Europeiska unionen - svenska - EMA (European Medicines Agency)

taw pharma (ireland) limited - klopidogrelhydroklorid - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antitrombotiska medel - , , , , 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. , , ,.

Europeiska unionen - svenska - EMA (European Medicines Agency)

glaxo group limited  - retigabin - epilepsi - antiepileptika, - trobalt är indicerat som tilläggsbehandling av läkemedelsresistenta anfall vid anfall med eller utan sekundär generalisering hos patienter i åldrarna 18 år med epilepsi, där andra lämpliga läkemedelskombinationer har visat sig otillräckliga eller inte tolererats.

Europeiska unionen - svenska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - fluticasone furoate, vilanterol - pulmonell sjukdom, kronisk obstruktiv - adrenergika och andra läkemedel för obstruktiva luftvägssjukdomar - astma indikation:relvar ellipta anges i regelbunden behandling av astma hos vuxna och ungdomar i åldern 12 år och äldre, där man använder en kombination produkt (långverkande beta2-agonist och inhalerad kortikosteroid) är lämplig:för patienter som inte kontrolleras på ett adekvat sätt med inhalerade kortikosteroider och "som behövs" inhalerad kortverkande beta2-agonister. patienter som redan kontrolleras på ett adekvat sätt på både inhalerad kortikosteroid och långverkande beta2-agonist. kol indikation:relvar ellipta är indicerat för symtomatisk behandling av vuxna med kol med fev1.

Europeiska unionen - svenska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - fluticasone furoate, vilanterol trifenatate - astma - adrenergika och andra läkemedel för obstruktiva luftvägssjukdomar - astma indicationrevinty ellipta anges i regelbunden behandling av astma hos vuxna och ungdomar i åldern 12 år och äldre, där man använder en kombination produkt (långverkande beta2-agonist och inhalerad kortikosteroid) är lämplig:för patienter som inte kontrolleras på ett adekvat sätt med inhalerade kortikosteroider och "som behövs" inhalerad kortverkande beta2-agonister. kol indicationrevinty ellipta är indicerat för symtomatisk behandling av vuxna med kol med fev1.

Europeiska unionen - svenska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastiska medel - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Europeiska unionen - svenska - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastiska medel - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. för vidare information om human epidermal growth factor receptor 2 (her2) status, se avsnitt 5. abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. för ytterligare information om her2-status, se avsnitt 5. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Europeiska unionen - svenska - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydroklorid - multipel skleros, skovvis förlöpande - immunsuppressiva - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 och 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Europeiska unionen - svenska - EMA (European Medicines Agency)

mylan ireland limited - dimetylfumarat - multipel skleros, skovvis förlöpande - immunsuppressiva - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Europeiska unionen - svenska - EMA (European Medicines Agency)

fennec pharmaceuticals (eu) limited - sodium thiosulfate - ear diseases; ototoxicity - alla andra terapeutiska produkter - pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

brillpharma (ireland) limited - ibuprofen - filmdragerad tablett - 200 mg - ibuprofen 200 mg aktiv substans; laktosmonohydrat hjälpämne; natriumlaurilsulfat hjälpämne - ibuprofen