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RESOLUÇÃO RE Nº 3.320, DE 27 DE Agosto DE 2021

Brasão do Brasil

Diário Oficial da União

Publicado em: 30/08/2021 | Edição: 164 | Seção: 1 | Página: 164

Órgão: Ministério da Saúde/Agência Nacional de Vigilância Sanitária/2ª Diretoria/Gerência-Geral de Medicamentos e Produtos Biológicos

RESOLUÇÃO RE Nº 3.320, DE 27 DE Agosto DE 2021

O Gerente-Geral de Medicamentos e Produtos Biológicos, no uso das atribuições que lhe confere o art. 130, aliado ao art. 54, I, § 1º do Regimento Interno aprovado pela Resolução de Diretoria Colegiada - RDC nº 255, de 10 de dezembro de 2018, resolve:

Art. 1º Deferir petições relacionadas à Gerência-Geral de Medicamentos, conforme anexo.

Art. 2º Esta Resolução entra em vigor na data de sua publicação.

GUSTAVO MENDES LIMA SANTOS

ANEXO

NOME DA EMPRESA                                        CNPJ

PRINCIPIO(S) ATIVO(S)

NOME DO MEDICAMENTO                 NUMERO DO PROCESSO                VENCIMENTO DO REGISTRO

ASSUNTO DA PETIÇÃO                              EXPEDIENTE

NUMERO DE REGISTRO                              VALIDADE

APRESENTAÇÃO DO PRODUTO

PRINCIPIO(S) ATIVO(S)

----------------------------

ABBOTT LABORATÓRIOS DO BRASIL LTDA                                     56998701000116

COLAGENASE + CLORANFENICOL

IRUXOL                                               25992.008483/73           03/2029

10393 PRODUTO BIOLÓGICO - ATUALIZAÇÃO DE ESPECIFICAÇÕES E MÉTODO ANALÍTICO DO PRINCÍPIO ATIVO, DO PRODUTO A GRANEL, DO PRODUTO TERMINADO, DO ADJUVANTE E DOS ESTABILIZANTES QUE NÃO CONSTAM EM COMPÊNDIO OFICIAL 3465835/20-1

11948 PRODUTOS BIOLÓGICOS - 58. ALTERAÇÃO NA ESPECIFICAÇÃO OU NO PROCEDIMENTO ANALÍTICO USADO PARA LIBERAÇÃO DO PRODUTO TERMINADO - MODERADA 2654625/21-6

11948 PRODUTOS BIOLÓGICOS - 58. ALTERAÇÃO NA ESPECIFICAÇÃO OU NO PROCEDIMENTO ANALÍTICO USADO PARA LIBERAÇÃO DO PRODUTO TERMINADO - MODERADA 2654627/21-2

1.0553.0259.001-6                                                   24 Meses

0,6 U/G + 0,01 G POM DERM CT BG AL X 10 G

1.0553.0259.002-4                                                   24 Meses

0,6 U/G + 0,01 G POM DERM CT BG AL X 15 G

1.0553.0259.003-2                                                   24 Meses

0,6 U/G + 0,01 G POM DERM CT BG AL X 30 G

1.0553.0259.004-0                                                   24 Meses

0,6 U/G + 0,01 G POM DERM CT BG AL X 50 G

1.0553.0259.005-9                                                   24 Meses

0,6 U/G + 0,01 G POM DERM CT BG AL X 15 G + ESP

1.0553.0259.006-7                                                   24 Meses

0,6 U/G + 0,01 G POM DERM CT BG AL X 50 G + ESP

1.0553.0259.007-5                                                   24 Meses

0,6 UI/G + 10 MG/G POM VAG CT BG AL X 30 G + APLIC

1.0553.0259.010-5                                                   24 Meses

0,6 U/G + 0,01 G POM DERM CT 50 BG AL X 30 G

----------------------------

Aché Laboratórios Farmacêuticos S.A                                    60659463002992

RIVASTIGMINA

Vivencia Patch                                  25351.764538/2018-24           08/2031

10490 SIMILAR - REGISTRO DE PRODUTO - CLONE                                1071098/18-1

(155 GENERICO - REGISTRO DE MEDICAMENTO - 1107074/15-9 - 25351.775739/2015-03)

1.0573.0780.001-5                                                   24 Meses

9 MG ADES TRANSD CT ENV PAP/PLAS PET/AL/PAN X 7

1.0573.0780.002-3                                                   24 Meses

9 MG ADES TRANSD CT ENV PAP/PLAS PET/AL/PAN X 15

1.0573.0780.003-1                                                   24 Meses

9 MG ADES TRANSD CT ENV PAP/PLAS PET/AL/PAN X 30

1.0573.0780.004-1                                                   24 Meses

18 MG ADES TRANSD CT ENV PAP/PLAS PET/AL/PAN X 7

1.0573.0780.005-8                                                   24 Meses

18 MG ADES TRANSD CT ENV PAP/PLAS PET/AL/PAN X 15

1.0573.0780.006-6                                                   24 Meses

18 MG ADES TRANSD CT ENV PAP/PLAS PET/AL/PAN X 30

1.0573.0780.007-4                                                   24 Meses

27 MG ADES TRANSD CT ENV PAP/PLAS PET/AL/PAN X 7

1.0573.0780.008-2                                                   24 Meses

27 MG ADES TRANSD CT ENV PAP/PLAS PET/AL/PAN X 15

1.0573.0780.009-0                                                   24 Meses

27 MG ADES TRANSD CT ENV PAP/PLAS PET/AL/PAN X 30

----------------------------

ANTIBIÓTICOS DO BRASIL LTDA                                            05439635000103

sulfato de polimixina B                         25351.359613/2020-53           08/2031

155 GENERICO - REGISTRO DE MEDICAMENTO                                     3841090/20-7

1.5562.0062.001-3                                                   Meses

500.000 UI PO LIOF SOL INJ

----------------------------

APSEN FARMACEUTICA S/A                                                 62462015000129

LISADO BACTERIANO

PAXORAL                                         25351.375560/2017-97           09/2025

10393 PRODUTO BIOLÓGICO - ATUALIZAÇÃO DE ESPECIFICAÇÕES E MÉTODO ANALÍTICO DO PRINCÍPIO ATIVO, DO PRODUTO A GRANEL, DO PRODUTO TERMINADO, DO ADJUVANTE E DOS ESTABILIZANTES QUE NÃO CONSTAM EM COMPÊNDIO OFICIAL 4536277/20-7

10395 PRODUTO BIOLÓGICO - ATUALIZAÇÃO DE ESPECIFICAÇÕES E MÉTODO ANALÍTICO DE EXCIPIENTES E DILUENTES QUE NÃO CONSTAM EM COMPÊNDIO OFICIAL 4536346/20-3

1.0118.0616.001-3                                                   36 Meses

7 MG CAPS GEL DURA CT BL AL PLAST INC X 10 

1.0118.0616.002-1                                                   36 Meses

7 MG CAPS GEL DURA CT BL AL PLAST INC X 30 

1.0118.0616.003-1                                                   36 Meses

3,5 MG CAPS GEL DURA CT BL AL PLAST INC X 10 

1.0118.0616.004-8                                                   36 Meses

3,5 MG CAPS GEL DURA CT BL AL PLAST INC X 30

1.0118.0616.005-6                                                   36 Meses

3,5 MG GRAN CT SACH X 10 

1.0118.0616.006-4                                                   36 Meses

3,5 MG GRAN CT SACH X 30

ramelteona                                      25351.664035/2020-74           08/2031

155 GENERICO - REGISTRO DE MEDICAMENTO                                     4432022/20-1

1.0118.0634.001-1                                                   24 Meses

8 MG COM REV CT BL AL PLAS PVC/PCTFE TRANS X 5

1.0118.0634.002-1                                                   24 Meses

8 MG COM REV CT BL AL PLAS PVC/PCTFE TRANS X 7

1.0118.0634.003-8                                                   24 Meses

8 MG COM REV CT BL AL PLAS PVC/PCTFE TRANS X 10

1.0118.0634.004-6                                                   24 Meses

8 MG COM REV CT BL AL PLAS PVC/PCTFE TRANS X 20

1.0118.0634.005-4                                                   24 Meses

8 MG COM REV CT BL AL PLAS PVC/PCTFE TRANS X 30

1.0118.0634.006-2                                                   24 Meses

8 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 5

1.0118.0634.007-0                                                   24 Meses

8 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 7

1.0118.0634.008-9                                                   24 Meses

8 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 10

1.0118.0634.009-7                                                   24 Meses

8 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 20

1.0118.0634.010-0                                                   24 Meses

8 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 30

----------------------------

ASTRAZENECA DO BRASIL LTDA                                             60318797000100

CLORIDRATO DE METFORMINA + dapagliflozina

dapagliflozina +cloridrato de metformina        25351.626915/2021-23           08/2031

10488 GENÉRICO - REGISTRO DE MEDICAMENTO - CLONE                           2325796/21-2

(11200 MEDICAMENTO NOVO - SOLICITAÇÃO DE TRANSFERÊNCIA DE TITULARIDADE DE REGISTRO (OPERAÇÃO COMERCIAL) - 0040542/17-3 - 25351.012399/2017-05)

1.1618.0289.001-1                                                   24 Meses

5MG + 500MG COM REV LIB PROL CT BL AL/AL X 30

1.1618.0289.002-8                                                   24 Meses

5MG + 1000MG COM REV LIB PROL CT BL AL/AL X 14

1.1618.0289.003-6                                                   24 Meses

5MG + 1000MG COM REV LIB PROL CT BL AL/AL X 30

1.1618.0289.004-4                                                   24 Meses

5MG + 1000MG COM REV LIB PROL CT BL AL/AL X 60 

1.1618.0289.005-2                                                   24 Meses

10MG + 500MG COM REV LIB PROL CT BL AL/AL X 14

1.1618.0289.006-0                                                   24 Meses

10MG + 500MG COM REV LIB PROL CT BL AL/AL X 30

1.1618.0289.007-9                                                   24 Meses

10MG + 1000MG COM REV LIB PROL CT BL AL/AL X 14 

1.1618.0289.008-7                                                   24 Meses

10MG + 1000MG COM REV LIB PROL CT BL AL/AL X 30

dapagliflozina

EDISTRIDE                                       25351.626946/2021-84           08/2031

10490 SIMILAR - REGISTRO DE PRODUTO - CLONE                                2325923/21-0

(11200 MEDICAMENTO NOVO - SOLICITAÇÃO DE TRANSFERÊNCIA DE TITULARIDADE DE REGISTRO (OPERAÇÃO COMERCIAL) - 0040545/17-5 - 25351.012411/2017-02)

1.1618.0290.001-5                                                   36 Meses

5 MG COM REV CT BL AL AL X 7

1.1618.0290.002-3                                                   36 Meses

5 MG COM REV CT BL AL AL X 14

1.1618.0290.003-1                                                   36 Meses

10 MG COM REV CT BL AL AL X 7 

1.1618.0290.004-1                                                   36 Meses

5 MG COM REV CT BL AL AL X 30

1.1618.0290.005-8                                                   36 Meses

10 MG COM REV CT BL AL AL X 14

1.1618.0290.006-6                                                   36 Meses

10 MG COM REV CT BL AL AL X 30

CLORIDRATO DE METFORMINA + dapagliflozina

EBYMECT                                         25351.626949/2021-18           08/2031

10490 SIMILAR - REGISTRO DE PRODUTO - CLONE                                2325933/21-7

(11200 MEDICAMENTO NOVO - SOLICITAÇÃO DE TRANSFERÊNCIA DE TITULARIDADE DE REGISTRO (OPERAÇÃO COMERCIAL) - 0040542/17-3 - 25351.012399/2017-05)

1.1618.0291.001-0                                                   24 Meses

5MG + 500MG COM REV LIB PROL CT BL AL/AL X 30

1.1618.0291.002-9                                                   24 Meses

5MG + 1000MG COM REV LIB PROL CT BL AL/AL X 14

1.1618.0291.003-7                                                   24 Meses

5MG + 1000MG COM REV LIB PROL CT BL AL/AL X 30

1.1618.0291.004-5                                                   24 Meses

5MG + 1000MG COM REV LIB PROL CT BL AL/AL X 60 

1.1618.0291.005-3                                                   24 Meses

10MG + 500MG COM REV LIB PROL CT BL AL/AL X 14

1.1618.0291.006-1                                                   24 Meses

10MG + 500MG COM REV LIB PROL CT BL AL/AL X 30

1.1618.0291.007-1                                                   24 Meses

10MG + 1000MG COM REV LIB PROL CT BL AL/AL X 14 

1.1618.0291.008-8                                                   24 Meses

10MG + 1000MG COM REV LIB PROL CT BL AL/AL X 30

----------------------------

BAYER S.A.                                                             18459628000115

VALERATO DE ESTRADIOL + DIENOGESTe

Qlaira                                          25351.368550/2009-52           12/2029

1449 MEDICAMENTO NOVO - INCLUSÃO DE INDICAÇÃO TERAPÊUTICA NOVA NO PAÍS     989551/10-5

1.7056.0049.001-8                                                   24 Meses

COM REV A + COM REV B + COM REV C + COM REV D ESTOJ CARTOL BL AL PLAS INC X 26 + 2 PLACEBOS 

1.7056.0049.002-6                                                   24 Meses

COM REV A + COM REV B + COM REV C + COM REV D 3 ESTOJ CARTOL BL AL PLAS INC X 26 + 2 PLACEBOS 

----------------------------

BRISTOL-MYERS SQUIBB FARMACÊUTICA LTDA                                 56998982000107

nivolumabe

OPDIVO                                          25351.308360/2015-10           04/2026

11967 PRODUTOS BIOLÓGICOS - 77A. INCLUSÃO OU MODIFICAÇÃO DE INDICAÇÃO TERAPÊUTICA 0855229/21-1

11973 PRODUTOS BIOLÓGICOS - 80. EXCLUSÃO OU ALTERAÇÃO DE INFORMAÇÕES DE SEGURANÇA 0855231/21-2

1.0180.0408.001-5                                                   24 Meses

40 MG SOL INJ CT 1 FA VD INC X 4 ML

1.0180.0408.002-3                                                   24 Meses

100 MG SOL INJ CT 1 FA VD INC X 10 ML

----------------------------

Camber Farmaceutica Ltda                                               24633934000129

lacosamida

LAPSU                                           25351.175830/2019-59           08/2031

150 SIMILAR - REGISTRO DE MEDICAMENTO SIMILAR                              0269199/19-0

1.6507.0016.001-9                                                   24 Meses

50 MG COM REV CT BL AL AL X 14

1.6507.0016.002-7                                                   24 Meses

100 MG COM REV CT BL AL AL X 14

1.6507.0016.003-5                                                   24 Meses

100 MG COM REV CT BL AL AL X 28

1.6507.0016.004-3                                                   24 Meses

100 MG COM REV CT BL AL AL X 56

1.6507.0016.005-1                                                   24 Meses

150 MG COM REV CT BL AL AL X 14

1.6507.0016.006-1                                                   24 Meses

150 MG COM REV CT BL AL AL X 28

1.6507.0016.007-8                                                   24 Meses

150 MG COM REV CT BL AL AL X 56

1.6507.0016.008-6                                                   24 Meses

200 MG COM REV CT BL AL AL X 14

1.6507.0016.009-4                                                   24 Meses

200 MG COM REV CT BL AL AL X 28

1.6507.0016.010-8                                                   24 Meses

200 MG COM REV CT BL AL AL X 56

1.6507.0016.011-6                                                   24 Meses

50 MG COM REV CT AL PLAS PVC/PVDC TRANS X 14

1.6507.0016.012-4                                                   24 Meses

100 MG COM REV CT AL PLAS PVC/PVDC TRANS X 14

1.6507.0016.013-2                                                   24 Meses

100 MG COM REV CT AL PLAS PVC/PVDC TRANS X 24

1.6507.0016.014-0                                                   24 Meses

100 MG COM REV CT AL PLAS PVC/PVDC TRANS X 56

1.6507.0016.015-9                                                   24 Meses

150 MG COM REV CT AL PLAS PVC/PVDC TRANS X 14

1.6507.0016.016-7                                                   24 Meses

150 MG COM REV CT AL PLAS PVC/PVDC TRANS X 28

1.6507.0016.017-5                                                   24 Meses

150 MG COM REV CT AL PLAS PVC/PVDC TRANS X 56

1.6507.0016.018-3                                                   24 Meses

200 MG COM REV CT AL PLAS PVC/PVDC TRANS X 14

1.6507.0016.019-1                                                   24 Meses

200 MG COM REV CT AL PLAS PVC/PVDC TRANS X 28

1.6507.0016.020-5                                                   24 Meses

200 MG COM REV CT AL PLAS PVC/PVDC TRANS X 56

----------------------------

CIFARMA CIENTÍFICA FARMACÊUTICA LTDA                                   17562075000169

MALEATO DE DEXCLORFENIRAMINA + BETAMETASONA

DEXTAMINE                                         25000.004455/99-75           07/2025

11069 RDC 73/2016 - SIMILAR - INCLUSÃO MAIOR DE COMPOSIÇÃO DE EMBALAGEM PRIMÁRIA DO MEDICAMENTO 3039575/20-5

1.1560.0072.008-6                                                   24 Meses

(0,4 + 0,05) MG/ML XPE CT FR PLAS PET AMB X 120 ML + COP

FLUORETO DE SÓDIO + CIANOCOBALAMINA + FOSFATO DE CÁLCIO TRIBÁSICO

CALCIFIX COMPOSTO B12                           25351.131014/2007-08           05/2027

10167 ESPECÍFICO - ALTERAÇÃO MODERADA DO PROCESSO DE PRODUÇÃO              0280137/17-5

10187 ESPECÍFICO - INCLUSÃO DE EQUIPAMENTO COM DIFERENTE DESENHO E PRINCÍPIO DE FUNCIONAMENTO 0280140/17-9

10199 ESPECÍFICO - ALTERAÇÃO MODERADA DE EXCIPIENTE                        0280060/17-5

1.1560.0163.003-1                                                   24 Meses

(0,10 + 0,0012 + 45)MG/ML SUS OR CT FR PLAS PEAD X 300 ML + COP MED

----------------------------

COSMED INDUSTRIA DE COSMETICOS E MEDICAMENTOS S.A.                     61082426000207

SENNA ALEXANDRINA MILL. + CASSIA FISTULA L.

TAMARINE                                        25351.651335/2009-92           04/2030

10621 MEDICAMENTO FITOTERÁPICO - ALTERAÇÃO OU INCLUSÃO DE FABRICANTE DA MATÉRIA-PRIMA VEGETAL, QUANDO FOREM MANTIDAS AS ESPECIFICAÇÕES APROVADAS NO DOSSIÊ 3277085/20-5

1.7817.0023.016-1                                                   24 Meses

(4,878 + 4,719) MG GEL CT FR PLAS PE OPC X 150 G + COL (SUCRALOSE)

1.7817.0023.017-1                                                   24 Meses

(4,878 + 4,719) MG GEL CT FR PLAS PE OPC X 250 G + COL (SUCRALOSE)

----------------------------

CRISTÁLIA PRODUTOS QUÍMICOS FARMACÊUTICOS LTDA.                        44734671000151

LIDOCAÍNA + TETRACAÍNA

SKINCAINE                                       25351.223362/2019-36           08/2031

10490 SIMILAR - REGISTRO DE PRODUTO - CLONE                                0341033/19-1

(155 GENERICO - REGISTRO DE MEDICAMENTO - 1172610/18-5 - 25351.832090/2018-89)

1.0298.0565.001-1                                                   24 Meses

(70,0 + 70,0) MG/G CREM DERM CT BG PLAS PEAD/PEBD OPC X 5 G

1.0298.0565.002-8                                                   24 Meses

(70,0 + 70,0) MG/G CREM DERM CT BG PLAS PEAD/PEBD OPC X 30 G

ácido zoledrônico monoidratado

ACEZO                                           25351.338698/2019-01           08/2031

150 SIMILAR - REGISTRO DE MEDICAMENTO SIMILAR                              0517133/19-4

1.0298.0564.001-4                                                   24 Meses

4 MG SOL INJ IV CT FR PLAS TRANS X 100 ML

1.0298.0564.002-2                                                   24 Meses

4 MG SOL INJ IV CX 5 FR PLAS TRANS X 100 ML

----------------------------

DR. REDDYS FARMACÊUTICA DO BRASIL LTDA                                 03978166000175

rivaroxabana                                    25351.187031/2017-47           09/2028

11106 RDC 73/2016 - GENÉRICO - AMPLIAÇÃO DO PRAZO DE VALIDADE DO MEDICAMENTO 2255115/21-8

1.5143.0037.001-3                                                   36 Meses

10 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 5

1.5143.0037.002-1                                                   36 Meses

10 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 10

1.5143.0037.003-1                                                   36 Meses

10 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 30

1.5143.0037.004-8                                                   36 Meses

10 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 100

1.5143.0037.005-6                                                   36 Meses

15 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 7

1.5143.0037.006-4                                                   36 Meses

15 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 14

1.5143.0037.007-2                                                   36 Meses

15 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 28

1.5143.0037.008-0                                                   36 Meses

15 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 42

1.5143.0037.009-9                                                   36 Meses

15 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 98

1.5143.0037.010-2                                                   36 Meses

20 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 7

1.5143.0037.011-0                                                   36 Meses

20 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 14

1.5143.0037.012-9                                                   36 Meses

20 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 28

1.5143.0037.013-7                                                   36 Meses

20 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 42

1.5143.0037.014-5                                                   36 Meses

20 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 98

RIVAROXABANA

VAROXRED                                        25351.729666/2018-21           04/2029

10507 SIMILAR - MODIFICAÇÃO PÓS-REGISTRO - CLONE                           2311055/21-4

1.5143.0043.001-6                                                   36 Meses

10 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 5

1.5143.0043.002-4                                                   36 Meses

10 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 10

1.5143.0043.003-2                                                   36 Meses

10 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 30

1.5143.0043.004-0                                                   36 Meses

10 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 100

1.5143.0043.005-9                                                   36 Meses

15 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 7

1.5143.0043.006-7                                                   36 Meses

15 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 14

1.5143.0043.007-5                                                   36 Meses

15 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 28

1.5143.0043.008-3                                                   36 Meses

15 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 42

1.5143.0043.009-1                                                   36 Meses

15 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 98

1.5143.0043.010-5                                                   36 Meses

20 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 7

1.5143.0043.011-3                                                   36 Meses

20 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 14

1.5143.0043.012-1                                                   36 Meses

20 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 28

1.5143.0043.013-1                                                   36 Meses

20 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 42

1.5143.0043.014-8                                                   36 Meses

20 MG COM REV CT BL AL PLAS PVC/PVDC TRANS X 98

----------------------------

EMS S/A                                                                57507378000365

REPOFLOR                                          25000.000910/97-56           04/2029

11922 PRODUTOS BIOLÓGICOS - 36. ALTERAÇÃO DA DESCRIÇÃO OU COMPOSIÇÃO DO PRODUTO TERMINADO - MAIOR 3323049/19-8

1.0235.0420.002-4                                                   24 Meses

200 MG PO OR CT 4 ENV KRAFT PE X 800 MG

SACCHAROMYCES BOULARDII - 17

1.0235.0420.003-2                                                   24 Meses

200 MG PO OR CT 4 ENV AL PE X 800 MG

SACCHAROMYCES BOULARDII - 17

1.0235.0420.005-9                                                   24 Meses

200 MG PO OR CT 10 ENV KRAFT PE X 800 MG (EMB FRAC)

SACCHAROMYCES BOULARDII - 17

1533 PRODUTO BIOLÓGICO - INCLUSÃO DE NOVA CONCENTRAÇÃO                     3323507/19-4

1.0235.0420.008-3                                                   24 Meses

250 MG PO OR CT 6 ENV AL POLIET X 800 MG

SACCHAROMYCES BOULARDII

1.0235.0420.009-1                                                   24 Meses

250 MG PO OR CT 10 ENVL AL POLIET X 800 MG

SACCHAROMYCES BOULARDII

RIVAROXABANA

VYNAXA                                          25351.176278/2017-54           10/2028

10507 SIMILAR - MODIFICAÇÃO PÓS-REGISTRO - CLONE                           3246413/21-4

1.0235.1283.031-7                                                   24 Meses

15 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.0235.1283.032-5                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 15

1.0235.1283.033-3                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.0235.1283.034-1                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 60

rivaroxabana                                    25351.595763/2016-04           07/2028

11097 RDC 73/2016 - GENÉRICO - INCLUSÃO DE NOVA APRESENTAÇÃO RESTRITA AO NÚMERO DE UNIDADES FARMACOTÉCNICAS 2956804/21-8

1.0235.1265.016-5                                                   24 Meses

15 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.0235.1265.017-3                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 15

1.0235.1265.018-1                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.0235.1265.019-1                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 60

CLORIDRATO DE MEMANTINA + CLORIDRATO DE DONEPEZILA

cloridrato de memantina+cloridrato de donepezila 25351.618008/2021-19           08/2031

10488 GENÉRICO - REGISTRO DE MEDICAMENTO - CLONE                           2296337/21-5

(150 SIMILAR - REGISTRO DE MEDICAMENTO SIMILAR - 0193084/19-2 - 25351.127338/2019-77)

1.0235.1385.001-1                                                   24 Meses

(5,0 + 10,0) MG COM REV CT BL AL PLAS PVDC OPC X 7

1.0235.1385.002-8                                                   24 Meses

(10,0 + 10,0) MG COM REV CT BL AL PLAS PVDC OPC X 7

1.0235.1385.003-6                                                   24 Meses

(15,0 + 10,0) MG COM REV CT BL AL PLAS PVDC OPC X 7

1.0235.1385.004-4                                                   24 Meses

(20,0 + 10,0) MG COM REV CT BL AL PLAS PVDC OPC X 7

1.0235.1385.005-2                                                   24 Meses

(20,0 + 10,0) MG COM REV CT BL AL PLAS PVDC OPC X 30

1.0235.1385.006-0                                                   24 Meses

(20,0 + 10,0) MG COM REV CT BL AL PLAS PVDC OPC X 60

1.0235.1385.007-9                                                   24 Meses

(20,0 + 10,0) MG COM REV CT BL AL PLAS PVDC OPC X 100

----------------------------

EUROFARMA LABORATÓRIOS S.A.                                            61190096000192

TARTARATO DE EVOGLIPTINA

SUGANON                                         25351.218919/2019-17           08/2031

10464 MEDICAMENTO NOVO - REGISTRO ELETRÔNICO DE MEDICAMENTO NOVO           0334781/19-5

1.0043.1343.001-0                                                   36 Meses

5 MG COM REV CT BL AL AL X 10

1.0043.1343.002-9                                                   36 Meses

5 MG COM REV CT BL AL AL X 30

1.0043.1343.003-7                                                   36 Meses

5 MG COM REV CT BL AL AL X 60

bilastina                                       25351.660984/2020-85           08/2031

155 GENERICO - REGISTRO DE MEDICAMENTO                                     2259443/20-4

1.0043.1342.001-5                                                   24 Meses

20 MG COM CT BL AL AL X 4

1.0043.1342.002-3                                                   24 Meses

20 MG COM CT BL AL AL X 8

1.0043.1342.003-1                                                   24 Meses

20 MG COM CT BL AL AL X 10

1.0043.1342.004-1                                                   24 Meses

20 MG COM CT BL AL AL X 15

1.0043.1342.005-8                                                   24 Meses

20 MG COM CT BL AL AL X 20

1.0043.1342.006-6                                                   24 Meses

20 MG COM CT BL AL AL X 30

1.0043.1342.007-4                                                   24 Meses

20 MG COM CT BL AL PLAS PVC/PE/PCTFE TRANS X 4

1.0043.1342.008-2                                                   24 Meses

20 MG COM CT BL AL PLAS PVC/PE/PCTFE TRANS X 8

1.0043.1342.009-0                                                   24 Meses

20 MG COM CT BL AL PLAS PVC/PE/PCTFE TRANS X 10

1.0043.1342.010-4                                                   24 Meses

20 MG COM CT BL AL PLAS PVC/PE/PCTFE TRANS X 15

1.0043.1342.011-2                                                   24 Meses

20 MG COM CT BL AL PLAS PVC/PE/PCTFE TRANS X 20

1.0043.1342.012-0                                                   24 Meses

20 MG COM CT BL AL PLAS PVC/PE/PCTFE TRANS X 30

----------------------------

FRESENIUS KABI BRASIL LTDA                                             49324221000104

AMOXICILINA SÓDICA + CLAVULANATO DE POTÁSSIO

amoxilina sódica + clavulanato de potássio      25351.459322/2012-30           08/2031

155 GENERICO - REGISTRO DE MEDICAMENTO                                     0659914/12-1

1.0041.0227.001-3                                                   24 Meses

(500 + 100) MG PO SOL INJ IV CT FA VD TRANS

1.0041.0227.002-1                                                   24 Meses

(500 + 100) MG PO SOL INJ IV CX 5 FA VD TRANS

1.0041.0227.003-1                                                   24 Meses

(500 + 100) MG PO SOL INJ IV CX 10 FA VD TRANS

1.0041.0227.004-8                                                   24 Meses

(500 + 100) MG PO SOL INJ IV CX 25 FA VD TRANS

1.0041.0227.005-6                                                   24 Meses

(500 + 100) MG PO SOL INJ IV CX 50 FA VD TRANS

1.0041.0227.006-4                                                   24 Meses

(500 + 100) MG PO SOL INJ IV CX 100 FA VD TRANS

1.0041.0227.007-2                                                   24 Meses

(1000 + 200) MG PO SOL INJ IV CT FA VD TRANS

1.0041.0227.008-0                                                   24 Meses

(1000 + 200) MG PO SOL INJ IV CX 5 FA VD TRANS

1.0041.0227.009-9                                                   24 Meses

(1000 + 200) MG PO SOL INJ IV CX 10 FA VD TRANS

1.0041.0227.010-2                                                   24 Meses

(1000 + 200) MG PO SOL INJ IV CX 25 FA VD TRANS

1.0041.0227.011-0                                                   24 Meses

(1000 + 200) MG PO SOL INJ IV CX 50 FA VD TRANS

1.0041.0227.012-9                                                   24 Meses

(1000 + 200) MG PO SOL INJ IV CX 100 FA VD TRANS

----------------------------

GERMED FARMACEUTICA LTDA                                               45992062000165

rivaroxabana                                    25351.176273/2017-21           07/2028

10506 GENÉRICO - MODIFICAÇÃO PÓS-REGISTRO - CLONE                          3246407/21-0

1.0583.0931.016-1                                                   24 Meses

15 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.0583.0931.017-1                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 15

1.0583.0931.018-8                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.0583.0931.019-6                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 60

RIVAROXABANA

FAXXA                                           25351.735543/2020-44           11/2030

10507 SIMILAR - MODIFICAÇÃO PÓS-REGISTRO - CLONE                           3246411/21-8

1.0583.0984.016-0                                                   24 Meses

15 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.0583.0984.017-9                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 15

1.0583.0984.018-7                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.0583.0984.019-5                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 60

----------------------------

HALEX ISTAR INDÚSTRIA FARMACÊUTICA SA                                  01571702000198

CETOPROFENO

AXIFLENNID                                      25351.326952/2018-39           08/2031

1456 MEDICAMENTO NOVO - REGISTRO DE FORMA FARMACÊUTICA NOVA NO PAÍS        0466288/18-1

1.0311.0183.001-2                                                   24 Meses

1 MG/ML SOL INFUS IV CT ENVOL BOLS PLAS PES/PE/PP TRANS SIST FECH X 100 ML

1.0311.0183.002-0                                                   24 Meses

1 MG/ML SOL INFUS IV CX 10 ENVOL BOLS PLAS PES/PE/PP TRANS SIST FECH X 100 ML

1.0311.0183.003-9                                                   24 Meses

1 MG/ML SOL INFUS IV CX 20 ENVOL BOLS PLAS PES/PE/PP TRANS SIST FECH X 100 ML

1.0311.0183.004-7                                                   24 Meses

1 MG/ML SOL INFUS IV CX 60 ENVOL BOLS PLAS PES/PE/PP TRANS SIST FECH X 100 ML

----------------------------

HERBARIUM LABORATORIO BOTANICO LTDA                                    78950011000120

Pelargonium sidoides DC.

IMUNOFLAN                                       25351.440032/2006-99           11/2028

10277 MEDICAMENTO FITOTERÁPICO - ALTERAÇÃO DE TEXTO DE BULA (QUE NÃO POSSUI BULA PADRÃO) 2300806/21-7

1.1860.0089.001-3                                                   24 Meses

307,39 MG/ML XPE CT FR PLAS PET AMB X 100 ML + COP + SER DOS

1.1860.0089.002-1                                                   24 Meses

307,39 MG/ML XPE CT FR PLAS PET AMB X 120 ML + COP + SER DOS

1.1860.0089.003-1                                                   24 Meses

307,39 MG/ML XPE CT FR PLAS PET AMB X 150 ML + COP + SER DOS

1.1860.0089.004-8                                                   36 Meses

307,39 MG/ML SOL OR CT FR PLAS PET AMB X 120 ML + COP + SER DOS

1.1860.0089.005-6                                                   36 Meses

307,39 MG/ML SOL OR CT FR PLAS PET AMB X 200 ML + COP + SER DOS

----------------------------

HOSPITAL DAS CLINICAS DA FACULDADE DE MEDICINA DA USP                  60448040000122

FLUORETO DE SÓDIO

HC-EsqueleRad                                   25351.763780/2020-03           07/2028

11635 RADIOFÁRMACO - ALTERAÇÃO DE NOME COMERCIAL                           3314635/20-7

1.1104.0001.001-0                                                   12 Horas

740 MBQ SOL INJ FA VD TRANS X ATÉ 15ML

1.1104.0001.002-9                                                   12 Horas

1850 MBQ SOL INJ FA VD TRANS X ATÉ 15ML

1.1104.0001.003-7                                                   12 Horas

3700 MBQ SOL INJ FA VD TRANS X ATÉ 15ML

1.1104.0001.004-5                                                   12 Horas

5550 MBQ SOL INJ FA VD TRANS X ATÉ 15ML

1.1104.0001.005-3                                                   12 Horas

9250 MBQ SOL INJ FA VD TRANS X ATÉ 15ML

1.1104.0001.006-1                                                   12 Horas

12950 MBQ SOL INJ FA VD TRANS X ATÉ 15ML

1.1104.0001.007-1                                                   12 Horas

20350 MBQ SOL INJ FA VD TRANS X ATÉ 15ML

1.1104.0001.008-8                                                   12 Horas

29600 MBQ SOL INJ FA VD TRANS X ATÉ 15ML

----------------------------

INSTITUTO VITAL BRAZIL S/A                                             30064034000100

rivaroxabana                                    25351.679774/2018-46           12/2028

10506 GENÉRICO - MODIFICAÇÃO PÓS-REGISTRO - CLONE                          3285391/21-2

1.0407.0109.016-7                                                   24 Meses

15 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.0407.0109.017-5                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 15

1.0407.0109.018-3                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.0407.0109.019-1                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 60

----------------------------

LABORATÓRIOS FERRING LTDA                                              74232034000148

MESALAZINA

PENTASA                                           25000.023216/95-18           12/2026

10951 RDC 73/2016 - NOVO - EXCLUSÃO DE UM TESTE OU MÉTODO OBSOLETO         1973499/19-9

10957 RDC 73/2016 - NOVO - MUDANÇA MAIOR DE MÉTODO ANALÍTICO               1022708/19-3

10990 RDC 73/2016 - NOVO - MUDANÇA MENOR DE EXCIPIENTE PARA FORMAS FARMACÊUTICAS SÓLIDAS 1022711/19-3

11023 RDC 73/2016 - NOVO - INCLUSÃO DE LOCAL DE FABRICAÇÃO DE MEDICAMENTO DE LIBERAÇÃO CONVENCIONAL 1022703/19-2

11050 RDC 73/2016 - NOVO - INCLUSÃO MAIOR DE EQUIPAMENTO                   1022707/19-5

1.2876.0002.008-1                                                   36 Meses

1000 MG/SUP RET CT BL AL/AL X 15 + DEDEIRAS X 15

1.2876.0002.009-1                                                   36 Meses

1000 MG/SUP RET CT BL AL/AL X 28 + DEDEIRAS X 28

----------------------------

LEGRAND PHARMA INDÚSTRIA FARMACÊUTICA LTDA                             05044984000126

rivaroxabana                                    25351.176274/2017-76           07/2028

10506 GENÉRICO - MODIFICAÇÃO PÓS-REGISTRO - CLONE                          3246409/21-6

1.6773.0594.016-5                                                   24 Meses

15 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.6773.0594.017-3                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 15

1.6773.0594.018-1                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.6773.0594.019-1                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 60

RIVAROXABANA

RIXANTIL                                        25351.640305/2017-56           10/2028

10507 SIMILAR - MODIFICAÇÃO PÓS-REGISTRO - CLONE                           3246415/21-1

1.6773.0603.016-2                                                   24 Meses

15 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.6773.0603.017-0                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 15

1.6773.0603.018-9                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 30

1.6773.0603.019-7                                                   24 Meses

20 MG COM REV CT BL AL PLAS PVDC OPC X 60

----------------------------

MOMENTA FARMACÊUTICA LTDA.                                             14806008000154

SILYBUM MARIANUM (L.) GAERTN

FORFIG                                          25351.012258/2017-05           02/2030

10670 PRODUTO TRADICIONAL FITOTERÁPICO - INCLUSÃO DE NOVA CONCENTRAÇÃO     2009149/20-4

1.9427.0064.011-6                                                   24 Meses

300 MG CAP DURA CT BL AL PLAS PVC/PVDC TRANS X 10

1.9427.0064.012-4                                                   24 Meses

300 MG CAP DURA CT BL AL PLAS PVC/PVDC TRANS X 30

1.9427.0064.013-2                                                   24 Meses

300 MG CAP DURA CT BL AL PLAS PVC/PVDC TRANS X 60

1.9427.0064.014-0                                                   24 Meses

300 MG CAP DURA CT BL AL PLAS PVC/PE/PVDC TRANS X 10

1.9427.0064.015-9                                                   24 Meses

300 MG CAP DURA CT BL AL PLAS PVC/PE/PVDC TRANS X 30

1.9427.0064.016-7                                                   24 Meses

300 MG CAP DURA CT BL AL PLAS PVC/PE/PVDC TRANS X 60

----------------------------

MULTILAB INDÚSTRIA E COMÉRCIO DE PRODUTOS FARMACÊUTICOS LTDA           92265552000140

PROPIONATO DE CLOBETASOL

TOPIREX                                         25351.252857/2021-97           08/2031

10490 SIMILAR - REGISTRO DE PRODUTO - CLONE                                1196760/21-9

(155 GENERICO - REGISTRO DE MEDICAMENTO - 373265/04-7 - 25351.259961/2004-10)

1.1819.0220.001-1                                                   24 Meses

0,5 MG/G CREM DERM CT BG AL X 15 G

1.1819.0220.002-8                                                   24 Meses

0,5 MG/G CREM DERM CT BG AL X 30 G

propionato de clobetasol                        25351.404199/2021-25           08/2031

10488 GENÉRICO - REGISTRO DE MEDICAMENTO - CLONE                           1654955/21-4

(155 GENERICO - REGISTRO DE MEDICAMENTO - 373265/04-7 - 25351.259961/2004-10)

1.1819.0221.001-5                                                   24 Meses

0,5 MG/G CREM DERM CT BG AL X 15 G

1.1819.0221.002-3                                                   24 Meses

0,5 MG/G CREM DERM CT BG AL X 30 G

acetato de dexametasona                         25351.404222/2021-81           08/2031

10488 GENÉRICO - REGISTRO DE MEDICAMENTO - CLONE                           1655132/21-0

(155 GENERICO - REGISTRO DE MEDICAMENTO - 652156/06-8 - 25351.486639/2006-15)

1.1819.0222.001-0                                                   24 Meses

1 MG/G CREM DERM CT BG AL X 10 G  

1.1819.0222.002-9                                                   24 Meses

1 MG/G CREM DERM CT BG AL X 20 G

1.1819.0222.003-7                                                   24 Meses

1 MG/G CREM DERM CT BG AL X 30 G

----------------------------

PHARMASCIENCE INDUSTRIA FARMACEUTICA S.A                               25773037000183

FOSFOMICINA TROMETAMOL

FOSMORYL                                        25351.600307/2019-74           08/2031

150 SIMILAR - REGISTRO DE MEDICAMENTO SIMILAR                              2513806/19-5

1.1717.0083.001-5                                                   24 Meses

5,631 G GRAN SOL OR CT ENV AL/PLAS PES/PE OPC

1.1717.0083.002-3                                                   24 Meses

5,631 G GRAN SOL OR CT ENV AL/PLAS PES/PE OPC X 2

----------------------------

PRATI DONADUZZI &CIA LTDA                                             73856593000166

CLORIDRATO DE PAROXETINA                        25351.316245/2011-33           06/2028

10941 RDC 73/2016 - GENÉRICO - INCLUSÃO DE NOVO FABRICANTE DO IFA          1592646/20-0

10941 RDC 73/2016 - GENÉRICO - INCLUSÃO DE NOVO FABRICANTE DO IFA          1592648/20-6

10944 RDC 73/2016 - GENÉRICO - ALTERAÇÃO MAIOR DE PRODUÇÃO DO IFA          1592631/20-1

1.2568.0266.001-4                                                   24 Meses

20 MG COM REV CT BL AL PVC TRANS X 20

1.2568.0266.002-2                                                   24 Meses

20 MG COM REV CT BL AL PVC TRANS X 30

1.2568.0266.003-0                                                   24 Meses

20 MG COM REV CT BL AL PVC TRANS X 300

1.2568.0266.004-9                                                   24 Meses

20 MG COM REV CT BL AL PVC TRANS X 500

1.2568.0266.005-7                                                   24 Meses

20 MG COM REV CT BL AL PVDC TRANS X 20

1.2568.0266.006-5                                                   24 Meses

20 MG COM REV CT BL AL PVDC TRANS X 30

1.2568.0266.007-3                                                   24 Meses

20 MG COM REV CT BL AL PVDC TRANS X 300

1.2568.0266.008-1                                                   24 Meses

20 MG COM REV CT BL AL PVDC TRANS X 500

----------------------------

PROCTER &GAMBLE DO BRASIL LTDA                                        59476770000158

PARACETAMOL + MALEATO DE CLORFENIRAMINA + CLORIDRATO DE FENILEFRINA

VICK PYRENA GRIP - 7                            25351.098712/2021-34           08/2031

10490 SIMILAR - REGISTRO DE PRODUTO - CLONE                                0736683/21-3

(1995 SIMILAR - SOLICITAÇÃO DE TRANSFERÊNCIA DE TITULARIDADE DE REGISTRO (INCORPORAÇÃO DE EMPRESA) - 909454/08-7 - 25351.707779/2008-02)

1.2142.0672.001-5                                                   24 Meses

400 MG + 4 MG + 4 MG CAP DURA CT BL AL PLAS PVC TRANS X 20

1.2142.0672.002-3                                                   24 Meses

400 MG + 4 MG + 4 MG CAP DURA CT BL AL PLAS PVC TRANS X 10

1.2142.0672.003-1                                                   24 Meses

400 MG + 4 MG + 4 MG CAP DURA CT BL AL PLAS PVC TRANS X 100

1.2142.0672.004-1                                                   24 Meses

400 MG + 4 MG + 4 MG CAP DURA CT BL AL PLAS PVC TRANS X 120

1.2142.0672.005-8                                                   24 Meses

400 MG + 4 MG + 4 MG CAP DURA CT BL AL PLAS PVC TRANS X 200

1.2142.0672.006-6                                                   24 Meses

400 MG + 4 MG + 4 MG CAP DURA CT BL AL PLAS PVC TRANS X 500

----------------------------

RANBAXY FARMACÊUTICA LTDA                                              73663650000190

mesalazina                                      25351.610661/2020-41           08/2031

155 GENERICO - REGISTRO DE MEDICAMENTO                                     2101767/20-1

1.2352.0285.001-4                                                   24 Meses

1200 MG COM REV LIB MOD CT BL AL AL X 10

1.2352.0285.002-2                                                   24 Meses

1200 MG COM REV LIB MOD CT BL AL AL X 30

1.2352.0285.003-0                                                   24 Meses

1200 MG COM REV LIB MOD CT BL AL AL X 200

1.2352.0285.004-9                                                   24 Meses

1200 MG COM REV LIB MOD CT BL AL AL X 500

----------------------------

SUPERA FARMA LABORATÓRIOS S.A                                          43312503000105

CLORIDRATO DE TIAMINA + CLORIDRATO DE PIRIDOXINA + CIANOCOBALAMINA + FOSFATO DISSÓDICO DE DEXAMETASONA

RENOVI B PLUS                                   25351.068837/2021-30           08/2031

10490 SIMILAR - REGISTRO DE PRODUTO - CLONE                                0649222/21-3

(155 GENERICO - REGISTRO DE MEDICAMENTO - 0203409/20-3 - 25351.042463/2020-41)

1.0372.0306.001-0                                                   18 Meses

(100 + 100) MG/ML SOL INJ IM CT AMP VD AMB X 1 ML + (5 + 4,37) MG SOL INJ IM CT AMP VD AMB X 2 ML

1.0372.0306.002-9                                                   18 Meses

(100 + 100) MG/ML SOL INJ IM CT 3 AMP VD AMB X 1 ML + (5 + 4,37) MG SOL INJ IM CT 3 AMP VD AMB X 2 ML

----------------------------

TAKEDA PHARMA LTDA.                                                    60397775000174

IDURSULFASE

Elaprase                                        25351.779252/2020-68           05/2028

10408 PRODUTO BIOLÓGICO - AMPLIAÇÃO DO PRAZO DE VALIDADE DO PRODUTO TERMINADO 4620804/20-6

1.0639.0300.001-1                                                   36 Meses

2 MG/ML SOL INJ CT FA VD INC X 3 ML

----------------------------

VIDORA FARMACÊUTICA LTDA                                               92762277000170

GINKGO BILOBA L.

GINKGO VIDORA                                   25351.120871/2020-41           01/2031

10759 MEDICAMENTO FITOTERÁPICO - ALTERAÇÃO OU INCLUSÃO DE LOCAL DE FABRICAÇÃO COM PRAZO DE ANÁLISE 3178479/21-8

1.0473.0044.001-6                                                   36 Meses

80 MG COM REV CT BL AL PLAS PVDC TRANS X 20

1.0473.0044.002-4                                                   36 Meses

80 MG COM REV CT BL AL PLAS PVDC TRANS X 30

1.0473.0044.003-2                                                   36 Meses

80 MG COM REV CT BL AL PLAS PVDC TRANS X 40

1.0473.0044.004-0                                                   36 Meses

80 MG COM REV CT BL AL PLAS PVDC TRANS X 50

1.0473.0044.005-9                                                   36 Meses

80 MG COM REV CT BL AL PLAS PVDC TRANS X 60

1.0473.0044.006-7                                                   36 Meses

120 MG COM REV CT BL AL PLAS PVDC TRANS X 20

1.0473.0044.007-5                                                   36 Meses

120 MG COM REV CT BL AL PLAS PVDC TRANS X 30

1.0473.0044.008-3                                                   36 Meses

120 MG COM REV CT BL AL PLAS PVDC TRANS X 40

1.0473.0044.009-1                                                   36 Meses

120 MG COM REV CT BL AL PLAS PVDC TRANS X 50

1.0473.0044.010-5                                                   36 Meses

120 MG COM REV CT BL AL PLAS PVDC TRANS X 60

----------------------------

ZODIAC PRODUTOS FARMACÊUTICOS S/A                                      55980684000127

ZANUBRUTINIBE

BRUKINSA                                        25351.441503/2020-34           08/2024

11306 MEDICAMENTO NOVO - REGISTRO DE MEDICAMENTO NOVO                      3993552/20-3

1.2214.0116.001-8                                                   24 Meses

80 MG CAP DURA CT FR PLAS PEAD OPC X 120

----------------------------

ZYDUS NIKKHO FARMACÊUTICA LTDA                                         05254971000181

ÁCIDO GAMAMINOBUTÍRICO + CLORIDRATO DE LISINA + CLORIDRATO DE TIAMINA + CLORIDRATO DE PIRIDOXINA + PANTOTENATO DE CÁLCIO

GABALLON                                        25351.527096/2011-95           05/2028

1886 ESPECÍFICO - INCLUSÃO DE NOVA APRESENTAÇÃO COMERCIAL                  1426511/21-7

1.5651.0040.004-5                                                   24 Meses

50 MG + 50 MG + 2 MG + 4 MG + 4 MG COM CT BL AL PLAS PVC/ACLAR OPC X 60

1.5651.0040.005-3                                                   24 Meses

50 MG + 50 MG + 2 MG + 4 MG + 4 MG COM CT BL AL PLAS PVC/ACLAR OPC X 100

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