Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

menarini international operations luxembourg s.a., 1, avenue de la gare, luksemburg, luksemburg - bilastin - oralna otopina - urbroj: jedan ml oralne otopine sadrži 2,5 mg bilastina

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

alfred e. tiefenbacher, van-der-smissen-strasse 1, hamburg, njemačka - bilastin - tableta - urbroj: jedna tableta sadrži 20 mg bilastina

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

stada d.o.o., hercegovačka 14, zagreb, hrvatska - bilastin hidrat - tableta - urbroj: jedna tableta sadrži 20 mg bilastina (u obliku hidrata)

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi b.v. - olipudase alfa - acid sphingomyelinase deficiency (asmd) type a/b or type b - drugi gastrointestinalni trakt i metabolizam, lijekovi, - xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-central nervous system (cns) manifestations of acid sphingomyelinase deficiency (asmd) in paediatric and adult patients with type a/b or type b.

Europska Unija - hrvatski - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sun pharmaceutical industries (europe) b.v. - ertapenem natrij - bakterijske infekcije - эртапенем - treatmentertapenem sun is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4. 4 i 5. 1):- intra-abdominal infections- community acquired pneumonia- acute gynaecological infections- diabetic foot infections of the skin and soft tissue (see section 4. 4)preventionertapenem sun is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4. treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Europska Unija - hrvatski - 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).

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - Иммуностимуляторы, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Europska Unija - hrvatski - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - sugammadex sodium - neuromuskularna blokada - svi ostali terapeutski proizvodi - uklanjanje neuromuskularne blokade izazvane rokoronom ili vekuronomom. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.