Fosfomycin STADA

Hauptinformation

  • Handelsname:
  • Fosfomycin STADA 3 g Granulat zur Herstellung einer Lösung zum Einnehmen
  • Verschreibungstyp:
  • Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Fosfomycin STADA 3 g Granulat zur Herstellung einer Lösung zum Einnehmen
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 137665
  • Berechtigungsdatum:
  • 09-06-2017
  • Letzte Änderung:
  • 07-03-2018

Öffentlichen Beurteilungsberichts

CMDh/223/2005

February 2014

Public Assessment Report

Scientific discussion

Fosfomycin STADA 3 g Granulat zur Herstellung einer

Lösung zum Einnehmen

FOSFOMYCIN-TROMETAMOL

AT/H/0691/001/DC

Date: 25.01.2018

This module reflects the scientific discussion for the approval of Fosfomycin STADA 3 g

Granulat zur Herstellung einer Lösung zum Einnehmen. The procedure was finalised at

15.05.2017. 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 for

Fosfomycin STADA 3 g Granulat zur Herstellung einer Lösung zum

Einnehmen

from STADA Arzneimittel AG.

The product is indicated for

he treatment of acute uncomplicated urinary tract infections

caused by fosfomycin sensitive organisms, in women (adults and adolescents from 12 years of

age) over 50 kg body weight

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

marketing

authorisation

been

granted

pursuant

Article

10(1)

Directive

2001/83/EC (generic application).

II.

QUALITY ASPECTS

II.1

Introduction

Fosfomycin STADA

granules for oral solution

which is presented in

single dose sachets.

II.2

Drug Substance

The active substance in Fosfomycin STADA is fosfomycin trometamol. 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

Fosfomycin STADA contains the following excipients:

Sucrose, 2.213 g

Mandarin

flavour

(maltodextrin,

arabic

gum,

ascorbic

acid

(E300),

butylhydroxyanisole (E320), and flavouring preparations),

Orange flavour (maltodextrin, arabic gum, and flavouring preparations).

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 when stored below 30 °C.

The pharmaceutical quality of Fosfomycin STADA 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 Fosfomycin trometamol

are well known. As Fosfomycin trometamol is a widely used, well-known active substance,

the applicant has not provided additional studies and further studies are not required.

III.2

Ecotoxicity/environmental risk assessment (ERA)

The applicant has not conducted an in depth environmental risk assessment in accordance

with regulatory guidelines (EMEA/CHMP/SWP/4447/00).

Since Fosfomycin STADA 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

As Fosfomycin trometamol is a widely used, well-known active substance, no further studies

are required for this application and the applicant provides none.

IV.2

Pharmacokinetics

Biowaiver

According to the ”Guideline on the Investigation of Bioequivalence” a bioequivalence study

is not required for an aqueous oral solution with the same active substance in the same

concentration and the same excipients in very similar amounts.

IV.3

Clinical efficacy and safety

Efficacy and safety of fosfomycin trometamol in the proposed indications are known and assessed as

being scientifically based considering recent knowledge, guidelines and recommendations.

IV.4

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

identify,

characterise,

prevent

minimise

risks

relating

Fosfomycin STADA Granulat zur Herstellung einer Lösung zum Einnehmen.

- Summary table of safety concerns as approved in RMP

Important identified risks

- Hypersensitivity

- Use in patients with severe renal insufficiency

(creatinine clearance <80ml/min)

- Antibiotic associated colitis

- Lack of efficacy if used concomitantly with

metoclopramide or concurrently with calcium salts

Important potential risks

- off label use in children under 12 years of age

Missing information

- Use in pregnancy

- Effects on fertility

- Summary of Safety Concerns and Planned Risk Minimisation Activities as approved in

V.

USER CONSULTATION

The package leaflet has been evaluated via a user consultation study 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

The pharmaceutical quality of Fosfomycin STADA has been adequately shown.

There are no non-clinical or clinical concerns.

The benefit/risk relation is considered positive.

Public Assessment Report

Update

Fosfomycin STADA 3 g Granulat zur Herstellung einer

Lösung zum Einnehmen

FOSFOMYCIN-TROMETAMOL

AT/H/0691/001/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