Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

biofrontera bioscience gmbh - 5-aminolevulinic acid hydrochloride - keratosis, actinic; carcinoma, basal cell - antineoplastic agents - treatment of actinic keratosis of mild to moderate severity on the face and scalp (olsen grade 1 to 2; see section 5.1) and of field cancerization in adults.treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

teva b.v.  - clopidogrel (as hydrochloride) - myocardial infarction; peripheral vascular diseases; stroke - antithrombotic agents - 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.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.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

archie samiel s.r.o. - 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.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

chanelle pharmaceuticals manufacturing limited - meloxicam - oxicams, anti-inflammatory and anti-rheumatic products, non-steroids - dogs; horses; cats; cattle; pigs - dogsalleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs. to reduce post-operative pain and inflammation following orthopaedic and soft tissue surgery.catsreduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.cattlefor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs. for use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. for adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.pigsfor use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. for adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy. for the relief of post operative pain associated with minor soft tissue such as castration.horsesalleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses..for the relief of pain associated with equine colic.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

ratiopharm gmbh - leflunomide - arthritis, rheumatoid - immunosuppressants - leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard);active psoriatic arthritis.recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

Ευρωπαϊκή Ένωση - Αγγλικά - 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.

Ευρωπαϊκή Ένωση - Αγγλικά - 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.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd - netupitant, palonosetron hydrochloride - vomiting; neoplasms; nausea; cancer - antiemetics and antinauseants, - akynzeo is indicated in adults for the:prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy.prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

viatris limited - clopidogrel besilate - peripheral vascular diseases; stroke; myocardial infarction - 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), ischemic 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.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - docetaxel - stomach neoplasms; adenoma; breast neoplasms; carcinoma, non-small-cell lung; prostatic neoplasms - antineoplastic agents - breast cancerdocetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.docetaxel 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.docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express her2 and who previously have not received chemotherapy for metastatic disease.docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline.non-small cell lung cancerdocetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.docetaxel 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 in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.gastric adenocarcinomadocetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.head and neck cancerdocetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.