Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

teva b.v., haarlem array - 21412 agomelatin s moČovinou - potahovaná tableta - 25mg - agomelatin

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

accord healthcare polska sp. z o.o., varšava array - 11194 exemestan - potahovaná tableta - 25mg - exemestan

Evropská unie - čeština - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cystická fibróza - jiné produkty dýchacích cest - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 a 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 a 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

aurovitas, spol. s r.o., praha ČeskÁ republika - 10264 dihydrÁt azithromycinu - potahovaná tableta - 500mg - azithromycin

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

actavis group ptc ehf., hafnarfjördur array - 16590 escitalopram-oxalÁt - potahovaná tableta - 10mg - escitalopram

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

actavis group ptc ehf., hafnarfjördur array - 16590 escitalopram-oxalÁt - potahovaná tableta - 20mg - escitalopram

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

actavis group ptc ehf., hafnarfjördur array - 16590 escitalopram-oxalÁt - potahovaná tableta - 5mg - escitalopram

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

aurovitas, spol. s r.o., praha array - 11237 levetiracetam - potahovaná tableta - 1000mg - levetiracetam

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

aurovitas, spol. s r.o., praha array - 11237 levetiracetam - potahovaná tableta - 250mg - levetiracetam

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

aurovitas, spol. s r.o., praha array - 11237 levetiracetam - potahovaná tableta - 500mg - levetiracetam