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  • 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

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  • 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.

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  • 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).

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  • 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.

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  • PAR Levosert 20microgram/24 hours Intrauterine Delivery System
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TABLE OF CONTENTS

Module 1: Information about initial procedure Module 2: Summary of Product Characteristics Module 3: Patient Information Leaflets Module 4: Labelling
Page 6 Page7 Page 8 Page 9

  • Page 11
  • Module 5: Scientific Discussion

I Introduction II About the Product III Scientific Overview and Discussion III.1 Quality aspects III.2 III.3
Non-clinical aspects Clinical aspects
IV Overall conclusions

Module 6 Annex 1

  • Steps taken after initial procedure
  • Page 21

Page 22

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  • PAR Levosert 20microgram/24 hours Intrauterine Delivery System
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Module 1
Information about the initial procedure

Product Name

Levosert 20 microgram/24 hours Intrauterine Delivery System

Hybrid, Article 10(3) Levonorgestrel

Type of Application Active Substance Form

Intrauterine delivery system 52mg levonorgestrel

Strength

Mithra Pharmaceuticals SA, rue Saint Georges 5-7, Liege, B-400, Belgium

MA Holder

UK

Reference Member State (RMS) Concerned Member States (CMS)

Bulgaria, Czech Republic, Hungary, Lithuania, Latvia, Poland, Romania, Slovakia

UK/H/3030/001/DC

Procedure Number Timetable

Day 210 – 14 November 2012

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  • 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.

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  • 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.

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  • PAR Levosert 20microgram/24 hours Intrauterine Delivery System
  • UK/H/3030/001/DC

Module 4 Labelling

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  • PAR Levosert 20microgram/24 hours Intrauterine Delivery System
  • UK/H/3030/001/DC

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  • PAR Levosert 20microgram/24 hours Intrauterine Delivery System
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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. This application was submitted via the Decentralised Procedure, with the UK as Reference Member State (RMS), and Bulgaria, Czech Republic, Hungary, Lithuania, Latvia, Poland, Romania, and Slovakia as Concerned Member States (CMS).

This is a prescription-only medicine, indicated for heavy menstrual bleeding. This was an application made under the Decentralised Procedure (DCP), according to Article 10(3) of Directive 2001/83/EC, as amended, claiming to be a hybrid medicinal product of the originator product Mirena 52mg – 20microgram/24 hours Intrauterine Device, which was initially granted in Finland to Bayer Schering Pharma Oy in May 1990.

Levosert is a levonorgestrel-releasing Intrauterine System (LNG-IUS) containing 52 mg of levonorgestrel in a cylindrical-shaped silastic reservoir. The reservoir is mounted on the vertical arm of a T-shaped polyethylene frame and is covered with a release-rate-controlling polydimethylsiloxane membrane. This drug delivery system releases LNG at an initial release-rate of approximately 20 µg per day in vivo. After insertion in the uterus, the product will release LNG directly and continuously for up to five years.

No new non-clinical studies were conducted, which is acceptable given that this is a hybrid application cross-referring to a product that has been licensed for over 10 years.

With the exception of the bioequivalence study, no new clinical studies were conducted and none are required for this application. A single study was submitted to show the therapeutic equivalence of the proposed product to Mirena 52mg - 20microgram/24 hours Intrauterine Device (Bayer SA, Belgium).

The RMS has been assured that acceptable standards of Good Manufacturing Practice are in place for these product types at all sites responsible for the manufacture, assembly and batch release of this product.

The RMS and CMS considered that the application could be approved with the end of procedure (Day 210) on 14 November 2012. After a subsequent national phase, the licence 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.

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  • PAR Levosert 20microgram/24 hours Intrauterine Delivery System
  • UK/H/3030/001/DC

  • II.
  • ABOUT THE PRODUCT

  • Name of the product in the Reference Member State
  • Levosert 20microgram/24 hours

Intrauterine Delivery System

Levonorgestrel
Name(s) of the active substance(s) (INN)

Pharmacotherapeutic classification (ATC code)
Intrauterine contraceptives (G02 BA) 52mg levonorgestrel UK/H/3030/001/DC
Pharmaceutical form and strength(s) Reference numbers for the Mutual Recognition Procedure Reference Member State
United Kingdom

  • Member States concerned
  • Bulgaria, Czech Republic, Hungary,

Lithuania, Latvia, Poland, Romania, and Slovakia

PL 34096/0003
Marketing Authorisation Number(s)

  • Name and address of the authorisation holder
  • Mithra Pharmaceuticals SA, rue Saint

Georges 5-7, Liege, B-4000, Belgium

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  • PAR Levosert 20microgram/24 hours Intrauterine Delivery System
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  • III
  • SCIENTIFIC OVERVIEW AND DISCUSSION

III.1 QUALITY ASPECTS

  • S.
  • Active substance – Levonorgestrel

  • rINN:
  • Levonorgestrel

Chemical name: Structure:
13β-ethyl-17β-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one
Molecular formula: C21H28O2 Molecular weight: Appearance: Solubility:
312.45 g.mol-1 A white to almost-white crystalline powder Practically insoluble in water, sparingly soluble in methylene chloride, slightly soluble in alcohol

Levonorgestrel is the subject of a European Pharmacopoeia monograph. With the exception of the packaging and the retest period, all aspects of the manufacture and control of the active substance is covered by a European Directorate for the Quality of Medicines Certificate of Suitability.

Suitable specifications have been provided for all packaging used. The primary packaging has been shown to comply with current guidelines concerning contact with food.

Appropriate stability data have been generated supporting a suitable retest period when stored in the proposed packaging.

  • P.
  • Medicinal Product

Other Ingredients

Other ingredients consist of the pharmaceutical excipients, namely silicon base, tetra-n-propyl silicate, stannous octoate, polydimethylsiloxane elastomer, polydimethylsiloxane tubing, polyethylene T-frame (with 20-24% barium sulphate), polypropylene thread, copper phthalocyanine blue.

All excipients comply with suitable in-house specifications. Suitable batch analysis data have been provided for all excipients, showing compliance with their respective specifications.

None of the excipients are sourced from animal or human origin. No genetically modified organisms (GMO) have been used in the preparation of this product.

Pharmaceutical Development

The objective of the development programme was to formulate a globally acceptable, stable and bioequivalent product to the originator product Mirena 52mg – 20microgram/24 hours Intrauterine Device (Bayer Schering Pharma Oy, Finland).

A satisfactory account of the pharmaceutical development has been provided. Comparative physico-chemical characteristics have been provided for the proposed product versus the originator product.

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  • PAR Levosert 20microgram/24 hours Intrauterine Delivery System
  • UK/H/3030/001/DC

Manufacturing Process

Satisfactory batch formulae have been provided for the manufacture of the finished product. The manufacturing process has been validated using industrial-scale batches and has shown satisfactory results.

Finished Product Specification

The finished product specification proposed is acceptable. Test methods have been described and have been adequately validated. Batch data have been provided and comply with the release specifications. Certificates of analysis have been provided for all working standards used.

Container-Closure System

The product is individually packed with an inserter device into a thermoformed blister (polyester) package with a peelable lid (TYVEK-Polyethylene).

Satisfactory specifications and Certificates of Analysis have been provided for all packaging components. All primary packaging complies with current European regulations.

Stability of the product

Stability studies were performed in accordance with current guidelines on batches of finished product packed in the packaging proposed for marketing. The data from these studies support a shelf-life of 48 months, with the storage conditions “Store in the original package.”

Bioequivalence/bioavailability

A single study was submitted to show the therapeutic equivalence of the proposed product to Mirena 52mg - 20microgram/24 hours Intrauterine Device (Bayer SA, Belgium).

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    HIGHLIGHTS OF PRESCRIBING INFORMATION with implants in pulmonary vessels include chest pain, dyspnea, These highlights do not include all the information needed to use cough, or hemoptysis. Surgical interventions may be necessary to NEXPLANON safely and effectively. See full prescribing remove implants. (5.1) information for NEXPLANON. • Menstrual bleeding pattern: Counsel women regarding changes in bleeding frequency, intensity, or duration. (5.2) NEXPLANON (etonogestrel implant) • Ectopic pregnancies: Be alert to the possibility of an ectopic Radiopaque pregnancy in women using NEXPLANON who become pregnant Subdermal Use Only or complain of lower abdominal pain. (5.3) Initial U.S. Approval: 2001 • Thrombotic and other vascular events: The NEXPLANON implant should be removed in the event of a thrombosis. (5.4) --------------------------- RECENT MAJOR CHANGES --------------------------- • Liver disease: Remove the NEXPLANON implant if jaundice Warnings and Precautions, Complications of Insertion and Removal occurs. (5.7) (5.1) ---------------------------------------- ------------------------------------- 9/2020 • Elevated blood pressure: The NEXPLANON implant should be Warnings and Precautions, Broken or Bent Implant (5.16) ------- 10/2020 removed if blood pressure rises significantly and becomes ----------------------------INDICATIONS AND USAGE ---------------------------- uncontrolled. (5.9) NEXPLANON is a progestin indicated for use by women to prevent • Carbohydrate and lipid metabolic effects: Monitor prediabetic and pregnancy. (1) diabetic women using NEXPLANON. (5.11) ----------------------- DOSAGE AND ADMINISTRATION ----------------------- ------------------------------ ADVERSE REACTIONS ------------------------------ Insert one NEXPLANON subdermally just under the skin at the inner Most common (≥10%) adverse reactions reported in clinical trials were side of the non-dominant upper arm. NEXPLANON must be removed no change in menstrual bleeding pattern, headache, vaginitis, weight later than by the end of the third year.
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    CADTH Canadian Drug Expert Committee Recommendation (Final)

    CADTH COMMON DRUG REVIEW CADTH Canadian Drug Expert Committee Recommendation (Final) ETONOGESTREL EXTENDED-RELEASE SUBDERMAL IMPLANT (NEXPLANON — MERCK CANADA INC.) Indication: Prevention of pregnancy for up to three years. RECOMMENDATION The CADTH Canadian Drug Expert Committee recommends that etonogestrel extended-release radiopaque subdermal implant should be reimbursed for the prevention of pregnancy for up to three years only if the following condition is met. Condition for Reimbursement Cost should not exceed the negotiated annualized cost of reimbursed comparable long-acting contraceptive options. Service Line: CADTH Drug Reimbursement Recommendation Version: 1.0 Publication Date: October 2020 Report Length: 9 Pages Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect.
  • Gynaecology and Perinatology

    Gynaecology and Perinatology

    Page 35 to 38 Volume 1 • Issue 1 • 2017 Review Article Gynaecology and Perinatology ISSN: 2576-8301 Family Planning and Birth Control in the Developing World: New Opportunities Thanks to Updated Research Kraetschmer K* Austrian American Medical Research Institute, Hermanng 4, A-2700 WrNeustadt, Austria *Corresponding Author: Kraetschmer K, Austrian American Medical Research Institute, Hermanng 4, A-2700 WrNeustadt, Austria. Received: June 07, 2017; Published: July 20, 2017 Abstract On the basis of a steadily-increasing literature on family planning and birth control the paper addresses central questions in the area of contraception in the developing world. Its aim is to describe the possibilities of contraception in regions with limited resources. It draws attention to the most suitable low-cost effective methods of contraception presently available and provides detailed analyses of their efficacy. In concluding it stipulates expansion of their use as well as intensified education on their practicability. Volume 1 Issue 1 July 2017 © All Copy Rights are Reserved by Kraetschmer K. Numerous are the publications and websites on birth control and family planning and even more numerous the data presented in the various statistical analyses. [1] Among the pivotal topics in these studies are unwanted pregnancies, abortion, and maternal mortal- ity ratio, ie, the risk of maternal death per 100.000 livebirths. These issues are a focus of interest not only in public health research but also in socio-economic investigations, and one of the frequently
  • Scoping Review to Map Evidence on Mechanism of Action, Pharmacokinetics, Effectiveness and Side Effects of Centchroman As a Contraceptive Pill

    Scoping Review to Map Evidence on Mechanism of Action, Pharmacokinetics, Effectiveness and Side Effects of Centchroman As a Contraceptive Pill

    Open access Original research BMJ Open: first published as 10.1136/bmjopen-2019-030373 on 7 October 2019. Downloaded from Scoping review to map evidence on mechanism of action, pharmacokinetics, effectiveness and side effects of centchroman as a contraceptive pill Rita Kabra,1 Komal Preet Allagh ,2 Moazzam Ali ,1 Chandani Anoma Jayathilaka,3 Kasonde Mwinga,4 James Kiarie1 To cite: Kabra R, Allagh KP, ABSTRACT Strengths and limitations of this study Ali M, et al. Scoping review to Objective To systematically identify and map the available map evidence on mechanism evidence on effectiveness, side effects, pharmacokinetics ► Strength of our study is that it is the first scoping of action, pharmacokinetics, and mechanism of action of centchroman as a effectiveness and side review to explore the mechanism of action, phar- contraceptive pill. effects of centchroman as a macokinetics, effectiveness and side effects of Introduction Centchroman was introduced in the Indian contraceptive pill. BMJ Open centchroman, when used as a weekly or postcoital national family planning programme in 2016 as a once- 2019;9:e030373. doi:10.1136/ contraceptive pill. bmjopen-2019-030373 a-week short-term contraceptive pill/oral contraceptive. ► A limitation of our review is that we are likely to have At present there are no WHO recommendations on this missed studies on mechanism of action of centchro- ► Prepublication history for method of contraception. We examined the available this paper is available online. man since animal studies were excluded from the evidence through a scoping review. To view these files, please visit review. Methods A search was conducted inclusive to the years the journal online (http:// dx.