Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - oxycodone hydrochloride 30 mg; naloxone hydrochloride dihydrate 16,35 mg - eq. naloxone hydrochloride 15 mg - prolonged-release tablet - 30 mg - 15 mg - oxycodone hydrochloride 30 mg; naloxone hydrochloride dihydrate 16.35 mg - oxycodone, combinations

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - oxycodone hydrochloride 10 mg; naloxone hydrochloride dihydrate 5,45 mg - eq. naloxone hydrochloride 5 mg - prolonged-release tablet - 10 mg - 5 mg - oxycodone hydrochloride 10 mg; naloxone hydrochloride dihydrate 5.45 mg - oxycodone, combinations

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - oxycodone hydrochloride 40 mg; naloxone hydrochloride dihydrate 21,8 mg - eq. naloxone hydrochloride 20 mg - prolonged-release tablet - 40 mg - 20 mg - oxycodone hydrochloride 40 mg; naloxone hydrochloride dihydrate 21.8 mg - oxycodone, combinations

New Zealand - English - Medsafe (Medicines Safety Authority)

mundipharma new zealand ltd - naloxone hydrochloride dihydrate 5.45mg equivalent to naloxone hydrochloride anhydrous 5 mg; oxycodone hydrochloride 10mg;   - modified release tablet - 10/5mg - active: naloxone hydrochloride dihydrate 5.45mg equivalent to naloxone hydrochloride anhydrous 5 mg oxycodone hydrochloride 10mg   excipient: ethylcellulose lactose monohydrate magnesium stearate opadry white 85f18422 povidone purified talc   stearyl alcohol - the management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. the naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.

New Zealand - English - Medsafe (Medicines Safety Authority)

mundipharma new zealand ltd - naloxone hydrochloride dihydrate 10.9mg equivalent to naloxone hydrochloride anhydrous 10 mg; oxycodone hydrochloride 20mg;   - modified release tablet - 20/10mg - active: naloxone hydrochloride dihydrate 10.9mg equivalent to naloxone hydrochloride anhydrous 10 mg oxycodone hydrochloride 20mg   excipient: ethylcellulose lactose monohydrate magnesium stearate opadry pink 85f24151 povidone purified talc   stearyl alcohol - the management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. the naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.

New Zealand - English - Medsafe (Medicines Safety Authority)

mundipharma new zealand ltd - naloxone hydrochloride dihydrate 21.8mg equivalent to naloxone hydrochloride anhydrous 20 mg; oxycodone hydrochloride 40mg;   - modified release tablet - 40/20mg - active: naloxone hydrochloride dihydrate 21.8mg equivalent to naloxone hydrochloride anhydrous 20 mg oxycodone hydrochloride 40mg   excipient: ethylcellulose lactose monohydrate magnesium stearate opadry yellow 85f32109 povidone purified talc   stearyl alcohol - the management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. the naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

mundipharma pharmaceuticals sdn. bhd. - oxycodone hydrochloride; naloxone hydrochloride -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

mundipharma pharmaceuticals sdn. bhd. - oxycodone hydrochloride; naloxone hydrochloride -

Ireland - English - HPRA (Health Products Regulatory Authority)

hcs bvba - oxycodone hydrochloride, naloxone hydrochloride dihydrate - prolonged release capsules - 10mg/5 milligram - 02aa55

Ireland - English - HPRA (Health Products Regulatory Authority)

hcs bvba - oxycodone hydrochloride, naloxone hydrochloride dihydrate - prolonged release capsules - 20mg/10 milligram - 02aa55