European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - atosiban (as acetate) - premature birth - other gynecologicals - atosiban is indicated to delay imminent pre-term birth in pregnant adult women with:regular uterine contractions of at least 30 seconds’ duration at a rate of ≥ 4 per 30 minutes;a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50%;a gestational age from 24 until 33 completed weeks;a normal foetal heart rate.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - capecitabine - stomach neoplasms; breast neoplasms; colonic neoplasms; colorectal neoplasms - capecitabine - capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-iii (dukes’ stage-c) colon cancer.capecitabine is indicated for the treatment of metastatic colorectal cancer.capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.capecitabine in combination with docetaxel 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. capecitabine is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - docetaxel - stomach neoplasms; adenoma; breast neoplasms; carcinoma, non-small-cell lung; prostatic neoplasms - antineoplastic agents - breast cancerdocetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.docetaxel 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.docetaxel 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.docetaxel in 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.docetaxel 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 cancerdocetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.docetaxel 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 cancerdocetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.gastric adenocarcinomadocetaxel 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 cancerdocetaxel 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

sun pharmaceutical industries europe b.v. - estradiol - vaginal tablet - 10 microgram(s) - estradiol

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i.e. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control.as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - teriparatide - osteoporosis; osteoporosis, postmenopausal - calcium homeostasis - teriparatide sun is indicated in adults.treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated.treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - levetiracetam - epilepsy - other antiepileptics - levetiracetam sun is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.levetiracetam sun is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four years of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.levetiracetam sun concentrate is an alternative for patients when oral administration is temporarily not feasible.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - temozolomide - glioma; glioblastoma - antineoplastic agents - temozolomide sun is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (rt) and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries (europe) b.v. - ertapenem sodium - bacterial infections - ertapenem - treatmentertapenem sun is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1):- intra-abdominal infections- community acquired pneumonia- acute gynaecological infections- diabetic foot infections of the skin and soft tissue (see section 4.4)preventionertapenem sun is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4).consideration should be given to official guidance on the appropriate use of antibacterial agents.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride sun is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.sitagliptin/metformin hydrochloride sun is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.sitagliptin/metformin hydrochloride sun is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist.sitagliptin/metformin hydrochloride sun is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.