Spedra Europska Unija - hrvatski - EMA (European Medicines Agency)

spedra

menarini international operations luxembourg s.a. - avanafil - poremećaj erekcije - lijekovi koji se koriste u erekcijskoj disfunkciji - liječenje erektilne disfunkcije kod odraslih muškaraca. kako za spedra biti učinkovit, potrebno seksualnu stimulaciju .

Cerdelga Europska Unija - hrvatski - EMA (European Medicines Agency)

cerdelga

sanofi b.v. - eliglustat - gaucherova bolest - drugi gastrointestinalni trakt i metabolizam, lijekovi, - cerdelga je indiciran za dugoročno liječenje odraslih bolesnika s gaucherove bolesti tipa 1 (gd1), koji su cyp2d6 slabih metabolizatora (pms), srednji metabolizatori (ims) ili opsežna metabolizatori (ems).

Nuedexta Europska Unija - hrvatski - EMA (European Medicines Agency)

nuedexta

jenson pharmaceutical services limited - dextromethorphan, kinidin - neuronske manifestacije - ostali lijekovi protiv živčanog sustava - nuedexta je indiciran za simptomatsko liječenje pseudobulbarskih učinaka (pba) u odraslih osoba. učinkovitost je ispitivana samo u bolesnika s temeljnom amiloidnom lateralnom sklerozom ili multipla sklerozom.

Copiktra Europska Unija - hrvatski - EMA (European Medicines Agency)

copiktra

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - antineoplastična sredstva - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Brukinsa Europska Unija - hrvatski - EMA (European Medicines Agency)

brukinsa

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastična sredstva - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Imbruvica Europska Unija - hrvatski - EMA (European Medicines Agency)

imbruvica

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Instanyl Europska Unija - hrvatski - EMA (European Medicines Agency)

instanyl

takeda pharma a/s - fentanil citrat - pain; cancer - analgetici - instanyl je indiciran za upravljanje probavnom boli kod odraslih koji već primaju opioidnu terapiju za kroničnu bol u raku. probijanje boli je prolazno pogoršanje boli koja se javlja na pozadini drugačije kontrolirane upornosti boli.  patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Intuniv Europska Unija - hrvatski - EMA (European Medicines Agency)

intuniv

takeda pharmaceuticals international ag ireland branch - guanfacin hidroklorid - deficit poremećaja pozornosti s hiperaktivnošću - antiadrenergic agents, centrally acting, antihypertensives, - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. intuniv bi trebao biti korišten kao dio integriranog programa za liječenje adhd-om, kao i obično, uključujući psihološke, obrazovne i socijalne mjere.