Class 4 caution in use- Gemcitabine 2g/52.6ml concentrate for solution for infusion

Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.

MHRA drug alert Date: 04/09/25

MHRA drug alert link: Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43 - GOV.UK

This is a caution in use only we are not accepting stock returns

further information

For medical information queries please telephone +351 21 960 8410, or email portugaleupharmacovigilance@hikma.com.

For all stock control enquiries please telephone +44 020 7399 2760, or email customerserviceuk@hikma.com