guidelines

DHPC | LPI

Rare Diseases

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.

Safety Update Information for Healthcare Professionals (Oncology):

Direct Healthcare Professional Communication Alecensa® (Alectinib), Warning and Precaution and Specific Dose Modification Guidance for Management of Haemolytic AnaemiaDHPC package issued for Tecentriq regarding SCARs (Severe Cutaneous Adverse Reactions) an Identified Risk dated | 6th Nov 20205-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 2020DHPC Tecentriq Atezolizumab Injection 1200mg/20ml Safety Update Identified risk -Immune-related myositis dated | 31st January 2019DHPC Xeloda Important Safety update of PI for Xeloda_DPD deficiency dated | 3rd October 2018DHPC Tecentriq Atezolizumab Injection 1200mg/20ml Important Identified risk immune related nephritis dated | 30th July, 2018DHPC Tecentriq Atezolizumab Injection 1200MG/20ML restriction to Tecentriq 1L Cisplatin-Ineligible mUC Indication dated | July 23, 2018

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