Fluoxetin "Stada"

Hauptinformation

  • Handelsname:
  • Fluoxetin "Stada" 20 mg Kapseln
  • Einheiten im Paket:
  • 12 Stück, Laufzeit: 48 Monate,14 Stück, Laufzeit: 48 Monate,20 Stück, Laufzeit: 48 Monate,28 Stück, Laufzeit: 48 Monate,50 Stück
  • Verschreibungstyp:
  • Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Fluoxetin "Stada"  20 mg Kapseln
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiebereich:
  • Fluoxetin
  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 1-21930
  • Berechtigungsdatum:
  • 17-04-1997
  • Letzte Änderung:
  • 07-03-2018

Öffentlichen Beurteilungsberichts

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

Public Assessment Report

Scientific discussion

Fluoxetine “Stada” 20 mg capsules, hard

Fluoxetine (as hydrochloride)

AT/H/0101/001

This module reflects the scientific discussion for the approval of Fluoxetine “Stada” 20 mg

capsules, hard. The procedure was finalised on 01.12.1997. For information on changes after this

date please refer to the module ‘Update’.

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

I.

INTRODUCTION

This is an abridged product licence application for marketing authorisation for Fluoxetine „Stada“ 20

mg capsules. The application has been submitted under Article 4.8 (a) (iii) of Directive 65/65/EEC as

amended.

The primary indication for fluoxetine is depression. Obsessive compulsive disorder (OCD) and

bulimia nervosa are also registered in Austria for the brand leader Fluctine by Eli Lilly.

II.

QUALITY ASPECTS

II.1

Introduction

Fluoxetine “Stada” 20 mg capsules, hard is a Capsule, hard which is presented in a thermoformed

PVC/PVDC - aluminium blister pack.

II.2

Drug Substance

The active substance in Fluoxetine “Stada” 20 mg capsules, hard is fluoxetine (as hydrochloride). 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

Fluoxetine “Stada” 20 mg capsules, hard contains the following excipients:

146,60 mg Lactose monohydrate, Microcrystalline cellulose, Magnesium stearate, Colloidal

anhydrous silica, Gelatin, Titanium dioxide (E 171) and Yellow iron oxide (E172).

The manufacturer/s responsible for batch release are:

Doppel Farmaceutici S.r.l., Stradone Farnese, 118, 29100 Piacenza (PC), Italy

Doppel Farmaceutici S.r.l., Via Volturno, 48 - Quinto De Stampi, 20089 Rozzano (MI), Italy

Stada Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel, 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 48 months when stored below 30°C and stored in the original

package to protect from light and moisture.

The pharmaceutical quality of Fluoxetine “Stada” 20 mg capsules, hard has been adequately shown.

II.4

Discussion on chemical, pharmaceutical and biological aspects

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

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

The pharmaco-toxicological properties of Fluoxetine are well documented and known after many

years of clinical usage and have been adequately reviewed in the Expert Report. Consequently, no

pharmacological and toxicological studies have been submitted on the active substance itself.

Expert

Report

Professor

O.G.

Nilsen,

Head

Department

Pharmacology

Toxicology, University of Trondheim, provides a profound overview of the pharmaco-toxicological

data of fluoxetine.

IV.

CLINICAL ASPECTS

IV.1

Pharmacokinetics

After oral application the drug is rapidly and almost completely absorbed. Maximal concentrations in

plasma

occur

after

approximately

hours.

drug

mainly

eliminated

oxidative

bio-

transformation

form

metabolites.

main

metabolite

norfluoxetine

which

also

pharmacological activity. The elimination half-life of fluoxetine is 2-3 days, whereas norfluoxetine has

a half-life of 7-9 days. Protein-binding amounts to >94%. A larger interindividual variability in the

disposition of fluoxetine as well as non-linear pharmacokinetics were found.

IV.2

Pharmacodynamics

No new data have been submitted. The Expert Report by T.O. Aamo, Consultant Physician and Head

of the Section of Clinical Pharmacology, University of Trondheim, is a critical evaluation of the

clinical data of fluoxetine.

IV.3

Clinical efficacy and safety

No studies with Fluoxetine „Stada“ have been submitted. The Expert report has extensively reviewed

the literature. Furthermore the company has provided a published review (Life Sci 57 (1995), 411-441;

Supplement I, Vol. 7/9) and a monography on fluoxetine (Micromedex Inc.; Supplement II, Vol. 7/9)

which give a good overview of the efficacy and safety profile of fluoxetine.

Bioequivalence studies

Single dose study:

The applicant has performed a bioequivalence study comparing Fluoxetine „Stada“ 20 mg capsules (in

the study report called: Fluoxetine 20 mg capsule Siegfried Pharma AG) with the in Germany

registered 20 mg capsule (Fluctine

) from Eli Lilly. 30 healthy volunteers (15 males, 15 females)

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

participated in a single dose, fasting, open-label, randomised, 2-way cross over study with a 42-day-

wash-out period in between.

Adequate sampling, analytical and statistical methods were employed. Fluoxetine and norfluoxetine

were measured at the following time points: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48, 72

hours and 5, 7, 14, 21, 28, 35 and 42 days post-dose. After completion of the last treatment period, a

safety check-up was done. Plasma concentrations of fluoxetine and norfluoxetine were determined by

GC/MS in accordance with GLP regulations. The results obtained in this study show that Fluoxetine

„Stada“ is bioequivalent with Fluctine

20 mg. The 90 % confidence intervals of AUC and Cmax of

the test compound were within the required ranges (Cmax: 70-143%, AUC: 80-125%) to accept

bioequivalence. The study was performed in compliance with the EC GCP-Guideline.

Multiple dose study:

A multiple dose, fasting, open label, randomized 2-way cross over bioequivalence study has been

performed in 30 healthy volunteers (15 males, 15 females) comparing Fluoxetine „Stada“ 20 mg

capsules (in the study report called: Fluoxetine 20 mg capsule Siegfried Pharma AG) with the in

Norway/Sweden registered 20 mg capsule (Fontex

) from Eli Lilly.

The dosage was 40 mg fluoxetine once daily over 5 days (loading dose) and 20 mg fluoxetine once-

daily during 16 days with a wash out period of 4 weeks between the two treatments. 28 subjects

completed the study according to the protocol. There were two premature withdrawals not related to

study medication (patient nr. 1 due to seizures and patient nr. 28 due to influenza). Medical assessment

of the relation to study medication by T. Aamo and CRFs of patient 1 see Appendix I of the study,

Vol. 9/9.

Adequate sampling, analytical and statistical methods were employed. The following pharmacokinetic

parameters were determined from individual plasma concentration time courses of fluoxetine and

norfluoxetine: C

through

on days 1, 5, 12, 19 and 21, C

, AUC

, % PTF and F

for day

21. Plasma concentrations of fluoxetine and norfluoxetine were determined by GC/MS in accordance

with GLP regulations. The study was performed in compliance with the EC GCP-Guideline.

IV.4

Discussion on the clinical aspects

From the results of the above mentioned bioequivalence studies it can be concluded that Fluoxetine

„Stada“ 20 mg capsules and Fluctine 20 mg capsules from Eli Lilly are bioequivalent at single dose

and at steady-state conditions of both fluoxetine and its metabolite norfluoxetine. No serious adverse

events were observed.

V.

OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND

RECOMMENDATION

The efficacy and safety of Fluoxetine „Stada“ 20 mg capsules are considered satisfactory, and the

grant of a marketing authorisation is recommended.

The pharmaceutical quality of Fluoxetine “Stada” 20 mg capsules, hard has been adequately shown.

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

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

initial procedure.

Scope

Procedure

number

Product

Information

affected

Date of end

of

procedure

Approval/

non

approval

Assessment

report

attached

deletion of colorants

V/001

19.08.1998

approval

Name change in Italy

V/006

19.11.1999

approval

Alternative batch releaser in Italy

V/007

19.11.1999

approval

Name change in Ireland

V/008

17.03.2000

approval

Implementation of the request of

PhVWP with regard to

haemorrhagic reactions and

withdrawl reactions for SRIs

W/009

05.07.2000

approval

Renewal

R/002

17.07.2009

approval

Change to batch release

arrangements

IA/015

22.07.2005

approval

new shelf-life: 48 months

amended storage conditions: Do

not store above 30°C

IB/018

28.09.2009

approval

New package size: 48 capsules

IA/028

30.10.2009

approval

Including of warnings

concerning: risk of congenital

malformations, bone fractures

and persistent pulmonary

hypertension in neonates

IB/030

30.06.2010

approval

Name change in Germany

IB/032

21.07.2011

approval

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

28-11-2018

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EU/3/10/810 (Celgene Europe B.V.)

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EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety