European Union - English - EMA (European Medicines Agency)

viiv healthcare b.v. - cabotegravir - hiv infections - antivirals for systemic use - apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1).

European Union - English - EMA (European Medicines Agency)

takeda manufacturing austria ag - c1 inhibitor (human) - angioedemas, hereditary - c1-inhibitor, plasma derived, drugs used in hereditary angioedema - treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (hae).routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (hae), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - radionuclide imaging - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.4).

United States - English - NLM (National Library of Medicine)

cisen pharmaceutical co., ltd. - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - adults esomeprazole magnesium delayed-release capsules is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed ee in adults. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of nexium may be considered. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsules is indicated for the short-term treatment (4 to 8 weeks) for the healing of ee in pediatric patients 12 years to 17 years of age. esomeprazole magnesium delayed-release capsules is indicated for the maintenance of healing of ee in adults. controlled studies do not extend beyond 6 months. adults esomeprazole magnesium delayed-release capsules is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with gerd in adults. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsules is indicated for short-term treatment (4

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - hepatitis a vaccine - solution for injection - 25iu/0.5 m units/ml - hepatitis vaccines

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

cisen pharmaceutical co.,ltd. - omeprazol - omeprazol ....40.00 mg

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - upadacitinib as hemihydrate - tablets prolonged release - upadacitinib as hemihydrate 45 mg - upadacitinib - ulcerative colitisrinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.crohn’s diseaserinvoq is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Israel - English - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - glivec is indicated for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). glivec is also indicated for the treament of : adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph + all as monotherapy. adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr ( platelet - derived growth factor receptor ) gene re- arrangements. adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration for chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative . adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation . adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Israel - English - Ministry of Health

novartis israel ltd - lutetium (177lu) vipivotide tetraxetan - solution for injection / infusion - lutetium (177lu) vipivotide tetraxetan 1000 mbq/ml - lutetium (177lu) vipivotide tetraxetan - pluvicto is indicated for the treatment of adult patients with prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with androgen receptor (ar) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

Israel - English - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 100 mg - imatinib - imatinib - glivec is indicated for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).glivec is also indicated for the treament of : * adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy.* adult patients with relapsed or refractory ph + all as monotherapy.* adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. * adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet - derived growth factor receptor ) gene re- arrangements. * adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration fo chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative. * adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation.* adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.