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First paediatric EC approval of HIV drug

European Pharmaceutical Review

At Week two or Week 4, selected participants were given a pharmacokinetic (PK) evaluation to confirm the dosage that the participants would receive. In this study, no new adverse reactions (ARs) have been observed in paediatric subjects aged two years and older living with HIV-1 compared to adults. Treatment cohort 3.

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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

When information specific to the reference product is described in the biosimilar or interchangeable biosimilar product’s labeling (for example, data from clinical trials of the reference product in the ADVERSE REACTIONS and CLINICAL STUDIES sections), the reference product’s proper name should be used.

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BeiGene’s Brukinsa FDA approved for CLL/SLL

pharmaphorum

The most common adverse reactions noted in the clinical trials of zanubrutinib were neutrophil count decrease (42%), upper respiratory tract infection (39%), platelet count decrease (34%), haemorrhage (30%), and musculoskeletal pain (30%). The median DOR was not reached in either arm, however, after a median follow-up of 14.1

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How authentication of drugs has become a fundamental pillar of patient safety

Express Pharma

Counterfeit drugs, intentionally mislabeled or misrepresented, often contain substandard or harmful ingredients, incorrect dosages, or no active ingredients at all. This widespread issue has led to treatment failures, adverse reactions, and even loss of life among patients.

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PMPRB takes jurisdiction over medicine (again) following Federal Court of Appeal remand

Pharma in Brief

The PMPRB accepted that there was a slightly elevated incidence of adverse reactions as well as higher efficacy for DIFFERIN XP when compared to DIFFERIN. In this context, the PMPRB noted that “no topical acne product…is considered unsubstitutable”, based on expert evidence.

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Panadol Types: Which One Should I Use

FADIC

Dosage:   Adults, elders, and children 16 years and over: Two tablets up to four times a day with a maximum of 8 tablets/ day. Apply 4 hours as a minimum safe interval between dosages. Dosage:   Menstruating women above 12 years: One-Two tablets up to three times a day as needed with a maximum of 6 tablets in 24 hours.

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Ministry of Health Medicines Formulary (MOHMF)

RX Note

However, the information such as indications, dosages, adverse reaction, contraindications, interactions, precautions and method of purchase, in FUKKM is continuously being updated throughout the year. It is typically updated 2-3 times a year to add, modify or delist the medications in it.