Norditropin NordiLet New Zealand - English - Medsafe (Medicines Safety Authority)

norditropin nordilet

novo nordisk pharmaceuticals ltd - somatropin 10 mg/ml - solution for injection - 15 mg/1.5ml - active: somatropin 10 mg/ml excipient: histidine hydrochloric acid mannitol phenol poloxamer 188 sodium hydroxide water - treatment of growth failure in children due to chronic renal insufficency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. chronic renal insufficiency is defined as a glomerular filtration rate of for the treatment of severe growth failure due to intrauterine growth retardation (i.e. children born small for gestational age [sga] (birth weight and/or length <-2 sd) without spontaneous catch-up growth by 2 years of age). treatment of growth failure in children due to pituitary growth hormone deficiency treatment of growth failure in girls due to gonadal dysgenesis (turner's syndrome). treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml.latest regulatory activityapplication dateapplication typechange(s)statuspayment datepriority9/11/2016changed medicine notificationbulk active methods of manufacture; administrative fee (cmn); finished product manufacturing process - grade 3; test methods and specifications - grade 5; test methods and specifications - grade 6; shelf life/storage conditions - finished product; labelling - grade 1granted 20/2/201728/11/2016 27/11/2012new higher-risk medicine applicationadditional name - grade 2granted 19/12/201317/12/2012 

Norditropin NordiLet New Zealand - English - Medsafe (Medicines Safety Authority)

norditropin nordilet

novo nordisk pharmaceuticals ltd - somatropin 3.3 mg/ml - solution for injection - 5 mg/1.5ml - active: somatropin 3.3 mg/ml excipient: histidine hydrochloric acid mannitol phenol poloxamer 188 sodium hydroxide water for injection - treatment of growth failure in children due to chronic renal insufficency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. chronic renal insufficiency is defined as a glomerular filtration rate of for the treatment of severe growth failure due to intrauterine growth retardation (i.e. children born small for gestational age [sga] (birth weight and/or length <-2 sd) without spontaneous catch-up growth by 2 years of age). treatment of growth failure in children due to pituitary growth hormone deficiency treatment of growth failure in girls due to gonadal dysgenesis (turner's syndrome). treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml.latest regulatory activityapplication dateapplication typechange(s)statuspayment datepriority9/11/2016changed medicine notificationbulk active methods of manufacture; administrative fee (cmn); finished product manufacturing process - grade 3; test methods and specifications - grade 5; test methods and specifications - grade 6; shelf life/storage conditions - finished product; labelling - grade 1granted 20/2/201728/11/2016 27/11/2012new higher-risk medicine applicationadditional name - grade 2granted 19/12/201317/12/2012 

Norditropin SimpleXx 15mg/1.5ml solution for injection cartridges United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

norditropin simplexx 15mg/1.5ml solution for injection cartridges

waymade healthcare plc - somatropin (epr) - solution for injection - 10mg/1ml

Norditropin SimpleXx 5mg/1.5ml solution for injection cartridges United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

norditropin simplexx 5mg/1.5ml solution for injection cartridges

waymade healthcare plc - somatropin (epr) - solution for injection - 3.3mg/1ml

Norditropin SimpleXx 10mg/1.5ml solution for injection cartridges United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

norditropin simplexx 10mg/1.5ml solution for injection cartridges

waymade healthcare plc - somatropin (epr) - solution for injection - 6.7mg/1ml

Norditropin SimpleXx 10mg/1.5ml solution for injection cartridges United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

norditropin simplexx 10mg/1.5ml solution for injection cartridges

mawdsley-brooks & company ltd - somatropin (epr) - solution for injection - 6.7mg/1ml

Norditropin NordiLet Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

norditropin nordilet

novo nordisk a/s - somatropin - solution for s/c injection - 6,7mg/ml

Norditropin Flexpro 5 mg/1.5 ml inj. sol. s.c. pre-filled pen Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

norditropin flexpro 5 mg/1.5 ml inj. sol. s.c. pre-filled pen

novo nordisk pharma sa-nv - somatropin 3,3 mg/ml - solution for injection - 5 mg - 1,5 ml - somatropin 3.3 mg/ml - somatropin

Norditropin Flexpro 10 mg/1.5 ml inj. sol. s.c. pre-filled pen Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

norditropin flexpro 10 mg/1.5 ml inj. sol. s.c. pre-filled pen

novo nordisk pharma sa-nv - somatropin 6,7 mg/ml - solution for injection - 10 mg - 1,5 ml - somatropin 6.7 mg/ml - somatropin

Norditropin Flexpro 15 mg/1.5 ml inj. sol. s.c. pre-filled pen Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

norditropin flexpro 15 mg/1.5 ml inj. sol. s.c. pre-filled pen

novo nordisk pharma sa-nv - somatropin 10 mg/ml - solution for injection - 15 mg - 1,5 ml - somatropin 10 mg/ml - somatropin