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New medicine safety measures: ibuprofen, fampridine and PMDA updates

  • 29-09-2026
  • Posted by: Eldaniz Hasanov
  • Category: Regulatory Updates
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Six new substantive pharmacovigilance and medicine-safety materials or regulatory bundles were identified on 29 September 2026.

Roszdravnadzor: batch quality actions

  • Ibuprofen Velfarm 400 mg, batch 301025: circulation ceased following a dissolution specification failure (letter 02И-1107/26). Official communication.
  • Ibuprofen Velfarm 200 mg, batches 0530225 and 2690825: circulation ceased following a dissolution specification failure (letter 02И-1108/26). Official communication.
  • Linezolid infusion 2 mg/mL, 300 mL, batch 0160526: the batch was identified as non-compliant for bacterial endotoxins (letter 02И-1111/26). Official communication.

Health Canada: PMS-FAMPRIDINE recall

Health Canada published a Type II recall of PMS-FAMPRIDINE 10 mg tablets, lot 24123884 (DIN 02496216), because the affected lot may contain foreign-material particles. Official recall RA-82684.

PMDA: risk signals and PRECAUTIONS revisions

PMDA published new signals under evaluation for ibuprofen L-lysine (toxic epidermal necrolysis/Stevens–Johnson syndrome), inclisiran sodium (hypersensitivity) and amenamevir (anaphylaxis). These are ongoing evaluations rather than final labelling decisions. PMDA risk communications.

PMDA also published final PRECAUTIONS revisions involving azathioprine, apremilast, several immune-checkpoint inhibitors, alectinib, osimertinib, selpercatinib and tocilizumab/biosimilars. The revisions address serious risks including PRES/SOS-VOD, hepatic impairment, severe gastritis or oesophagitis, hypertriglyceridaemia with pancreatitis, aplastic anaemia, SJS and DIHS/DRESS. PMDA PRECAUTIONS and investigation summaries.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official communications issued by Roszdravnadzor, Health Canada and PMDA on 28–29 September 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by the manufacturer/marketing authorisation holder or a quality concern affecting any company’s entire product portfolio. Company and product names are used only to identify the official material accurately. Decisions should be based on the primary sources, the regulators’ instructions and the approved product information.