Europese Unie - Sloveens - EMA (European Medicines Agency)

novartis europharm limited - trametinib - melanoma - antineoplastična sredstva - melanomatrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 in 5. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy (see section 5. adjuvant treatment of melanomatrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection. non-small cell lung cancer (nsclc)trametinib v kombinaciji z dabrafenib je indiciran za zdravljenje odraslih bolnikov z napredovalim non-small cell lung cancer z braf v600 mutacija.

Europese Unie - Sloveens - EMA (European Medicines Agency)

orexigen therapeutics ireland limited - bupropion hidroklorid, naltrekson hidroklorid - obesity; overweight - preparati za zaščito proti sončenju, prehrambeni izdelki - mysimba je označena, kot dodatek k zmanjšano kalorično prehrano in večjo telesno dejavnost, za upravljanje teža v odrasli bolniki (≥18 let) z začetnim indeksom telesne mase (bmi)≥ 30 kg/m2 (debelih), ali≥ 27 kg/m2 < 30 kg/m2 (prekomerno telesno težo) v prisotnosti enega ali več teže, povezanih s co morbidities (e. tip 2 sladkorne bolezni, dyslipidaemia, ali pod nadzorom hipertenzija), zdravljenje z mysimba je treba prekiniti po 16 tednih, če bolniki niso izgubili vsaj 5% njihove začetne telesne teže.

Europese Unie - Sloveens - EMA (European Medicines Agency)

accord healthcare s.l.u. - vorikonazol - aspergillosis; candidiasis; mycoses - antimycotics za sistemsko uporabo, triazol derivati - voriconazole je v širokem spektru, triazol protiglivično sredstvo, ter je označena pri odraslih in otrocih, starih dve leti ali več, kot sledi:zdravljenje invazivne aspergillosis;zdravljenje candidaemia v ne-neutropenic bolnikov;zdravljenje fluconazole-odporne resno invazivne candida okužbe (vključno c. krusei);zdravljenje hude glivične okužbe, ki jih povzročajo scedosporium spp. in oxysporum spp. voriconazole soglasju mora biti urejen, predvsem pri bolnikih z napredujočo, morda celo smrtno nevarne okužbe.

Europese Unie - Sloveens - EMA (European Medicines Agency)

hikma farmaceutica (portugal) s.a. - vorikonazol - bacterial infections and mycoses; aspergillosis; candidiasis - antimikotiki za sistemsko uporabo - voriconazole je širok spekter, triazol protiglivično sredstvo, ter je označena pri odraslih in otrocih, starih 2 leti in več, kot sledi:zdravljenje invazivne aspergillosis;zdravljenje candidaemia v ne-neutropenic bolnikov;zdravljenje fluconazole-odporne resno invazivne candida okužbe (vključno c. krusei);zdravljenje hude glivične okužbe, ki jih povzročajo scedosporium spp. in oxysporum spp. voriconazole je treba preskusiti, predvsem pri bolnikih z napredujočo, morda celo smrtno nevarne okužbe. profilaksa invazivnih glivičnih okužb v visoko tveganje allogeneic hematopoietic matičnih celic za presajanje (hsct)prejemniki.

Europese Unie - Sloveens - EMA (European Medicines Agency)

swedish orphan biovitrum international ab - nitizinon - tyrosinemias - drugi zdravljene bolezni prebavil in presnove izdelki, - 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).

Europese Unie - Sloveens - EMA (European Medicines Agency)

actavis group ptc ehf   - pioglitazon hidroklorid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:as monotherapyin adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. as dual oral therapy in combination withmetformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin. a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. as triple oral therapy in combination withmetformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4. po začetku terapije z pioglitazone, bolnike je treba pregledati in po 3 do 6 mesecev, da oceni ustreznost odziva na zdravljenje (e. zmanjšanje hba1c). pri bolnikih, ki ne kažejo ustrezen odgovor, pioglitazone, je treba prekiniti,. v luči možnih tveganj z dolgotrajna terapija, predpisovalce morajo potrditi na kasnejše redne preglede, da je korist pioglitazone je ohranjena (glej poglavje 4.

Europese Unie - Sloveens - EMA (European Medicines Agency)

les laboratoires servier - ivabradinijev klorid - angina pectoris; heart failure - srčna terapija - simptomatsko zdravljenje kronične stabilne angine pektoris ivabradine je indicirano za simptomatsko zdravljenje kronične stabilne angine pektoris pri koronarne bolezni odraslih s običajen sinusni ritem in srčni utrip ≥ 70 bpm. ivabradine is indicated :in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. zdravljenje kroničnega srčnega popuščanja ivabradine navedena v kronično srčno popuščanje nyha ii do iv razreda z sistolični disfunkcija, pri bolnikih v sinusni ritem in katerih srčni utrip je ≥ 75 bpm, v kombinaciji s standardno zdravljenje, vključno z zdravljenjem s beta-blocker ali kdaj je terapija beta-blocker kontraindiciran ali ne prenaša.

Europese Unie - Sloveens - EMA (European Medicines Agency)

shionogi b.v. - ospemifen - postmenopavza - spolni hormoni in zdravila genitalni sistem, - senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (vva) in post-menopausal women.

Europese Unie - Sloveens - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabine, tenofovir disoproxil fumarate - okužbe z virusom hiv - antivirusi za sistemsko uporabo - treatment of hiv-1 infection: , truvada is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults. , truvada je tudi navedeno, za zdravljenje okužbe z virusom hiv-1 okuženih mladostniki, z nrti odpornost ali toxicities nasprotuje uporabi prvo vrstico agenti, starih od 12 < 18 let. , pre-exposure prophylaxis (prep): , truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults at high risk.

Europese Unie - Sloveens - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastična sredstva - vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with: intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification. vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for hsct with aml with >30% marrow blasts according to the who classification.