3 Important Drug Safety Updates — 3 August 2026

PharmExpert LLC Pharmacovigilance Review | 3 August 2026

Our monitoring of official Roszdravnadzor communications identified three updates of practical relevance to marketing authorisation holders and pharmacovigilance, medical information and regulatory professionals.

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1. Adalimumab: materials on safe use

Roszdravnadzor published information materials on the safe use of medicinal products containing adalimumab. Marketing authorisation holders and responsible specialists should assess their applicability to registered products, current product information, risk-minimisation measures and communications with healthcare professionals and patients.

Importance: medium — an official communication directly concerning the safe use of a medicinal product.

Official Roszdravnadzor publication

2. Safe use of immunobiological medicinal products

Roszdravnadzor published information letter No. 01I-867/26 dated 28 July 2026 on the safe use of immunobiological medicinal products. Companies should identify affected products and compare the recommendations with their pharmacovigilance procedures, medical information and materials for healthcare professionals.

Importance: medium — the update concerns post-authorisation safety and the safe-use practice for immunobiological medicines.

Official Roszdravnadzor publication

3. Mycophenolate mofetil (CellCept): new safety materials

Roszdravnadzor published information materials on the safe use of CellCept (mycophenolate mofetil), letter No. 01I-896/26. The publication card lists the letter date as 31 August 2026, while the official PDF is dated 31 July 2026. When documenting the update, companies should use the date shown on the primary document and record the metadata discrepancy separately.

Importance: medium — an official product-specific safety communication requiring assessment of its impact on local product information, risk-minimisation materials and communications.

Official Roszdravnadzor publication

Practical conclusion

For every affected product, companies should perform and document an applicability assessment and verify the currency of the SmPC, package leaflet, risk-minimisation measures, educational materials, medical-information standard responses and local safety-communication procedures.

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This material is based exclusively on official regulatory publications and is provided for information purposes. It does not replace a product-specific applicability assessment. The current status and content of each document should be verified using the primary-source link.