Austrália - inglês - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 80 mg - tablet, modified release - excipient ingredients: polyethylene oxide; magnesium stearate; hypromellose; indigo carmine; hyprolose; polysorbate 80; iron oxide yellow; macrogol 400 - novacodone is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long term treatment. novacodone modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. novacodone is not indicated as an as-needed-(prn) analgesia.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 40 mg - tablet, modified release - excipient ingredients: magnesium stearate; polyethylene oxide; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; macrogol 400 - novacodone is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long term treatment. novacodone modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. novacodone is not indicated as an as-needed-(prn) analgesia.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 20 mg - tablet, modified release - excipient ingredients: polyethylene oxide; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400 - novacodone is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long term treatment. novacodone modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. novacodone is not indicated as an as-needed-(prn) analgesia.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 10 mg - tablet, modified release - excipient ingredients: magnesium stearate; polyethylene oxide; titanium dioxide; hypromellose; hyprolose; macrogol 400 - novacodone is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long term treatment. novacodone modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. novacodone is not indicated as an as-needed-(prn) analgesia.

União Europeia - inglês - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - naloxone hydrochloride dihydrate - opioid-related disorders - all other therapeutic products - nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings.nyxoid is indicated in adults and adolescents aged 14 years and over.nyxoid is not a substitute for emergency medical care.

União Europeia - inglês - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastim - neutropenia - immunostimulants, - to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - leuprorelin acetate, quantity: 30 mg - injection, modified release - excipient ingredients: n-methyl-2-pyrrolidone; polyglactin - prostate cancer,eligard 7.5mg 1 month, eligard 22.5mg 3 month, eligard 30mg 4 month and eligard 45mg 6 month are indicated for the:,? palliative treatment of advanced prostate cancer.,? treatment of high-risk localised and locally advanced hormone-dependent prostate cancer in combination with radiotherapy.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - leuprorelin acetate, quantity: 22.5 mg - injection, modified release - excipient ingredients: n-methyl-2-pyrrolidone; polyglactin - prostate cancer,eligard 7.5mg 1 month, eligard 22.5mg 3 month, eligard 30mg 4 month and eligard 45mg 6 month are indicated for the:,? palliative treatment of advanced prostate cancer.,? treatment of high-risk localised and locally advanced hormone-dependent prostate cancer in combination with radiotherapy.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - leuprorelin acetate, quantity: 7.5 mg - injection, modified release - excipient ingredients: n-methyl-2-pyrrolidone; polyglactin - eligard 7.5mg 1 month, eligard 22.5mg 3 month, eligard 30mg 4 month and eligard 45mg 6 month are indicated for the:,? palliative treatment of advanced prostate cancer.,? treatment of high-risk localised and locally advanced hormone-dependent prostate cancer in combination with radiotherapy.1

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 1 mg/ml - oral liquid, solution - excipient ingredients: saccharin sodium; sodium citrate dihydrate; sodium benzoate; hypromellose; sodium hydroxide; hydrochloric acid; purified water; citric acid monohydrate - oxynorm is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.