Evrópusambandið - króatíska - EMA (European Medicines Agency)

mylan ireland limited - rivaroksaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombotska sredstva - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Evrópusambandið - króatíska - EMA (European Medicines Agency)

chanelle pharmaceuticals manufacturing ltd - имидаклоприд, моксидектин - antiparasitic products, insecticides and repellents, macrocyclic lactones, milbemycins - cats; dogs; ferrets - for cats suffering from, or at risk from, mixed parasitic infections:• the treatment and prevention of flea infestation (ctenocephalides felis),• the treatment of ear mite infestation (otodectes cynotis),• the treatment of notoedric mange (notoedres cati),• the treatment of the lungworm eucoleus aerophilus (syn. capillaria aerophila) (adults),• the prevention of lungworm disease (l3/l4 larvae of aelurostrongylus abstrusus),• the treatment of the lungworm aelurostrongylus abstrusus (adults),• the treatment of the eye worm thelazia callipaeda (adults),• the prevention of heartworm disease (l3 and l4 larvae of dirofilaria immitis),• the treatment of infections with gastrointestinal nematodes (l4 larvae, immature adults and adults of toxocara cati and ancylostoma tubaeforme). the veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (fad).  for ferrets suffering from, or at risk from, mixed parasitic infections:• the treatment and prevention of flea infestation (ctenocephalides felis),• the prevention of heartworm disease (l3 and l4 larvae of dirofilaria immitis).  for dogs suffering from, or at risk from, mixed parasitic infections:• the treatment and prevention of flea infestation (ctenocephalides felis),• the treatment of biting lice (trichodectes canis),• the treatment of ear mite infestation (otodectes cynotis), sarcoptic mange (caused by sarcoptes scabiei var. canis), demodicosis (caused by demodex canis),• the prevention of heartworm disease (l3 and l4 larvae of dirofilaria immitis),• the treatment of circulating microfilariae (dirofilaria immitis),• the treatment of cutaneous dirofilariosis (adult stages of dirofilaria repens)• the prevention of cutaneous dirofilariosis (l3 larvae of dirofilaria repens),• the reduction of circulating microfilariae (dirofilaria repens),• the prevention of angiostrongylosis (l4 larvae and immature adults of angiostrongylus vasorum),• the treatment of angiostrongylus vasorum and crenosoma vulpis,• the prevention of spirocercosis (spirocerca lupi),• the treatment of eucoleus (syn. capillaria) boehmi (adults),• the treatment of the eye worm thelazia callipaeda (adults),• the treatment of infections with gastrointestinal nematodes (l4 larvae, immature adults and adults of toxocara canis, ancylostoma caninum and uncinaria stenocephala, adults of toxascaris leonina and trichuris vulpis). the veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (fad).

Evrópusambandið - króatíska - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivima selektivni imunosupresivima - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Evrópusambandið - króatíska - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - prostatske neoplazme - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Króatía - króatíska - HALMED (Agencija za lijekove i medicinske proizvode)

mundipharma gesellschaft m.b.h., wiedner gurtel 13, turm 24, og 15, beč, austrija - morfinsulfat - tableta s produljenim oslobađanjem - 10 mg - urbroj: jedna tableta sadrži 10 mg morfinsulfata što odgovara 7,5 mg morfina

Króatía - króatíska - HALMED (Agencija za lijekove i medicinske proizvode)

mundipharma gesellschaft m.b.h., wiedner gurtel 13, turm 24, og 15, beč, austrija - morfinsulfat - tableta s produljenim oslobađanjem - 100 mg - urbroj: jedna tableta sadrži 100 mg morfinsulfata što odgovara 75 mg morfina

Króatía - króatíska - HALMED (Agencija za lijekove i medicinske proizvode)

mundipharma gesellschaft m.b.h., wiedner gurtel 13, turm 24, og 15, beč, austrija - morfinsulfat - tableta s produljenim oslobađanjem - 30 mg - urbroj: jedna tableta sadrži 30 mg morfinsulfata što odgovara 22,5 mg morfina

Króatía - króatíska - HALMED (Agencija za lijekove i medicinske proizvode)

mundipharma gesellschaft m.b.h., wiedner gurtel 13, turm 24, og 15, beč, austrija - morfinsulfat - tableta s produljenim oslobađanjem - 60 mg - urbroj: jedna tableta sadrži 60 mg morfinsulfata što odgovara 45 mg morfina

Evrópusambandið - króatíska - EMA (European Medicines Agency)

extrovis eu ltd. - lakozamida - epilepsija - antiepileptici sredstva, - lacosamide adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. lacosamide adroiq is indicated as adjunctive therapyin the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Evrópusambandið - króatíska - EMA (European Medicines Agency)

viiv healthcare bv - dolutegravir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.