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  • post marketing...

Tag: post marketing surveillance

You Searched For "post marketing surveillance"
Akum Drugs Gets CDSCO Panel Nod To Conduct Post Marketing  Surveillance study of Linezolid Sustained Release Tablets

Akum Drugs Gets CDSCO Panel Nod To Conduct Post Marketing Surveillance study of Linezolid Sustained Release Tablets

Dr. Divya Colin8 April 2025 5:45 PM IST
New Delhi: Akums Drugs and Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Novartis oral Fabhalta gets USFDA nod for adults with C3 glomerulopathy

Generate PMS data to assess patient safety : CDSCO Panel Tells Novartis Healthcare on additional indications of Secukinumab

Dr. Divya Colin17 March 2025 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major...
CDSCO Panel Approves Fabrazyme Label Update, Asks Sanofi to Submit EMA Nod

Submit post-marketing safety data of Belumosudil in Chronic graft versus host disease: CDSCO Panel Tells Sanofi

Dr. Divya Colin21 April 2024 6:00 PM IST
New Delhi: Responding to the proposal presented by the drug major Sanofi to import and market Belumosudil tablets 200 mg, the Subject Expert Committee...
Zydus Told to Withdraw Unmarketed Strengths, Conduct Phase IV Trial for Approved Combinations Only

Zydus Healthcare Gets CDSCO Nod to study Fluticasone Furoate plus Vilanterol Trifenatate FDC

Dr. Divya Colin22 Jan 2024 6:00 PM IST
New Delhi: The drug major Zydus Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Submit Justification to study Tocilizumab in patients with giant cell  arteritis: CDSCO Panel Tells Cipla

Submit Justification to study Tocilizumab in patients with giant cell arteritis: CDSCO Panel Tells Cipla

Dr. Divya Colin30 Nov 2023 6:00 PM IST
New Delhi: Reviewing the protocol presented by the drug major Cipla for the approval post-marketing active surveillance of Tocilizumab in patients of...
Biological E Gets CDSCO panel Nod for Post-marketing Surveillance study of Hepatitis B Vaccine

Biological E Gets CDSCO panel Nod for Post-marketing Surveillance study of Hepatitis B Vaccine

Dr. Divya Colin30 July 2023 5:30 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has given its nod to the vaccine...
CDSCO panel declares Pfizers antifungal drug Isavuconazole safe, well tolerated

CDSCO panel declares Pfizer's antifungal drug Isavuconazole safe, well tolerated

Dr. Divya Colin10 Feb 2023 6:00 PM IST
New Delhi: Deliberating the post-marketing surveillance (PMS) study report of the Isavuconazole Capsule 100mg & 200mg powder for concentrate for...
Sun Pharma, Philogen complete patient enrollment in Phase III trial for Soft Tissue Sarcoma

Sun Pharma Gets CDSCO panel nod for active post marketing surveillance of Tofacitinib ER Tablets

Dr. Divya Colin23 Jan 2023 6:00 PM IST
New Delhi: Pharmaceutical major, Sun Pharma has got the green signal from the Subject Expert Panel (SEC) functional under the Central Drug Standard...

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