European Union - English - EMA (European Medicines Agency)

abz-pharma gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - colony stimulating factors - biograstim is indicated for the 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 for the 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.biograstim is indicated for the mobilisation of peripheral blood progenitor cells (pbpc).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.biograstim is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. 

European Union - English - EMA (European Medicines Agency)

taw pharma (ireland) limited - clopidogrel hydrochloride - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antithrombotic agents - , , , , secondary prevention of atherothrombotic events, , clopidogrel is indicated in: , - adult 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., - adult 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., , in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is), clopidogrel in combination with asa is indicated in:, - adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. , , prevention of atherothrombotic and thromboembolic events in atrial fibrillation, in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke., , for further information please refer to section 5.1. , , ,

European Union - English - EMA (European Medicines Agency)

tillotts pharma gmbh - fidaxomicin - clostridium infections - antidiarrheals, intestinal antiinflammatory / antiinfective agents - dificlir film-coated tablets is indicated for the treatment of clostridioides difficile infections (cdi) also known as c. difficile-associated diarrhoea (cdad) in adult and paediatric patients with a body weight of at least 12.5 kg.consideration should be given to official guidelines on the appropriate use of antibacterial agents.dificlir granules for oral suspension is indicated for the treatment of clostridioides  difficile infections (cdi) also known as c. difficile-associated diarrhoea (cdad) in adults and paediatric patients from birth to < 18 years of age.consideration should be given to official guidelines on the appropriate use of antibacterial agents.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - docetaxel - carcinoma, non-small-cell lung; breast neoplasms; prostatic neoplasms - antineoplastic agents - breast cancerdocetaxel teva pharma 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.non-small-cell lung cancerdocetaxel teva pharma is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.docetaxel teva pharma 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 teva pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

European Union - English - EMA (European Medicines Agency)

merz pharmaceuticals gmbh   - memantine hydrochloride - alzheimer disease - other anti-dementia drugs - treatment of patients with moderate to severe alzheimer’s disease.

European Union - English - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - ziconotide - injections, spinal; pain - analgesics - ziconotide is indicated for the treatment of severe, chronic pain in patients who require intrathecal (it) analgesia.

European Union - English - EMA (European Medicines Agency)

pari pharma gmbh - tobramycin - cystic fibrosis; respiratory tract infections - antibacterials for systemic use, , aminoglycoside antibacterials - vantobra is indicated for the management of chronic pulmonary infection due to pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (cf).consideration should be given to official guidance on the appropriate use of antibacterial agents.

European Union - English - EMA (European Medicines Agency)

biotest pharma gmbh - human hepatitis b immunoglobulin - immunization, passive; hepatitis b; liver transplantation - immune sera and immunoglobulins, - prevention of hepatitis b virus (hbv) re-infection in hbsag and hbv-dna negative adult patients at least one week after liver transplantation for hepatitis b induced liver failure. hbv-dna negative status should be confirmed within the last 3 months prior to olt. patients should be hbsag negative before treatment start. the concomitant use of adequate virostatic agents should be considered as standard of hepatitis b re-infection prophylaxis.,

Malta - English - Medicines Authority

1 a pharma gmbh keltenring 1+3, 82041 oberhaching, germany - tigecycline - powder for solution for infusion - tigecycline 50 mg - antibacterials for systemic use