- Trials with a EudraCT protocol (15)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (22)

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: Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326. |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24626 |
Study title: Ala-Houhala M, Koskinen T, Koskinen M, Visakorpi JK.Double blind study on the need for vitamin D supplementation in prepubertal children.Acta Paediatr Scand. 1988 Jan;77(1):89-93. |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24634 |
Study title: Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143. |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24627 |
Study title: De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167 |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24628 |
Study title: Empfehlung der Deutschen Akademie fuer Kinderheilkunde und Jugendmedizin yur Kariesprophylaxe mit Fluoriden (Monatsschrift Kinderheilkunde 2000 148, 1154-57) |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24624 |
Study title: Fábián K, Velkey L, Fodor E. [Preventive value of vitamin D in various doses based on a prospective study of healthy infants. [Article in Hungarian] Orv Hetil. 1990 Mar 4;131(9):447-50. |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24635 |
Study title: Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9 |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24629 |
Study title: Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307 |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24631 |
Study title: Effect of caries-prophylaxis with Fluor-Vigantoletten 1000 on fluoride concentration in plasma of infants - Einfluß der Kariesprophylaxe mit Fluor-Vigantoletten 1000 auf die Plasma-Fluoridkonzentrationen beim Säugling.Monatsschr Kinderheilk 1979; 127: 192-195. Fuchs C. |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 24623 |
Study title: Lehtonen-Veroma M, Mottonen T, Nuotio I et al. Vitamin D and attainment of peak bone mass among peripubertal Finish girls: a 3-year prospective study. Am J Clin Nutr 2002; 76: 1446-53. |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24636 |
Study title: Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179. |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24632 |
Study title: Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800. |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24633 |
Study title: Meier C, Woitge HW, Witte K, Lemmer B, Seibel MJ. Supplementation with oral vitamin D3 and calcium during winter prevents seasonal bone loss: a randomized controlled open-label prospective trial. J Bone Miner Res. 2004 Aug;19(8):1221-30. |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24637 |
Study title: Nicolaidou P, Georgouli H, Kotsalis H, Matsinos Y, Papadopoulou A, Fretzayas A, Syriopoulou V, Krikos X, Karantana A, Karpathios T. Effects of anticonvulsant therapy on vitamin D status in children: prospective monitoring study. J Child Neurol. 2006 Mar;21(3):205-9. |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24638 |
Study title: Specker BL, Ho ML, Oestreich A, Yin TA, Shui QM, Chen XC, Tsang RC.Prospective study of vitamin D supplementation and rickets in China.J Pediatr. 1992 May;120(5):733-9. |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24639 |
Study title: A Multiclinic Evaluation of the efficacy and safety of Ciprofloxacin Ophthalmic Ointment versus TOBREX Ophthalmic Ointment in treating bacterial conjuncivitis (C8824a). |
Active substance: TOBRAMYCIN |
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Document reference: 44815 |
Study title: C8559 - November 15, 1989; C8569 (011:37150:0688) - June 30, 1988; C8569 (016:38610:0490) - March 14, 1994; C8569 (010:34350:1287) - April 21, 1988; C8569 (015:38610:0490) - November 5, 1990; C8569 (017:38610:0490) - June 16, 1994; C8569 (02:38610:0194) - July 6, 1994; C8569 (009:34350:1287) - April 21, 1988; C8569 (008:34350:1287) - April 21, 1988; C8569A (055:38610:1189) - November 13, 1989; C8569A (022:38610:0490) - November 6, 1990; C8569A (024:38610:0490) - May 27, 1994; C8881 - June 2, 1994; C9126 - April 21, 1995; C9144 - June 30, 1993; C9151 - August 3, 1994; C9165 - March 8, 1994; C9171 - June 29, 1993; C9274 - October 3, 1995 |
Active substance: LODOXAMIDE |
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Document reference: 46926 |
Study title: Efficacy and safety evaluation of Lodoxamide Ophthalmic Solution versus OPTICROM Ophthalmic Solution in patients with vernal conjunctivitis, giant papillary conjunctivitis and allergic/atopic conjunctivitis (C8559) |
Active substance: LODOXAMIDE |
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Document reference: 46925 |
Study title: Epidemiologische Begleituntersuchungen yur Gruppenprophylaxe 2000 - Gutachten (Prof. Dr. K. Pieper, im Auftrag der Deutschen Arbeitsgemeinschaft fuer Jugendzahnpflege, 2001 ISBN 3/926 228 16-4) |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24625 |
Study title: ND: 27179 AU: BOUISSOU F, FABRE C, REMESY M, MESTERY D,YUNG M, CABAL G, PIQUEMAL J, MARMIN G, BOESEN G, FOURES M F, BARTHE PH. IN: NEPHROLOGIE PEDIATRIQUE, HOPITAL DES ENFANTS, TOULOUSE, FRANCE. TI: CARNITINE SUPPLEMENTATION IN HEMODIALYSED CHILDREN: EFFECTS ON HEMATOLOGICAL FINDINGS, LIPID PROFILE AND MUSCLES. UROPEAN SOCIETY FOR PAEDIATRIC NEPHROLOGY; SO: 33RD ANNUAL MEETING OF THE EUROPEAN SOCIETY FOR PAEDIATRIC NEPHROLOGY, PRAGUE, CZECH REPUBLIC, SEPTEMBER 2-5, 1999 SPONSORED BY: EUROPEAN SOCIETY FORPAEDIATRIC NEPHROLOGY. PEDIATRIC-NEPHROLOGY, SEPT., 1999, VOL. 13, NO. 7, C82;REUNION ANNUELLE NOVEMBER 1998, LUXEMBOURGND: 27179 AU: BOUISSOU F, FABRE C, REMESY M, MESTERY D,YUNG M, CABAL G, PIQUEMAL J, MARMIN G, BOESEN G, FOURES M F, BARTHE PH. IN: NEPHROLOGIE PEDIATRIQUE, HOPITAL DES ... |
Active substance: LEVOCARNITINE |
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Document reference: 31145 |