31.03.2015
At its March 2015 meeting, the EMA’s Committee for Human Medicinal Products (CHMP) recommended five new medicines for approval, gave recommendation on extensions of indication for Tamiflu and adopted PRAC’s recommendations for Aclasta (zolendronic acid) that followed the periodic review of this medicine.
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19.03.2015
Remedia d.o.o. , in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) is sending a letter to healthcare professionals to inform them of the new measures associated with the use of Linoladiol 0.01% vaginal cream (estradiol) due to a potential risk of systemic adverse reactions to estradiol.
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13.03.2015
The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) on its March 2015 meeting recommended restrictions on the use codein for cold and cough relief in children and further measures to minimise known risk of osteonecrosis of the jaw associated with bisphosphonate medicine.
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13.03.2015
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of codeine-containing medicines for cough and cold in children because of the risk of serious side effects with these medicines, including the risk of breathing problems.
The PRAC recommended specifically that:
• Codeine should be contraindicated in children below 12 years. This means it must not be used in this patient group.
• Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have problems with breathing.
• All liquid codeine medicines should be available in child-resistant containers to avoid accidental ingestion.
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13.03.2015
Following to the Notice on temporary supply and use discontinuation of the batch 15HG229F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion, published on 14 November 2014, the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs on the returning of the batch 15HG229F1 of this medicinal product.
The procedure of discontinuation of the supply chain and use of this medicine was initiated as a precautionary measure, due to a suspected quality defect following to an allergic adverse reaction reported to HALMED.
Based on the conducted investigation and special quality control, HALMED concludes that the samples of the medicine comply to the specification with regard tested parameters. Following to these results, the temporary discontinuation of the supply chain and use of the batch 15HG2291 of this medicine is being alleviated and the existing stocks may be returned to distribution and use.
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02.03.2015
Farmal d.d., the marketing authorisation holder for Ramipril H Farmal 5 mg/25 mg tablets (ramipril, hydrochlorothiazide) has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the recall of the batch 140802 of this medicine due to a discovered quality defect. The quality defect relates to the labelling on the aluminium foil on blisters in Ramipril H Farmal 5 mg/25 mg tablets, where there is an incorrect product name Ramipril Farmal 5 mg tablets (ramipril) instead of Ramipril H farmal 5mg/25 mg tablets (ramipril, hydrochlorothiazide).
It is a pharmacy level recall.
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06.02.2015
Farmal d.d., the marketing authorisation holder for Cadil 25 mg tablets and Excita 10 mg film-coated tablets has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the discovered quality defect of the batch 3055005A of Cadil 25 mg and batch 4242001B of Excita 10 mg.
The concerned batches are placed on the Croatian market with an obligation to provide a written note on this quality defect to pharmacies.
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27.01.2015
The Croatian Institute for Transfusion Medicine, the marketing authorisation holder for Soludeks 40, 100 mg/ml solution for infusion has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the quality defect of batches 1280064, 1281064, 1282064, 1283064 of this medicine.
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23.01.2015
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended seven new medicines for granting a marketing authorisation, seven medicines for extensions of therapeutic indications and concluded the review of the GVK Biosciences investigation site.
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12.01.2015
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing ambroxol or bromhexine. This follows concerns over the risk of allergic reactions with these medicines.
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