News and Educations

Changes in the use of Macrolane medical device – discontinuation of the indication for breast enhancement


Q-Med, the manufacturer has decided to discontinue the promotion of Macrolane for breast enhancement as it may interefere with the reading of mammograms. In those cases, additional ultrasound examinations are needed. Macrolane may sometimes in certain cases cause harmless lumps in brest, which results with unnecessary examinations and patient anxiety.

Macrolane is a non-permanent gel consisting of stabilised hyaluronic acid and it is intended for temporary augmentation, volume restauration and body contour shaping. The promotion of Macrolane is being discontinued for breast enhancement only due to the interference in radiology diagnostics. Macrolane is a safe product with regard to the fact that hyaluronic acid is a natural component of human tissues and is in certain time period degradable by natural processes.

Macrolana may be further on promoted for volume augmentation of other body surface parts, i.e. buttocks, calfs, breast in men etc., as well as for restauration and shaping of dammaged body contours, caused by soft tissue difects, i.e. lipoatrophy.

In Croatia, Macrolane is not widely used and it is implanted in only two patients, who will be informed by their doctors about the change in the use of this product. Proximun d.o.o., the registration holder has committed himself to inform all the users about this change. The change in the use of macrolane medical device will be included in the information leaflet and labelling of this product.


Dear Health Care Professionals letter on new contraindications and revised warnings for medicinal products containing the active substance strontium ranelate (Osseor/Protelos)


Servier Pharma d.o.o. company which is the marketing authorisation holder for finished medicinal products Osseor 2 g granules for oral suspension and Protelos 2 g granules for oral suspension, has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals on new contraiondications and revised warnings for medicinal products containing the active substance strontium ranelate.


Information on preventive recall of certain batches of the solution for organ transfusion ViaSpan due to a contamination risk


The supplier of the ViaSpan solution for organ perfusion, PharmaSwiss d.o.o. Company has informed on the March 30th 2012 the Agency for medicinal products and medical devices (HALMED) on the initiation of a preventive racall of all the solutions for organ perfusion ViaSpan, manufactured as of July 2011 due to a doubt about a quality defect and a possible contamination risk.


"Dear Healthcare Professional Letter" on volontary recall of certain batches of the medicinal product Carboplatin Ebewe


The marketing authorisation holder for the Carboplatin Ebewe medicinal product, Wϋrth d.o.o. Company, in collaboration with the Croatian Agency for medicinal Products and medical Devices (HALMED), has sent a "Dear Healthcare Professional Letter" on recall of certain batches of the Carboplatin Ebewe medicine. HALMED has affirmed that a replacement therapy for patients on the Croatian market exists.