Croatie - croate - HALMED (Agencija za lijekove i medicinske proizvode)

mylan s.a.s., 117 allee des parcs, saint priest, francuska - aripiprazolum - tableta - 30 mg - urbroj: jedna tableta sadrži 30 mg aripiprazola

Union européenne - croate - EMA (European Medicines Agency)

mylan ireland limited - финголимод hidroklorid - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 i 5. 1)orpatients s brzo razvija težak relapsing ublažavanje multiplom sklerozom određuje se 2 ili više teških recidiva u roku od jedne godine, s 1 ili više gadolinij revitalizacije lezija na mr mozga ili značajno povećanje opterećenja t2 lezija u odnosu na najnoviji mri.

Croatie - croate - HALMED (Agencija za lijekove i medicinske proizvode)

mylan ireland limited, unit 35/36 grange parade, baldoyle industrial estate, dublin 13, irska - meropenem trihidrat - prašak za otopinu za injekciju / infuziju - urbroj: jedna bočica sadrži meropenem trihidrat što odgovara 500 mg meropenema

Union européenne - croate - 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.

Union européenne - croate - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neuromuskularna blokada - svi ostali terapeutski proizvodi - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Union européenne - croate - EMA (European Medicines Agency)

mylan ireland limited - финголимод hidroklorid - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 i 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Union européenne - croate - EMA (European Medicines Agency)

mylan s.a.s. - docetaksel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - antineoplastična sredstva - liječenje raka dojke, posebni oblici raka pluća (karcinom pluća ne-malih stanica), rak prostate, rak želuca ili rak glave i vrata.

Union européenne - croate - EMA (European Medicines Agency)

mylan pharmaceuticals limited - memantin hidroklorid - alzheimerova bolest - other anti-dementia drugs, psychoanaleptics, - liječenje bolesnika s umjerenom ili teškom alzheimerovom bolesti.

Union européenne - croate - EMA (European Medicines Agency)

mylan pharmaceuticals limited - olanzapin - schizophrenia; bipolar disorder - psycholeptics - adultsolanzapine indiciran za liječenje shizofrenije. Оланзапин učinkovit u održavanju kliničkog poboljšanja u roku od nastavka terapije kod pacijenata koji su pokazali odgovor na liječenje . Оланзапин je indiciran za liječenje umjerene do teških maničnih epizoda. kod pacijenata epizoda kojega je manično reagirao na liječenje Оланзапин, Оланзапин je indiciran za prevenciju relapsa kod pacijenata s bipolarnim poremećajem.

Union européenne - croate - EMA (European Medicines Agency)

mylan pharmaceuticals limited - zoledronske kiseline - prijelom, kosti - lijekovi za liječenje bolesti kostiju - sprečavanje događaja povezanih s kostiju (patološke frakture, kompresija leđne moždine, zračenje ili operaciju na kockice, ili tumor-induced гиперкальциемии) u odraslih bolesnika s поздними fazama malignih tumora sa dogovori koji uključuju kosti, liječenje odraslih bolesnika s tumorom-induced гиперкальциемии (tpu).