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

cipla australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

janssen-cilag pty ltd - ad26.cov2.s, quantity: 50000000000 vp - injection, suspension - excipient ingredients: sodium chloride; polysorbate 80; sodium hydroxide; hydroxypropylbetadex; citric acid monohydrate; sodium citrate dihydrate; ethanol absolute; hydrochloric acid; water for injections - covid-19 vaccine janssen has provisional approval for the indication:,covid-19 vaccine janssen is indicated for active immunisation to prevent 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 efficacy and safety data. continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Malta - English - Medicines Authority

viatris healthcare limited damastown industrial park, mulhuddart, dublin 15, dublin , ireland - suspension for injection in pre-filled syringe - influenza vaccine (split virion, inactivated) 15 µg - vaccines

Malta - English - Medicines Authority

smithkline beecham limited - mumps vaccine rit 4385; measles virus - schwarz strain; rubella virus - wistar ra27/3 strain - powder and solvent for solution for injection - mumps vaccine rit 4385; measles virus - schwarz strain; rubella virus - wistar ra27/3 strain - vaccines

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - tetanus toxoid, diphtheria toxoid, haemophilus type, b polysaccharide, polyribosylribitol phosphate, conjugated to, as carrier, protein, bordetella pertussis - powder and suspension for suspension for injection - diphtheria toxoid haemophilus type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus toxoid as carrier protein 10 µg bordetella pertussis 4 iu tetanus toxoid 60 iu - vaccines

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

emergent sales and marketing australia pty ltd - vaccinia virus, quantity: 100000000 pfu/ml - injection, powder for - excipient ingredients: sodium chloride; albumin; neomycin sulfate; mannitol; hepes; polymyxin b sulfate - acam2000 is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection in an officially declared outbreak.

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - influenza vaccine, split virion, inactivated - suspension for injection in pre-filled syringe - influenza vaccine (split virion, inactivated) a/victoria/4897/2022 (h1n1) pdm09 - like strain (a/victoria/4897/2022 ivr-238 15 µg a/darwin/9/2021 (h3n2) - like strain (a/darwin/6/2021, ivr-227 15 µg b/austria/1359417/2021 - like strain (b/austria/1359417/2021 bvr-26 15 µg b/phuket/3073/2013 - like strain (b/phuket/3073/2013, wild type) - vaccines

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

baxter healthcare pty ltd - mesna, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: disodium edetate; sodium hydroxide; water for injections - for the reduction and prevention of urinary tract toxicity (haemorrhagic cystitis) of oxazaphosphorines (see adverse effects section of the cyclophosphamide and ifosfamide product information).

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

baxter healthcare pty ltd - mesna, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: disodium edetate; sodium hydroxide; water for injections - for the reduction and prevention of urinary tract toxicity (haemorrhagic cystitis) of oxazaphosphorines (see adverse effects section of the cyclophosphamide and ifosfamide product information).

European Union - English - EMA (European Medicines Agency)

seqirus s.r.l.  - zoonotic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza a virus, h5n1 subtype - vaccines - active immunisation against h5 subtype of influenza a virus