- Trials with a EudraCT protocol (13)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (7)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: |
Active substance: BENZATHINE BENZYLPENICILLIN |
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Document reference: 22273 |
Study title: Measuring the comparative efficacy of antibacterial agents for acute otitis media: the "Pollyanna phenomenon";J Pediatr. 1992 Jan;120(1):72-7Measuring the comparative efficacy of antibacterial agents for acute otitis media: the "Pollyanna phenomenon";J Pediatr. 1992 Jan;120(1):72-7 |
Active substance: BENZATHINE BENZYLPENICILLIN |
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Document reference: 22274 |
Study title: Randomized, multicenter open study comparing the efficacy of potassium-phenoxymethylpenicillin V three times daily for 10 days versus benzathine penicillin V twice daily for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in childrenClinical efficacy and tolerance of bacampicillin and amoxycillin suspensions in children with acute otitis media; J Int Med Res. 1989 Jan-Feb;17(1):41-7. |
Active substance: BENZATHINE BENZYLPENICILLIN |
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Document reference: 22276 |
Study title: Randomized, multicenter pilot study comparing the efficacy of potassium-phenoxymethylpenicillin granules for oral suspension 100.000 IU /kg/day tid for 10 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 7 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in childrenEffect on urogenital flora of antibiotic therapy for urinary tract infection; Scand J Infect Dis. 1990;22(1):43-7. |
Active substance: BENZATHINE BENZYLPENICILLIN |
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Document reference: 22275 |
Study title: Investigating the neurotoxicity of penicillin G at different serum- and CSF-concentrations.Holloway et al. (The American journal of clinical pathology, 1969 Jun;51(6):705-8) |
Active substance: BENZATHINE BENZYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Benzylpenicillin sodium_1.xlsx |
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Document reference: 49070 |
Study title: Investigating the neurotoxicity of penicillin G at different serum- and CSF-concentrations.Lerner et al. (Ann NY Acad Sci 145, 310-8, no 2 1967) |
Active substance: BENZATHINE BENZYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Benzylpenicillin sodium_2.xlsx |
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Document reference: 49071 |
Study title: The purpose uf this study was to determine what beneficiaI effect, if any, large doses of penicillin G procaine have on the treatment of hospitalized patients with pneumococcal pneumonia of varying severity, and to examine the effect of this treatment on the colonization and superinfection rates in these patients.Brewin et al. (JAMA 230:409-413, 1974) |
Active substance: BENZATHINE BENZYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Benzylpenicillin sodium_3.xlsx |
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Document reference: 49072 |