Vilspox

Hauptinformation

  • Handelsname:
  • Vilspox 50 mg/1000 mg – Filmtabletten
  • Verschreibungstyp:
  • Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Vilspox 50 mg/1000 mg – Filmtabletten
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 137684
  • Berechtigungsdatum:
  • 09-06-2017
  • Letzte Änderung:
  • 08-03-2018

Öffentlichen Beurteilungsberichts

CMDh/223/2005

February 2014

Public Assessment Report

Scientific discussion

Vilspox 50 mg/850 mg, 50 mg/1000 mg – Filmtabletten

VILDAGLIPTIN, METFORMIN HYDROCHLORID

AT/H/0686/001-002/DC

Date: 15.11.2017

This module reflects the scientific discussion for the approval of Vilspox 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 Vilspox 50 mg/850 mg, 50 mg/1000 mg – Filmtabletten, from

Sandoz GmbH.

The product is indicated for:

Vilspox 50 mg/850 mg, 50 mg/1000 mg – Filmtabletten is indicated in the treatment of type 2

diabetes mellitus:

Vilspox 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.

Vilspox 50 mg/850 mg, 50 mg/1000 mg – 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.

Vilspox 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.

Vilspox 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

Vilspox 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 Vilspox 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

Vilspox 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 two 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 Vilspox 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 Vilspox 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.

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.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 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 Vilspox 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

Vilspox 50 mg/850 mg, 50 mg/1000 mg – Filmtabletten

VILDAGLIPTIN, METFORMIN HYDROCHLORID

AT/H/0686/001-002/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

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

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

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Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety