- Trials with a EudraCT protocol (634)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (348)

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: Tolérance de 5 jours par voie orale chez le raton et le rat adulte suivie d’une période sans traitement de 15 jours (documentation toxicologique du dossier d’AMM du 30/10/87 du spectral enfant solution buvable 40mg/ml) - Briffaux - 02/10/1987 |
Active substance: ACEBUTOLOL |
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Document reference: 46194 |
Study title: Evaluation of anthroposophic supportive medicine on treatment -related toxicity in children receiving cancer therapy. |
Active substance: acqueous extract(1:20) from fresh herb of white-berry mistletoe (Viscum album L.): HELIXOR® A: produced from mistletoe growing on fir (Viscum album L. abietis), HELIXOR® M: produced from mistletoe growing on apple tree (Viscum album L. mali), HELIXOR® P: produced from mistletoe growing on pine (Viscum album L. pini) |
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Document reference: 39775 |
Study title: Aluminium toxicity in childhood - Sedman A. - 1992 (Pediatr Nephrol 1992; 6(4): 383-393) Publication in Clinical Overview - Aluminium hydroxide and combination - Anaemia Microcytic - Caratas M. - 2006Aluminium toxicity in childhood - Sedman A. - 1992 (Pediatr Nephrol 1992; 6(4): 383-393) Publication in Clinical Overview - Aluminium hydroxide and combination - Anaemia Microcytic - Caratas M. - 2006 |
Active substance: ALGELDRATE + MAGNESIUM HYDROXIDE + SIMETICONE/ ALDEGRATE+ MAGNESIUM HYDROXIDE |
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Document reference: 46412 |
Study title: Aluminium toxicity in childhood. Pediatric nephrology, Jul 1992, vol.6, no. 4, p. 383-93, 68 refs, ISSN:0931-041 X. Sedman-A.Aluminium toxicity in childhood. Pediatric nephrology, Jul 1992, vol.6, no. 4, p. 383-93, 68 refs, ISSN:0931-041 X. Sedman-A. |
Active substance: ALGELDRATE + MAGNESIUM HYDROXIDE + SIMETICONE/ ALDEGRATE+ MAGNESIUM HYDROXIDE |
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Document reference: 46408 |
Study title: Intraperitoneal Deferoxamine Therapy for Aluminium Intoxication in a Child Undergoing Continuous Ambulatory Peritoneal Dialysis. Andreoli-S-P, Dunn-D, DeMyer-W, Sherrard-D-J, Bergstein-J-M. J-Pediatr (107,No.5,760-63,1985) Coden:JOPDAB ISSN:0022-3476.Intraperitoneal Deferoxamine Therapy for Aluminium Intoxication in a Child Undergoing Continuous Ambulatory Peritoneal Dialysis. Andreoli-S-P, Dunn-D, DeMyer-W, Sherrard-D-J, Bergstein-J-M. J-Pediatr (107,No.5,760-63,1985) Coden:JOPDAB ISSN:0022-3476. |
Active substance: ALGELDRATE + MAGNESIUM HYDROXIDE + SIMETICONE/ ALDEGRATE+ MAGNESIUM HYDROXIDE |
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Document reference: 46409 |
Study title: Intraperitoneal deferoxamine therapy for aluminium intoxication in achild undergoing continuous ambulatory peritoneal dialysis - Andreoli SP - 1985 (J. of Pediatrics; 107 (5): 760-764)Intraperitoneal deferoxamine therapy for aluminium intoxication in achild undergoing continuous ambulatory peritoneal dialysis - Andreoli SP - 1985 (J. of Pediatrics; 107 (5): 760-764) |
Active substance: ALGELDRATE + MAGNESIUM HYDROXIDE + SIMETICONE/ ALDEGRATE+ MAGNESIUM HYDROXIDE |
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Document reference: 46417 |
Study title: Oral toxicity study in juvenile rats |
Active substance: ALFUZOCIN (HYDROCHLORIDE) |
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Document reference: 46380 |
Study title: Aluminium toxicity in childhood - Sedman A. - 1992 (Pediatr Nephrol 1992; 6(4): 383-393) Publication in Clinical Overview - Aluminium hydroxide and combination - Anaemia Microcytic - Caratas M. - 2006Aluminium toxicity in childhood - Sedman A. - 1992 (Pediatr Nephrol 1992; 6(4): 383-393) Publication in Clinical Overview - Aluminium hydroxide and combination - Anaemia Microcytic - Caratas M. - 2006 |
Active substance: ALUMINIUM HYDROXIDE AND MAGNESIUM HYDROXIDE |
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Document reference: 46469 |
Study title: Study N° 430 : Analysis of Amikacin Study 430, Pharmacokinetics, Efficacy and Toxicity of Amikacin Sulfate in the NeonateStudy N° 430 : Analysis of Amikacin Study 430, Pharmacokinetics, Efficacy and Toxicity of Amikacin Sulfate in the Neonate |
Active substance: AMICACIN SULPHATE |
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Document reference: 46560 |
Study title: The dialysis dementia syndrome and aluminium intoxication - Sideman S - 1982 (Nephron 1982; 31(1): 1-10) - Publication in Clinical Overview - Aluminium Hydroxide and combination - Dementia - Caratas M - 2006 -The dialysis dementia syndrome and aluminium intoxication - Sideman S - 1982 (Nephron 1982; 31(1): 1-10) - Publication in Clinical Overview - Aluminium Hydroxide and combination - Dementia - Caratas M - 2006 - |
Active substance: ALGELDRATE + MAGNESIUM HYDROXIDE + SIMETICONE/ ALDEGRATE+ MAGNESIUM HYDROXIDE |
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Document reference: 46420 |
Study title: Intraperitoneal deferoxamine therapy for aluminium intoxication in achild undergoing continuous ambulatory peritoneal dialysis - Andreoli SP - 1985 (J. of Pediatrics; 107 (5): 760-764)Intraperitoneal deferoxamine therapy for aluminium intoxication in achild undergoing continuous ambulatory peritoneal dialysis - Andreoli SP - 1985 (J. of Pediatrics; 107 (5): 760-764) |
Active substance: ALUMINIUM HYDROXIDE AND MAGNESIUM HYDROXIDE |
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Document reference: 46474 |
Study title: The dialysis dementia syndrome and aluminium intoxication - Sideman S - 1982 (Nephron 1982; 31(1): 1-10) - Publication in Clinical Overview - Aluminium Hydroxide and combination - Dementia - Caratas M - 2006 -The dialysis dementia syndrome and aluminium intoxication - Sideman S - 1982 (Nephron 1982; 31(1): 1-10) - Publication in Clinical Overview - Aluminium Hydroxide and combination - Dementia - Caratas M - 2006 - |
Active substance: ALUMINIUM HYDROXIDE AND MAGNESIUM HYDROXIDE |
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Document reference: 46478 |
Study title: Amantadine neurotoxicity in a pediatric patient with renal insufficiency.Amantadine neurotoxicity in a pediatric patient with renal insufficiency. |
Active substance: AMANTADINE |
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Document reference: 46499 |
Study title: "Acute pulmonary toxicity in an infant from intravenous amiodarone. - Daniels CJ et al. - 1997 (Am. Cardiol., 80 (8): 1113-1116) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" "Acute pulmonary toxicity in an infant from intravenous amiodarone. - Daniels CJ et al. - 1997 (Am. Cardiol., 80 (8): 1113-1116) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" |
Active substance: AMIODARONE |
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Document reference: 45209 |
Study title: "Optimizing oral dosing and monitoring of noncardiac toxicities with chronic amiodarone therapy. - Tsikouris JP et al. - 2000 (Connecticut Medecine, 64: 35-38) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" "Optimizing oral dosing and monitoring of noncardiac toxicities with chronic amiodarone therapy. - Tsikouris JP et al. - 2000 (Connecticut Medecine, 64: 35-38) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" |
Active substance: AMIODARONE |
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Document reference: 45185 |
Study title: Acute toxicity of KWD2183 in young rats after single oral administration |
Active substance: BAMBUTEROL HYDROCHLORIDE |
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Document reference: 22123 |
Study title: General toxicity of KWD2183 given orally to young rats for three months |
Active substance: BAMBUTEROL HYDROCHLORIDE |
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Document reference: 22124 |
Study title: General toxicity of bambuterol (KWD2183) given orally to young rats for three months. Plasma concentration study. (Appendix 4:2 to report T2030) |
Active substance: BAMBUTEROL HYDROCHLORIDE |
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Document reference: 22125 |
Study title: Reversal of antiparkinsonian drug toxicity by physostigmine: a controlled study. |
Active substance: BENZATROPINE |
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Document reference: 22253 |
Study title: Reversal of antiparkinsonian drug toxicity by physostigmine: a controlled study. |
Active substance: BENZATROPINE |
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Document reference: 41957 |