Clopidogrel Taw Pharma (previously Clopidogrel Mylan) Европейски съюз - български - EMA (European Medicines Agency)

clopidogrel taw pharma (previously clopidogrel mylan)

taw pharma (ireland) limited - клопидогрел хидрохлорид - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - Антитромботични агенти - , , , , 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. , , ,.

Elonva Европейски съюз - български - EMA (European Medicines Agency)

elonva

n.v. organon - корифолитропин алфа - reproductive techniques, assisted; ovulation induction; investigative techniques - Полови хормони и слиза на половата система, - controlled ovarian stimulation (cos) in combination with a gnrh antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (art) program. elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human chorionic gonadotropin (hcg).

Firmagon Европейски съюз - български - EMA (European Medicines Agency)

firmagon

ferring pharmaceuticals a/s - дегареликс - Простатни неоплазми - Ендокринна терапия - firmagon is a gonadotrophin releasing hormone (gnrh) antagonist indicated:- for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Trimbow Европейски съюз - български - EMA (European Medicines Agency)

trimbow

chiesi farmaceutici s.p.a. - beclometasone дипропионат, формотерола фумарата дигидрат бромид glycopyrronium - Белодробна болест, хронична обструктивна болест - Лекарства за обструктивна заболявания на дихателните пътища, - maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. copdmaintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5. asthmamaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

Ajovy Европейски съюз - български - EMA (European Medicines Agency)

ajovy

teva gmbh - fremanezumab - Мигренозни разстройства - calcitonin gene-related peptide (cgrp) antagonists - ajovy е показан за профилактика на мигрена при възрастни, които имат най-малко 4 дни мигрена на месец.

Trixeo Aerosphere Европейски съюз - български - EMA (European Medicines Agency)

trixeo aerosphere

astrazeneca ab - formoterol fumarate dihydrate, glycopyrronium bromide, budesonide - Белодробна болест, хронична обструктивна болест - Лекарства за обструктивна заболявания на дихателните пътища, - trixeo aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

Abiraterone Mylan Европейски съюз - български - EMA (European Medicines Agency)

abiraterone mylan

mylan ireland limited - абаратер ацетат - Простатни неоплазми - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Riltrava Aerosphere Европейски съюз - български - EMA (European Medicines Agency)

riltrava aerosphere

astrazeneca ab - budesonide, formoterol fumarate dihydrate, glycopyrronium bromide - Белодробна болест, хронична обструктивна болест - Лекарства за обструктивна заболявания на дихателните пътища, - riltrava aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2 agonist or combination of a long-acting beta2 agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.

Vydura Европейски съюз - български - EMA (European Medicines Agency)

vydura

pfizer europe ma eeig  - rimegepant - Мигренозни разстройства - antimigraine preparations, calcitonin gene-related peptide (cgrp) antagonists - vydura is indicated for theacute treatment of migraine with or without aura in adults;preventative treatment of episodic migraine in adults who have at least 4 migraine attacks per month.

Tyenne Европейски съюз - български - EMA (European Medicines Agency)

tyenne

fresenius kabi deutschland gmbh - тоцилизумаб - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - Имуносупресори - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.