RegulatoryOfficial

SÚKL approves revised preparation instructions for STAMICIS 1 mg radiopharmaceutical kit

🇨🇿 SÚKL · Tue 10 Nov 2026

Czech regulator SÚKL has approved a variation to STAMICIS 1 mg, raising the heating temperature, shortening incubation, allowing dilution with saline and capping vial withdrawals at ten.

The State Institute for Drug Control (SÚKL) has told healthcare professionals that it approved, with effect from 20 October 2026, a change to the marketing authorisation for STAMICIS 1 mg kit for radiopharmaceutical preparation. The product is registered under number 88/422/09-C, with SÚKL code 138561. SÚKL published the notice on 10 November 2026.

The variation updates section 12 of the Summary of Product Characteristics (SmPC), which contains the instructions for preparing the radiopharmaceutical. In the heating procedure, the vial is now to be placed in a heating block at 120 °C and incubated for at least 10 minutes. The previous text specified 100 °C and at least 15 minutes.

SÚKL also reports that both the boiling procedure (part A) and the heating procedure (part B) now state that the preparation can be diluted with 0.9% sodium chloride solution where necessary. In addition, the SmPC now specifies that a maximum of 10 withdrawals may be made from a vial.

The full preparation instructions are in section 12 of the SmPC, and the current version is available in SÚKL's medicines database.

What it means for your team

  • Radiopharmacy and QA teams preparing STAMICIS should check local preparation procedures and work instructions against the revised section 12, in particular the 120 °C / 10-minute heating step.
  • Any procedures or training materials that still cite 100 °C and 15 minutes will need to be reviewed and updated.
  • The new 10-withdrawal limit and the option to dilute with 0.9% sodium chloride should be reflected in dispensing and documentation practices where relevant.
  • Regulatory affairs teams should confirm that the current SmPC from the SÚKL database is the version used for reference.

Official source: SÚKL ↗

Article written by VigiEye from the official source (SÚKL). AI-assisted; check the source before acting.

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