Summary Public Assessment Report. Generics. Escitalopram Ratiopharm PT/H/0846/01-04/DC. Date:

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1 Summary Public Assessment Report Generics 5 mg, 10 mg, 15 mg, 20 mg, Orodisperdible tablets (escitalopram, oxalate) PT/H/0846/ /DC Date: /7

2 Summary Public Assessment Report Generics Escitalopram, oxalate, 5 mg, 10 mg, 15 mg, 20 mg, Orodisperdible tablets This is a summary of the public assessment report (PAR) for. It explains how 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 Escitalopram Ratiopharm. For practical information about using, patients should read the package leaflet or contact their doctor or pharmacist. What is and what is it used for? is a generic medicine. This means that is similar to a reference medicine already authorised in the European Union (EU) called Cipralex. contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalised anxiety disorder and obsessive-compulsive disorder). How does work? belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin-system in the brain by increasing the serotonin level. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases. How is used? The pharmaceutical form of is orodispersible tablets and the route of administration is oral. Please read section 3 of the PL for detailed information on dosing recommendations, the route of administration, and the duration of treatment. The medicine can only be obtained with a prescription. What benefits of have been shown in studies? Because is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Cipralex. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. 2/7

3 What are the possible side effects of? Because 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 restrictions, see the package leaflet. Why is approved? It was concluded that, in accordance with EU requirements, has been shown to have comparable quality and to be bioequivalent to Cipralex. Therefore, the Infarmed decided that, as for Cipralex, the benefits are greater than its risk and recommended that it can be approved for use. Other information about The marketing authorisation for was granted on The full PAR for can be found on the website For more information about treatment with Escitalopram Ratiopharm, read the package leaflet or contact your doctor or pharmacist. This summary was last updated in MM-YYYY. 3/7

4 Public Assessment Report 5 mg, 10 mg, 15 mg, 20 mg, Orodisperdible tablets (escitalopram, oxalate) PT/H/0846/ /DC This module reflects the scientific discussion for the approval of. The procedure was finalised at For information on changes after this date please refer to the module Update. I. INTRODUCTION 4/7

5 Based on the review of the quality, safety and efficacy data, the Member States have agreed in granting a marketing authorisation for 5 mg, 10 mg, 15 mg and 20 mg Orodispersible tablets, from Ratiopharm. The product is indicated for: the treatment of major depressive episodes, panic disorder with or without agoraphobia, social anxiety disorder (social phobia); generalised anxiety disorder and obsessive-compulsive disorder. A comprehensive description of the indications and posology is given in the SmPC. The originator product is Cipralex 5 mg, film-coated tablets, Cipralex Odis, 10 mg orodispersible tablet, Cipralex 15 mg, film-coated tablets and Cipralex Odis, 20 mg orodispersible tablet by H. Lundbeck A/S, registered since (5 mg and 15 mg strengths) and (10 mg and 20 mg strengths). The marketing authorisation has been granted pursuant to Article 10.1 of Directive 2001/83/EC. This type of application refers to information that is contained in the pharmacological-toxicological and clinical part of the dossier of the authorisation of the reference product. A reference product is a medicinal product authorised and marketed on the basis of a full dossier, i.e. including chemical, biological, pharmaceutical, pharmacological-toxicological and clinical data. This information is not fully available in the public domain. Authorisations for generic products are therefore only allowed once the data protection time of the dossier of the reference product has expired. For this kind of application, it has to be demonstrated that the pharmacokinetic profile of the product is similar to the pharmacokinetic profile of the reference product. This generic product can be used instead of its reference product. II. II.1 QUALITY ASPECTS Introduction is white to off-white round, flat tablets with beveled edges. Each tablet contains 5 mg, 10 mg or 15 mg or 20 mg of escitalopram. Blister Packs (Peelable paper/pet/aluminium-pvc/aluminium/opa) of PT/H/0846/001, 003: 10, 12, 14, 15, 28, 30, 56, 60, 98, 100, 120 orodispersible tablets PT/H/0846/002, 004: 10, 12, 14, 15, 28, 30, 56, 60, 98, 100, 120 orodispersible tablets The excipients are: Cellulose, microcrystalline Lactose monohydrate Croscarmellose sodium Polacrilin potassium Acesulfame potassium Neohesperidine-dihydrochalcone Magnesium stearate Peppermint flavor [containing Maltodextrin (maize), Modified starch E1450 (waxy maize) and Peppermint oil (mentha arvensis)] Hydrochloric acid concentrated (for ph adjustment) 5/7

6 II.2 Drug Substance Escitalopram, oxalate A white to an off white crystalline powder, freely soluble in methanol and in dimethyl sulfoxide, sparingly soluble in water and in alcohol, very slightly soluble in ethyl acetate and in isopropyl alcohol and insoluble in heptane. The chemical-pharmaceutical documentation and Expert Report in relation to escitalopram oxalate are of sufficient quality in view of the present European regulatory requirements. II.3 Medicinal Product The documentation provided complies with relevant EU guidelines and directives. Manufacture is performed in accordance with cgmp and consistency in quality and homogeneity is demonstrated. The finished product specification is based on relevant development and stability studies. The development of the product has been described, the choice of excipients is justified and their functions explained. Appropriate validation data have been provided for the analytical methods. Batch analyses data support the proposed finished product specification. The conditions used in the stability studies are according to the ICH stability guideline. The control tests and specifications for drug product are adequately drawn up. The proposed shelf-life of 30 months for the drug product with no special temperature storage requirements and storing in the original package in order to protect from moisture and light is considered acceptable III. NON-CLINICAL ASPECTS The pharmacodynamic, pharmacokinetic and toxicological properties of escitalopram are well known. As escitalopram is a widely used, well-known active substance, the applicant has not provided additional studies and further studies are not required. An overview based on literature review is, thus, appropriate. Environmental Risk Assessment (ERA) An Environmental Risk Assessment has not been performed as the product is intended for generic substitution, however ERA omission has been justified. A disposal advice has been added to the 6/7

7 SmPC. IV. CLINICAL ASPECTS To support the application, the applicant has submitted one bioequivalence study titled: A Single- Dose, Randomized, Open-Label, Crossover, Pivotal, Comparative Bioavailability Study of Escitalopram 20 mg Orodispersible Tablets and Cipralex 20 mg Film-Coated Tablets in Healthy Male and Female Volunteers under Fasting Conditions (Study code: 1433). Pharmacovigilance system The RMS considers that the pharmacovigilance system as described by the applicant fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. Risk Management Plan The current application for authorization concerns the generic version of Cipralex (escitalopram), Lundbeck, a medicinal product for human use that has been authorized in the European Union since The product is also marketed in countries outside the European Union since many years. As a result, the safety profile of escitalopram containing medicinal products is well established and has maintained a positive benefit/risk ratio after many years of extensive patient exposure. The innovator has not implemented any special measures for risk minimisation for escitalopram containing medicinal products. Therefore the applicant proposes to use the routine pharmacovigilance system, as described in Volume 9A of the Rules governing medicinal products in the European Union, and does not plan to install for Escitalopram 5, 10, 15 and 20 mg oro-dispersible tablets special measures for risk minimization. The applicant has a Pharmacovigilance system in place including a Drug Safety database with electronic reporting facilities, Standard Operating Procedures, Work Instructions, trained staff, etc. meeting the current pharmacovigilance standards. V. USER CONSULTATION The package leaflet has been evaluated in accordance with the requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC. The language used for the purpose of user testing the PIL was English. The results show that the package leaflet meets the criteria for readability as set out in the Guideline on the readability of the label and package leaflet of medicinal products for human use. VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Based on the review of the data on quality, safety and efficacy, the RMS considered that the application for 5 mg, 10 mg, 15 mg and 20 mg, orodispersible tablets, is approvable. 7/7

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