- Trials with a EudraCT protocol (9)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (13)

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: A clinical trial with Solcoderm, Haim S., Cohen A., 1983, Publication: Solcoderm treatment of epidermal growths including intradermmal nevi, 1984 |
Active substance: ACETIC ACID_OXALIC ACID_NITRIC ACID_LACTIC ACID_COPPER (II) NITRATE |
Study summary document link (including results): |
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Document reference: 21254 |
Study title: 1 Month Oral (Gavage) Toxicity and Toxicokinetic Study in the Neonatal Sprague Dawley Rat, Followed by a 3 Month Recovery Period. AstraZeneca R&D Södertälje, Safety Assessment, Sweden (Charles River Laboratories Preclinical Services Montreal Inc, Sennevi |
Active substance: ESOMEPRAZOLE |
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Document reference: 26609 |
Study title: 1 Month Oral (Gavage) Toxicity and Toxicokinetic Study in the Neonatal Sprague Dawley Rat. AstraZeneca R&D Södertälje, Safety Assessment, Sweden (Charles River Laboratories Preclinical Services Montreal Inc, Senneville, Canada). May 2006. |
Active substance: ESOMEPRAZOLE |
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Document reference: 26622 |
Study title: A 3-Month Oral (Gavage) Toxicity and Toxicokinetic Study in the Neonatal Beagle Dog (a Second Complementary Study). AstraZeneca R&D Södertälje, Safety Assessment, Sweden (Charles River Laboratories Preclinical Services Montreal Inc, Senneville, Canada). |
Active substance: ESOMEPRAZOLE |
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Document reference: 26611 |
Study title: Open-label, multicenter trial of Magnevist® enteral in magnetic resonance imaging of patients = 16 years of age |
Active substance: GADOPENTETIC ACID |
Study summary document link (including results): ME90095 ME91005 ME91006.pdf |
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Document reference: 28825 |
Study title: A Prospective Blinded Read to Explore the Efficacy of MULTIHANCE and MAGNEVIST (0.10 mmol/kg) in Magnetic Resonance Imaging (MRI) of Brain and Spine Tumors in Pediatric Population |
Active substance: FUSIDIC ACID |
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Document reference: 28722 |
Study title: Contrast Enhanced Magnetic Resonance Imaging of the Central Nervous System in Patients Between 2 and 18 Years of Age by Intravenous Administration: A Randomized Double-Blind Comparison of Gadodiamide Injection (Gd DTPA BMA) 0.1 mmol/kg with MAGNEVIST®(G d DTPA) 0.1 mmol/kg |
Active substance: GADODIAMIDE |
Study summary document link (including results): SW1357 Redacted.pdf |
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Document reference: 47577 |
Study title: Contrast Enhanced Magnetic Resonance Imaging of the Central Nervous System in Patients Between 2 and 18 Years of Age by Intravenous Administration: A Randomized Double-Blind Comparison of Gadodiamide Injection (Gd DTPA BMA) 0.1 mmol/kg with MAGNEVIST® (Gd DTPA) 0.1 mmol/kg (Protocol 50678-005, Study B) |
Active substance: GADODIAMIDE |
Study summary document link (including results): SW1358 Redacted.pdf |
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Document reference: 47578 |
Study title: A phase III, double-blind, parallel-group, randomized, comparative, two-centre study on gadodiamide injection (Omniscan) and Magnevist® at 0.1 mmol/kg b.w. in MR examinations of the CNS in children and adolescents in a 0.5 T Philips Gyroscan MR unit at the University Hospital Eppendorf, Hamburg, Germany, and in a 1.5T Philips Gyroscan S15 MR unit at the Department of Diagnostic Radiology, University of Cologne, Cologne, Germany |
Active substance: GADODIAMIDE |
Study summary document link (including results): SOV033 Redacted.pdf |
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Document reference: 47574 |
Study title: An open, multicenter clinical trial of Magnevist® in newborns and infants up to the second year of life in CNS indications |
Active substance: GADOPENTETIC ACID |
Study summary document link (including results): Bayer Pharma_Gadopentetate Dimeglumine_90104_study_synopsis.pdf |
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Document reference: 28833 |
Study title: Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. |
Active substance: IODIXANOL |
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Document reference: 30352 |
Study title: Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. |
Active substance: IOHEXOL |
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Document reference: 30372 |
Study title: BERATO 1969, DESRUS FOURNIE 1969, REBOUILLAT 1966, WEBER 1986, BADY 1969, GENEVIEVE 1970, GERAUD 1968, GRIMAUD CHEVRIER 1971, 1968, JAROUSSE 1973, BERARD 1969, GILLE 1970, MASSE 1969, PREVOT 1969, VIALLE 1969, SCHILLIRO 1971 - Publications in the Clinical expert report - Dr.A.Hernandez vidal - No date - |
Active substance: TETRAZEPAM |
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Document reference: 44480 |