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

apotex pty ltd - pantoprazole sodium sesquihydrate -

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

apotex pty ltd - pantoprazole sodium sesquihydrate -

Ireland - English - HPRA (Health Products Regulatory Authority)

apotex europe b.v. - voriconazole - film coated tablet - 50 milligram - voriconazole - antimycotics for systemic use, triazole derivatives - voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis. treatment of candidemia in non-neutropenic patients. treatment of fluconazole-resistant serious invasive candida infections (including c. krusei). treatment of serious fungal infections caused by scedosporium spp. and fusarium spp. voriconazole apotex should be administered primarily to patients with progressive, possibly life-threatening infections. prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients

Ireland - English - HPRA (Health Products Regulatory Authority)

apotex europe b.v. - voriconazole - film coated tablet - 200 milligram - voriconazole - antimycotics for systemic use, triazole derivatives - voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis. treatment of candidemia in non-neutropenic patients. treatment of fluconazole-resistant serious invasive candida infections (including c. krusei). treatment of serious fungal infections caused by scedosporium spp. and fusarium spp. voriconazole apotex should be administered primarily to patients with progressive, possibly life-threatening infections. prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients

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

apotex pty ltd - pioglitazone hydrochloride -

European Union - English - EMA (European Medicines Agency)

apotex europe bv - olanzapine - schizophrenia; bipolar disorder - psycholeptics - olanzapine is indicated for the treatment of schizophrenia.olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.olanzapine is indicated for the treatment of moderate to severe manic episode.in patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.

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

apotex pty ltd - nevirapine -

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

apotex pty ltd - abacavir sulfate,lamivudine -

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

apotex pty ltd - flumazenil -

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

apotex pty ltd - remifentanil hydrochloride, quantity: 1.097 mg - injection, powder for - excipient ingredients: hydrochloric acid; glycine - remifentanil is indicated:,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures, including cardiac surgery, in adults;,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical, but not cardiac procedures, in children aged 1?12 years;,- for continuation as an analgesic into the immediate post-operative period under the close supervision of medically-qualified persons trained in the use of anaesthetic agents, during transition to longer-acting analgesia following adult cardiac surgery ? when endotracheal intubation and controlled ventilation are anticipated;,- for provision of analgesia and sedation in mechanically-ventilated intensive care patients.