Women taking tamoxifen are also guaranteed treatment after the MAH has reported an interruption of delivery of Tamoxifen Sandoz 10 mg and 20 mg. A medicine with the same active substance is available on the Slovak market, which is used in oncology practice for a long time and as standard. It is the same drug from another manufacturer.
The supply disruption concerns a particular producer, not the active substance itself. It follows from the production measures relating to the modification of the registration documentation and covers all markets of the European Union in which those medicinal products are distributed. This is already the third interruption in the delivery of this medicinal product for the last two years at the request of the marketing authorisation holder.
For the patient, this means one thing in practice: in the pharmacy it will receive another pack with the same active substance. The available product allows the tablet to be divided into equivalent doses in accordance with the summary of product characteristics and thus covers both strengths of the original product. Therefore, the dosage indicated by the treating physician may not be altered.
The medicine is available in Slovakia and the treatment of patients continues. stated prof. MUDr. Michal Mego, DrSc., head expert of MZ SR for clinical oncology.The interruption of deliveries concerns one producer, not tamoxifen as such. The medicine on the market covers both strengths, so the patient continues with the same dosage as previously added.
The State Drug Control Institute does not record reports of adverse effects on the available medicine containing tamoxifen, either in Slovakia or at European Union level. If a patient experiences any problems after a change, she should report them to her doctor and the State Drug Control Institute. Reporting is a patient tool, not a formality.
This is the same active substance in the same dosageÞ said Roman Dorčík, director of the State Institute for Drug Control. We do not record reports of adverse reactions with this medicine in Slovakia or at European Union level. However, if the patient experiences difficulties after the change, it is necessary to report this to us. That's the only way we can catch it, stressed.
At the same time, the treating oncologist will assess individually in each patient whether it is appropriate to continue, modify or choose another treatment.
Patient advice: do not stop treatment and follow the dosage. Consult your treating doctor for continued treatment. If any difficulty is reported to the doctor and the State Medicine Control Institute.