Union européenne - français - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosuppresseurs - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Union européenne - français - EMA (European Medicines Agency)

zoetis belgium sa - maléate d'oclacitinib - agents contre la dermatite, à l'exclusion des corticostéroïdes - chiens - - treatment of pruritus associated with allergic dermatitis in dogs. - treatment of clinical manifestations of atopic dermatitis in dogs.

Union européenne - français - EMA (European Medicines Agency)

novartis europharm limited - trametinib - mélanome - agents antinéoplasiques - 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 et 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 en combinaison avec le dabrafenib est indiqué pour le traitement de patients adultes atteints avancé non à petites cellules, le cancer du poumon avec une mutation de braf v600.

Union européenne - français - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ozanimod de chlorhydrate de - multiple sclerosis, relapsing-remitting; colitis, ulcerative - immunosuppresseurs - multiple sclerosiszeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features. ulcerative colitiszeposia 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.

Union européenne - français - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - autres médicaments du système nerveux - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Union européenne - français - EMA (European Medicines Agency)

ceva santé animale - clostridium perfringens type c, beta1 toxoid / clostridium perfringens, type a, alpha toxoid / clostridium perfringens, type a, beta2 toxoid / escherichia coli, fimbrial adhesin f4ab / escherichia coli, fimbrial adhesin f4ac / escherichia coli, fimbrial adhesin f5 / escherichia coli, fimbrial adhesin f6 - immunologicals for suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium - les cochons - for the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce:-           clinical signs (severe diarrhoea) and mortality caused by escherichia coli strains expressing the fimbrial adhesins f4ab, f4ac, f5 and f6-           clinical signs (diarrhoea during the first days of life) associated with clostridium perfringens type a expressing alpha and beta 2 toxins-           clinical signs and mortality associated with haemorrhagic and necrotising enteritis caused by clostridium perfringens type c expressing beta1 toxin.

Union européenne - français - EMA (European Medicines Agency)

curium pet france - piflufolastat (18f) - néoplasmes prostatiques - produits radiopharmaceutiques de diagnostic - ce médicament est destiné à un usage diagnostique uniquement. pylclari is indicated for the detection of prostate-specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high-risk pca prior to initial curative therapy,to localize recurrence of pca in patients with a suspected recurrence based on increasing serum prostate-specific antigen (psa) levels after primary treatment with curative intent. pylclari is indicated for use with positron emission tomography (pet).

Union européenne - français - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - attenuated feline rhinotracheitis herpesvirus (fhv f2 strain), inactivated feline calicivirosis antigens (fcv 431 and g1 strains), attenuated feline panleucopenia virus (pli iv), felv recombinant canarypox virus (vcp97), attenuated chlamydophila felis (905 strain) - immunologicals pour felidae, - chats - active immunisation of cats aged 8 weeks and older:against feline viral rhinotracheitis to reduce clinical signs;against calicivirus infection to reduce clinical signs;against chlamydophila felis infection to reduce clinical signs;against feline panleucopenia to prevent mortality and clinical signs;against leukaemia to prevent persistent viraemia and clinical signs of the related disease. onsets of immunity are 1 week after primary vaccination course for rhinotracheitis, calicivirus, chlamydophila felis and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component. the duration of immunity is one year after the last re-vaccination for the chlamydiosis and feline leukaemia components, and one year after primary vaccination course and three years after the last re-vaccination for the rhinotracheitis, calicivirosis and panleucopenia components.

Union européenne - français - EMA (European Medicines Agency)

astrazeneca ab - olaparib - néoplasmes ovariens - agents antinéoplasiques - de l'ovaire cancerlynparza est indiqué en monothérapie pour le:le traitement d'entretien chez les patients adultes atteints avancé (stades figo iii et iv) les gènes brca1/2-muté (de la lignée germinale et/ou somatiques) de haute qualité épithélial de l'ovaire, des trompes de fallope ou péritonéal primitif du cancer et qui sont en réponse (complète ou partielle) à la suite de l'achèvement de la première ligne de chimiothérapie à base de platine. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 et 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. les patients doivent avoir été précédemment traités avec une anthracycline et un taxane dans le (néo)adjuvante ou métastatique à moins que les patients n'étaient pas adaptés à ces traitements (voir la section 5. les patients ayant des récepteurs hormonaux (rh)-cancer du sein devraient également avoir progressé sur l'avant ou après traitement endocrinien, ou être considéré comme impropre à la thérapie endocrinienne. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Union européenne - français - EMA (European Medicines Agency)

janssen-cilag international n.v.    - ponesimod - la sclérose en plaques, sep récurrente-rémittente - immunosuppresseurs - ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.