Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - milbemycin oxime; praziquantel - chewable tablet - 16, 40 mg/tablet - milbemycin oxime, combinations

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:as monotherapyin adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;as dual oral therapy in combination withmetformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;as triple oral therapy in combination withmetformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. after initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in hba1c). in patients who fail to show an adequate response, pioglitazone should be discontinued. in light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - ramipril; amlodipine - capsule, hard - 10mg/10 milligram(s) - ace inhibitors and calcium channel blockers; ramipril and amlodipine

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - ramipril; amlodipine - capsule, hard - 10mg/5 milligram(s) - ace inhibitors and calcium channel blockers; ramipril and amlodipine

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - ramipril; amlodipine - capsule, hard - 5mg/10 milligram(s) - ace inhibitors and calcium channel blockers; ramipril and amlodipine

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - ramipril; amlodipine - capsule, hard - 5mg/5 milligram(s) - ace inhibitors and calcium channel blockers; ramipril and amlodipine

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - abiraterone acetate - prostatic neoplasms - endocrine therapy - abiraterone krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt) (see section 5.1)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - desloratadine - rhinitis, allergic, perennial; rhinitis, allergic, seasonal; urticaria - antihistamines for systemic use, - dasselta is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.

Ireland - English - HPRA (Health Products Regulatory Authority)

krka d.d., novo mesto - paliperidone - prolonged-release tablet - 3 milligram(s) - other antipsychotics; paliperidone

Ireland - English - HPRA (Health Products Regulatory Authority)

krka d.d., novo mesto - paliperidone - prolonged-release tablet - 6 milligram(s) - other antipsychotics; paliperidone