Philippines - English - FDA (Food And Drug Administration)

n/a; importer: sandoz philippines corporation; distributor: sandoz philippines corporation - null - tablet - null

European Union - English - EMA (European Medicines Agency)

csl behring gmbh - alpha1-proteinase inhibitor (human) - genetic diseases, inborn, lung diseases - antihemorrhagics, - respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes pizz, piz(null), pi(null,null), pisz). patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (fev1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.,

Zimbabwe - English - Medicines Control Authority

null - {"initialdelaytime":0 - skin:"silk" - zindex:90000}

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

grifols australia pty ltd - alpha-1-proteinase inhibitor, quantity: 1000 mg - solution - excipient ingredients: monobasic sodium phosphate; alanine; water for injections - prolastin? c liquid is an alpha-1-proteinase inhibitor indicated to increase serum alpha-1-proteinase inhibitor levels in adults with congenital deficiency of alpha-1-antitrypsin and with clinically significant emphysema (fev1 <80%).,the data for clinical efficacy of prolastin? c liquid is derived from changes in the biomarkers alpha-1 anti-protease level and ct lung density. efficacy on fev1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials.,clinical trials have only included patients who were not smoking.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - copper (375mm² surface area) - intrauterine contraceptive device - active: copper (375mm² surface area) - intrauterine contraception

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - copper - intrauterine contraceptive device - active: copper - intrauterine contraception

Israel - English - Ministry of Health

propharm ltd - atosiban - solution for injection/ concentrate for solution for infusion - atosiban 7.5 mg / 1 ml - atosiban - atosiban altan is indicated to delay imminent pre-term birth in pregnant women with: - regular uterine contractions of at least 30 seconds duration at a rate of 4 or more per 30 minutes- a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of 50 % or more - age: 18 years and above - a gestational age from 24 until 33 completed weeks - a normal foetal heart rate

Israel - English - Ministry of Health

a.l. medi-market ltd. - atosiban as acetate - solution for injection/ concentrate for solution for infusion - atosiban as acetate 7.5 mg/ml - atosiban - atosiban is indicated to delay imminent pre-term birth in pregnant women with: - regular uterine contractions of at least 30 seconds duration at a rate of 4 or more per 30 minutes- a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of 50 % or more - age: 18 years and above - a gestational age from 24 until 33 completed weeks - a normal foetal heart rate.