Europäische Union - Deutsch - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastische mittel - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 und 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.

Europäische Union - Deutsch - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - mittel gegen dermatitis, ausgenommen corticosteroide - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

alfred e. tiefenbacher (gmbh & co. kg) (8016331) - lacosamid - filmtablette - teil 1 - filmtablette; lacosamid (31188) 100 milligramm

Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

alfred e. tiefenbacher (gmbh & co. kg) (8016331) - lacosamid - filmtablette - teil 1 - filmtablette; lacosamid (31188) 150 milligramm

Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

alfred e. tiefenbacher (gmbh & co. kg) (8016331) - lacosamid - filmtablette - teil 1 - filmtablette; lacosamid (31188) 200 milligramm

Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

alfred e. tiefenbacher (gmbh & co. kg) (8016331) - lacosamid - filmtablette - teil 1 - filmtablette; lacosamid (31188) 50 milligramm

Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

meda pharma gmbh & co. kg (8043598) - oxetacain; magnesiumhydroxid; aluminiumhydroxid - suspension - oxetacain (07762) 20 milligramm; magnesiumhydroxid (02250) 196 milligramm; aluminiumhydroxid (12820) 582 milligramm

Europäische Union - Deutsch - EMA (European Medicines Agency)

ucb pharma sa - brivaracetam - epilepsie - antiepileptika, - briviact ist indiziert als zusatztherapie bei der behandlung von partiellen epileptischen anfällen mit oder ohne sekundäre generalisierung bei erwachsenen und jugendlichen patienten ab 16 jahren mit epilepsie.

Europäische Union - Deutsch - EMA (European Medicines Agency)

eisai gmbh - rufinamide - epilepsie - antiepileptika, - inovelon ist angezeigt als zusatztherapie in der behandlung von epileptischen anfällen verbunden mit lennox-gastaut-syndrom bei patienten 4 jahren und älter.

Europäische Union - Deutsch - EMA (European Medicines Agency)

ucb pharma sa - levetiracetam - epilepsie - antiepileptika, - keppra ist als monotherapie bei partiellen anfällen mit oder ohne sekundäre generalisierung bei patienten ab 16 jahren mit neu diagnostizierter epilepsie indiziert. keppra ist indiziert als adjuvante therapie:bei der behandlung von partiellen epileptischen anfällen mit oder ohne sekundäre generalisierung bei erwachsenen, kindern und säuglingen ab einem monat alt mit epilepsie;in der behandlung von myoklonischen anfällen bei erwachsenen und jugendlichen ab 12 jahren mit juvenilen myoklonischen epilepsie, bei der behandlung von primär generalisierten tonisch-klonischen anfällen bei erwachsenen und jugendlichen ab 12 jahren mit idiopathischer generalisierter epilepsie.