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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 0.375 mg - tablet, modified release - excipient ingredients: hypromellose; calcium hydrogen phosphate; silicon dioxide; magnesium stearate - for the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.

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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 2.25 mg - tablet, modified release - excipient ingredients: hypromellose; calcium hydrogen phosphate; silicon dioxide; magnesium stearate - for the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.

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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 0.75 mg - tablet, modified release - excipient ingredients: magnesium stearate; silicon dioxide; hypromellose; calcium hydrogen phosphate - for the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.

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

a-s medication solutions - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.5 mg - pramipexole dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic parkinson's disease. none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total

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

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate -

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

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate -

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

macleods pharmaceuticals limited - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.375 mg - pramipexole dihydrochloride extended-release tablets are indicated for the treatment of parkinson's disease. none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride extended-release tablets in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis result

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

torrent pharmaceuticals limited - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson's disease. pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride tablets in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, o

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

sciegen pharmaceuticals inc - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson’s disease. pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexo

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

strides pharma science limited - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson's disease. pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). none risk summary there are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride tablets in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, or