Norditropin® flexpro® (DrugBank: -)
1 diseaseID | Disease name (Link within this page) | Number of trials |
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78 | Hypopituitarism | 19 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
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1 | NCT04614337 (ClinicalTrials.gov) | October 7, 2020 | 26/10/2020 | Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial) | A Multicenter, 6-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2b Study of Daily Oral LUM-201 in Naïve to Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency | Drug: LUM-201;Drug: rhGH Norditropin® FlexPro® pen (34 µg/kg) | Lumos Pharma | NULL | Recruiting | 3 Years | 10 Years | All | 80 | Phase 2 | United States |
2 | NCT03972345 (ClinicalTrials.gov) | June 21, 2019 | 31/5/2019 | Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA) | A Non-interventional, Prospective Study in Germany to Investigate the Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in a Patient Population With Isolated Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA) | Growth Hormone Deficiency in Children;Born Small for Gestational Age | Drug: Norditropin® FlexPro® | Novo Nordisk A/S | NULL | Enrolling by invitation | N/A | 15 Years | All | 750 | Germany | |
3 | NCT03075644 (ClinicalTrials.gov) | March 3, 2017 | 28/2/2017 | A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency | A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: Norditropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 79 Years | All | 62 | Phase 3 | Japan |
4 | NCT02616562 (ClinicalTrials.gov) | March 23, 2016 | 25/11/2015 | Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency | A Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency naïve Pre-pubertal Children With Growth Hormone Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somapacitan;Drug: Norditropin® FlexPro® pen | Novo Nordisk A/S | NULL | Recruiting | N/A | 17 Years | All | 74 | Phase 2 | United States;Austria;Belgium;Brazil;France;Germany;India;Israel;Japan;Slovenia;Sweden;Turkey;Ukraine |
5 | EUCTR2015-000531-32-DE (EUCTR) | 14/03/2016 | 20/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | |||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
6 | EUCTR2015-000531-32-BE (EUCTR) | 17/02/2016 | 30/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Canada;Belgium;Brazil;Germany;Japan;Sweden | ||
7 | EUCTR2015-000531-32-SE (EUCTR) | 14/01/2016 | 04/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
8 | EUCTR2015-000531-32-SI (EUCTR) | 15/12/2015 | 11/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | |||
9 | EUCTR2015-000531-32-AT (EUCTR) | 10/12/2015 | 03/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
10 | EUCTR2013-002892-16-LV (EUCTR) | 12/10/2015 | 31/07/2015 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Germany;Latvia;Japan;Sweden | |||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
11 | EUCTR2013-002892-16-LT (EUCTR) | 30/09/2015 | 27/07/2015 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
12 | NCT02382939 (ClinicalTrials.gov) | February 12, 2015 | 10/2/2015 | A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency | A Multicentre, Multinational, Randomised, Open-labelled, Parallel-group, Active-controlled Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency | Adult Growth Hormone Deficiency;Growth Hormone Disorder | Drug: somapacitan;Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 79 Years | All | 92 | Phase 3 | Denmark;France;Germany;Japan;Sweden;United Kingdom |
13 | EUCTR2014-000290-39-GB (EUCTR) | 30/01/2015 | 22/01/2015 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | European Union;Denmark;Japan;United Kingdom;Sweden | ||
14 | EUCTR2014-000290-39-DK (EUCTR) | 22/01/2015 | 22/01/2015 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | European Union;Denmark;United Kingdom;Japan;Sweden | |||
15 | EUCTR2013-002892-16-DE (EUCTR) | 22/12/2014 | 29/09/2014 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
16 | EUCTR2013-002892-16-GB (EUCTR) | 20/11/2014 | 24/09/2014 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | |||
17 | EUCTR2014-000290-39-SE (EUCTR) | 07/11/2014 | 07/10/2014 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | European Union;Denmark;United Kingdom;Japan;Sweden | |||
18 | NCT02229851 (ClinicalTrials.gov) | October 31, 2014 | 26/8/2014 | Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. | A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: somatropin;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 23 Years | 79 Years | All | 301 | Phase 3 | United States;Australia;Brazil;Germany;India;Israel;Japan;Latvia;Lithuania;Malaysia;Norway;Poland;Romania;Russian Federation;South Africa;Sweden;Turkey;Ukraine;United Kingdom |
19 | EUCTR2013-002892-16-SE (EUCTR) | 07/10/2014 | 03/09/2014 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden |