No Long-Term Safety Data: CDSCO Panel Denies Novo Nordisk's proposal to amend warning statement of Semaglutide Dr. Divya Colin16 March 2025 5:15 PM ISTNew Delhi: Citing that there is no real world long-term safety data for Novo Nordisk's antidiabetic drug Semaglutide tablets (3 mg, 7 mg, 14 mg), the...
CDSCO Panel Rejects Novo Nordisk Proposal to amend warning statement of Semaglutide Injection Dr. Divya Colin8 March 2025 5:15 PM ISTNew Delhi: Noting that post-marketing safety data in Indian patients is not presented, the Subject Expert Committee (SEC) functional under the Central...
Inclisiran be sold by retail under prescription of cardiologist only: CDSCO panel tells Novartis Healthcare Dr. Divya Colin7 Dec 2024 5:30 PM ISTNew Delhi: Rejecting the drug major Novartis Healthcare's proposal for amendment in the warning statement of Inclisiran Solution for injection, the...
Eli Lilly gets CDSCO Panel nod to modify prescription warning for Insulin Lispro Ultrarapid Injection Dr. Divya Colin25 Nov 2024 5:15 PM ISTNew Delhi: In line with the proposal for amending the warning statement of Insulin Lispro Ultrarapid Injection 100 IU & 200 IU, the Subject Expert...
Submit Scientific Evidence: CDSCO Panel Tells Bayer on Vericiguat Warning Statement Amendment Proposal Dr. Divya Colin11 Aug 2024 3:30 PM ISTNew Delhi: In response to the proposal presented by Bayer Pharmaceuticals for amendment in the warning statement for Vericiguat 2.5 mg, 5 mg, and 10...
Expansion of warning statement may be considered after submission of first year PSUR data: CDSCO panel on AstraZeneca's anticancer drug Dr. Divya Colin25 Jun 2024 10:28 PM ISTNew Delhi: Noting that Tremelimumab Concentrate for Solution for infusion 20 mg/ml is not yet launched in the Indian market, the Subject Expert...
Submit Post Marketing Safety Data of Indians: CDSCO Panel Tells Novo Nordisk on Semaglutide Warning Statement Dr. Divya Colin5 March 2024 6:00 PM ISTNew Delhi: In response to the proposal presented by the drug major Novo Nordisk for the amendment in the warning statement for the antidiabetic drug...
CDSCO Panel revises warning statement of Sanofi's antidiabetic FDC Insulin Glargine plus Lixisenatide Dr. Divya Colin13 Dec 2023 6:00 PM ISTNew Delhi: Approving the amendment in the warning statement for Sanofi's Fixed Ratio Combination of Insulin Glargine 100U/mL plus Lixisenatide 50...
GSK pharma's Mepolizumab to be used on prescription of experienced Registered Medical Specialists: CDSCO Panel Dr. Divya Colin26 Nov 2022 6:00 PM ISTNew Delhi: Approving for the amendment in warning statement for GSK Pharmaceuticals' Mepolizumab 100 mg, the Subject Expert Committee (SEC) functional...
