Nuwiq® (human coagulation FVIII (simoctocog alfa))

Only available in the UK

United Kingdom

Summary of Product Characteristics Nuwiq®

Patient Information Leaflet Nuwiq®

United Kingdom: Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

UK/P/UKN/C/V2 August 2020

This site is intended for UK healthcare professionals and may contain promotional information.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Octapharma by telephoning 0845 1300 522.

Product Information

Summary of Product Characteristics Nuwiq®

Therapeutic Indicators

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency). Nuwiq can be used for all age groups.

Shelf Life & Storage

Shelf life two years (+2° to +8°C).

During the shelf-life, the product may be kept at room temperature (up to 25°C) for a single period not exceeding one month. Once the product has been taken out of the refrigerator the product must not be returned to the refrigerator. Please record the beginning of storage at room temperature on the product carton.

After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours when stored at room temperature. From a microbiological point of view, the product should be used immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Vial Sizes

Our licensed vial sizes are listed below:

  • 250 IU

  • 500 IU

  • 1000 IU

  • 2000 IU

  • 2500 IU

  • 3000 IU

  • 4000 IU

For questions about availability please contact customer services.


Legal classification: Prescription-only Medicine

Basic NHS cost: £0.76p per IU


UK/P/UKNHCP/C/V3 August 2020