Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - riltozinameran, quantity: 50 microgram/ml; tozinameran, quantity: 50 microgram/ml - injection, suspension - excipient ingredients: water for injections; distearoylphosphatidylcholine; trometamol; trometamol hydrochloride; sucrose; 2-((polyethylene glycol)-2000)-n-n-ditetradecylacetamide; ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate); cholesterol - comirnaty original/omicron ba.1 vaccine has provisional approval for the indication below: as a booster dose for active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2, in individuals 18 years of age and older. the use of this vaccine should be in accordance with official recommendations. the decision has been made on the basis of short term immunogenicity and safety data. continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - tozinameran, quantity: 50 microgram/ml; famtozinameran, quantity: 50 microgram/ml - injection, suspension - excipient ingredients: cholesterol; sucrose; distearoylphosphatidylcholine; ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate); 2-((polyethylene glycol)-2000)-n-n-ditetradecylacetamide; trometamol hydrochloride; water for injections; trometamol - comirnaty original/omicron ba.4-5 vaccine has provisional approval for the indication below:,active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov- 2, in individuals12 years of age and older.,the use of this vaccine should be in accordance with official recommendations.,the decision has been made on the basis of short term immunogenicity and safety data. continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

Malta - İngilizce - Medicines Authority

adamed sp. z.o.o. pieńków 149, 05-152 czosnów, poland - solifenacin succinate - film-coated tablet - solifenacin succinate 5 mg - urologicals

Malta - İngilizce - Medicines Authority

adamed sp. z.o.o. pieńków 149, 05-152 czosnów, poland - solifenacin succinate - film-coated tablet - solifenacin succinate 10 mg - urologicals

Malta - İngilizce - Medicines Authority

teva pharma b.v. (utrecht) swensweg 5, 2031 ga haarlem, netherlands - solifenacin succinate - film-coated tablet - solifenacin succinate 5 mg - urologicals

Malta - İngilizce - Medicines Authority

teva pharma b.v. (utrecht) swensweg 5, 2031 ga haarlem, netherlands - solifenacin succinate - film-coated tablet - solifenacin succinate 10 mg - urologicals

Birleşik Krallık - İngilizce - MHRA (Medicines & Healthcare Products Regulatory Agency)

upjohn uk ltd - atorvastatin calcium trihydrate - oral tablet - 10mg

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

vericel denmark aps - autologous cultured chondrocytes - fractures, cartilage - other drugs for disorders of the musculo-skeletal system - repair of symptomatic cartilage defects of the knee.

Birleşik Krallık - İngilizce - MHRA (Medicines & Healthcare Products Regulatory Agency)

zentiva pharma uk ltd - fluvastatin sodium - modified-release tablet - 80mg

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - formoterol fumarate, quantity: 12 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - for long-term, regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercised-induced asthma) in patients aged 5 years or more who are receiving inhaled or oral corticosteroids. it should not be used in patients whose asthma can be managed by occasional use of short-acting inhaled beta-2 agonists. indications as at 27 march 2001: for the long-term regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercise-induced asthma) in patients aged 5 years or more who are receiving inhaled or oral corticosteroids. it should not be used in patients whose asthma can be managed by occasional use of short-acting inhaled beta-2 agonists. for the prophylaxis and treatment of bronchoconstriction in patients with reversible or irreversible chronic obstructive pulmonary disease (copd).