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

pierre fabre pharmaceuticals, inc. - propranolol hydrochloride (unii: f8a3652h1v) (propranolol - unii:9y8nxq24vq) - propranolol hydrochloride 4.28 mg in 1 ml - hemangeol oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. hemangeol is contraindicated in the following conditions: - premature infants with corrected age < 5 weeks - infants weighing less than 2 kg - known hypersensitivity to propranolol or any of the excipients [see description (11)] - asthma or history of bronchospasm - heart rate <80 beats per minute, greater than first degree heart block, or decompensated heart failure - blood pressure <50/30 mmhg - pheochromocytoma of 460 infants with proliferating infantile hemangioma requiring systemic therapy who were treated with hemangeol starting at 5 weeks to 5 months of age, 60% had complete or nearly complete resolution of their hemangioma at week 24 [see  clinical studies (14)]. safety and effectiveness for infantile hemangioma have not been established in pediatric

European Union - English - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - mogamulizumab - sezary syndrome; mycosis fungoides - antineoplastic agents - poteligeo is indicated for the treatment of adult patients with mycosis fungoides (mf) or sézary syndrome (ss) who have received at least one prior systemic therapy.

Israel - English - Ministry of Health

medison pharma ltd - mogamulizumab - concentrate for solution for infusion - mogamulizumab 4 mg / 1 ml - mogamulizumab - poteligeo is indicated for the treatment of adult patients with mycosis fungoides (mf) or sézary syndrome (ss) who have received at least one prior systemic therapy.

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

pharmacor pty ltd - gabapentin, quantity: 300 mg - capsule, hard - excipient ingredients: maize starch; lactose; purified talc; titanium dioxide; purified water; iron oxide yellow; gelatin; sodium lauryl sulfate - pharmagabapentin is indicated for the treatment of,? partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,? neuropathic pain.

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

pharmacor pty ltd - gabapentin, quantity: 400 mg - capsule, hard - excipient ingredients: maize starch; lactose; purified talc; titanium dioxide; purified water; iron oxide yellow; iron oxide red; gelatin; sodium lauryl sulfate - pharmagabapentin is indicated for the treatment of,? partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,? neuropathic pain.

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

pharmacor pty ltd - gabapentin, quantity: 100 mg - capsule, hard - excipient ingredients: lactose; purified talc; maize starch; titanium dioxide; purified water; gelatin; sodium lauryl sulfate - pharmagabapentin is indicated for the treatment of,? partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,? neuropathic pain.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - pigeon paramyxovirus-1 strain p201 (inactivated) - unknown - pigeon paramyxovirus-1 strain p201 (inactivated) virus active 0.0 - active constituent

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

kyowa kirin, inc. - mogamulizumab (unii: yi437801be) (mogamulizumab - unii:yi437801be) - poteligeo is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (mf) or sézary syndrome (ss) after at least one prior systemic therapy. none. risk summary there are no available data on poteligeo use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in an animal reproduction study, administration of mogamulizumab-kpkc to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show a potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose, based on auc (see data ). in general, igg molecules are known to cross the placental barrier and in the monkey reproduction study mogamulizumab-kpkc was detected in fetal plasma. therefore, poteligeo has the potential to be transmitted from the mother to the developing fetus. poteligeo is not recommended during pregnancy or in women of childbearing potential not using contraception. the es

Malta - English - Medicines Authority

pharmazac, s.a. 31 naousis str., 104 47, athens,, greece - sugammadex - solution for injection - sugammadex 200 mg - all other therapeutic products

Malta - English - Medicines Authority

pharmazac, s.a. 31 naousis str., 104 47, athens,, greece - sugammadex - solution for injection - sugammadex 500 mg - all other therapeutic products