Israel - English - Ministry of Health

novartis israel ltd - capmatinib as dihydrochloride monohydrate - film coated tablets - capmatinib as dihydrochloride monohydrate 200 mg - capmatinib - tabrecta is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors have a mutation that leads to mesenchymal-epithelial transition (met) exon 14 skipping as detected by an approved test.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - cabotegravir - prolonged release suspension for injection - cabotegravir 200 mg / 1 ml - vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the nnrti and ini class

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - cabotegravir as sodium - film coated tablets - cabotegravir as sodium 30 mg - vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the nnrti and ini class for: • oral lead in to assess tolerability of vocabria and rilpivirine prior to administration of long acting cabotegravir injection plus long acting rilpivirine injection. • oral therapy for adults who will miss planned dosing with cabotegravir injection plus rilpivirine injection.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - carcinoma, non-small-cell lung - antineoplastic agents - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

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

astrazeneca pharmaceuticals lp - acalabrutinib (unii: i42748elqw) (acalabrutinib - unii:i42748elqw) - acalabrutinib 100 mg - calquence is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy. this indication is approved under accelerated approval based on overall response rate [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. calquence is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll). none. risk summary based on findings in animals, calquence may cause fetal harm and dystocia when administered to a pregnant woman. there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of acalabrutinib to animals during organogenesis resulted in dystocia in rats and reduced fetal growth in rabbits at maternal exposures (auc) 2 times exposures in patients at the recommended dose of 100 mg approximately every 12 hours (s

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

boston oncology arabia, saudi arabia - acalabrutinib - capsule, hard - 100 mg,

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

amgen inc - ivabradine hydrochloride (unii: tp19837bzk) (ivabradine - unii:3h48l0lpzq) - ivabradine 5 mg - corlanor is indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.  corlanor is indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (dcm) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate. corlanor is contraindicated in patients with: • acute decompensated heart failure • clinically significant hypotension • sick sinus syndrome, sinoatrial block or 3rd degree av block, unless a functioning demand pacemaker is present • clinically significant bradycardia [see warnings and precautions ( 5.3 )] • severe hepatic impairment [see use in specific populations ( 8.6 )] • pacemaker dependence (heart rate maintained exclu

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - ivabradine hydrochloride - tablet - 5mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - ivabradine hydrochloride - tablet - 7.5mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

actavis uk ltd - ivabradine hydrochloride - tablet - 5mg