CDSCO Panel grants Sanofi's Updated Prescribing Information for FDC Ibuprofen plus Paracetamol

This came after the firm presented the proposal for updated prescribing information for the FDC changes based on the updated company core data sheet (CCDS) version 7 dated 02.03.2023 and version 8 dated 11.05.2023.

Ibuprofen is a pharmaceutical drug that is classified as a non-steroidal anti-inflammatory drug (NSAID). Ibuprofen exerts its anti-inflammatory and analgesic effects through inhibition of both COX isoforms. In addition, ibuprofen scavenges HO•, •NO, and ONOO− radicals and can potentiate or inhibit nitric oxide formation through its effects on nitric oxide synthase (NOS) isoforms.

Ibuprofen is a medication used to manage and treat inflammatory diseases, rheumatoid disorders, mild to moderate pain, fever, dysmenorrhea, and osteoarthritis. It is also available as an over-the-counter medication for pain, usually mild. It is in the non-steroidal anti-inflammatory drug (NSAID) class of medications.

Paracetamol is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Paracetamol is a medicine used to treat mild to moderate pain. Paracetamol can also be used to treat fever (high temperature). It's dangerous to take more than the recommended dose of paracetamol. Paracetamol overdose can damage the liver and cause death.

At the recent SEC meeting for Analgesic and Rheumatology held on 6th February 2024, the expert panel reviewed the proposal for updated prescribing information for the FDC changes based on the updated company core data sheet (CCDS).

After detailed deliberation, the committee recommended the grant of approval for the proposed update in prescribing information as presented by the firm.

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