Local Prescribing Information (Oncology):

 

Pertuzumab Trastuzumab Injection [Phesgo] ® - Phesgo PI v2.0 dt. Jan 2022

Atezolizumab Injection [Tecentriq®] - Tecentriq PI v21.0 dt. Mar 2022

Bevacizumab Injection [Avastin® and Syndyma®] - Avastin PI v19. dt. Oct 2021 Cipla | Avastin PI v19.0 dt. Oct 2021 Roche

Obinutuzumab Injection [Gazyva®] - Gazyva PI v15.0 dt. Feb 2022

Trastuzumab for Injection [Herclon™ and Biceltis®] - Herclon PI v13.0 dt. Feb 2021 | Biceltis PI v13.0 dt. Feb 2021

Trastuzumab emtansine for Injection [Kadcyla®] - Kadcyla PI v11.0 dt. Jun 2021

Pertuzumab Injection [Perjeta®] - Perjeta PI v12.0 dt. Mar 2021

Rituximab Injection [Ristova® and Ikgdar®] - Ristova PI v12.0 dt. Jan 2021 | Ikgdar PI v12.0 dt. Jan 2021

Alectinib Capsules [Alecensa®] - Alecensa PI v9.0 dt. Jan 2022

Erlotinib Tablets I.P. [Tarceva®] - Tarceva PI v14.0 Dec 2021

Capecitabine Tablets I.P. [Xeloda®] - Tecentriq PI v21.0 dt. Mar 2022

 

 

Safety Update Information for Healthcare Professionals (Oncology):

 

DHPC package issued for Tecentriq regarding SCARs (Severe Cutaneous Adverse Reactions) an Identified Risk dated 6th Nov 2020

5-Fluorouracil (i.v.), Capecitabine and Tegafur containing products: Pre-treatment testing to identify DPD deficient patients at increased risk of severe toxicity dated 19th May 2020

DHPC Tecentriq Atezolizumab Injection 1200mg/20ml Safety Update Identified risk -Immune-related myositis dated 31st January 2019

DHPC Xeloda Important Safety update of PI for Xeloda_DPD deficiency dated 3rd October 2018

DHPC Tecentriq Atezolizumab Injection 1200mg/20ml Important Identified risk immune related nephritis dated 30th July, 2018

DHPC Tecentriq Atezolizumab Injection 1200MG/20ML restriction to Tecentriq 1L Cisplatin-Ineligible mUC Indication dated July 23, 2018

 

 

Disclaimer - Kindly note that it takes approximately up to 6 months to implement the revised PI in commercial stocks imported into India after submission to the health authorities. All PIs notified to or approved by the CDSCO are published on this website for all the HCPs prescribing Roche drugs within 10 calendar days.