Malta - angielski - Medicines Authority

janssen-cilag international nv turnhoutsewes 30, b-2340 beerse, belgium - itraconazole - hard capsule - itraconazole 100 mg - antimycotics for systemic use

Malta - angielski - Medicines Authority

janssen-cilag international nv turnhoutsewes 30, b-2340 beerse, belgium - haloperidol - tablet - haloperidol 5 mg - psycholeptics

Malta - angielski - Medicines Authority

janssen-cilag international nv turnhoutsewes 30, b-2340 beerse, belgium - ketoconazole - cream - ketoconazole 2 percent weight/weight - antifungals for dermatological use

Malta - angielski - Medicines Authority

janssen-cilag international nv turnhoutsewes 30, b-2340 beerse, belgium - miconazole nitrate - cutaneous powder - miconazole nitrate 20 milligram(s)/gram - antifungals for dermatological use

Arabia Saudyjska - angielski - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

janssen-cilag international nv, belgium - ad26 cov2s - suspension for injection - 1000000000 vector genomes/ml

Unia Europejska - angielski - EMA (European Medicines Agency)

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 5.1).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.

Unia Europejska - angielski - EMA (European Medicines Agency)

janssen-cilag international nv - bedaquiline fumarate - tuberculosis, multidrug-resistant - antimycobacterials - sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (mdr tb) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. consideration should be given to official guidance on the appropriate use of antibacterial agents.

Unia Europejska - angielski - EMA (European Medicines Agency)

janssen-cilag international nv - bosentan (as monohydrate) - hypertension, pulmonary; scleroderma, systemic - other antihypertensives - treatment of pulmonary arterial hypertension (pah) to improve exercise capacity and symptoms in patients with world health organization (who) functional class iii. efficacy has been shown in:primary (idiopathic and familial) pah;pah secondary to scleroderma without significant interstitial pulmonary disease;pah associated with congenital systemic-to-pulmonary shunts and eisenmenger’s physiology.some improvements have also been shown in patients with pah who functional class ii.stayveer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital-ulcer disease.

Unia Europejska - angielski - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, cobicistat, emtricitabine, tenofovir alafenamide - hiv infections - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza is indicated for the treatment of human immunodeficiency virus type 1 (hiv‑1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg).genotypic testing should guide the use of symtuza.

Unia Europejska - angielski - EMA (European Medicines Agency)

janssen-cilag international nv - apalutamide - prostatic neoplasms - endocrine therapy - erleada is indicated:in adult men for the treatment of non metastatic castration resistant prostate cancer (nmcrpc) who are at high risk of developing metastatic disease.in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt).