Intrarosa European Union - English - EMA (European Medicines Agency)

intrarosa

endoceutics s.a. - prasterone - postmenopause - other sex hormones and modulators of the genital system - intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.,

Reagila European Union - English - EMA (European Medicines Agency)

reagila

gedeon richter - cariprazine hydrochloride - schizophrenia - psycholeptics - reagila is indicated for the treatment of schizophrenia in adult patients.

Ziextenzo European Union - English - EMA (European Medicines Agency)

ziextenzo

sandoz gmbh - pegfilgrastim - neutropenia - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

LysaKare European Union - English - EMA (European Medicines Agency)

lysakare

advanced accelerator applications - l-arginine hydrochloride, l-lysine hydrochloride - radiation injuries - detoxifying agents for antineoplastic treatment - lysakare is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide therapy (prrt) with lutetium (177lu) oxodotreotide in adults.

Bylvay European Union - English - EMA (European Medicines Agency)

bylvay

albireo - odevixibat - cholestasis, intrahepatic - bile and liver therapy - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or older (see sections 4.4 and 5.1).

Sitagliptin SUN European Union - English - EMA (European Medicines Agency)

sitagliptin sun

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.

Dimethyl fumarate Neuraxpharm European Union - English - EMA (European Medicines Agency)

dimethyl fumarate neuraxpharm

laboratorios lesvi s.l. - dimethyl fumarate - multiple sclerosis, relapsing-remitting - immunosuppressants - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Ertapenem SUN European Union - English - EMA (European Medicines Agency)

ertapenem sun

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.