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

accord healthcare b.v. - naltrexone hydrochloride 50 mg - film-coated tablet - 50 mg - naltrexone hydrochloride 50 mg - naltrexone

New Zealand - English - Medsafe (Medicines Safety Authority)

max health limited - naltrexone hydrochloride 50mg equivalent to 45.2 mg naltrexone - film coated tablet - 50 mg - active: naltrexone hydrochloride 50mg equivalent to 45.2 mg naltrexone excipient: cellactose 80 colloidal silicon dioxide crospovidone lactose monohydrate magnesium stearate microcrystalline cellulose opadry beige 31f27245 - naltrexone is indicated for use within a comprehensive treatment programme for alcohol dependence.

United States - English - NLM (National Library of Medicine)

a-s medication solutions - naltrexone hydrochloride (unii: z6375yw9sf) (naltrexone - unii:5s6w795cqm), bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - contrave is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (bmi) of: - 30 kg/m2 or greater (obese) or - 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). limitations of use: - the effect of contrave on cardiovascular morbidity and mortality has not been established. - the safety and effectiveness of contrave in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. contrave is contraindicated in - uncontrolled hypertension [see warnings and precautions (5.5)] - seizure disorder or a history of seizures [see warnings and precautions (5.3)] - use of other bupropion-containing products (including, but not limited to, wellbutrin, wellbutrin sr, wellbutrin xl, aplenzin and zyban) - bulimi

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

generic health pty ltd - naltrexone hydrochloride -

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - naltrexone hydrochloride - film-coated tablet - naltrexone hydrochloride 50 mg naltrexone hydrochloride 50 mg - other nervous system drugs

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - naltrexone hydrochloride - film-coated tablet - naltrexone hydrochloride 50 mg - other nervous system drugs

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

inova pharmaceuticals (singapore) pte ltd (incorporated in singapore) malaysia branch - bupropion; naltrexone -

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

orexigen therapeutics ireland ltd - bupropion hydrochloride; naltrexone hydrochloride - modified-release tablet - 90mg ; 8mg

United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c), naltrexone hydrochloride (unii: z6375yw9sf) (naltrexone - unii:5s6w795cqm) - morphine sulfate 20 mg - embeda is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions (5.1)] , reserve embeda for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - embeda is not indicated as an as-needed (prn) analgesic. embeda is contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.3)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.6)] - con

Canada - English - Health Canada

apotex inc - naltrexone hydrochloride - tablet - 50mg - naltrexone hydrochloride 50mg - opiate antagonists