- Trials with a EudraCT protocol (371)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (1,733)

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: Patients with seasonal allergic rhinitis, conjunctivitis and possobly asthma symptoms so far only statistical analysis, Publication sheduled. Age of patients: 5 - 79 Years |
Active substance: 158 Rye |
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Document reference: 39753 |
Study title: Retrospective survey for documentation of appllication and dosage of Abropernol N (tablets) in children < 12 years of age [Bef-014] |
Active substance: Abropernol - Tabletten |
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Document reference: 39761 |
Study title: Assessment of efficacy and tolerability of Acarbose in children under 16 years |
Active substance: ACARBOSE |
Study summary document link (including results): Bayer Pharma_Acarbose_9981_study_synopsis.pdf |
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Document reference: 46160 |
Study title: Blockers and hypoglycaemia (assesment of cadioselective and intrinsic sympathometic properties in relation to severity of hypoglycaemia - No author - 1984 (Current Therapeutic Research 36, n° 2, p. 361-373) ; - Publication in Documentation clinique du dossier d'AMM du 30/10/1987 - |
Active substance: ACEBUTOLOL |
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Document reference: 46182 |
Study title: Short-time-immunotherapy with Allergoids, results from prospective, open Study in allergergological practices; Allergovit patients with seasonal rhino conjunctivitis and/or asthma symptoms Age of patients: 4 – 75 Years, 2047 Patients Allergologie, Jahrgang 28, Nr. 10/2005, S. 391-400 |
Active substance: 006 Grasses (178 Kentucky Blue Grass, 179 Meadow Fescue, 140 Orchard Grass, 157 Rye Grass, 177 Timothy Grass, 133 Velvet Grass) |
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Document reference: 39754 |
Study title: Yen RF, Chen TH, Ting LL, Tzen KY, Pan MH, Hong RL.. Epub 2005 Jun 18. Early restaging whole-body (18)F-FDG PET during induction chemotherapy predicts clinical outcome in patients with locoregionally advanced nasopharyngeal carcinoma. [yen-2005-a]Eur J Nucl Med Mol Imaging. 2005 Oct;32(10):1152-9. Yen RF 2005 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48716 |
Study title: Acitretin in Children. Retinoids: 10 Years On. Basel Karger, 1991:228-232 Acitretin in Children. Retinoids: 10 Years On. Basel Karger, 1991:228-232 |
Active substance: ACITRETIN |
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Document reference: 46219 |
Study title: A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ZENTEL IN THE TREATMENT OF INTESTINAL HELMINTHIASIS IN KENYAN CHILDREN LESS THAN 2 YEARS OF AGE |
Active substance: ALBENDAZOLE |
Study summary document link (including results): Study AL-MEA-0172-Albendazole.xls |
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Document reference: 46322 |
Study title: AN OPEN STUDY OF ALBENDAZOLE (ZENTEL) IN THE TREATMENT OF INTESTINAL HELMINTH INFECTIONS IN INFANTS UNDER 2 YEARS OF AGE |
Active substance: ALBENDAZOLE |
Study summary document link (including results): Study AL-MEA-0212-Albendazole.xls |
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Document reference: 46320 |
Study title: An open, randomised, controlled, phase III study of the immunogenicity and safety of combined adsorbed tetanus, low dose diphtheria, five component acellular pertussis and inactivated poliomyelitis vaccine (Td5aP-IPV), concomitant combined adsorbed tetanus, low dose diphtheria and five component acellular pertussis vaccine (Td5aP) and oral poliomyelitis vaccine (OPV) and combined adsorbed diphtheria, tetanus, two component acellular pertussis and inactivated poliomyelitis vaccine (DT2aP-IPV) given to healthy UK children a minimum of 3 years after priming with diphtheria, tetanus and whole cell pertussis (DTwP) vaccine at 2, 3 & 4 months of age. |
Active substance: Adorbed, inactivated diphteria, tetanus, acellular pertussis and poliomyelitis vaccine |
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Document reference: 41402 |
Study title: Comparative Safety and lmmunogenicity Study of Diphtheria, Tetanus, Acellular Pertussis, Poliomyelitis Vaccine (DTacP-IPV) and Diphtheria, Tetanus, Whole-cell Pertussis, Poliomyelitis 1 1 Vaccine (TETRACOC!@) Given as a Second Booster to 4- to 7-year-old Children |
Active substance: Adorbed, inactivated diphteria, tetanus, acellular pertussis and poliomyelitis vaccine |
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Document reference: 47159 |
Study title: Trial on the persistence of antibodies 4 years after a first booster with PENTAVAC vaccine and the immunogenicity and safety of a second booster with TETRAVAC-ACELLULAIRE vaccine at the age of 5-6 years. |
Active substance: Adorbed, inactivated diphteria, tetanus, acellular pertussis and poliomyelitis vaccine |
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Document reference: 41401 |
Study title: Adenosine or adenosine triphosphate for supraventricular tachycardias ? Comparartive double blind randomized study in patients with spontaneous or inducible arrhytmias - Rankin AC, Olroyd KG, Chong E. - 1990 (Am. Heart J., 119: 316-323)Adenosine or adenosine triphosphate for supraventricular tachycardias ? Comparartive double blind randomized study in patients with spontaneous or inducible arrhytmias - Rankin AC, Olroyd KG, Chong E. - 1990 (Am. Heart J., 119: 316-323) |
Active substance: ADENOSINE |
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Document reference: 46297 |
Study title: Efficacy and safety of albendazole in the treatment of intestinal helminthiasis in Kenyan children less than 2 years of age. |
Active substance: ALBENDAZOLE |
Study summary document link (including results): Study AL-MEA-194-Albendazole.xls |
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Document reference: 46910 |
Study title: SAFETY AND EFFICACY OF ALBENDAZOLE 200 MG IN THE TREATMENT OF INTESTINAL HELMINTHIASIS IN CHILDREN AGED 1 TO 2 YEARS |
Active substance: ALBENDAZOLE |
Study summary document link (including results): Study UK0G-065-Albendazole.xls |
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Document reference: 46321 |
Study title: lmmunogenicity and reactogenicity of two dosages of acellular pettussis vaccine compared with whole-cell pertussis vaccine at prirnary (2, 4 and 6 rnonths of age) and booster (1 5-24 months'and 4-6 years of age) immunisation |
Active substance: Adorbed, inactivated diphteria, tetanus, acellular pertussis and poliomyelitis vaccine |
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Document reference: 47161 |
Study title: Phase III trial on the persistence of antibodies 5 years after a primo-vaccination and 4 years after a first booster with PENTAVAC® vaccine and the immunogenicity and safety of a second booster with TETRAVAC-ACELLULAIRE® vaccine at the age of 5-6 years. |
Active substance: Adorbed, inactivated diphteria, tetanus, acellular pertussis and poliomyelitis vaccine |
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Document reference: 47162 |
Study title: Annila P, Viitanen H, Reinikainen P, Baer G and Lindgren L Induction characteristics of thiopentone/suxamethonium,propofol/alfentanil or halothane alone in children aged 1-3 years. European Journal of Anaesthesiology 16: 359-366, 1999Annila P, Viitanen H, Reinikainen P, Baer G and Lindgren L Induction characteristics of thiopentone/suxamethonium,propofol/alfentanil or halothane alone in children aged 1-3 years. European Journal of Anaesthesiology 16: 359-366, 1999 |
Active substance: ALFENTANIL |
Study summary document link (including results): annila_ind char_alfentanil.pdf |
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Document reference: 46374 |
Study title: Holter-monitored cardiac arrhythmias during induction of anaesthesia in children aged 1-3 years. Britisch Journal Anaesthesia 82 (suppl. 1): 147-148, 1999Holter-monitored cardiac arrhythmias during induction of anaesthesia in children aged 1-3 years. Britisch Journal Anaesthesia 82 (suppl. 1): 147-148, 1999 |
Active substance: ALFENTANIL |
Study summary document link (including results): annila_holter_alfentanil.pdf |
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Document reference: 46347 |
Study title: Pharmacokinetics of alfentanil in infants and children with congenital heart defects. Abstract Nr. 815, Wien 7.-12.9.1986Pharmacokinetics of alfentanil in infants and children with congenital heart defects. Abstract Nr. 815, Wien 7.-12.9.1986 |
Active substance: ALFENTANIL |
Study summary document link (including results): sale_alfentanil.pdf |
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Document reference: 46364 |