Union européenne - français - 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. 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.

Union européenne - français - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibrose kystique - autres produits du système respiratoire - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 et 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 et 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Belgique - français - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

rotop pharmaka gmbh - (bis)tétrafluoroborate de tétrofosmine 0,34 mg - eq. tétrofosmine 0,23 mg - trousse pour préparation radiopharmaceutique - 0,23 mg - (bis)tétrafluoroborate de tétrofosmine 0.34 mg - technetium (99mtc) tetrofosmin

Union européenne - français - EMA (European Medicines Agency)

janssen-cilag international nv - doripénème - pneumonia, ventilator-associated; pneumonia, bacterial; urinary tract infections; bacterial infections; cross infection - les antibactériens à usage systémique, - doribax est indiqué pour le traitement des infections suivantes chez l'adulte:la pneumonie nosocomiale (y compris pneumonie);compliquées intra-abdominales, infections, infections urinaires compliquées. la considération devrait être donnée à des recommandations officielles concernant l'utilisation appropriée des antibactériens.

Union européenne - français - EMA (European Medicines Agency)

amgen europe b.v. - pegfilgrastim - neutropénie - les immunostimulants, - réduction de la durée de la neutropénie et l’incidence des neutropénies fébriles chez les patients adultes traités par chimiothérapie cytotoxique pour tumeur maligne (à l’exception de la chronique syndrome myélodysplasique et de leucémie myéloïde).

Union européenne - français - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - immunosuppresseurs - veuillez vous référer à la section 4. 1 du résumé des caractéristiques du produit dans le document d'information sur le produit.

Union européenne - français - EMA (European Medicines Agency)

amgen europe b.v. - darbepoetin alfa - anemia; cancer; kidney failure, chronic - d'autres antianémique préparations - traitement de l'anémie symptomatique associée à l'insuffisance rénale chronique (irc) chez les adultes et les patients pédiatriques. traitement de l'anémie symptomatique chez les adultes chez les patients avec cancer non myéloïde recevant une chimiothérapie.

Union européenne - français - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - cellule précurseur leucémie lymphoblastique - lymphome - agents antinéoplasiques - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Union européenne - français - EMA (European Medicines Agency)

janssen-cilag international n.v.   - décitabine - leucémie, myéloïde - agents antinéoplasiques - traitement des patients adultes présentant une leucémie myéloïde aiguë (lma) de novo ou secondaire nouvellement diagnostiquée, selon la classification de l'organisation mondiale de la santé (oms), qui ne sont pas candidats à la chimiothérapie d'induction standard.

Union européenne - français - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - le myélome multiple - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. en association avec le bortézomib, la thalidomide et la dexaméthasone pour le traitement de patients adultes atteints de myélome multiple nouvellement diagnostiqué, qui sont admissibles à une greffe de cellules souches autologues. en combinaison avec le lénalidomide et de la dexaméthasone, ou le bortézomib et la dexaméthasone, pour le traitement de patients adultes atteints de myélome multiple qui ont reçu au moins un traitement antérieur. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. en tant que monothérapie pour le traitement des patients adultes en rechute et réfractaire myélome multiple, dont le traitement antérieur inclus un inhibiteur du protéasome et un agent immunomodulateur et qui ont démontré la progression de la maladie sur la dernière thérapie. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.