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

pharmacor pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.4 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: mannitol; sodium carbonate; sodium starch glycollate; crospovidone; colloidal anhydrous silica; calcium stearate; hypromellose; macrogol 6000; sodium hydroxide; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: i) duodenal ulcer; ii) gastric ulcer; iii) gastro-oesophageal reflux disease (gord): symptomatic gord. the treatment of heartburn and other symptoms associated with gord; reflux oesophagitis; iv) gastrointestinal lesions refractory h2 blockers; v) zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment.

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

strides pharma science pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.4 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: colloidal anhydrous silica; hypromellose; macrogol 6000; sodium starch glycollate; mannitol; calcium stearate; sodium carbonate; crospovidone; sodium hydroxide; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: i) duodenal ulcer; ii) gastric ulcer; iii) gastro-oesophageal reflux disease (gord): symptomatic gord. the treatment of heartburn and other symptoms associated with gord; reflux oesophagitis; iv) gastrointestinal lesions refractory h2 blockers; v) zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment.

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

strides pharma science pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.7 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: sodium starch glycollate; hypromellose; sodium carbonate; crospovidone; colloidal anhydrous silica; mannitol; sodium hydroxide; calcium stearate; macrogol 6000; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: i) duodenal ulcer; ii) gastric ulcer; iii) gastro-oesophageal reflux disease (gord): symptomatic gord. the treatment of heartburn and other symptoms associated with gord; reflux oesophagitis; iv) gastrointestinal lesions refractory h2 blockers; v) zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment.

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

janssen-cilag pty ltd - golimumab, quantity: 50 mg - injection, solution - excipient ingredients: histidine; polysorbate 80; water for injections; sorbitol - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

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

janssen-cilag pty ltd - golimumab, quantity: 50 mg - injection, solution - excipient ingredients: polysorbate 80; water for injections; histidine; sorbitol - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

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

sun pharma anz pty ltd - pantoprazole sodium, quantity: 45.113 mg - tablet, enteric coated - excipient ingredients: hyprolose; triethyl citrate; crospovidone; purified talc; calcium stearate; sodium lauryl sulfate; sodium carbonate; microcrystalline cellulose; methacrylic acid - ethyl acrylate copolymer (1:1); mannitol; titanium dioxide; iron oxide yellow; hypromellose; propylene glycol; povidone; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion i.e for duodenal ulcer, gastric ulcer, gastro-oesophageal reflux disease (gord) including - symptomatic gord. the treatment of heartburn and other symptoms associated with gord; - reflux oesophagitis; gastrointestinal lesions refractory to h2 blockers, and zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment.

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

sun pharma anz pty ltd - pantoprazole sodium, quantity: 22.557 mg - tablet, enteric coated - excipient ingredients: purified talc; microcrystalline cellulose; sodium carbonate; sodium lauryl sulfate; iron oxide yellow; titanium dioxide; triethyl citrate; mannitol; crospovidone; hyprolose; methacrylic acid - ethyl acrylate copolymer (1:1); calcium stearate; hypromellose; propylene glycol; povidone; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion i.e for duodenal ulcer, gastric ulcer, gastro-oesophageal reflux disease (gord) including - symptomatic gord. the treatment of heartburn and other symptoms associated with gord; - reflux oesophagitis; gastrointestinal lesions refractory to h2 blockers, and zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment.

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

pharmacor pty ltd - omeprazole, quantity: 20 mg - capsule - excipient ingredients: quinoline yellow; purified water; gelatin; titanium dioxide; sodium lauryl sulfate; dibasic sodium phosphate; mannitol; hypromellose; macrogol 6000; purified talc; polysorbate 80; methacrylic acid copolymer; maize starch; sucrose - the relief of heartburn and other symptoms associated with gord. the treatment and prevention of relapse in erosive oesophagitis. the treatment of duodenal and gastric ulcer. combination therapy for the treatment of peptic ulcer disease associated with h. pylori infection. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs.the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be h. pylori negative, or in whom eradication is inappropriate, e.g. the elderly or ineffective. the treatment of zollinger-ellison syndrome.

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

pharmacor pty ltd - omeprazole, quantity: 20 mg - capsule - excipient ingredients: purified water; gelatin; quinoline yellow; titanium dioxide; sodium lauryl sulfate; dibasic sodium phosphate; mannitol; hypromellose; macrogol 6000; purified talc; polysorbate 80; methacrylic acid copolymer; maize starch; sucrose - the relief of heartburn and other symptoms associated with gord. the treatment and prevention of relapse in erosive oesophagitis. the treatment of duodenal and gastric ulcer. combination therapy for the treatment of peptic ulcer disease associated with h. pylori infection. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs.the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be h. pylori negative, or in whom eradication is inappropriate, e.g. the elderly or ineffective. the treatment of zollinger-ellison syndrome.

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

pharmacor pty ltd - omeprazole, quantity: 20 mg - capsule - excipient ingredients: purified water; titanium dioxide; quinoline yellow; gelatin; sodium lauryl sulfate; dibasic sodium phosphate; mannitol; hypromellose; macrogol 6000; purified talc; polysorbate 80; methacrylic acid copolymer; maize starch; sucrose - the relief of heartburn and other symptoms associated with gord. the treatment and prevention of relapse in erosive oesophagitis. the treatment of duodenal and gastric ulcer. combination therapy for the treatment of peptic ulcer disease associated with h. pylori infection. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs.the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be h. pylori negative, or in whom eradication is inappropriate, e.g. the elderly or ineffective. the treatment of zollinger-ellison syndrome.