Medicinal Products

Notice on recall of the batch 242562 of Nitronal solution for infusion 50 ml (1 mg/ml) (glyceryl trinitrate)

11.11.2015

The Agency for Medicinal Products and Medical Devices (HALMED) would like to inform of the recall of the batch 242562 of Nitronal solution for infusion 50 ml (1 mg/ml) (glyceryl trinitrate) of the manufacturer Pohl Boskamp, Germany, due to a suspected quality defect.

PRAC News – November 2015

09.11.2015

PRAC concludes evidence does not support that HPV vaccines cause CRPS or POTs

05.11.2015

Dear Healthcare Professional Letter on the risk of osteonecrosis of the jaw associated with use of denosumab (XGEVA): new contraindication and introduction of a patient reminder card to minimise the risk

30.10.2015

Amgen d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), would like to inform healthcare professionals of a new contraindication in patients with unhealed lesions from a dental or oral surgery and the introduction of a patient reminder card, to minimise the risk of osteonecrosis of the jaw during treatment with XGEVA (denosumab).

Further information and the Dear Healthcare Professional Letter are accessible here.

Notice on recall of the batch 140802 of Ramipril H Farmal 2.5 mg/12.5 mg tablets (Ramipril, hydrochlorothiazide)

28.10.2015

The Agency for Medicinal Products and Medical Devices (HALMED) would like to inform about the recall of the batch 140802 of Ramipril H Farmal 2.5 mg/12.5 mg tablets of the marketing authorisation holder Farmal d.d. due to a discovered quality defect.

CHMP News – October 2015

23.10.2015

EMA recommends additional measures to prevent use of mycophenolate in pregnancy

23.10.2015

The European Medicines Agency (EMA) has warned that the transplant medicine mycophenolate must not be used in pregnancy unless no suitable alternative is available to prevent transplant rejection.

Notice on reinstatement of batches 15HK211F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and batch 15IB515P2 of Ciprofloxacin Kabi 200 mg/100 ml solution for infusion

20.10.2015

Following to the Notice on temporary discontinuation of distribution and use of the batches 15HK211F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and the batches 15IB515P2 and Ciprofloxacin Kabi 200 mg/100 ml solution for infusion, released on 26th May 2015, the Agency for Medicinal Products and Medical Devices (HALMED) would like to inform on the reinstatement of these batches on the market.

Further information is accessible under the link below.

Dear Healthcare Professional Letter on potentiation of radiation toxicity associated with Zelboraf (vemurafenib)

20.10.2015

Roche d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) would like to inform healthcare professionals of the potentiation of radiation toxicity associated with Zelboraf (vemurafenib).

Further information and the Dear Healthcare Professional Letter is accessible under the link below.

Notice on the recall of three batches of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

14.10.2015

The Agency for Medicinal Products and Medical devices (HALMED) would like to inform on the recall of the batches B514AD and BL10AD of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion of the marketing authorisation holder Medicuspharma d.o.o. from the Croatian market due to a suspected quality defect.

Further information is accessible under th elink bellow.

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