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Levosert 20Microgram/24 Hours Intrauterine Delivery System UK/H/3030/001/DC

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Levosert 20Microgram/24 Hours Intrauterine Delivery System UK/H/3030/001/DC PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC Public Assessment Report Decentralised Procedure LEVOSERT 20MICROGRAM/24 HOURS INTRAUTERINE DELIVERY SYSTEM (levonorgestrel) Procedure No: UK/H/3030/001/DC UK Licence No: PL 30306/0438 ACTAVIS GROUP PTC ehf 1 PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC LAY SUMMARY Levosert 20 microgram/24 hours Intrauterine Delivery System (levonorgestrel, intrauterine delivery system, 52mg (20 micrograms/24 hours)) This is a summary of the Public Assessment Report (PAR) for Levosert 20 microgram/24 hours Intrauterine Delivery System (PL 30306/0438; UK/H/3030/001/DC, previously PL 34096/0003; UK/H/3030/001/DC). It explains how Levosert 20 microgram/24 hours Intrauterine Delivery System 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 Levosert 20 microgram/24 hours Intrauterine Delivery System. For practical information about using Levosert 20 microgram/24 hours Intrauterine Delivery System, patients should read the package leaflet or contact their doctor or pharmacist. Levosert 20 microgram/24 hours Intrauterine Delivery System may be referred to as Levosert in this report. What is Levosert and what is it used for? Levosert is an intrauterine delivery system (IUS) for insertion in the womb. It can be used in the following ways: • as an effective method of contraception (prevention of pregnancy); • for heavy menstrual bleeding (heavy periods). Levosert is also useful for reducing menstrual blood flow, so it can be used if you suffer from heavy menstrual bleeding (periods). This is called menorrhagia. Levosert is a ‘hybrid generic medicine’. This means that Levosert is similar to a reference medicine already authorised in the European Union (EU) and it is a locally acting product, available as a Levonorgestrel Intrauterine delivery system (IUS). The reference medicine is Mirena, 52 mg – 20 µg/24h Intrauterine Delivery System, which was first granted in Finland to Bayer Schering Pharma Oy on 05 May 1990. Mirena is an intrauterine system (IUS) placed inside the womb (uterus) where it slowly releases the hormone levonorgestrel. It can be used in the following three ways: 1. As an effective long-term and reversible method of contraception. 2. For reducing menstrual blood flow, if the patient suffers from heavy periods (heavy menstrual bleeding). It can be used for contraception and heavy menstrual bleeding until it is removed or up to a maximum of 5 years. How does Levosert work? Levosert prevents pregnancy by controlling the monthly development of the womb lining so that it is not thick enough for pregnancy to occur; by making the normal mucus in the opening to the womb (the cervical canal) thicker so that the sperm cannot get through to fertilise the egg; by preventing the release of eggs (ovulation) in some women. There are also local effects on the lining of the womb caused by the presence of the T-shaped frame. The hormone in Levosert, levonorgestrel, acts by controlling the monthly development of the womb lining, making it thinner, so that there is less bleeding every month. 2 PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC How is Levosert used? Levosert 20 microgram/24 hours Intrauterine Delivery System is fitted by a doctor or specially trained nurse into the uterus (womb) where it slowly releases the hormone levonorgestrel over a period of 3 years or until it is removed. Please read section 3 of the Patient Information Leaflet (available on the MHRA website) for detailed information on dosing recommendations, the route of administration, and the duration of treatment. Levosert can only be obtained with a prescription. What benefits of Levosert have been shown in studies? As Levosert is a hybrid application and is considered to be therapeutically equivalent, to the reference product Mirena, the benefits and risks are taken as being the same as those of the reference medicine. What are the possible side effects from Levosert? Like all medicines, this medicine can cause side effects, although not everybody gets them. With Levosert, side effects are most common during the first months after the system is fitted and decrease as time goes on. Severe pain or fever developing shortly after insertion may mean that the patient has a severe infection which must be treated immediately. In rare cases very severe infection (sepsis) can occur. The doctor should be contacted immediately if you experience such side effects (see Patient Information Leaflet, Section 2 Warnings and Precautions). Very common (affects more than 1 in 10 women) side effects can include: - menstrual changes. You might experience spotting, shorter or longer periods, painful periods. Though Levosert usually achieves a significant reduction in menstrual blood loss in 3 to 6 months of treatment, you may have an increase in bleeding, usually in the first 2 to 3 months, before a reduction in blood loss is achieved. Periods can totally disappear. If a significant reduction in blood loss is not achieved after 3 to 6 months, alternative treatments should be considered. - ovarian cysts. They are fluid-filled sacs in the ovary. Common (may affect up to 1 in 10 women) side effects can include: - bloating or swelling of your legs or ankles; - weight gain; - depression, nervousness or other mood changes; - headache; - abdominal, pelvic or back pain; - feeling sick (nausea); - spots (acne); - painful periods; - increased vaginal discharge; - inflammation of the neck of the womb (cervicitis); - tender, painful breasts; or - Levosert coming out by itself. Uncommon (may affect up to 1 in 100 women) side effects can include: - genital infections that may cause: vaginal itching; pain on passing urine; or lower abdominal (tummy) pain from inflammation of the womb, ovaries or Fallopian tubes; - increased growth of hair on the face and body; - hair loss; or - itchy skin (pruritus). 3 PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC Rare (may affect up to 1 in 1000 women) side effects can include: - reduced sex drive; - migraine; - bloated abdomen; - rashes, itching, eczema; or - the wall of the womb torn when Levosert is fitted. Why is Levosert approved? It was concluded that, in accordance with EU requirements, Levosert has been shown to have comparable quality and to be therapeutically equivalent to Mirena 52mg - 20 micrograms/24 hours Intrauterine Delivery System (Schering). It was therefore considered that, as for Mirena 52mg - 20 micrograms/24 hours Intrauterine Delivery System (Schering), the benefits outweigh the identified risks and the grant of the Marketing Authorisation was recommended. What measures are being taken to ensure the safe and effective use of Levosert? A Risk Management Plan has been developed to ensure that Levosert 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 Levosert, 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. Other information about Levosert. A Marketing Authorisation (Levosert 20 microgram/24 hours Intrauterine Delivery System (PL 34096/0003; UK/H/3030/001/DC) was granted in the UK on 28 December 2012. Subsequent to a Change of Ownership procedure, the Marketing Authorisation (PL 30306/0438; UK/H/3030/001/DC) was granted in the UK to Actavis Group PTC ehf on 18 September 2013. The full PAR for Levosert follows this summary. For more information about treatment with Levosert read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in December 2014. 4 PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC TABLE OF CONTENTS Module 1: Information about initial procedure Page 6 Module 2: Summary of Product Characteristics Page7 Module 3: Patient Information Leaflets Page 8 Module 4: Labelling Page 9 Module 5: Scientific Discussion Page 11 I Introduction II About the Product III Scientific Overview and Discussion III.1 Quality aspects III.2 Non-clinical aspects III.3 Clinical aspects IV Overall conclusions Module 6 Steps taken after initial procedure Page 21 Annex 1 Page 22 5 PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC Module 1 Information about the initial procedure Product Name Levosert 20 microgram/24 hours Intrauterine Delivery System Type of Application Hybrid, Article 10(3) Active Substance Levonorgestrel Form Intrauterine delivery system Strength 52mg levonorgestrel MA Holder Mithra Pharmaceuticals SA, rue Saint Georges 5-7, Liege, B-400, Belgium Reference Member State (RMS) UK Concerned Member States (CMS) Bulgaria, Czech Republic, Hungary, Lithuania, Latvia, Poland, Romania, Slovakia Procedure Number UK/H/3030/001/DC Timetable Day 210 – 14 November 2012 6 PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC Module 2 Summary of Product Characteristics The current approved UK version of the Summary of Product Characteristics (SmPC) for this product is available on the MHRA website. 7 PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC Module 3 Patient Information Leaflet The current approved UK version of the Patient Information Leaflet (PIL) for this product is available on the MHRA website. 8 PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC Module 4 Labelling 9 PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC 10 PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC Module 5 Scientific discussion during the initial procedure I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the member states considered that the application for Levosert 20 microgram/24 hours Intrauterine Delivery System (PL 34096/0003; UK/H/3030/001/DC) could be approved.
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