Japan’s Ministry of Health, Labour and Welfare has approved a human milk-based fortifier for very low birth weight (VLBW) infants, marking a world-first approval for this type of product.

• Regulatory Approval: The fortifier is approved as a prescription medicine in Japan for VLBW infants.
• Medical Use: Intended for nutritional management of VLBW infants and other vulnerable neonatal populations.
• Product Holder: Clinigen is the marketing authorisation holder for the product in Japan.

This summary is based on a report from BioSpectrum Asia and related press releases.