Malta - English - Medicines Authority

hexal pharma gmbh stella-klein-low-weg 17, 1020 wein, austria - cilostazol - tablet - cilostazol 100 mg - antithrombotic agents

European Union - English - EMA (European Medicines Agency)

acino pharma gmbh - clopidogrel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - antithrombotic agents - clopidogrel is indicated in adults for the prevention of atherothrombotic events in:patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease;patients suffering from acute coronary syndrome:- non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa);- st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy.for further information please refer to section 5.1.

European Union - English - EMA (European Medicines Agency)

hexal ag  - rivastigmine - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - symptomatic treatment of mild to moderately severe alzheimer's dementia.symptomatic treatment of mild to moderately severe dementia in patients with idiopathic parkinson's disease.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

imeks pharma sdn. bhd. - carvedilol -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

imeks pharma sdn. bhd. - carvedilol -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

imeks pharma sdn. bhd. - carvedilol -

European Union - English - EMA (European Medicines Agency)

hexal ag - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.mobilisation of peripheral blood progenitor cells (pbpcs).in children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.treatment of persistent neutropenia (anc ≤ 0.5 x 109/l), and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.

European Union - English - EMA (European Medicines Agency)

1 a pharma gmbh - rivastigmine - alzheimer disease; dementia; parkinson disease - psychoanaleptics, - symptomatic treatment of mild to moderately severe alzheimer's dementia.symptomatic treatment of mild to moderately severe dementia in patients with idiopathic parkinson's disease.

European Union - English - EMA (European Medicines Agency)

hexal ag - temozolomide - glioma; glioblastoma - antineoplastic agents - for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (rt) and subsequently as monotherapy treatment.for the treatment of 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.

Malta - English - Medicines Authority

1 a pharma gmbh keltenring 1+3, 82041 oberhaching, germany - buprenorphine - transdermal patch - buprenorphine 35 µg - analgesics