Vildagliptin/Metformin Sandoz

Hauptinformation

  • Handelsname:
  • Vildagliptin/Metformin Sandoz 50 mg/850 mg – Filmtabletten
  • Verschreibungstyp:
  • Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Vildagliptin/Metformin Sandoz 50 mg/850 mg – Filmtabletten
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 137703
  • Berechtigungsdatum:
  • 19-06-2017
  • Letzte Änderung:
  • 22-01-2019

Öffentlichen Beurteilungsberichts

CMDh/223/2005

February 2014

Public Assessment Report

Scientific discussion

Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50

mg/1000 mg - Filmtabletten

VILDAGLIPTIN, METFORMIN HYDROCHLORID

AT/H/0687/001-002/DC

Date: 15.11.2017

This module reflects the scientific discussion for the approval of Vildagliptin/Metformin

Sandoz 50 mg/850 mg, 50 mg/1000 mg - Filmtabletten. The procedure was finalised on

17.05.2017.

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 a

marketing authorisation Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50 mg/1000 mg

Filmtabletten, from Sandoz GmbH.

The product is indicated for:

Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50 mg/1000 mg - Filmtabletten is indicated in

the treatment of type 2 diabetes mellitus:

Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50 mg/1000 mg - Filmtabletten is

indicated in the treatment of adult patients who are unable to achieve sufficient

glycaemic control at their maximally tolerated dose of oral metformin alone or who are

already treated with the combination of vildagliptin and metformin as separate tablets.

Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50 mg/1000 mg - Filmtabletten

Filmtabletten is indicated in combination with a sulphonylurea (i.e. triple combination

therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with

metformin and a sulphonylurea.

Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50 mg/1000 mg - Filmtabletten is

indicated in triple combination therapy with insulin as an adjunct to diet and exercise to

improve glycaemic control in adult patients when insulin at a stable dose and metformin

alone do not provide adequate glycaemic control.

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

marketing

authorisation

been

granted

pursuant

Article

Directive

2001/83/EC.

Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50 mg/1000 mg - Filmtabletten combines two

antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic

control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and

metformin hydrochloride, a member of the biguanide class.

Vildagliptin, a member of the islet enhancer class, is a potent and selective dipeptidyl-

peptidase-4 (DPP-4) inhibitor. Metformin acts primarily by decreasing endogenous hepatic

glucose production.

II.

QUALITY ASPECTS

II.1

Introduction

Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50 mg/1000 mg - Filmtabletten is a film-

coated tablet which is presented in a PA/Alu/PVC/Alu blister or in a PCTFE/PVC/Alu blister.

II.2

Drug Substance

The active substances in Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50 mg/1000 mg -

Filmtabletten are vildagliptin and metformin hydrochloride . The specification of the active

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

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

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

support the established retest-period.

II.3

Medicinal Product

Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50 mg/1000 mg - Filmtabletten contains the

following excipients:

Tablet core:

Hydroxypropylcellulose

Magnesium stearate

Film-coating:

Hypromellose 2910 3cP

Titanium dioxide (E 171)

Iron oxide, yellow (E 172)

Macrogol 4000

Talc

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 2 years (PA/Alu/PVC/Alu) or 18 months

(PCTFE/PVC/Alu) when stored below 30°C and stored in the original package to protect

from moisture.

The pharmaceutical quality of Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50 mg/1000

mg - Filmtabletten 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 and

Metformin Hydrochloride are well known. As Vildagliptin and Metformin Hydrochloride is a

widely used, well-known active substance, the applicant has not provided additional studies

and further studies are not required. Overview based on literature review is, thus, appropriate.

non-clinical

overview

pre-clinical

pharmacology,

pharmacokinetics

toxicology is adequate.

III.2

Ecotoxicity/environmental risk assessment (ERA)

Since Vildagliptin/Metformin Sandoz 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 15th December 2015. The Report refers 257 publications up to

year 2015.

IV.2

Pharmacokinetics

Bioequivalence studies

Vildagliptin/Metformin 50 mg/850 mg and 50 mg/1000 mg film-coated tablets will be

produced with the same qualitative and quantitative composition, at the same manufacturing

site, using the same manufacturing procedure and the same source of active substances as the

currently approved reference product Eucreas 50 mg/850 mg and 50 mg/1000 mg film-coated

tablets. Therefore, no bioequivalence study was performed.

The submission is a generic application; therefore no new data on clinical safety have been

provided and none are required.

The clinical overview on the clinical pharmacology, efficacy and safety is adequate.

IV.3

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 Vilspox

50 mg/850 mg, 50 mg/1000 mg – Filmtabletten, Vildagliptin/Metformin Sandoz 50 mg/850

mg, 50 mg/1000 mg - Filmtabletten and Vildagliptin/Metformin 1A Pharma 50 mg/850 mg,

50 mg/1000 mg – Filmtabletten (vildagliptin and metformin hydrochloride).

Summary table of safety concerns as approved in RMP

Only routine pharmacovigilance activities have been proposed by the MAH, including

targeted follow up questionnaire for some safety concerns (liver injury, angioedema, severe

skin reactions, glycemia disorders, myopathies including rhabdomyolysis, malignancy and

neoplasm, pancreatitis and amylase & lipase elevations, breast cancer, lactic acidosis).

No additional risk minimisation measures are required at the moment.

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 LMF-273 film coated

tablets 50/500mg, 50/850 mg and 50/1000 mg. The bridging report submitted by the applicant

has been found acceptable.

VI.

OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND

RECOMMENDATION

The pharmaceutical quality of Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50 mg/1000

mg - Filmtabletten has been adequately shown.

There are no non-clinical or clinical concerns.

The benefit/risk relation is considered positive.

Public Assessment Report

Update

Vildagliptin/Metformin Sandoz 50 mg/850 mg, 50

mg/1000 mg - Filmtabletten

VILDAGLIPTIN, METFORMIN HYDROCHLORID

AT/H/0687/001-002/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: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

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

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EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

14-11-2018

Ebymect (AstraZeneca AB)

Ebymect (AstraZeneca AB)

Ebymect (Active substance: dapagliflozin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)7605 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4162/WS/1380

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Xigduo (AstraZeneca AB)

Xigduo (AstraZeneca AB)

Xigduo (Active substance: dapagliflozin/metformin) - Centralised - Renewal - Commission Decision (2018)6462 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2672/R/44

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety