Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - risperidone 1mg - orodispersible tablet - 1 mg - active: risperidone 1mg excipient: aspartame carbomer gelatin glycine iron oxide red mannitol peppermint oil polacrilin simeticone sodium hydroxide - risperdal is indicated for the treatment of schizophrenia and other psychotic disorders. these include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - risperidone 2mg; risperidone 2mg - orodispersible tablet - 2 mg - active: risperidone 2mg excipient: aspartame carbomer 934p gelatin glycine iron oxide red mannitol peppermint oil polacrilin simeticone sodium hydroxide active: risperidone 2mg excipient: aspartame carbomer 934p gelatin glycine iron oxide red mannitol peppermint oil polacrilin simeticone sodium hydroxide xanthan gum - risperdal is indicated for the treatment of schizophrenia and other psychotic disorders. these include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - risperidone 3mg - orodispersible tablet - 3 mg - active: risperidone 3mg excipient: aspartame carbomer 934p gelatin glycine iron oxide red mannitol peppermint oil polacrilin simeticone sodium hydroxide xanthan gum - risperdal is indicated for the treatment of schizophrenia and other psychotic disorders. these include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - risperidone 4mg - orodispersible tablet - 4 mg - active: risperidone 4mg excipient: aspartame carbomer 934p gelatin glycine iron oxide red mannitol peppermint oil polacrilin simeticone sodium hydroxide xanthan gum - risperdal is indicated for the treatment of schizophrenia and other psychotic disorders. these include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - itraconazole 100mg;   - capsule - 100 mg - active: itraconazole 100mg   excipient: erythrosine gelatin   hypromellose indigo carmine macrogol 20000 sugar spheres titanium dioxide - sporanox capsules are indicated for the following conditions: - treatment of vulvovaginal candidiasis. - treatment of pityriasis versicolor. - treatment of dermatomycosis – including highly keratinised regions as in plantar tinea pedis and palmer tinea manus. - treatment of fungal keratitis. - treatment of oral candidiasis. - treatment of onychomycosis caused by dermatophytes and/or yeasts. - systemic mycoses, only in the following fungal infections: o treatment of systemic aspergillosis and candidiasis, o treatment of histoplasmosis, o histoplasmosis, maintenance therapy only in aids patients. o treatment of sporotrichosis (including lymphocutaneous/cutaneous and extracutaneous), o treatment of paracoccidioidomycosis, o treatment of chromomycosis, o treatment of blastomycosis.

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - bosentan 125mg;   - film coated tablet - 125 mg - active: bosentan 125mg   excipient: ethylcellulose glyceryl behenate hypromellose iron oxide red iron oxide yellow magnesium stearate maize starch povidone purified talc sodium starch glycolate starch titanium dioxide triacetin - tracleer® is indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who class iii or iv symptoms.

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - bosentan 62.5mg (as monohydrate);   - film coated tablet - 62.5 mg - active: bosentan 62.5mg (as monohydrate)   excipient: ethylcellulose glyceryl behenate hypromellose iron oxide red iron oxide yellow magnesium stearate maize starch povidone purified talc sodium starch glycolate starch titanium dioxide triacetin - tracleer® is indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who class iii or iv symptoms.

Union européenne - anglais - EMA (European Medicines Agency)

janssen-cilag international n.v.   - decitabine - leukemia, myeloid - antineoplastic agents - treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (aml), according to the world health organization (who) classification, who are not candidates for standard induction chemotherapy.

Union européenne - anglais - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multiple myeloma - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1).as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Union européenne - anglais - 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