BR112015001313A2 - composições de vacina - Google Patents

composições de vacina

Info

Publication number
BR112015001313A2
BR112015001313A2 BR112015001313A BR112015001313A BR112015001313A2 BR 112015001313 A2 BR112015001313 A2 BR 112015001313A2 BR 112015001313 A BR112015001313 A BR 112015001313A BR 112015001313 A BR112015001313 A BR 112015001313A BR 112015001313 A2 BR112015001313 A2 BR 112015001313A2
Authority
BR
Brazil
Prior art keywords
vaccine compositions
dengue
serotype
protecting
virus
Prior art date
Application number
BR112015001313A
Other languages
English (en)
Inventor
Guy Bruno
Legastelois Isabelle
Lang Jean
Yao Jiansheng
Mantel Nathalie
Barban Véronique
Girerd-Chambaz Yves
Original Assignee
Sanofi Pasteur
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi Pasteur filed Critical Sanofi Pasteur
Publication of BR112015001313A2 publication Critical patent/BR112015001313A2/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/295—Polyvalent viral antigens; Mixtures of viral and bacterial antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5252—Virus inactivated (killed)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5254—Virus avirulent or attenuated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5258—Virus-like particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/53—DNA (RNA) vaccination
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/70—Multivalent vaccine
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/24011—Flaviviridae
    • C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
    • C12N2770/24134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

resumo patente de invenção: "composições de vacina". a presente invenção refere-se a composições de vacina do vírus da dengue sorotipo 2 que são úteis em um método de proteção de um ser humano contra a doença da dengue. a presente invenção compreende ainda um kit compreendendo uma composição de vacina do vírus da dengue sorotipo 2 e instruções de uso da dita composição em um método de proteção de um ser humano contra a doença da dengue causada por um vírus da dengue sorotipo 2.
BR112015001313A 2012-07-24 2013-07-24 composições de vacina BR112015001313A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP12305908 2012-07-24
EP12305911 2012-07-25
PCT/EP2013/065669 WO2014016362A1 (en) 2012-07-24 2013-07-24 Vaccine compositions for prevention against dengue virus infection

Publications (1)

Publication Number Publication Date
BR112015001313A2 true BR112015001313A2 (pt) 2017-08-01

Family

ID=48856641

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112015001313A BR112015001313A2 (pt) 2012-07-24 2013-07-24 composições de vacina

Country Status (15)

Country Link
US (1) US20150265695A1 (pt)
EP (1) EP2877207A1 (pt)
JP (1) JP2015524422A (pt)
KR (1) KR20150036593A (pt)
CN (1) CN104812408A (pt)
AU (1) AU2013295016A1 (pt)
BR (1) BR112015001313A2 (pt)
CA (1) CA2878599A1 (pt)
GT (1) GT201500005A (pt)
HK (1) HK1212905A1 (pt)
MX (1) MX2015000446A (pt)
PE (1) PE20150356A1 (pt)
PH (1) PH12014502875A1 (pt)
SG (1) SG11201500439RA (pt)
WO (1) WO2014016362A1 (pt)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ630869A (en) 2013-03-15 2017-11-24 Us Gov Health & Human Services Compositions and methods for dengue virus chimeric constructs in vaccines
US9861692B2 (en) 2013-06-21 2018-01-09 Merck Sharp & Dohme Corp. Dengue virus vaccine compositions and methods of use thereof
CN106999564A (zh) 2014-09-02 2017-08-01 赛诺菲巴斯德有限公司 针对登革热病毒疾病的疫苗组合物
US10098943B2 (en) * 2014-09-11 2018-10-16 Vlp Therapeutics, Llc Flavivirus virus like particle
BR112017013270A2 (pt) * 2014-12-22 2018-03-06 Merck Sharp & Dohme ?composição de vacina contra vírus da dengue, métodos para induzir uma resposta imune contra dengue, para reduzir a probabilidade de infecção por dengue, ou prevenir ou atenuar os sintomas da mesma, e, uso de uma composição de vacina contra vírus da dengue?.
US10857222B2 (en) 2015-07-03 2020-12-08 Sanofi Pasteur Concomitant dengue and yellow fever vaccination
US10105434B2 (en) 2015-08-03 2018-10-23 The United States Of America As Represented By The Secretary Of The Navy Immune enhancing recombinant dengue protein
EP3355915B1 (en) * 2015-09-29 2023-11-01 Boehringer Ingelheim Animal Health USA Inc. Canine parvovirus (cpv) virus-like particle (vlp) vaccines and uses thereof
US11531029B2 (en) 2017-05-08 2022-12-20 University Of Pittsburgh-Of The Commonwealth System Of Higher Education Methods and compositions for the detection of flavivirus infections
SG11202002933TA (en) 2017-10-05 2020-04-29 Sanofi Pasteur Compositions for booster vaccination against dengu
EP3730620A4 (en) 2017-12-21 2022-01-05 Green Biomed, Inc. CROSS-IMMUNIZATION ANTIGENIC VACCINE AND PROCESS FOR PREPARATION
US11464815B2 (en) * 2018-09-05 2022-10-11 Takeda Vaccines, Inc. Dengue vaccine unit dose and administration thereof
US11426461B2 (en) 2018-09-05 2022-08-30 Takeda Vaccines, Inc. Methods for preventing dengue and hepatitis A
ES2908304T3 (es) 2018-09-05 2022-04-28 Takeda Vaccines Inc Dosis unitaria de vacuna contra el dengue y administración de la misma

Family Cites Families (44)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2017507C (en) 1989-05-25 1996-11-12 Gary Van Nest Adjuvant formulation comprising a submicron oil droplet emulsion
FR2649013B1 (fr) 1989-07-03 1991-10-25 Seppic Sa Vaccins et vecteurs de principes actifs fluides contenant une huile metabolisable
FR2649012B1 (fr) 1989-07-03 1991-10-25 Seppic Sa Emulsions multiphasiques injectables
GB9326253D0 (en) 1993-12-23 1994-02-23 Smithkline Beecham Biolog Vaccines
US6254873B1 (en) 1995-04-17 2001-07-03 The United States Of America As Represented By The Secretary Of The Army Inactivated dengue virus vaccine
WO1996040933A1 (en) 1995-06-07 1996-12-19 The Government Of The United States Of America, Represented By The Secretary Department Of Health And Human Services Infectious dengue 2 virus pdk-53 as quadravalent vaccine
PT1625852E (pt) 1997-02-28 2010-08-27 Acambis Inc Vacinas quiméricas de flavivírus
GB9711990D0 (en) 1997-06-11 1997-08-06 Smithkline Beecham Biolog Vaccine
GB9718901D0 (en) 1997-09-05 1997-11-12 Smithkline Beecham Biolog Vaccine
DE69838992T2 (de) 1997-09-05 2008-12-24 Glaxosmithkline Biologicals S.A., Rixensart Öl-in-Wasser Emulsionen mit Saponinen
US7227011B2 (en) * 1998-06-04 2007-06-05 United States Of America As Represented By The Secretary Of The Department Of Health And Human Services, Centers For Disease Control And Prevention Nucleic acid vaccines for prevention of flavivirus infection
CA2368790A1 (en) 1999-03-26 2000-10-05 Walter Reed Army Institute Of Research Attenuated dengue-3 virus vaccine
CA2365728A1 (en) 1999-03-26 2000-10-05 Walter Reed Army Institute Of Research Attenuated dengue-1 virus vaccine
JP2002540170A (ja) 1999-03-26 2002-11-26 ウォルター リード アーミー インスティテュート オブ リサーチ 弱毒化デング熱２型ウイルスワクチン
AU4040400A (en) 1999-03-26 2000-10-16 Walter Reed Army Institute Of Research Attenuated dengue-4 virus vaccine
WO2001009309A2 (en) * 1999-08-02 2001-02-08 American Home Products Corporation RESCUE OF MUMPS VIRUS FROM cDNA
DK2278012T3 (en) 2000-02-16 2015-12-07 Us Government Immunogenic dengue 2 virus chimeras
ES2315221T3 (es) 2000-05-30 2009-04-01 Mahidol University Cepas atenuadas del virus del dengue y su utilizacion en una composicion vaccinea.
AT410634B (de) 2001-02-21 2003-06-25 Franz X Dr Heinz Attenuierte lebendimpfstoffe
WO2002095007A2 (en) 2001-05-23 2002-11-28 Dendreon San Diego Llc Conjugates activated by cell surface proteases and therapeutic uses thereof
EP1401859B1 (en) 2001-06-01 2013-08-07 Sanofi Pasteur Biologics Co. Chimeric flavivirus vectors
WO2003010197A2 (en) 2001-07-25 2003-02-06 Genset S.A. Gmg-1 polynucleotides and polypeptides and uses thereof
WO2003092592A2 (en) * 2002-05-03 2003-11-13 The Government Of The United States Of America, As Represented By The Secretary, Department Of Health And Human Services Dengue tetravalent vaccine containing a common 30 nucleotide deletion in the 3'-utr of dengue types 1,2,3, and 4, or antigenic chimeric dengue viruses 1,2,3, and 4
WO2003101397A2 (en) 2002-05-31 2003-12-11 Acambis, Inc. Tetravalent dengue vaccines
US8071107B2 (en) * 2003-09-17 2011-12-06 Duke University Nucleic acids encoding modified human immunodeficiency virus type 1 (HIV-1) group M consensus envelope glycoproteins
BRPI0613328A2 (pt) 2005-06-17 2011-01-04 Sanofi Pasteur cepa do vìrus da dengue-1 vivo atenuado, composição imunogênica, composição de vacina, ácido nucléico isolado, poliproteìna isolada e fragmento de poliproteìna
CA2611954C (en) * 2005-06-17 2014-01-28 Sanofi Pasteur Dengue serotype 2 attenuated strain
AR054822A1 (es) 2005-07-07 2007-07-18 Sanofi Pasteur Emulsion inmuno adyuvante
CA2618783A1 (en) 2005-08-10 2007-02-22 Acambis Inc. Vaccination against dengue virus infection
CU23586A1 (es) * 2005-11-22 2010-10-30 Ct Ingenieria Genetica Biotech Métodos y proteínas para el tratamiento profiláctico y/o terapéutico de los cuatro serotipos del virus de dengue y otros flavivirus
US7968102B2 (en) * 2006-01-13 2011-06-28 Sanofi Pasteur S.A. Dengue chimeric viruses
FR2896162B1 (fr) 2006-01-13 2008-02-15 Sanofi Pasteur Sa Emulsion huile dans eau thermoreversible
FR2903605A1 (fr) 2006-07-12 2008-01-18 Sanofi Pasteur Sa Methode d'immunisation contre les quatres serotypes de la dengue
FR2906724B1 (fr) 2006-10-04 2009-03-20 Sanofi Pasteur Sa Methode d'immunisation contre les 4 serotypes de la dengue.
FR2909286B1 (fr) 2006-12-01 2012-06-08 Sanofi Pasteur Methode d'immunisation contre les 4 serotypes de la dengue
CA2676775A1 (en) * 2007-01-31 2008-09-25 Sanofi Pasteur Biologics Co. Flavivirus vaccine vector against influenza virus
US8715689B2 (en) * 2008-04-30 2014-05-06 The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services, Centers For Disease Control And Prevention Chimeric west nile/dengue viruses
EP2143440A1 (fr) 2008-07-09 2010-01-13 Sanofi Pasteur Agent stabilisant et composition vaccinale comprenant un ou plusieurs flavivirus vivants atténués
EA201290072A1 (ru) * 2009-07-29 2012-12-28 Бернд Хельмут Адам Рем Полимерные частицы и их применение
US8900596B2 (en) * 2009-11-18 2014-12-02 The Board Of Regents Of The University Of Texas System Physicochemical (PCP) based consensus sequences and uses thereof
GB201007531D0 (en) 2010-05-05 2010-06-23 Imp Innovations Ltd Composition
CN102906266A (zh) * 2010-05-21 2013-01-30 高等教育联邦系统-匹兹堡大学 登革病毒通用序列及其使用方法
WO2012051491A1 (en) * 2010-10-14 2012-04-19 The United States Of America, As Represented By The Secretary National Institutes Of Health Compositions and methods for controlling neurotropic viral pathogenesis by micro-rna targeting
SG10201912291YA (en) * 2012-07-24 2020-02-27 Sanofi Pasteur Vaccine compositions

Also Published As

Publication number Publication date
PH12014502875A1 (en) 2015-02-23
WO2014016362A1 (en) 2014-01-30
KR20150036593A (ko) 2015-04-07
US20150265695A1 (en) 2015-09-24
HK1212905A1 (zh) 2016-06-24
CA2878599A1 (en) 2014-01-30
EP2877207A1 (en) 2015-06-03
AU2013295016A1 (en) 2015-01-29
GT201500005A (es) 2015-10-13
JP2015524422A (ja) 2015-08-24
SG11201500439RA (en) 2015-02-27
PE20150356A1 (es) 2015-03-20
CN104812408A (zh) 2015-07-29
MX2015000446A (es) 2015-03-12

Similar Documents

Publication Publication Date Title
BR112015001313A2 (pt) composições de vacina
BR112015014477A2 (pt) composições para limpeza pessoal contendo aminoácido de zinco/haleto de trimetilglicina
BR112014008789A2 (pt) prevenção e tratamento de condições oculares
UY32793A (es) Compuestos inhibidores de los virus flaviviridae, composición farmacéutica que los contiene y sus usos
CR20110509A (es) Composicion farmaceutica
BR112014026703A2 (pt) inibidores de dna-pk
BR112014006220A2 (pt) composições de galacto-ramnogalacturonato para o tratamento de esteatohepatite não alcoólica e de doença de gordura no fígado não alcoólica
AR090465A1 (es) Formas solidas de un profarmaco de nucleotidos de tiofosforamidato
CO6290682A2 (es) Compuestos triciclicos fusionados inhibidores del virus de la hepatitis c.
BR112014016649A2 (pt) composições para tratamento dos cabelos
BR112013022094A2 (pt) composições e métodos para o tratamento não cirúrgico da ptose
UY32455A (es) Derivados de aminotetralina, composiciones farmacéuticas que la contienen, y sus usos en terapia
MX2021004211A (es) Composiciones vacuna.
BRPI0906444B8 (pt) compostos de 4-piridinona, composição farmacêutica que os compreende, bem como uso dos mesmos
BR112014014789A2 (pt) composição
BR112014005025A2 (pt) composição farmacêutica para uso no tratamento de uma doença neurodegenerativa
BR112014009376A2 (pt) composições
BR112013026661A2 (pt) método de entrega de vacina
BR112017004197A2 (pt) composições de vacina contra doenças do vírus da dengue
BR112014032759A2 (pt) composições lipídicas de racecadotril
BR112013000779A2 (pt) composições farmacêuticas de combinação, métodos de tratamento de paciente e uso de forma potencializada ativada de anticorpo para receptor at1 de angiotensina ii e forma potencializada ativada de anticorpo para sintase no endotelial
BR112015006464A2 (pt) composição farmacêutica compreendendo rebamipida
BR112013027369A2 (pt) composições e métodos
BR112014008190A2 (pt) composições para realce da saúde da unha
BR112015002979B8 (pt) Forma cristalina, e, composição farmacêutica

Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06I Publication of requirement cancelled [chapter 6.9 patent gazette]

Free format text: ANULADA A PUBLICACAO CODIGO 6.6.1 NA RPI NO 2462 DE 13/03/2018 POR TER SIDO INDEVIDA.

B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 6A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2524 DE 21-05-2019 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.