Saxotin

Hauptinformation

  • Handelsname:
  • Saxotin 50 mg Tabletten
  • Verschreibungstyp:
  • Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Saxotin 50 mg Tabletten
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 137640
  • Berechtigungsdatum:
  • 17-05-2017
  • Letzte Änderung:
  • 08-03-2018

Öffentlichen Beurteilungsberichts

CMDh/223/2005

February 2014

LILA: CAVE Unterschiede Dubletten

GELB: von PHV zu befüllen

Public Assessment Report

Scientific discussion

Saxotin 50 mg Tabletten

VILDAGLIPTIN

AT/H/0682/001/DC

Date: 15.11.2017

This module reflects the scientific discussion for the approval of Saxotin 50 mg

Tabletten. The procedure was finalised at 09.05.2017.

For information on changes after

this date please refer to the module ‘Update’.

I.

INTRODUCTION

“Based on the review of the quality, safety and efficacy data, the Member States have granted

marketing authorisation for Saxotin 50 mg Tabletten, from Sandoz GmbH.

The product is indicated for

the treatment of type 2 diabetes mellitus in adults:

As monotherapy

in patients inadequately controlled by diet and exercise alone and for whom metformin is

inappropriate due to contraindications or intolerance.

As dual oral therapy in combination with

metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of

monotherapy with metformin,

a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of

a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance,

a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a

thiazolidinedione is appropriate.

As triple oral therapy in combination with

a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal

products do not provide adequate glycaemic control.

Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when

diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.

A comprehensive description of the indications and posology is given in the SmPC.”

The marketing authorisation has been granted pursuant to Article 10 (1) of Directive

2001/83/EC.”

Vildagliptin, a member of the islet enhancer class, is a potent and selective DPP-4 inhibitor.

Mechanism of action

The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity,

resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1

(glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide).

Pharmacodynamic effects

By increasing the endogenous levels of these incretin hormones, vildagliptin enhances the sensitivity

of beta cells to glucose, resulting in improved glucose-dependent insulin secretion. Treatment with

vildagliptin 50-100 mg daily in patients with type 2 diabetes significantly improved markers of beta

cell function including HOMA-β (Homeostasis Model Assessment–β), proinsulin to insulin ratio and

measures of beta cell responsiveness from the frequently-sampled meal tolerance test. In non-diabetic

(normal glycaemic) individuals, vildagliptin does not stimulate insulin secretion or reduce glucose

levels.

By increasing endogenous GLP-1 levels, vildagliptin also enhances the sensitivity of alpha cells to

glucose, resulting in more glucose-appropriate glucagon secretion.

The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin

hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to

reduced glycaemia.

known

effect

increased

GLP-1

levels

delaying

gastric

emptying

observed

with

vildagliptin treatment.

II.

QUALITY ASPECTS

II.1

Introduction

Saxotin 50 mg Tabletten is a tablet which is presented in an

Aluminium/Aluminium

(PA/Al/PVC//Al) blister .

II.2

Drug Substance

The active substance Saxotin 50 mg Tabletten is

vildagliptin.

The specification of the active

substance meets the current scientific requirements. The adequate quality of the active

substance has been shown by submitting the appropriate control data. The stability of the

active substance has been tested under ICH conditions. The results of the stability studies

support the established retest-period.

II.3

Medicinal Product

Saxotin 50 mg Tabletten - contains the following excipients:

47.82 mg lactose (anhydrous)

Cellulose, microcrystalline

Sodium starch glycolate (type A)

Magnesium stearate

The development of the product has been sufficiently made and deemed appropriate. The

usage of all the excipients has been described.

The release specification includes the check of all parameters relevant to this pharmaceutical

form. Appropriate data concerning the control of the finished product support the compliance

with the release specifications.

The packaging of the medicinal product complies with the current legal requirements.

Stability studies under ICH conditions have been performed and data presented support the

shelf life claimed in the SmPC, with a shelf life of 3 years.

The pharmaceutical quality of Saxotin 50 mg Tabletten - has been adequately shown.

II.4

Discussion on chemical, pharmaceutical and biological aspects

Information on development, manufacture and control of active substance and medicinal

product has been presented in a satisfactory manner. The results of tests carried out indicate

satisfactory consistency and uniformity of important product quality characteristics.

III.

NON-CLINICAL ASPECTS

III.1

Introduction

Pharmacodynamic, pharmacokinetic and toxicological properties of vildagliptin are well

known. The applicant has not provided additional studies and further studies are not required.

Overview based on literature review is appropriate.

non-clinical

overview

pre-clinical

pharmacology,

pharmacokinetics

toxicology is adequate.

III.2

Ecotoxicity/environmental risk assessment (ERA)

Since Saxotin 50 mg Tabletten - is intended for generic substitution, this will not lead to an

increased exposure to the environment. An environmental risk assessment is therefore not

deemed necessary.

IV.

CLINICAL ASPECTS

IV.1

Introduction

The clinical overview is dated 10 Nov. 2015. Report refers 98 publications up to year 2015.

Bioequivalence studies

clinical

overview

clinical

pharmacology,

efficacy

safety

adequate.

No bioequivalence studies are required, because the product is pharmaceutically equal to the reference

medicinal product.

non-clinical

overview

pre-clinical

pharmacology,

pharmacokinetics

toxicology is adequate.

IV.2

Risk Management Plan

The MAH has submitted a risk management plan, in accordance with the requirements of

Directive

2001/83/EC

amended,

describing

pharmacovigilance

activities

interventions designed to identify, characterise, prevent or minimise risks relating to Saxotin

50 mg Tabletten.

- Summary table of safety concerns as approved in RMP

Routine pharmacovigilance activities and routine risk minimisation measures are considered sufficient

at the moment. For special risks specific adverse event follow up forms have been provided.

V.

USER CONSULTATION

A user consultation with target patient groups on the package information leaflet (PIL) has

been performed on the basis of a bridging report making reference to Galvus tablets. The

bridging report submitted by the applicant has been found acceptable.

VI.

OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND

RECOMMENDATION

The pharmaceutical quality of Saxotin 50 mg Tabletten - has been adequately shown.

There are no non-clinical or clinical concerns.

The benefit/risk relation is considered positive.

Public Assessment Report

Update

Saxotin 50 mg Tabletten

VILDAGLIPTIN

AT/H/0682/001/DC

This module reflects the procedural steps and scientific information after the finalisation

of the initial procedure.

Procedure

number*

Scope

Product Information

affected

Date of end

of procedure

Approval/

non approval

Summary/ Justification for

refuse

*Only procedure qualifier, chronological number and grouping qualifier (when applicable)

Packungsbeilage

Bundesamt für Sicherheit im Gesundheitswesen, Traisengasse 5, A-1200 Wien

www.ages.at, DVR: 2112611, Konto Nr.: 50670 871 619

BLZ: 12000, IBAN: AT971200050670871619; UID: ATU 54088605, BIC/SWIFT: BKAUATWW

1 von 1

Die gegenständliche Arzneispezialität wurde in einem europäischen Zulassungsverfahren

geprüft.

Die Vermarktung des Produktes in Österreich ist derzeit seitens des Zulassungsinhabers nicht

geplant, daher liegen zur Zeit keine deutschsprachigen Übersetzungen der Fach- und

Gebrauchsinformation vor.

Traisengasse 5, 1200 Wien