New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - teicoplanin 400mg - powder for injection - 400 mg - active: teicoplanin 400mg excipient: sodium chloride sodium hydroxide - teicoplanin mylan is indicated in adults and in children from 2 months for the treatment of the following serious infections due to staphylococci or streptococci, which cannot be treated satisfactorily with less toxic agents including beta-lactam antibiotics: bone - osteomyelitis

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - dimethyl fumarate - multiple sclerosis, relapsing-remitting - immunosuppressants - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer consumer healthcare div. of pfizer new zealand ltd - aluminium hydroxide gel dried 383.26mg;  ; magnesium hydroxide 423.61mg; simeticone 30.28mg - tablet - active: aluminium hydroxide gel dried 383.26mg   magnesium hydroxide 423.61mg simeticone 30.28mg excipient: hyprolose lactose monohydrate magnesium stearate maize starch mannitol quinoline yellow saccharin sodium spearmint oil sunset yellow fcf

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer consumer healthcare div. of pfizer new zealand ltd - aluminium hydroxide gel dried 193.11mg equivalent to to 201.1 mg aluminium oxide anhydrous/tablet; magnesium hydroxide 200mg; simeticone 20mg - tablet - active: aluminium hydroxide gel dried 193.11mg equivalent to to 201.1 mg aluminium oxide anhydrous/tablet magnesium hydroxide 200mg simeticone 20mg excipient: hyprolose lactose monohydrate magnesium stearate maize starch mannitol quinoline yellow saccharin sodium spearmint oil sunset yellow fcf

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - indometacin sodium trihydrate 1.061mg equivalent to indomethacin 1 mg - powder for injection - 1 mg - active: indometacin sodium trihydrate 1.061mg equivalent to indomethacin 1 mg - indomethacin is indicated for the closure of patent ductus arteriosus in premature babies. clear-cut clinical evidence of a haemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray. indomethacin should only be used in a hospital under supervision of a specialist neonatologist.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - amlodipine besilate, valsartan - hypertension - agents acting on the renin-angiotensin system - treatment of essential hypertension.amlodipine/valsartan mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole mylan pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole mylan pharma is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.aripiprazole mylan pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.

European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - docetaxel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - antineoplastic agents - treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - duloxetine - neuralgia; diabetic neuropathies; depressive disorder, major; anxiety disorders - psychoanaleptics, - treatment of major depressive disorder;treatment of diabetic peripheral neuropathic pain;treatment of generalised anxiety disorder;duloxetine mylan is indicated in adults.

European Union - English - EMA (European Medicines Agency)

mylan s.a.s - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin mylan is indicated for the treatment of chronic hepatitis c and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). ribavirin monotherapy must not be used.there is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).please refer also to the interferon alfa-2b summary of product characteristics (smpc) for prescribing information particular to that product.naïve patientsadult patientsribavirin mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (alt), who are positive for serum hepatitis-c-virus (hcv) rna.children and adolescentsribavirin mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three years of age and older, who have all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, and who are positive for serum hcv rna. when deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case-by-case basis (see section 4.4).previously treatment-failure patientsadult patientsribavirin mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis c who have previously responded (with normalisation of alt at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.