Letter to health care professionals about the market rerelease of specific series of the medicinal product Oxaliplatin Pliva


The company Pliva Hrvatska d.o.o., marketing authorisation holder for the drug Oxaliplatin Pliva, in cooperation with the Agency for Medicinal Products and Medical Devices (HALMED), has sent out a letter to health care professionals informing them of the market rerelease of the series 10C10QJ of the drug Oxaliplatin Pliva 50 mg/10 mL concentrate for infusion solution, and series 10J12PG, 11A18UD and 11A20NM of the drug Oxaliplatin Pliva 100 mg/20 mL concentrate for infusion solution.

The sale and use of these series of the drug was temporarily halted due to the observation of grouped serious oversensitivity reactions (three oversensitivity reactions were reported, including one case of angioedema), which HALMED informed health care professionals about in December 2011. Due to these reports, HALMED conducted extraordinary quality tests of these series of the drugs. The quality tests on the said series were found to correspond to the requirements, and thus the series are rereleased for sale.

The Letter to Health Care Professionals can be viewed here (in Croatian).

HALMED will continue to monitor the safe use of the drug Oxaliplatin Pliva, and the public will be informed of all new information in a timely manner.

We hereby remind all health care professionals that they are obliged to report every adverse reaction to medicinal products to HALMED (in Croatian). Patients developing an adverse reaction may also report the same directly to HALMED, with the recommendation that they consult their doctor or pharmacists regarding any adverse reactions they observe for consultations on the continuation of therapy.