Alprazolam Aurovitas 0.25 mg Comprimido

Portugal - português - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

Compre agora

Ingredientes ativos:
Alprazolam
Disponível em:
Generis Farmacêutica, S.A.
Código ATC:
N05BA12
DCI (Denominação Comum Internacional):
Alprazolam
Dosagem:
0.25 mg
Forma farmacêutica:
Comprimido
Composição:
Alprazolam 0.25 mg
Via de administração:
Via oral
Classe:
2.9.1 - Ansiolíticos, sedativos e hipnóticos
Tipo de prescrição:
MSRM Medicamento sujeito a receita médica
Grupo terapêutico:
Genérico
Área terapêutica:
alprazolam
Indicações terapêuticas:
Duração do Tratamento: Curta ou Média Duração
Resumo do produto:
Frasco 30 unidade(s) Não Comercializado Número de Registo: 5690714 CNPEM: 50001116 CHNM: 10009485 Grupo Homogéneo: N/A
Status de autorização:
Autorizado
Número de autorização:
PT/H/1536/001/DC
Data de autorização:
2016-09-30

Leia o documento completo

APROVADO EM

30-09-2016

INFARMED

Summary Public Assessment Report

Generics

Alprazolam Aurovitas

0.25 mg, 0.5 mg and 1.0 mg Tablets,

(Alprazolam)

PT/H/1536/001-003/DC

Date: 30-09-2016

APROVADO EM

30-09-2016

INFARMED

Summary Public Assessment Report

Generics

Alprazolam Aurovitas 0.25 mg, 0.5 mg and 1.0 mg Tablets

Alprazolam 0.25 mg, 0.5 mg and 1.0 mg Tablets

This is a summary of the public assessment report (PAR) for Alprazolam Aurovitas. It

explains how Alprazolam Aurovitas was assessed and its authorisation recommended

as well as its conditions of use. It is not intended to provide practical advice on how to

use Alprazolam Aurovitas.

For practical information about using Alprazolam Aurovitas, patients should read the

package leaflet or contact their doctor or pharmacist.

What is Alprazolam Aurovitas and what is it used for?

Alprazolam Aurovitas 0.25 mg, 0.5 mg and 1.0 mg Tablets is a ‘generic medicine’. This

means that Alprazolam Aurovitas 0.25 mg, 0.5 mg and 1.0 mg Tablets is similar to a

‘reference medicine’ already authorised in the European Union (EU) called Xanax 0.25

mg, 0.5 mg and 1.0 mg Tablets.

Alprazolam Aurovitas tablets are used for the treatment of

symptomatic treatment of anxiety.

Alprazolam is only indicated when disorder is severe, disabling or subjecting the

individual to extreme distress.

How does Alprazolam Aurovitas work?

The active ingredient is alprazolam. It belongs to the group of medicines called

benzodiazepines. Alprazolam acts through the central nervous system, reducing

anxiety. It also has sedative, drowsiness-inducing and muscle relaxant effects.

How is Alprazolam Aurovitas used?

pharmaceutical

form

Alprazolam

Aurovitas

Tablets

route

administration is oral.

Please read section 3 of the PL for detailed information on dosing recommendations,

the route of administration, and the duration of treatment.

The medicine can only be obtained with a prescription.

What benefits of Alprazolam Aurovitas have been shown in studies?

Because Alprazolam Aurovitas 0.25 mg, 0.5 mg and 1.0 mg Tablets is a generic

medicine, studies in patients have been limited to tests to determine that it is

bioequivalent to the reference medicine, Xanax 0.25 mg, 0.5 mg and 1.0 mg Tablets

Two medicines are bioequivalent when they produce the same levels of the active

substance in the body.

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The company provided data from the published literature on Alprazolam.

What are the possible side effects of Alprazolam Aurovitas?

Because Alprazolam Aurovitas is a generic medicine and is bioequivalent to the

reference medicine, its benefits and possible side effects are taken as being the same

as the reference medicine.

For the full list of restrictions, see the package leaflet.

Why is Alprazolam Aurovitas approved?

It was concluded that, in accordance with EU requirements, Alprazolam Aurovitas 0.25

mg, 0.5 mg and 1.0 mg Tablets has been shown to have comparable quality and to be

bioequivalent/be

comparable to Xanax 0.25 mg, 0.5 mg

and 1.0 mg Tablets.

Therefore, the INFARMED, I.P. decided that, as for <reference medicine called Xanax

0.25 mg, 0.5 mg and 1.0 mg Tablets, the benefits are greater than its risk and

recommended that it can be approved for use.

What measures are being taken to ensure the safe and effective use of Alprazolam

Aurovitas?

A Risk Management Plan-Version 2.0 dated of 28 April 2016 has been developed to

ensure that Alprazolam Aurovitas is used as safely as possible. Based on this plan,

safety information has been included in the summary of product characteristics and

the package leaflet for Alprazolam Aurovitas, including the appropriate precautions to

be followed by healthcare professionals and patients.

Known side effects are continuously monitored. Furthermore new safety signals

reported by patients/healthcare professionals will be monitored/reviewed continuously

as well.

Other information about Alprazolam Aurovitas

The marketing authorisation for Alprazolam Aurovitas 0.25 mg, 0.5 mg and 1.0 mg

Tablets was granted on 30-09-2016.

The full PAR for Alprazolam Aurovitas 0.25 mg, 0.5 mg and 1.0 mg Tablets can be

found

website

http://www.infarmed.pt/infomed/inicio.php

more

information about treatment with Alprazolam Aurovitas, read the package leaflet or

contact your doctor or pharmacist.

This summary was last updated in MM-YYYY.

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INFARMED

Public Assessment Report

Scientific discussion

Alprazolam Aurovitas

0.25 mg, 0.5 mg and 1.0 mg Tablets,

(Alprazolam)

PT/H/1536/001-003/DC

Date:30-09-2016

This module reflects the scientific discussion for the approval of Alprazolam

Aurovitas. The procedure was finalised at 14-09-2016. For information on

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

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Introduction

Based on the review of the quality, safety and efficacy data, the Member States have

agreed in granting a marketing authorisation for Alprazolam Aurovitas 0.25 mg, 0.5

mg and 1.0 mg Tablets, from Aurovitas, Unipessoal, Lda.

Alprazolam Aurovitas is indicated for:

Short-term symptomatic treatment of anxiety.

Alprazolam is only indicated when disorder is severe, disabling or subjecting the

individual to extreme distress.

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

With respect to the legal basis in the RMS and the CMSs, the application has been

made according to EU-directive 2001/83/EC article 10 (1) generic application.

This decentralised application concerns a generic version of alprazolam tablets, under

the trade name Alprazolam Aurobindo 0,25 mg, 0,5 mg and 1 mg tablets.

The originator product is Xanax 0,25 mg, 0,5 mg and 1 mg tablets registered since

1983-10-07 by Laboratórios Pfizer, Lda (Portugal).

With PT as the Reference Member State in this Decentralized Procedure, Aurovitas,

Unipessoal, Lda. is applying for the Marketing Authorisations for Alprazolam Aurovitas,

tablets, in BE, CZ, ES, HU, NL and PL.

marketing

authorization

granted

30-09-2016

based

Directive

2001/83/EC article 10.1 (a) (iii) first paragraph and the Marketing Authorisation

Holder is Aurovitas, Unipessoal, Lda..

Quality aspects

Introduction

Tablet.

Alprazolam Aurovitas 0.25 mg tablets:

White, oval shaped, uncoated tablets with breakline on one side debossed with ‘5’ and

‘0’ on either sides of the breakline and ‘Z’ on the other side. The tablet can be divided

into equal doses.

Alprazolam Aurovitas 0.5 mg tablets:

Peach coloured, oval shaped, uncoated tablets with breakline on one side debossed

with ‘5’ and ‘1’ on either sides of the breakline and ‘Z’ on the other side. The tablet

can be divided into equal doses.

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Alprazolam Aurovitas 1 mg tablets:

Lavender coloured, oval shaped, uncoated tablets with breakline on one side debossed

with ‘5’ and ‘2’ on either sides of the breakline and ‘Z’ on the other side. The tablet

can be divided into equal doses.

The other excipients are: Cellulose, microcrystalline, lactose monohydrate, maize

starch,

docusate

sodium,

sodium

benzoate

211),

silica, colloidal

anhydrous,

magnesium stearate, sunset yellow (E 110) (for 0.5 mg), indigotine (E 132) (for 1mg),

erythrosine aluminum lake (for 1mg).

Alprazolam Aurovitas tablets are available in HDPE bottle with polypropylene cap.

Pack sizes: 30 and 1000 tablets.

Not all pack sizes may be marketed

Drug Substance

Nomenclature

INN:

Alprazolam

Generic name:

Alprazolam

Chemical names:

8-chloro-1-methyl-6-phenyl-4H-[1, 2, 4] triazolo [4, 3-a] [1, 4]

benzodiazepine or 8-chloro-1-methyl-6-phenyl-4H-s-triazolo[4,3-

a][1,4]benzodiazepine

CAS Reg. No.: [28981-97-7]

Structure (structural formula)

Molecular formula:

Relative molecular mass:

308.8

Polymorphism

material

manufactured

Mylan

Laboratories

Limited is Polymorphic form-I.

Isomerism:

Alprazolam

contains

chiral

carbon

atoms

in its

structure and does not exhibit optical isomerism.

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General properties (physico-chemical characterisation)

Description

White or almost white, crystalline powder

Solubility

Practically insoluble in water, freely soluble in

methylene chloride, sparingly soluble in acetone and in

ethanol (96%).

Alprazolam is manufactured by Mylan Laboratories Limited and the module 3.2.S is

based on the valid CEP R0-CEP 2008-060-Rev 01 updated on 2011-11-14. Alprazolam

is a stable molecule. The proposed retest period of 60 months is indicated in the CEP.

Medicinal Product

The immediate release tablets are formulated with well-known excipients. The

pharmaceutical development work is acceptable and in accordance with relevant EU

guidelines. Justifications for the choice of dissolution test, manufacturing process and

packaging material have

been

described.

manufacturing

process

been

satisfactorily

described

and validated

in accordance

with

guidelines

Manufacture of the finished dosage form and Process validation. The manufacturing

process is conventional using a standard direct compression technique. The excipients

comply with the current version of the monograph in Ph.Eur. or internal monographs

and are tested according to the analytical methods in Ph. Eur.

The limits for dissolution are considered as adequate. Other requirements are justified

according to relevant EU/ICH guidelines and Ph.Eur.

The analytical methods used for the drug product are described and validated in

accordance with the relevant EU/ICH guidelines.

The description and choice of container closure system is in accordance with relevant

directives.

The stability studies have been carried out according to relevant EU/ICH stability

guidelines. In total, nine batches have been stored for up to 36 months at ICH long

term condition and 6 months at accelerated. Thus, according to results available, the

proposed shelf life of 24 month is acceptable, when stored in the original package in

order to protect from light and moisture.

Non-clinical aspects

Pharmacodynamic, pharmacokinetic and toxicological properties of alprazolam are well

known. As alprazolam 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.

Ecotoxicity/environmental risk assessment (ERA)

Since Alprazolam Aurovitas 0.25 mg, 0.5 mg and 1.0 mg Tablets 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.

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Discussion on the non-clinical aspects

Since this product has been shown to be essentially similar and refer to a product

approved based on a full application with regard to preclinical data, no further such

data have been submitted or are considered necessary.

Clinical aspects

To support the application, the applicant has submitted as report one bioequivalence

study between Alprazolam tablets of Aurobindo Pharma Ltd., India and Xanax tablets

of Pfizer Europe under fasting conditions with the higher strength of 1 mg.

Conclusion on bioequivalence studies

Based on the submitted bioequivalence study Alprazolam Aurovitas 0.25 mg, 0.5 mg

and 1.0 mg Tablets is considered bioequivalent with Xanax 0.25 mg, 0.5 mg and 1.0

mg Tablets

Risk Management Plan

The MAH has submitted a Risk Management Plan-Version 2.0 dated of 28 April 2016 -

in accordance with the requirements of Directive 2001/83/EC as amended, describing

the pharmacovigilance activities and interventions designed to identify, characterise,

prevent or minimise risks relating to Alprazolam Aurovitas 0.25 mg, 0.5 mg and 1.0

mg Tablets

Discussion on the clinical aspects

This type of application refers to information that is contained in the pharmacological-

toxicological and clinical part of the dossier of the authorisation of the reference

product. A reference product is a medicinal product authorised and marketed on the

basis

full

dossier,

i.e.

including

chemical,

biological,

pharmaceutical,

pharmacological-toxicological and clinical data. This information is not fully available in

the public domain. Authorisations for generic products are therefore linked to the

‘original’

authorized

medicinal

product,

which is

legally

allowed

once

data

protection time of the dossier of the reference product has expired. For this kind of

application, it has to be demonstrated that the pharmacokinetic profile of the product

is similar to the pharmacokinetic profile of the reference product. This generic product

can be used instead of its reference product.

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 Alprazolam

Hexal, 0,25 mg, 0,5 mg and 1 mg, tablets, DCP number NL/H/1135/001-003/DC.. The

bridging report submitted by the applicant has been found acceptable.

Overall conclusion, benefit/risk assessment and recommendation

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The application for Alprazolam Aurovitas 0.25 mg, 0.5 mg and 1.0 mg Tablets contains

adequate quality, non-clinical and clinical data and the bioequivalence has been

shown. A benefit/risk ratio comparable to the reference product can therefore be

concluded.

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