Development of paediatric medicines pharmaceutical development points

DEVELOPMENT OF PAEDIATRIC MEDICINES: PHARMACEUTICAL ...

Working document QAS/08.257 February 2008 RESTRICTED DEVELOPMENT OF PAEDIATRIC MEDICINES: PHARMACEUTICAL DEVELOPMENT. POINTS TO CONSIDER At the forty-second meeting of the WHO Expert Committee on Specifications for Pharmaceutical

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DEVELOPMENT OF PAEDIATRIC MEDICINES: POINTS TO CONSIDER IN ...

working document qas/08.257/rev.3 august 2011 restricted development of paediatric medicines: points to consider in pharmaceutical development

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AUSTRALIAN PRODUCT INFORMATION PANADOL ... - Medicines.org.au

3 Paediatric use Not recommended for children under 12 years of age. Effects on laboratory tests No data available. 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS The following interactions with paracetamol have been noted:

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Public Assessment Report - Medicines and Healthcare ...

PL 00030/0215 Lay Summary The Medicines and Healthcare products Regulatory Agency (MHRA) assessed a National simple abridged application in association with a reclassification application and granted a

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Scientific guidelines with SmPC recommendations

Scientific guidelines with SmPC recommendations EMA/813125/2012 Page 3/5 . Guidelines Reference to specific SmPC section(s) Evaluation of the pharmacokinetics of medicinal products in

Clinical Investigation of Medicinal Products for the ...

Guideline on clinical investigation of medicinal products for the treatment of rheumatoid arthritis CPMP/EWP/556/95 Rev. 2 Page 2/16 Guideline on clinical investigation of medicinal products

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New Zealand Data Sheet - Medsafe

New Zealand Data Sheet 3 If, in the physician’s opinion, visual and anatomic parameters indicate that the patient is not benefiting from continued treatment, Lucentis should be discontinued.