Brainfarma`s Batch of Nimesulide Is Forbidden By Anvisa
Widely used non-steroidal anti-inflammatory drugs (NSAIDs) are associated with an increased risk of heart failure - even in people without a history of cardiac issues, a recent study suggests.
India’s Ministry of Health and Family Welfare informed India’s Upper House of Parliament, Rajya Sabha, that safety issues involving drugs that may be banned in another country are reviewed with experts prior to making a final determination of continued marketing.
Nimesulide microspheres were prepared by the quasi-emulsion solvent diffusion method, using acetylated starches of the indigenous Ofada rice (Oryza glaberrima Steud) with degrees of substitution (DS) 1.42 and 2.62.
Nearly 40 per cent of doctors disagreed with the government's move to ban 344 fixed dose combination drugs, a survey said.
The gathering of nimesulide drugs 50mg / ml and 50mg erythromycin estolate / ml pharmaceutical suspension medium, it was a precautionary action Anvisa, manufactured because of the stability and dissolution studies with altered production process. The stability studies results are used to establish or confirm the expiration date and to recommend storage conditions. In this context, it is possible not to ratify the validity and performance of these drugs compared with the recorded condition. For diclofenac sodium 50mg, tablet, Anvisa's decision was also precautionary, based on the validation of the production process, which ensures the reproducibility of the lots within the parameters established in the drug registration. The change in the production process may involve inclusion or modification of equipment or some modification during production of the drug.
feira On Thursday (14/1), were suspended several batches of medicines company Prati Donaduzzi & Cia Ltda manufactured in violation of the registration at Anvisa.