Transcription of Scientific guidelines with SmPC recommendations
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Scientific guidelines with SmPC recommendations
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 25 January 2017 EMA/813125/2012 rev. 4 Scientific guidelines with SmPC recommendations Table of contents Table of contents .. 1 1. Clinical efficacy and safety .. 1 2. Quality and biological .. 4 3. Non-clinical .. 5 Note: the tables below only include adopted Scientific guidelines which refer specifically to the SmPC. For complete information on Scientific guidelines , please refer to the European Medicines Agency website ( ). guidelines under review are marked with an * 1. Clinical efficacy and safety guidelines Reference to specific SmPC section(s) Advanced therapies Guideline on xenogeneic cell-based medicinal products Reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products , , , , , , Anti-infectives for systemic use CHMP position paper on thiomersal implementation of the warning statement relating to sensitisation , , CHMP guideline on clinical evaluation of new vaccines.
Scientific guidelines with SmPC recommendations EMA/813125/2012 Page 2/5 Guidelines Reference to specific SmPC section(s) treatment of HIV infection
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