Candesarstad plus HCT 16 mg/12,5 mg Tabletten

Österreich - Deutsch - AGES (Agentur für Gesundheit und Ernährungssicherheit)

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Gebrauchsinformation Gebrauchsinformation (PIL)

01-05-2020

Fachinformation Fachinformation (SPC)

01-05-2020

Wirkstoff:
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZID
Verfügbar ab:
Stada Arzneimittel AG
ATC-Code:
C09DA06
INN (Internationale Bezeichnung):
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Verschreibungstyp:
Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung
Produktbesonderheiten:
Abgabe durch eine (öffentliche) Apotheke
Zulassungsnummer:
1-30773
Berechtigungsdatum:
2011-09-28

Lesen Sie das vollständige Dokument

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

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

Lesen Sie das vollständige Dokument

CMDh/223/2005

February 2014

Public Assessment Report

Scientific discussion

Candesartan/HCT STADA 8/12,5 & 16/12,5 mg Tabletten

Candesarstad plus HCT 8/12,5 & 16/12,5 mg Tabletten

(Candesartan cilexetil, Hydrochlorothiazide)

AT/H/0377/001-002/DC

AT/H/0378/001-002/DC

This module reflects the scientific discussion for the approval of Candesartan/HCT STADA/

Candesarstad plus HCT. The procedure was finalised at 27.07.2011/ Day 196. For information

on changes after this date please refer to the module ‘Update’.

I.

INTRODUCTION

Based on the review of the data and the Applicant’s response to the questions raised by RMS and

CMSs on quality, safety and efficacy, AGES (Austrian Competent Authority) granted Stada

Arzneimittel GmbH, Vienna, a marketing authorisation for Candesartan/HCT STADA 8/12,5 &

16/12,5 mg tablets and Candesarstad plus HCT 8/12,5 & 16/12,5 mg tablets in the treatment of

Essential hypertension, where monotherapy with candesartan cilexetil or hydrochlorothiazide

is not sufficient.

The product is a prescription only medicine.

II.

QUALITY ASPECTS

II.1

Introduction

Candesartan/HCT STADA/ Candesarstad plus HCT is a tablet which is presented in a PVC-

PVDC/Alu blister.

II.2

2.2

Drug Substance

The active substances in Candesartan/HCT STADA/ Candesarstad plus HCT are Candesartan cilexetil

and Hydrochlorothiazide. The specifications of the active substances meet 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

Candesartan/HCT STADA/ Candesarstad plus HCT contains the following excipients:

Lactose monohydrate (117.30 mg & 109.30 mg Lactose monohydrate for Candesartan/HCT STADA/

Candesarstad plus HCT 8/12,5 & 16/12,5 mg tablets , respectively), Maize starch,

Hydroxypropylcellulose, Croscarmellose sodium, Magnesium stearate, Triethyl Citrate.

The manufacturers responsible for batch release are

For Candesartan/HCT STADA:

STADA Arzneimittel AG, 61118 Bad Vilbel, Germany;

Stada Arzneimittel GmbH, 1190 Wien, Austria;

Centrafarm Services B.V., 4879 AC Etten Leur, The Netherlands;

Eurogenerics N.V., 1020 Brussels, Belgium;

LAMP SAN PROSPERO S.p.A., 41030 San Prospero (Modena), Italy;

Siegfried Generics Malta Ltd., Hal Far BBG3000, Malta;

Clonmel Healthcare Ltd, Clonmel, Co. Tipperary, Ireland.

For Candesarstad plus HCT:

STADA Arzneimittel AG, 61118 Bad Vilbel, Germany;

Centrafarm Services B.V., 4879 AC Etten Leur, The Netherlands;

Siegfried Generics Malta Ltd., Hal Far BBG3000, Malta;

ALIUD PHARMA GmbH, 89150 Laichingen, Germany.

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 36 months when stored below 25°C.

pharmaceutical

quality

Candesartan/HCT

STADA/

Candesarstad

plus

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

Pharmacodynamic,

pharmacokinetic

toxicological

properties

Candesartan

cilexetil

Hydrochlorothiazide are well known. As Candesartan cilexetil and Hydrochlorothiazide are widely

used, well-known active substances, the applicant has not provided additional studies and further

studies are not required. An overview based on literature review is, thus, appropriate.

The non-clinical overview has been written by an appropriately qualified person and is a suitable

summary of the non-clinical aspects of the dossier.

An Environmental Risk Assessment has not been provided and one is not required for an application

of this type.

The SmPC and PIL are consistent with those for the reference product, harmonised in an Article 30

Referral (20

of September 2010), where appropriate.

From a non-clinical point of view it is recommended that marketing authorisations are granted for

these applications.

IV.

CLINICAL ASPECTS

IV.1

Introduction

The applicant has submitted two single dose bioequivalence studies performed with the 8/12,5mg

strength and the 16/12,5mg strength under fasting conditions.

IV.2

Pharmacokinetics

In both studies the results for the primary pharmacokinetic parameters (AUC

and C

) indicated that

confidence

intervals

test/reference

ratio

geometric

means

candesartan

hydrochlorothiazide lie within the acceptance range of 80.00 - 125.00%. Thus, bioequivalence has

been shown between the test and reference products in these studies.

IV.3

Pharmacodynamics

With the exception of the bioequivalence studies, no new pharmacokinetic or pharmacodynamic data

were submitted with these applications and none were required.

IV.4

Clinical efficacy

No new efficacy data were submitted with these applications and none were required.

IV.5

Clinical safety

With the exception of the data submitted during the bioequivalence studies, no new safety data were

submitted and none were required. No new or unexpected safety concerns were raised during the

bioequivalence studies.

IV.6

Discussion on the clinical aspects

The clinical overview has been written by an appropriately qualified person and is a suitable summary

of the clinical aspects of the dossier.

The SmPC and PIL are consistent with those for the reference product, harmonised in an Article 30

Referral (20

of September 2010), where appropriate.

Based on the submitted bioequivalence studies the test product is considered bioequivalent with the

reference product Atacand plus 8/12,5mg and 16/12,5mg.

From a clinical point of view it is recommended that marketing authorisations are granted for these

applications.

V.

OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND

RECOMMENDATION

pharmaceutical

quality

Candesartan/HCT

STADA/

Candesarstad

plus

been

adequately shown.

The benefit risk assessment is considered positive.

User consultation

package

leaflet

been

evaluated

user

consultation

study

accordance

with

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.

Public Assessment Report

Update

Candesartan/HCT STADA 8/12,5 & 16/12,5 mg Tabletten

Candesarstad plus HCT 8/12,5 & 16/12,5 mg Tabletten

(Candesartan cilexetil, Hydrochlorothiazide)

AT/H/0377/001-002/DC

AT/H/0378/001-002/DC

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

initial procedure.

Bundesamt für Sicherheit im Gesundheitswesen

Schnirchgasse 9 l A-1030 Wien l www.basg.at l www.ages.at

DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW

Procedure

number*

Scope

Product Information

affected

Date of end

of procedure

Approval/

non approval

Summary/ Justification for

refuse

AT/H/0377-

378/001-

002/II/001

Introduction of a new manufacturer of the active substance that is supported by an

ASMF

21.06.2012

Approved

N.A.

AT/H/0377-

378/001-

002/R/001

Renewal of the marketing authorisation

08.09.2016

Approved

N.A.

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

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