European Union - English - EMA (European Medicines Agency)

hospira uk limited - docetaxel trihydrate - stomach neoplasms; prostatic neoplasms; breast neoplasms; head and neck neoplasms; carcinoma, non-small-cell lung - antineoplastic agents - breast cancertaxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.for patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.taxespira in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. previous chemotherapy should have included an anthracycline or an alkylating agent.taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express her2 and who previously have not received chemotherapy for metastatic disease.taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline.non-small cell lung cancer taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.taxespira in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.prostate cancer taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.gastric adenocarcinoma taxespira in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.head and neck cancer taxespira in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

United States - English - NLM (National Library of Medicine)

zydus lifesciences limited - clomipramine hydrochloride (unii: 2lxw0l6gwj) (clomipramine - unii:nuv44l116d) - clomipramine hydrochloride capsules, usp are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (ocd). the obsessions or compulsions must cause marked distress, be time-consuming, or significantly  interfere with  social  or  occupational  functioning,  in  order  to  meet  the dsm-iii-r (circa 1,989) diagnosis of ocd. obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego  dystonic. compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. the effectiveness of clomipramine hydrochloride for the treatment of ocd was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. patients in all studies had moderate-to-severe ocd (dsm-iii), with mean baseline ratings on t

Israel - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; lumacaftor - film coated tablets - ivacaftor 125 mg; lumacaftor 100 mg - ivacaftor and lumacaftor - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who are homozygous for the f508del mutation in the cftr gene limitations of use the efficacy and safety of orkambi have not been established in patients with cf other than those homozygous for the f508del mutation

Israel - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; lumacaftor - film coated tablets - ivacaftor 125 mg; lumacaftor 100 mg - ivacaftor and lumacaftor - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who are homozygous for the f508del mutation in the cftr gene limitations of use the efficacy and safety of orkambi have not been established in patients with cf other than those homozygous for the f508del mutation

Israel - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; lumacaftor - film coated tablets - ivacaftor 125 mg; lumacaftor 200 mg - ivacaftor and lumacaftor - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 12 years and older who are homozygous for the f508del mutation in the cftr gene.if the patient's genotype is unknown, cf mutation test should be used to detect the presence of the f508del mutation on both alleles of the cftr gene.limitations of usethe efficacy and safety of orkambi have not been established in patients with cf other than those homozygous for the f508del mutation.

Israel - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; lumacaftor - film coated tablets - ivacaftor 125 mg; lumacaftor 200 mg - ivacaftor and lumacaftor - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 12 years and older who are homozygous for the f508del mutation in the cftr gene.if the patient's genotype is unknown, cf mutation test should be used to detect the presence of the f508del mutation on both alleles of the cftr gene.limitations of usethe efficacy and safety of orkambi have not been established in patients with cf other than those homozygous for the f508del mutation.

Israel - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; lumacaftor - film coated tablets - ivacaftor 125 mg; lumacaftor 200 mg - ivacaftor and lumacaftor - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 12 years and older who are homozygous for the f508del mutation in the cftr gene.if the patient's genotype is unknown, cf mutation test should be used to detect the presence of the f508del mutation on both alleles of the cftr gene.limitations of usethe efficacy and safety of orkambi have not been established in patients with cf other than those homozygous for the f508del mutation.

Israel - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; lumacaftor - film coated tablets - ivacaftor 125 mg; lumacaftor 200 mg - ivacaftor and lumacaftor - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 12 years and older who are homozygous for the f508del mutation in the cftr gene.if the patient's genotype is unknown, cf mutation test should be used to detect the presence of the f508del mutation on both alleles of the cftr gene.limitations of usethe efficacy and safety of orkambi have not been established in patients with cf other than those homozygous for the f508del mutation.

Israel - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; lumacaftor - film coated tablets - ivacaftor 125 mg; lumacaftor 200 mg - ivacaftor and lumacaftor - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 12 years and older who are homozygous for the f508del mutation in the cftr gene.if the patient's genotype is unknown, cf mutation test should be used to detect the presence of the f508del mutation on both alleles of the cftr gene.limitations of usethe efficacy and safety of orkambi have not been established in patients with cf other than those homozygous for the f508del mutation

Israel - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; lumacaftor - film coated tablets - ivacaftor 125 mg; lumacaftor 200 mg - ivacaftor and lumacaftor - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 12 years and older who are homozygous for the f508del mutation in the cftr gene.if the patient's genotype is unknown, cf mutation test should be used to detect the presence of the f508del mutation on both alleles of the cftr gene.limitations of usethe efficacy and safety of orkambi have not been established in patients with cf other than those homozygous for the f508del mutation.