ANVISA PBRER list 2021 (Brazil)
ANVISA PBRER list 2021 (Brazil)
ANVISA PBRER list 2021 (Brazil)
Background
In 2009, the first pharmacovigilance legislation at the national level was published in Brazil.
On 22 July 2020, after more than a decade, two new pharmacovigilance legislation has been published.
- Good Pharmacovigilance Practices for Marketing Authorisation Holders (MAH) of Medicinal Products for Human Use
- Normative Instruction: Provides information about the Periodic Report on Benefit-Risk Assessment (RPBR) to be submitted to The Brazillian Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria – ANVISA) by the MAH
Here you can find new pharmacovigilance guidelines (Aggregate reports)
- Changed Periodic Safety Report format from PSUR to Periodic Benefit-Risk Evaluation Report format (PBRER) – ICH-aligned
- National Birth Date changed to International Birth Date (IBD) as a criterion in the preparation of periodic safety reports
- Modified the intervals between the data lock point and the PBRER submission
- 70 days for PBRER of 12 months or less
- 90 days for PBRER more than 12 months in duration
- 90 days for exceptional PBRER unless otherwise determined by HA
4. Added the PBRER should be submitted to the health authority (HA) according to the periodicity available on the ANVISA web portal.
As per new guidelines, ANVISA published the list of RPBRs to be submitted to Anvisa with a closing date in the first half of 2021
ANVISA PBRER list 2021 (Brazil)
| Active principles | International Date of Birth | Closing date | Submission Date |
| carboximaltose férrica (preparações parenterais) | 6-Dec-1949 | 1-Jan-2021 | 12-Mar-2021 |
| derisomaltose férrica (preparações parenterais) | 6-Dec-1949 | 1-Jan-2021 | 12-Mar-2021 |
| hidroclorotiazida + espironolactona | Not available | 1-Jan-2021 | 1-Apr-2021 |
| betametasona + ácido fusídico | Not available | 1-Jan-2021 | 1-Apr-2021 |
| betametasona + clioquinol + associações | Not available | 1-Jan-2021 | 1-Apr-2021 |
| calcitriol | 1-Jan-1978 | 1-Jan-2021 | 1-Apr-2021 |
| betametasona + ácido salicílico | Not available | 1-Jan-2021 | 1-Apr-2021 |
| betametasona | 25-Sep-1961 | 1-Jan-2021 | 1-Apr-2021 |
| alfalonoctocogue | 4-Jan-2017 | 3-Jan-2021 | 14-Mar-2021 |
| inotersena | 6-Jul-2018 | 5-Jan-2021 | 16-Mar-2021 |
| roflumilaste | 5-Jul-2010 | 5-Jan-2021 | 5-Apr-2021 |
| budesonida | 8-Jan-2018 | 7-Jan-2021 | 18-Mar-2021 |
| brexpiprazol | 10-Jul-2015 | 9-Jan-2021 | 20-Mar-2021 |
| alizaprida | 9-Jan-1979 | 9-Jan-2021 | 9-Apr-2021 |
| amitriptilina | 31-Jul-1961 | 10-Jan-2021 | 10-Apr-2021 |
| guselcumabe | 13-Jul-2017 | 12-Jan-2021 | 23-Mar-2021 |
| vacina meningocócica do grupo B (rDNA, componente adsorvido) | 14-Jan-2013 | 13-Jan-2021 | 13-Apr-2021 |
| risdiplam | Not available | 13-Jan-2021 | 13-Apr-2021 |
| asparaginase | 14-Jan-2016 | 14-Jan-2021 | 25-Mar-2021 |
| dapagliflozina + metformina | 16-Jan-2014 | 15-Jan-2021 | 26-Mar-2021 |
| alendronato | 10-Nov-2000 | 15-Jan-2021 | 15-Apr-2021 |
| dolutegravir | 16-Jan-2014 | 16-Jan-2021 | 27-Mar-2021 |
| dolutegravir + abacavir + lamivudina | 16-Jan-2014 | 16-Jan-2021 | 27-Mar-2021 |
| dolutegravir + lamivudina | 16-Jan-2014 | 16-Jan-2021 | 27-Mar-2021 |
| beclometasona + formoterol + brometo de glicopirrônio | 17-Jul-2017 | 16-Jan-2021 | 27-Mar-2021 |
| elbasvir + grazoprevir | 19-Jan-2016 | 18-Jan-2021 | 29-Mar-2021 |
| alfasimoctocogue | 22-Jul-2014 | 22-Jan-2021 | 22-Apr-2021 |
| voretigeno neparvoveque | 19-Dec-2017 | 23-Jan-2021 | 3-Apr-2021 |
| ácido valpróico | 23-Jan-1967 | 23-Jan-2021 | 23-Apr-2021 |
| valproato de sódio | 23-Jan-1967 | 23-Jan-2021 | 23-Apr-2021 |
| voretigeno neparvoveque | 19-Dec-2017 | 23-Jan-2021 | 3-Apr-2021 |
| glucagon | 24-Jul-2019 | 24-Jan-2021 | 4-Apr-2021 |
| alfa-albutrepenonacogue | 26-Jan-2016 | 26-Jan-2021 | 6-Apr-2021 |
| estradiol + nomegestrol | 27-Jul-2011 | 26-Jan-2021 | 26-Apr-2021 |
| ranolazina | 9-Jul-2008 | 26-Jan-2021 | 26-Apr-2021 |
| vismodegibe | 30-Jan-2012 | 29-Jan-2021 | 9-Apr-2021 |
| tafenoquina | Not available | 29-Jan-2021 | 29-Apr-2021 |
| darolutamida | 30-Jul-2019 | 30-Jan-2021 | 10-Apr-2021 |
| nilotinibe | 19-Nov-2007 | 31-Jan-2021 | 11-Apr-2021 |
| pregabalina | 6-Jul-2004 | 31-Jan-2021 | 11-Apr-2021 |
| toxina botulínica A | 29-Dec-1989 | 31-Jan-2021 | 11-Apr-2021 |
| zanamivir | 9-Feb-1999 | 31-Jan-2021 | 11-Apr-2021 |
| alprostadil (indicado para disfunção erétil) | 23-Jul-1981 | 31-Jan-2021 | 1-May-2021 |
| nomegestrol | Not available | 31-Jan-2021 | 1-May-2021 |
| atosibana | 20-Jan-2000 | 31-Jan-2021 | 1-May-2021 |
| baclofeno (intratecal) | 16-Jan-1963 | 31-Jan-2021 | 1-May-2021 |
| propafenona | 10-Dec-1978 | 31-Jan-2021 | 1-May-2021 |
| dexametasona | 1-Jan-1952 | 31-Jan-2021 | 1-May-2021 |
| pegfilgrastim | 31-Jan-2002 | 31-Jan-2021 | 1-May-2021 |
| etanercepte | 3-Feb-2000 | 2-Feb-2021 | 12-Apr-2021 |
| pemetrexede | 20-Sep-2004 | 4-Feb-2021 | 5-May-2021 |
| bictegravir + entricitabina + tenofovir alafenamida | 7-Feb-2018 | 6-Feb-2021 | 17-Apr-2021 |
| patisirana | 10-Aug-2018 | 9-Feb-2021 | 20-Apr-2021 |
| tezacaftor + ivacaftor | 12-Feb-2018 | 11-Feb-2021 | 22-Apr-2021 |
| alfaelosulfase | 14-Feb-2014 | 13-Feb-2021 | 24-Apr-2021 |
| baricitinibe | 13-Feb-2017 | 13-Feb-2021 | 24-Apr-2021 |
| apalutamida | 14-Feb-2018 | 13-Feb-2021 | 24-Apr-2021 |
| alfapeginterferona 2b | 15-Feb-2019 | 14-Feb-2021 | 25-Apr-2021 |
| upadacitinibe | 16-Aug-2019 | 15-Feb-2021 | 26-Apr-2021 |
| burosumabe | 19-Feb-2018 | 18-Feb-2021 | 28-Apr-2021 |
| granisetrona | 19-Feb-1991 | 18-Feb-2021 | 19-May-2021 |
| agomelatina | 19-Feb-2009 | 19-Feb-2021 | 20-May-2021 |
| nitisinona | 21-Feb-2005 | 20-Feb-2021 | 1-May-2021 |
| cilazapril | 21-Feb-1990 | 20-Feb-2021 | 21-May-2021 |
| cilazapril + hidroclorotiazida | 21-Feb-1990 | 20-Feb-2021 | 21-May-2021 |
| bavacizumabe | 12-Jan-2005 | 25-Feb-2021 | 5-May-2021 |
| bevacizumabe | 12-Jan-2005 | 25-Feb-2021 | 6-May-2021 |
| belinostate | Not available | 25-Feb-2021 | 25-May-2021 |
| prasugrel | 23-Feb-2009 | 25-Feb-2021 | 26-May-2021 |
| cladribina (exceto produtos com indicação para esclerose múltipla) | 26-Feb-1993 | 25-Feb-2021 | 26-May-2021 |
| colagenase | 28-Feb-2011 | 27-Feb-2021 | 8-May-2021 |
| vildagliptina | 26-Sep-2007 | 28-Feb-2021 | 29-May-2021 |
| metformina + vildagliptina | 26-Sep-2007 | 28-Feb-2021 | 29-May-2021 |
| nitrofurantoína | 28-Feb-1953 | 28-Feb-2021 | 29-May-2021 |
| butoconazol | 24-Oct-2003 | 28-Feb-2021 | 29-May-2021 |
| ampicilina + sulbactam | 24-Feb-1987 | 28-Feb-2021 | 29-May-2021 |
| gliclazida | 26-Apr-1971 | 28-Feb-2021 | 29-May-2021 |
| voriconazol | 19-Mar-2002 | 28-Feb-2021 | 29-May-2021 |
| tenoxicam | 20-Feb-1986 | 28-Feb-2021 | 29-May-2021 |
| ondansetrona | 23-Feb-1990 | 28-Feb-2021 | 29-May-2021 |
| tolcapona | 27-Aug-1997 | 1-Mar-2021 | 30-May-2021 |
| dobutamina | 21-Mar-1977 | 1-Mar-2021 | 30-May-2021 |
| nitrazepam | 2-Mar-1965 | 2-Mar-2021 | 31-May-2021 |
| olodaterol | 18-Sep-2013 | 3-Mar-2021 | 1-Jun-2021 |
| escetamina | 5-Mar-2019 | 4-Mar-2021 | 13-May-2021 |
| vacina meningocócica do grupo a, c, w135 e Y polissacarídeo | 5-Mar-2007 | 4-Mar-2021 | 2-Jun-2021 |
| bilastina | 8-Sep-2010 | 7-Mar-2021 | 16-May-2021 |
| bimatoprosta | 8-Mar-2002 | 7-Mar-2021 | 5-Jun-2021 |
| espironolactona | 1-Mar-1962 | 8-Mar-2021 | 6-Jun-2021 |
| esomeprazol | 10-Mar-2000 | 10-Mar-2021 | 8-Jun-2021 |
| vacina anti-rábica | 16-May-1975 | 11-Mar-2021 | 9-Jun-2021 |
| enfuvirtida | 27-May-2003 | 12-Mar-2021 | 10-Jun-2021 |
| fremanezumabe | 14-Sep-2018 | 13-Mar-2021 | 22-May-2021 |
| vacina influenza | Not available | 15-Mar-2021 | 24-May-2021 |
| etinilestradiol + gestodeno | 9-Jul-1986 | 16-Mar-2021 | 14-Jun-2021 |
| ciclosporina (uso tópico) | 19-Mar-2015 | 19-Mar-2021 | 28-May-2021 |
| lorlatinibe | 21-Sep-2018 | 20-Mar-2021 | 29-May-2021 |
| oseltamivir | 20-Jun-2002 | 20-Mar-2021 | 19-Jun-2021 |
| ceftriaxona | 27-May-1982 | 20-Mar-2021 | 19-Jun-2021 |
| azitromicina | 4-Apr-1991 | 20-Mar-2021 | 19-Jun-2021 |
| gilteritinib | 21-Sep-2018 | 20-Mar-2021 | 29-May-2021 |
| ciclossilicato de zircônio sódico | 22-Mar-2018 | 21-Mar-2021 | 30-May-2021 |
| alfavelmanase | 23-Mar-2018 | 22-Mar-2021 | 31-May-2021 |
| avelumabe | 23-Mar-2017 | 22-Mar-2021 | 31-May-2021 |
| tipiracila + trifluridina | 24-Mar-2014 | 24-Mar-2021 | 2-Jun-2021 |
| risanquizumabe | 26-Mar-2019 | 25-Mar-2021 | 3-Jun-2021 |
| fumarato de dimetila (indicado para esclerose múltipla) | 30-Jan-2014 | 26-Mar-2021 | 24-Jun-2021 |
| cemiplimabe | 28-Sep-2018 | 27-Mar-2021 | 5-Jun-2021 |
| galcanezumabe | 27-Sep-2018 | 27-Mar-2021 | 5-Jun-2021 |
| ocrelizumab | 28-Mar-2017 | 27-Mar-2021 | 5-Jun-2021 |
| valganciclovir | 29-Mar-2001 | 28-Mar-2021 | 26-Jun-2021 |
| dupilumabe | 28-Mar-2017 | 28-Mar-2021 | 6-Jun-2021 |
| alanilglutamina | 29-Mar-1995 | 29-Mar-2021 | 27-Jun-2021 |
| everolimo (indicado para Astrocitoma) | 2-Sep-2011 | 31-Mar-2021 | 29-Jun-2021 |
| everolimo (indicado para carcinoma, célula renal) | 3-Aug-2009 | 31-Mar-2021 | 29-Jun-2021 |
| anlodipino + ramipril | 31-Mar-2012 | 31-Mar-2021 | 29-Jun-2021 |
| anlodipino + hidroclorotiazida + ramipril | 31-Mar-2012 | 31-Mar-2021 | 29-Jun-2021 |
| hidroclorotiazida + ramipril | 31-Mar-2012 | 31-Mar-2021 | 29-Jun-2021 |
| nitrendipino | 31-Mar-1985 | 31-Mar-2021 | 29-Jun-2021 |
| dexametasona + tobramicina (uso oftalmológico) | Not available | 31-Mar-2021 | 29-Jun-2021 |
| tacrolimo (formulações sistêmicas) | 2-Apr-1993 | 31-Mar-2021 | 29-Jun-2021 |
| citarabina | 11-Jul-2001 | 31-Mar-2021 | 29-Jun-2021 |
| tacrolimo (formulações tópicas) | 28-Feb-2002 | 31-Mar-2021 | 29-Jun-2021 |
| promestrieno (uso ginecológico) | 31-Jan-1974 | 31-Mar-2021 | 29-Jun-2021 |
| tobramicina (uso oftalmológico) | 1-Jun-1977 | 31-Mar-2021 | 29-Jun-2021 |
| risedronato sódico | 31-Mar-1998 | 31-Mar-2021 | 29-Jun-2021 |
| metformina | 19-Mar-1959 | 1-Apr-2021 | 30-Jun-2021 |
| enoxaparina | 15-Sep-2016 | 3-Apr-2021 | 12-Jun-2021 |
| tenofovir alafenamida + entricitabina | 4-Apr-2016 | 3-Apr-2021 | 12-Jun-2021 |
| dapagliflozina | 5-Oct-2012 | 4-Apr-2021 | 13-Jun-2021 |
| brolucizumabe | 7-Oct-2019 | 6-Apr-2021 | 15-Jun-2021 |
| oxaliplatina | 12-Apr-1996 | 12-Apr-2021 | 11-Jul-2021 |
| nintedanibe (indicação respiratória) | 15-Oct-2014 | 15-Apr-2021 | 24-Jun-2021 |
| ofloxacino (uso sistêmico) | 16-Apr-1985 | 16-Apr-2021 | 15-Jul-2021 |
| ofloxacino (uso tópico) | 2-May-1989 | 16-Apr-2021 | 15-Jul-2021 |
| empagliflozina | 17-Apr-2014 | 17-Apr-2021 | 16-Jul-2021 |
| empagliflozina + metformina | 17-Apr-2014 | 17-Apr-2021 | 16-Jul-2021 |
| cloroquina | 20-Aug-1947 | 18-Apr-2021 | 17-Jul-2021 |
| hidroxicloroquina | 18-Apr-1955 | 18-Apr-2021 | 17-Jul-2021 |
| insulina glargina | 21-Apr-2000 | 21-Apr-2021 | 30-Jun-2021 |
| carmustina (solução para infusão) | 23-Apr-1974 | 22-Apr-2021 | 21-Jul-2021 |
| propranolol | 23-Apr-2014 | 23-Apr-2021 | 22-Jul-2021 |
| teriparatida | 24-Apr-2017 | 23-Apr-2021 | 2-Jul-2021 |
| furoato de fluticasona | 11-Jan-2008 | 26-Apr-2021 | 25-Jul-2021 |
| brigatinibe | 28-Apr-2017 | 27-Apr-2021 | 6-Jul-2021 |
| abiraterona | 28-Apr-2011 | 28-Apr-2021 | 27-Jul-2021 |
| capecitabina | 30-Apr-1998 | 29-Apr-2021 | 28-Jul-2021 |
| tafluprosta | 30-Apr-2008 | 29-Apr-2021 | 28-Jul-2021 |
| basiliximabe | 9-Oct-1998 | 30-Apr-2021 | 29-Jul-2021 |
| budesonida | 30-Apr-1992 | 30-Apr-2021 | 29-Jul-2021 |
| fentanila | 17-Jul-1995 | 30-Apr-2021 | 29-Jul-2021 |
| complexo humano de protrombina | Not available | 30-Apr-2021 | 29-Jul-2021 |
| laronidase | 10-Jun-2003 | 30-Apr-2021 | 29-Jul-2021 |
| latanoprosta (exceto produtos com indicação pediátrica) | 5-Jun-1996 | 30-Apr-2021 | 29-Jul-2021 |
| olopatadina | 17-May-2002 | 30-Apr-2021 | 29-Jul-2021 |
| praziquantel | 30-Apr-1980 | 30-Apr-2021 | 29-Jul-2021 |
| terlipressina | 1-May-1980 | 30-Apr-2021 | 29-Jul-2021 |
| milnaciprana | 6-Dec-1966 | 30-Apr-2021 | 29-Jul-2021 |
| durvalumabe | 1-May-2017 | 30-Apr-2021 | 9-Jul-2021 |
| linagliptina | 24-Aug-2011 | 2-May-2021 | 31-Jul-2021 |
| linagliptina + metformina | 24-Aug-2011 | 2-May-2021 | 31-Jul-2021 |
| betainterferona-1a (uso intramuscular) | 13-Mar-1997 | 3-May-2021 | 1-Aug-2021 |
| moxetumomabe pasudotox | 3-Aug-2020 | 3-May-2021 | 3-Aug-2021 |
| vacina sarampo + caxumba + rubéola (vivo, atenuada) | 28-Nov-1997 | 4-May-2021 | 2-Aug-2021 |
| nevirapina | 5-Feb-1998 | 6-May-2021 | 4-Aug-2021 |
| levonorgestrel (todas indicações exceto contracepção emergencial) | 9-May-1990 | 8-May-2021 | 6-Aug-2021 |
| furoato de fluticasona + vilanterol | 10-May-2013 | 9-May-2021 | 7-Aug-2021 |
| imatinibe | 7-Nov-2001 | 10-May-2021 | 8-Aug-2021 |
| alfarurioctocogue pegol | 13-Nov-2018 | 12-May-2021 | 21-Jul-2021 |
| alfavestronidase | 15-Nov-2017 | 14-May-2021 | 23-Jul-2021 |
| capsaicina | 15-May-2009 | 15-May-2021 | 13-Aug-2021 |
| cefuroxima sódica (exceto para uso intracameral) | 18-Aug-1987 | 15-May-2021 | 13-Aug-2021 |
| emicizumabe | 16-Nov-2017 | 15-May-2021 | 24-Jul-2021 |
| erenumabe | 17-May-2018 | 16-May-2021 | 25-Jul-2021 |
| remifentanila | 17-May-1996 | 16-May-2021 | 14-Aug-2021 |
| azacitidina | 17-Dec-2008 | 18-May-2021 | 16-Aug-2021 |
| olodaterol + tiotrópio | 20-May-2015 | 19-May-2021 | 17-Aug-2021 |
| givosiran | 20-Nov-2019 | 19-May-2021 | 28-Jul-2021 |
| insulina glargina + lixisenatida | 11-Jan-2017 | 21-May-2021 | 30-Jul-2021 |
| imiglucerase | 23-May-1994 | 23-May-2021 | 21-Aug-2021 |
| onasemnogeno abeparvoveque | 24-May-2019 | 23-May-2021 | 1-Aug-2021 |
| alpelisib | 24-May-2019 | 23-May-2021 | 1-Aug-2021 |
| fluoruracila | 25-May-1994 | 25-May-2021 | 23-Aug-2021 |
| hemina | 5-May-1995 | 31-May-2021 | 9-Aug-2021 |
| flunarizina | 1-Jun-1977 | 31-May-2021 | 29-Aug-2021 |
| lactulose | 21-May-1964 | 31-May-2021 | 29-Aug-2021 |
| moxifloxacino (uso oftálmico tópico) | 31-May-1999 | 31-May-2021 | 29-Aug-2021 |
| pamidronato | 2-May-1989 | 31-May-2021 | 29-Aug-2021 |
| ranitidina | 15-Jun-1981 | 31-May-2021 | 29-Aug-2021 |
| sildenafila (indicada para hipertensão pulmonar) | 28-Oct-2005 | 31-May-2021 | 29-Aug-2021 |
| loperamida | 31-May-1973 | 31-May-2021 | 29-Aug-2021 |
| loperamida + simeticona | 31-May-1973 | 31-May-2021 | 29-Aug-2021 |
| semaglutida | 5-Dec-2017 | 31-May-2021 | 9-Aug-2021 |
| crizanlizumabe | 2-Mar-2020 | 2-Jun-2021 | 2-Sep-2021 |
| daunorrubicina | 8-Jun-1966 | 7-Jun-2021 | 5-Sep-2021 |
| vacina contra dengue | 8-Dec-2015 | 7-Jun-2021 | 16-Aug-2021 |
| polatuzumabe vedotina | 10-Jun-2019 | 9-Jun-2021 | 18-Aug-2021 |
| inibidor de C1 esterase derivado de plasma humano | 16-Jul-2001 | 15-Jun-2021 | 13-Sep-2021 |
| fumarato de vonoprazana | 16-Mar-2020 | 16-Jun-2021 | 16-Sep-2021 |
| cabazitaxel | 17-Jun-2010 | 17-Jun-2021 | 15-Sep-2021 |
| glibenclamida + metformina | 18-Jun-1993 | 18-Jun-2021 | 16-Sep-2021 |
| atazanavir | 2-Mar-2004 | 19-Jun-2021 | 17-Sep-2021 |
| calcitonina sintética de salmão | 13-May-1975 | 19-Jun-2021 | 17-Sep-2021 |
| ácido ibandrônico | 25-Jun-1996 | 24-Jun-2021 | 22-Sep-2021 |
| ibandronato de sódio | 25-Jun-1996 | 24-Jun-2021 | 22-Sep-2021 |
| cefepima | 29-Jun-1993 | 28-Jun-2021 | 26-Sep-2021 |
| manidipino | 29-Jun-1990 | 29-Jun-2021 | 27-Sep-2021 |
| ravulizumabe | 1-Jan-2019 | 30-Jun-2021 | 8-Sep-2021 |
| canaquinumabe | 23-Oct-2009 | 30-Jun-2021 | 28-Sep-2021 |
| dexclorfeniramina | 18-Feb-1962 | 30-Jun-2021 | 28-Sep-2021 |
| fibrinogênio humano | 4-Jan-1966 | 30-Jun-2021 | 28-Sep-2021 |
| paliperidona | 25-Jun-2007 | 30-Jun-2021 | 28-Sep-2021 |
| palmitato de paliperidona | 25-Jun-2007 | 30-Jun-2021 | 28-Sep-2021 |
| tianeptina | 6-Feb-1987 | 30-Jun-2021 | 28-Sep-2021 |
| nimesulida (formulações sistêmicas) | 6-Aug-1985 | 30-Jun-2021 | 28-Sep-2021 |
| tobramicina (pó para inalação, cápsulas) | 20-Jul-2011 | 30-Jun-2021 | 28-Sep-2021 |
| mirabegrona | 1-Jul-2011 | 30-Jun-2021 | 28-Sep-2021 |
| propranolol | 30-Jun-1965 | 30-Jun-2021 | 28-Sep-2021 |
| imunoglobulina de coelho anti-timócitos humanos | 16-Apr-1984 | 30-Jun-2021 | 28-Sep-2021 |
| anlodipino + valsartana | 16-Jan-2007 | 30-Jun-2021 | 28-Sep-2021 |
| anlodipino + hidroclorotiazida + valsartana | 16-Jan-2007 | 30-Jun-2021 | 28-Sep-2021 |
| Version 1.1 – Updated on 23.12.2020 | |||
ANVISA PBRER list 2021 (Brazil) from ANVISA WEBPORTAL
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