Чехия - чешский - SUKL (Státní ústav pro kontrolu léčiv)

viatris limited, dublin array - 15483 dutasterid; 14672 tamsulosin-hydrochlorid - tvrdá tobolka - 0,5mg/0,4mg - tamsulosin a dutasterid

Европейский союз - чешский - EMA (European Medicines Agency)

pfizer europe ma eeig - tofacitinib - artritida, revmatoidní - imunosupresiva - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 a 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

Чехия - чешский - 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

Чехия - чешский - SUKL (Státní ústav pro kontrolu léčiv)

belupo lijekovi i kozmetika, d.d., koprivnica array - 15483 dutasterid; 14672 tamsulosin-hydrochlorid - tvrdá tobolka - 0,5mg/0,4mg - tamsulosin a dutasterid

Чехия - чешский - SUKL (Státní ústav pro kontrolu léčiv)

ardez pharma, spol. s r.o., kosoř array - 11225 finasterid - potahovaná tableta - 5mg - finasterid

Чехия - чешский - SUKL (Státní ústav pro kontrolu léčiv)

Újv Řež a.s., husinec - Řež array - 19576 fluorcholin-(18f) - injekční roztok - 100-3000mbq/ml - fluorcholin-(18f)

Чехия - чешский - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 13056 oxykodon-hydrochlorid; 12409 dihydrÁt naloxon-hydrochloridu - tableta s prodlouženým uvolňováním - 10mg/5mg - oxykodon a naloxon

Чехия - чешский - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 13056 oxykodon-hydrochlorid; 12409 dihydrÁt naloxon-hydrochloridu - tableta s prodlouženým uvolňováním - 20mg/10mg - oxykodon a naloxon

Чехия - чешский - SUKL (Státní ústav pro kontrolu léčiv)

krka, d.d., novo mesto, novo mesto array - 13056 oxykodon-hydrochlorid; 12409 dihydrÁt naloxon-hydrochloridu - tableta s prodlouženým uvolňováním - 40mg/20mg - oxykodon a naloxon

Чехия - чешский - SUKL (Státní ústav pro kontrolu léčiv)

heaton k.s., praha array - 578 ethinylestradiol; 8280 gestoden - obalená tableta - 0,02mg/0,075mg - gestoden a ethinylestradiol