaginal ring must be put in on the correct day in the monthly cycle and left in place for three weeks in a row. It is recommended to regularly check that Etonogestrel/Ethinylestradiol Mylan is in the vagina (for example, before and after intercourse) to ensure protection from pregnancy. After the third week, Etonogestrel/Ethinylestradiol Mylan should be taken out followed by a one week break. One will usually have the monthly period during this ring-free interval.

The medicine can only be obtained with a prescription.

Please read section 3 of the PL for detailed information on dosing recommendations, the route of administration, and the duration of treatment.

How has this medicine been studied? Because Etonogestrel/Ethinylestradiol Mylan is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, NuvaRing. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the possible side effects of this medicine? Because Etonogestrel/Ethinylestradiol Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and possible side effects are taken as being the same as the reference medicine. For the full list of all side effects reported with this medicine, see section 4 of the package leaflet.

Why is this medicine approved? It was concluded that, in accordance with EU requirements, this medicine has been shown to have comparable quality and to be bioequivalent to the reference medicine. Therefore, the Medicines Evaluation Board of the Netherlands decided that, as for NuvaRing, the benefits are greater than its risk and recommended that it can be approved for use.

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E B M What measures are being taken to ensure the safe and effective use of this medicine? A risk management plan has been developed to ensure that this medicine is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Etonogestrel/Ethinylestradiol Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.

Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously as well.

Additional risk minimisation measures are required relating to venous and arterial thromboembolic events. These have been laid down in line with the reference product. It concerns the following additional risk minimisation measures:  Patient information card  Checklist for prescribers

Other information about this medicine In the Netherlands, the marketing authorisation for Etonogestrel/Ethinylestradiol Mylan 0.120 mg/0.015 mg per 24 hours, vaginal delivery system was granted on 11 September 2017.

The full PAR for this medicine can be found on the website http://mri.medagencies.org/Human. For more information about treatment with Etonogestrel/Ethinylestradiol Mylan, read the package leaflet (https://mri.cts-mrp.eu/Human/Downloads/NL_H_3721_001_FinalPL.pdf) or contact your doctor or pharmacist.

This summary was last updated in October 2017.

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