- Trials with a EudraCT protocol (0)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (8)

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: Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Reye’s syndrome. - Hall SM.- (BMJ 1994; 309:411.)Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Reye’s syndrome. - Hall SM.- (BMJ 1994; 309:411.) |
Active substance: CARBOCYSTEINE AND PROMETHAZINE |
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Document reference: 23343 |
Study title: Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Treatment of undifferentiated respiratory infections in infants. - Ackerman BD.- (Clin Pediatr 1968, 7: 391–395.).Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Treatment of undifferentiated respiratory infections in infants. - Ackerman BD.- (Clin Pediatr 1968, 7: 391–395.). |
Active substance: CARBOCYSTEINE AND PROMETHAZINE |
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Document reference: 23344 |
Study title: Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Boxed warning added to promethazine labeling for pediatric use. Starke PR, et al. (N. Engl. Med. 2005; 352(25): 2653.)Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Boxed warning added to promethazine labeling for pediatric use. Starke PR, et al. (N. Engl. Med. 2005; 352(25): 2653.) |
Active substance: CARBOCYSTEINE AND PROMETHAZINE |
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Document reference: 23345 |
Study title: Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Comby F, Buxeraud J, Lagorce JF, Eichler B. Fluidifiants bronchiques ou mucomodificateurs. Lyon Pharmaceutique 1993, 44, 407-417Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Comby F, Buxeraud J, Lagorce JF, Eichler B. Fluidifiants bronchiques ou mucomodificateurs. Lyon Pharmaceutique 1993, 44, 407-417 |
Active substance: CARBOCYSTEINE AND PROMETHAZINE |
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Document reference: 23346 |
Study title: Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Experience with a new cough preparation: report of 203 cases. - Phillips FJ et al.- (Curr. Ther. Res. 1963; 5:17-23.).Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Experience with a new cough preparation: report of 203 cases. - Phillips FJ et al.- (Curr. Ther. Res. 1963; 5:17-23.). |
Active substance: CARBOCYSTEINE AND PROMETHAZINE |
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Document reference: 23347 |
Study title: Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Reye’s syndrome. - Casteels-Van Daele M et al.- (BMJ 1994; 308:919-20.)Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Reye’s syndrome. - Casteels-Van Daele M et al.- (BMJ 1994; 308:919-20.) |
Active substance: CARBOCYSTEINE AND PROMETHAZINE |
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Document reference: 23348 |
Study title: Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Risks to children from computed tomographic scan premedication. - Mitchell AA, et al.- (J Am Med Assoc 1982; 247(17): 2385-2388.)Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Risks to children from computed tomographic scan premedication. - Mitchell AA, et al.- (J Am Med Assoc 1982; 247(17): 2385-2388.) |
Active substance: CARBOCYSTEINE AND PROMETHAZINE |
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Document reference: 23349 |
Study title: L'utilisation d'une phenothiazine piperazinee et methylee (esucos ou dixyrazine) dans certains troubles fonctionnels et caracteriels. |
Active substance: DIXYRAZINE |
Study summary document link (including results): ARCF96K1024 - Dixyrazine.pdf |
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Document reference: 26262 |