Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

upsa s.a.s. - niflumic acid 2,5 g - gel - 2,5 % - niflumic acid 25 mg/g - niflumic acid

Israel - English - Ministry of Health

bayer israel ltd - regorafenib - film coated tablets - regorafenib 40 mg - regorafenib - regorafenib - stivarga is indicated as monotherapy for the treatment of adults patients:- with metastatic colorectal cancer (crc) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf therapy,and if kras wild- type, an anti-egfr therapy.- with locally advanced, unresectable or metastatic gastrointestinal stromal tumors (gist) who have been previously treated with imatinib mesylate and sunitinib malate.- hepatocellular carcinoma (hcc) who have been previously treated with sorafenib.

European Union - English - EMA (European Medicines Agency)

bayer pharma ag - regorafenib - colorectal neoplasms - antineoplastic agents, protein kinase inhibitors - stivarga is indicated as monotherapy for the treatment of adult patients with:metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-vegf therapy and an anti-egfr therapy;unresectable or metastatic gastrointestinal stromal tumors (gist) who progressed on or are intolerant to prior treatment with imatinib and sunitinib;hepatocellular carcinoma (hcc) who have been previously treated with sorafenib.

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

bayer plc - regorafenib - tablet - 40mg

Ireland - English - HPRA (Health Products Regulatory Authority)

mayne pharma (ireland) limited - niflumic acid - capsule

Ireland - English - HPRA (Health Products Regulatory Authority)

mayne pharma (ireland) limited - niflumic acid - cream

Singapore - English - HSA (Health Sciences Authority)

abbott laboratories (singapore ) private limited - racecadotril - granule, for suspension - 30.00mg - racecadotril 30.00mg

Singapore - English - HSA (Health Sciences Authority)

abbott laboratories (singapore ) private limited - racecadotril - granule, for suspension - 10.00mg - racecadotril 10.00mg

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - regorafenib monohydrate 41.49mg equivalent to regorafenib 40 mg - tablet - 40 mg - active: regorafenib monohydrate 41.49mg equivalent to regorafenib 40 mg excipient: colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose opadry pink 85g35294 povidone - stivarga is indicated for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies. these include fluoropyrimidine-based chemotherapy, an anti-vegf therapy, and an anti-egfr therapy.

European Union - English - EMA (European Medicines Agency)

bayer ag - riociguat - hypertension, pulmonary - antihypertensives for pulmonary arterial hypertension - chronic thromboembolic pulmonary hypertension (cteph) adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah) adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. efficacy has been shown in a pah population including aetiologies of idiopathic or heritable pah or pah associated with connective tissue disease.