European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - asthma biresp spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β₂ adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β₂ adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β₂ adrenoceptor agonists.copdbiresp spiromax is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev₁)

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - asthma duoresp spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β₂ adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β₂ adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β₂ adrenoceptor agonists.copdduoresp spiromax is indicated in adults, aged 18 years and older for the symptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev₁)

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig  - palbociclib - breast neoplasms - antineoplastic agents - ibrance is indicated for the treatment of hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer:in combination with an aromatase inhibitor;in combination with fulvestrant in women who have received prior endocrine therapy.in pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (lhrh) agonist.

European Union - English - EMA (European Medicines Agency)

janssen cilag international nv - selexipag - hypertension, pulmonary - antithrombotic agents - uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients with who functional class (fc) ii–iii, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (era) and/or a phosphodiesterase type 5 (pde-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. efficacy has been shown in a pah population including idiopathic and heritable pah, pah associated with connective tissue disorders, and pah associated with corrected simple congenital heart disease.,

Israel - English - Ministry of Health

medison pharma ltd - neratinib as maleate - tablets - neratinib as maleate 40 mg - neratinib - nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive her2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy."nerlynx in combination with capecitabine is indicated for the treatment of adult patients with advanced or metastatic her2-positive breast cancer who have received two or more prior anti-her2 based regimens in the metastatic setting.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - palbociclib, quantity: 100 mg - capsule, hard - excipient ingredients: magnesium stearate; iron oxide yellow; silicon dioxide; iron oxide red; microcrystalline cellulose; sodium starch glycollate type a; lactose monohydrate; titanium dioxide; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid - ibrance is indicated for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - palbociclib, quantity: 75 mg - capsule, hard - excipient ingredients: silicon dioxide; iron oxide yellow; iron oxide red; titanium dioxide; magnesium stearate; sodium starch glycollate type a; gelatin; lactose monohydrate; microcrystalline cellulose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid - ibrance is indicated for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - palbociclib, quantity: 125 mg - capsule, hard - excipient ingredients: gelatin; sodium starch glycollate type a; iron oxide yellow; silicon dioxide; magnesium stearate; titanium dioxide; iron oxide red; lactose monohydrate; microcrystalline cellulose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid - ibrance is indicated for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - palbociclib, quantity: 125 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; silicon dioxide; crospovidone; magnesium stearate; succinic acid; titanium dioxide; hypromellose; triacetin; iron oxide red; indigo carmine aluminium lake - ibrance is indicated for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - palbociclib, quantity: 100 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; silicon dioxide; crospovidone; magnesium stearate; succinic acid; titanium dioxide; hypromellose; triacetin; iron oxide yellow; indigo carmine aluminium lake - ibrance is indicated for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy.