A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to grow A research study to compare somapacitan once a week with Norditropin® once a day in children who nee ...
A study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. A study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® ...
Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859 MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature ...
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen INN or Proposed INN: Somapacitan Other descriptive name: Somapacitan Trade Name: Sogroya 5 mg/1.5 mL solution for injection in pre-filled pen Product Name: somapacitan 5 mg/1.5 mL PDS290 INN or Proposed INN: Somapacitan Other descriptive name: Somapacitan Product Name: Somapacitan 15 mg/1.5 mL PDS290 INN or Proposed INN: Somapacitan Other descriptive name: Somapacitan Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen INN or Proposed INN: Somatropin Other descriptive name: Somatropin Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen INN or Proposed INN: Somapa ...
Novo Nordisk A/S
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Female: yes Male: yes
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Phase 3
United States;Serbia;Saudi Arabia;Greece;Thailand;Ireland;Israel;Russian Federation;Switzerland;India;Malaysia;South Africa;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Brazil;Belgium;Poland;Japan United States;Serbia;Saudi Arabia;Greece;Thailand;Ireland;Israel;Russian Federation;Switzerland;Indi ...