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Brazil's health regulator scraps Bharat Biotech's EUA application of Covaxin


Synopsis
The move comes after Anvisa was informed by Bharat Biotech that it’s Brazilian partner-Necessidade no longer has authorization to represent them in Brazil.
AFP
Brazil’s health regulator, ANVISA has scrapped Bharat Biotech’s application seeking emergency use authorisation (EUA) of Covaxin.
“The Collegiate Board of the National Health Surveillance Agency unanimously decided to close the process that dealt with the temporary authorization of emergency use, on an experimental basis, of the Covaxin vaccine,” it said in a statement.
It said that the process will be closed without evaluating the merits of the request for temporary authorization for emergency use, on an experimental basis, filed by the company Necessidade Comercialização de Medicamentos Ltda. on June 29 this year. ....

Meiruze Freitas , Medicamentos Ltda , Necessidade Comercializa , Board Of The National Health Surveillance Agency , Bharat Biotech , Collegiate Board , National Health Surveillance Agency , Emergency Use , பாரத் பயோடெக் , கல்லூரி பலகை , அவசரம் பயன்பாடு ,

Brazil suspends phase-3 trials of Covaxin | Hyderabad News


Representative image
HYDERABAD: After Bharat Biotech terminated its MoU with Brazilian partner Precisa Medicamentos on Friday, Brazil’s health regulator Anvisa (Agencia Nacional de Vigilancia Sanitaria) said it has suspended Covaxin’s clinical trials in Brazil. Precisa had submitted a request for randomised, double-blind and placebo-controlled phase-3 study of Covaxin in Brazil to Anvisa.
“The Coordination of Clinical Research determined this Friday the precautionary suspension of clinical studies of Covaxin in Brazil,” said a notice by Anvisa on website.
“The suspension was carried out as a result of a statement from the Indian company Bharat Biotech Limited International, sent to Anvisa on Friday (23/7). In the statement, Bharat informs that the company Necessidade Comercializacao de Medicamentos Ltda is no longer authorized to represent Bharat in Brazil, which in Anvisa’s assessment makes it impossible to carry out the study. Bharat is the manufacturer ....

Sao Paulo , Andhra Pradesh , Rio De Janeiro , Estado Do Rio , Mato Grosso , Precisa Medicamentos , Instituto Albert Einstein , Medicamentos Ltda , Necessidade Comercializa , Anvisa Agencia Nacional , Jair Bolsonaro , Envixia Pharmaceuticals , Bharat Biotech Limited International , Coordination Of Clinical Research , After Bharat Biotech , Agencia Nacional De Vigilancia Sanitaria , Clinical Research , Necessidade Comercializacao De Medicamentos Ltda , Bharat Biotech , Brazilian President Jair Bolsonaro , ஸ்ம் பாலொ , ஆந்திரா பிரதேஷ் , ரியோ டி ஜானிரோ , எஸ்டாடோ செய் ரியோ , மாதோ மொத்த , ஜெயர் போல்சனாரோ ,

Brazil suspends clinical trials of Covaxin after termination of agreement


Brazil has suspended the clinical studies of Bharat Biotech s COVID-19 vaccine, Covaxin following termination of the company s agreement with its partner there, the South American Country s health regulator said.
Bharat Biotech on Friday announced cancellation of the MoU it signed with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its COVID-19 vaccine Covaxin for the Brazilian market.
The termination of the pact comes after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country.
In The Coordination of Clinical Research at Anvisa (Copec/GGMED) determined this Friday (23/7) the precautionary suspension of clinical studies of the Covaxin vaccine in Brazil ....

United States , Precisa Medicamentos , Medicamentos Ltda , Coordination Of Clinical Research At Anvisa Copec , Bharat Biotech Ltd , Bharat Biotech Limited International , Envixia Pharmaceuticals , Bharat Biotech , South American Country , Clinical Research , Precise Comercializao De Medicamentos , ஒன்றுபட்டது மாநிலங்களில் , பாரத் பயோடெக் லிமிடெட் , பாரத் பயோடெக் , தெற்கு அமெரிக்கன் நாடு , மருத்துவ ஆராய்ச்சி ,