European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - rilpivirine hydrochloride - hiv infections - antivirals for systemic use - edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (hiv‑1) infection in antiretroviral treatment‑naïve patients 12 years of age and older with a viral load ≤ 100,000 hiv‑1 rna copies/ml. as with other antiretroviral medicinal products, genotypic resistance testing should guide the use of edurant.,

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - rilpivirine - hiv infections - antivirals for systemic use - rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (hiv 1) infection in adults who are virologically suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the nnrti and ini class.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - norelgestromin; ethinylestradiol - transdermal patch - 203microgram/24hour ; 33.9microgram/24hour

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v. - paliperidone palmitate - schizophrenia - psycholeptics - xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.in selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - fentanyl hydrochloride - pain, postoperative - analgesics - management of acute moderate to severe post-operative pain for use in a hospital setting only

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

janssen-cilag pty ltd - ustekinumab, quantity: 135 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; sucrose; polysorbate 80; methionine; disodium edetate; water for injections; histidine - crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

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

janssen-cilag pty ltd - daratumumab, quantity: 400 mg - injection, concentrated - excipient ingredients: glacial acetic acid; sodium acetate trihydrate; sodium chloride; mannitol; polysorbate 20; water for injections - darzalex is indicated for the treatment of patients:,? with newly diagnosed multiple myeloma:,- who are eligible for autologous stem cell transplant. for use in combination with:,? bortezomib, thalidomide, and dexamethasone.,- who are ineligible for autologous stem cell transplant. for use in combination with:,? bortezomib, melphalan and prednisone, or,? lenalidomide and dexamethasone.,? with multiple myeloma who have received:,- at least one prior therapy. for use in combination with:,? bortezomib and dexamethasone, or,? lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent. for use as:,? monotherapy.

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

janssen-cilag pty ltd - daratumumab, quantity: 100 mg - injection, concentrated - excipient ingredients: glacial acetic acid; sodium acetate trihydrate; sodium chloride; mannitol; polysorbate 20; water for injections - darzalex is indicated for the treatment of patients:,? with newly diagnosed multiple myeloma:,- who are eligible for autologous stem cell transplant. for use in combination with:,? bortezomib, thalidomide, and dexamethasone.,- who are ineligible for autologous stem cell transplant. for use in combination with:,? bortezomib, melphalan and prednisone, or,? lenalidomide and dexamethasone.,? with multiple myeloma who have received:,- at least one prior therapy. for use in combination with:,? bortezomib and dexamethasone, or,? lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent. for use as:,? monotherapy.

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

janssen-cilag pty ltd - abiraterone acetate, quantity: 500 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; silicified microcrystalline cellulose; hypromellose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - zytiga is indicated in combination with prednisone or prednisolone for the treatment of: ? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt), or ? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcrpc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) or ? patients with mcrpc who have received prior chemotherapy containing a taxane.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 312 mg/ml (equivalent: paliperidone, qty 200 mg/ml) - injection, suspension - excipient ingredients: polysorbate 20; macrogol 4000; citric acid monohydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months.