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.

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

pharma regulatory solutions ltd - voriconazole - pdr for soln for infusion - 200 milligram - triazole derivatives - antimycotics for systemic use, triazole derivatives - voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis. treatment of candidaemia in non-neutropenic patients. treatment of fluconazole-resistant serious invasive candida infections (including c. krusei). treatment of serious fungal infections caused by scedosporium spp. and fusarium spp. voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients.

Kenya - English - Pharmacy and Poisons Board

bilthoven biologicals b.v antonie van leeuwenhoeklaan 9-13, bilthoven, 3721 - inactivated poliomyelitis virus type 1… - suspension for injection - inactivated poliomyelitis virus type 1 -40… - viral vaccines: poliomyelitis vaccines

Kenya - English - Pharmacy and Poisons Board

inactivated rabies vaccine - injection - inactivated rabies vaccine - antibacterials for systemic use

Kenya - English - Pharmacy and Poisons Board

ceva-phylaxia veterinary biologicals co ltd 1107 budapest, szállás utca 5 - inactivated newcastle disease virus strain ndv-sz… - injection - inactivated newcastle disease virus strain… - immunologicals for domestic fowl: inactivated

Kenya - English - Pharmacy and Poisons Board

ceva-phylaxia veterinary biologicals co ltd 1107 budapest, szállás utca 5 - inactivated newcastle disease virus strain ndv-sz… - injection - inactivated newcastle disease virus strain ndv-sz… - immunologicals for domestic fowl: inactivated

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

endo pharmaceuticals inc. - acrivastine (unii: a20f9xai7w) (acrivastine - unii:a20f9xai7w), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f) - acrivastine 8 mg - semprex-d capsules are indicated for relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion. semprex-d capsules should be administered when both the antihistaminic activity of acrivastine and the nasal decongestant activity of pseudoephedrine are desired (see clinical pharmacology ). the efficacy of semprex-d capsules beyond 14 days of continuous treatment in patients with seasonal allergic rhinitis has not been adequately investigated in clinical trials. semprex-d capsules have not been adequately studied for effectiveness in relieving the symptoms of the common cold. semprex-d capsules are contraindicated in patients with a known sensitivity to acrivastine, other alkylamine antihistamines (e.g., triprolidine), pseudoephedrine, other sympathomimetic amines (e.g., phenylpropanolamine), or to any other components of the formulation. semprex-d capsules are contraindicated in patients with severe hypertension or severe coronary arte

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole mylan pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole mylan pharma is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.aripiprazole mylan pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.