Inventory of paediatric therapeutic needs -EMA
May 12, 2015 14:04:07 GMT -5
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Post by harryx1 on May 12, 2015 14:04:07 GMT -5
www.ema.europa.eu/docs/en_GB/document_library/Other/2015/05/WC500186699.pdf
Start of public consultation 11 May 2015
Notes
For the designation of the products International Non-proprietary Names (INN) are used whenever possible. Products are listed in alphabetical order within the product classes, not in order of priority.
If not stated otherwise, the needs concern all paediatric age-groups. For information on products with an agreed Paediatric Investigation Plan (PIP) please consult the EMA website.
Product Needs
Insulines
Inhaled human insulin Data on PK, PD, efficacy and safety in children and adolescents < 18 years. Data on long-term safety
www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000096.jsp&mid=WC0b01ac05800260a1#section3
Start of public consultation 11 May 2015
Notes
For the designation of the products International Non-proprietary Names (INN) are used whenever possible. Products are listed in alphabetical order within the product classes, not in order of priority.
If not stated otherwise, the needs concern all paediatric age-groups. For information on products with an agreed Paediatric Investigation Plan (PIP) please consult the EMA website.
Product Needs
Insulines
Inhaled human insulin Data on PK, PD, efficacy and safety in children and adolescents < 18 years. Data on long-term safety
www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000096.jsp&mid=WC0b01ac05800260a1#section3