Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi pasteur - sars-cov-2 prefusion spike delta tm protein, recombinant (b.1.351 strain) - covid-19 virus infection - cjepiva - vidprevtyn beta is indicated as a booster for active immunisation to prevent covid-19 in adults who have previously received an mrna or adenoviral vector covid-19 vaccine (see sections 4. 2 i 5. 1 in product information document). korištenje ovog cjepiva mora se provoditi u skladu sa službenim preporukama.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - imuni serumi i homologna, - ronapreve is indicated for:treatment of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19 (see section 4. prevention of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4. the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. pogledajte odjeljke 4. 4 i 5.

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

imunološki zavod d.d., rockefellerova 2, zagreb - cjepivo protiv tuberkuloze (bcg) cryodesiccatum - prašak i otapalo za suspenziju za injekciju - 0,75 mg (2-8 x 106 cfu) - urbroj: 1 ml rekonstituiranog cjepiva sadržava: 0,75 mg (2-8 x 106 cfu) živih, atenuiranih bakterija mycobacterium bovis (bcg), danski soj 1331

Europska Unija - hrvatski - EMA (European Medicines Agency)

pierre fabre medicament - tabelecleucel - lymphoproliferative disorders - ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory epstein-barr virus positive post-transplant lymphoproliferative disease (ebv+ ptld) who have received at least one prior therapy. for solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

Europska Unija - hrvatski - EMA (European Medicines Agency)

incline therapeutics europe ltd - fentanil hidroklorid - bol, postoperativna - analgetici - ionsys je indiciran za liječenje akutne umjerene do teške postoperativne boli u odraslih bolesnika.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - atosiban (as acetate) - prerano rođenje - drugi gynecologicals - tractotile ukazuje na kašnjenje neizbježan prerano poroda u trudnica odrasle žene:redovite kontrakcije maternice u trajanju od najmanje 30 sekundi trajanja u iznosu od ≥ 4 30 minuta;grlića maternice od 1 do 3 cm (0-3 za nulliparas) i стертость ≥ 50%;gestacijski u dobi od 24 do 33 punih tjedana trudnoće;normalan puls fetusa.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - follitropin delta - anovulacija - spolni hormoni i modulatori genitalnog sustava, - kontrolirana stimulacija jajnika za razvoj folikula u žena prolazi asistirane reproduktivne tehnologije (art) kao što je oplodnja (ivf) ili intracitoplazmična injekcija spermija (icsi) ciklus.