Evrópusambandið - tékkneska - EMA (European Medicines Agency)

pfizer limited - celekoxib - adenomatózní polypóza coli - antineoplastická činidla - onsenal je indikován pro snížení počtu adenomatózní polypy střevní v familiární adenomatózní polypózy (fap), jako doplněk chirurgie a dále endoskopické sledování (viz bod 4. Účinek přípravku onsenal-snížení zátěže polypy vyvolaný na riziko střevního karcinomu nebyl prokázán (viz body 4. 4 a 5.

Evrópusambandið - tékkneska - EMA (European Medicines Agency)

accord healthcare s.l.u. - dimethyl fumarát - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresiva - dimethyl fumarate accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Evrópusambandið - tékkneska - EMA (European Medicines Agency)

amicus therapeutics europe limited - cipaglucosidase alfa - glykogen storage type ii - jiné zažívací trakt a produkty metabolismu, - pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset pompe disease (acid α-glucosidase [gaa] deficiency).

Evrópusambandið - tékkneska - EMA (European Medicines Agency)

mylan ireland limited - dimethyl fumarát - roztroušená skleróza, relaps-remitentní - imunosupresiva - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Evrópusambandið - tékkneska - EMA (European Medicines Agency)

zaklady farmafarmaceutyczne polpharma s.aceutyczne polpharma s.a. - dimethyl fumarát - roztroušená skleróza, relaps-remitentní - imunosupresiva - dimethyl fumarate polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Evrópusambandið - tékkneska - EMA (European Medicines Agency)

teva gmbh - dimethyl fumarát - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresiva - dimethyl fumarate teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Tékkland - tékkneska - SUKL (Státní ústav pro kontrolu léčiv)

g.l. pharma gmbh, lannach array - 15483 dutasterid; 14672 tamsulosin-hydrochlorid - tvrdá tobolka - 0,5mg/0,4mg - tamsulosin a dutasterid

Evrópusambandið - tékkneska - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - roztroušená skleróza, relaps-remitentní - imunosupresiva - 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).

Evrópusambandið - tékkneska - EMA (European Medicines Agency)

swedish orphan biovitrum international ab - nitisinon - tyrosinemie - jiné zažívací trakt a produkty metabolismu, - hereditary tyrosinemia type 1 (ht 1)orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht 1) in combination with dietary restriction of tyrosine and phenylalanine. alkaptonuria (aku)orfadin is indicated for the treatment of adult patients with alkaptonuria (aku).

Evrópusambandið - tékkneska - EMA (European Medicines Agency)

albireo - odevixibat - cholestasis, intrahepatic - Žlučová a jaterní terapie - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or older (see sections 4. 4 a 5.