Ástralía - enska - 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 - janssen abiraterone 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.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - abiraterone acetate, quantity: 250 mg - tablet - excipient ingredients: colloidal anhydrous silica; povidone; microcrystalline cellulose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; croscarmellose sodium - janssen abiraterone 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.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - apalutamide, quantity: 60 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; hypromellose acetate succinate; croscarmellose sodium; silicified microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black - janssen apalutamide (apalutamide) is indicated for the treatment of patients with: ? metastatic castration-sensitive prostate cancer (mcspc) or ? non-metastatic, castration-resistant prostate cancer (nmcrpc).

Evrópusambandið - enska - EMA (European Medicines Agency)

janssen-cilag international n.v.   - paliperidone palmitate - schizophrenia - psycholeptics - byannli (previously paliperidone janssen-cilag international) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.1).

Ástralía - enska - APVMA (Australian Pesticides and Veterinary Medicines Authority)

janssen pharmaceutica n.v. - imazalil - emulsifiable concentrate - imazalil imidazole active 500.0 g/l - fungicide - citrus - post-harvest dip | potato - post-harvest | rockmelon or canteloup - post-harvest | canteloup | musk melon - alternaria rot | blue mould on citrus - p. italicum | fusarium fruit rot | fusarium spp. | gangrene - phoma exigua | green mould | penicillium spp. | silver scurf | fusarium patch

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - daratumumab 20 mg/ml;  ;   - concentrate for infusion - 100 mg/5ml - active: daratumumab 20 mg/ml     excipient: glacial acetic acid mannitol polysorbate 20 sodium acetate trihydrate sodium chloride water for injection - 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

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - daratumumab 20 mg/ml;  ;   - concentrate for infusion - 400 mg/20ml - active: daratumumab 20 mg/ml     excipient: glacial acetic acid mannitol polysorbate 20 sodium acetate trihydrate sodium chloride water for injection - 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

Evrópusambandið - enska - EMA (European Medicines Agency)

janssen-cilag international nv - adenovirus type 26 encoding the sars-cov-2 spike glycoprotein (ad26.cov2-s) - covid-19 virus infection - vaccines - jcovden 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.

Evrópusambandið - enska - EMA (European Medicines Agency)

janssen pharmaceutica n.v. - mitratapide - antiobesity preparations, excl. diet products - dogs - as an aid in the management of overweight and obesity in adult dogs. to be used as part of an overall weight management programme which also includes appropriate dietary changes. introducing appropriate lifestyle changes (e.g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.

Evrópusambandið - enska - EMA (European Medicines Agency)

janssen-cilag international nv - paliperidone palmitate - schizophrenia - psycholeptics - trevicta, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitate injectable product.