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If the additional designation is a number, which does not refer to the strength, the number
must be provided in the "Product Short Name" field (AP.13.2) – see EXAMPLE 29.
If the additional designation is a number, which refers to a ratio (e.g. in case of insulin), the
number must be provided in the "Product Short Name" field (AP.13.2) if the invented name is
available – see EXAMPLE 16.
• If no invented (trade) name is included in the medicinal product name stated in Section 1. Name of
the medicinal product of the SmPC, then the field "Product Short Name" (AP.13.2) should must be
left blank – see EXAMPLE 19.
EXAMPLE 14
The SmPC of a medicinal product authorised in the UK states the following information:
1. Name of the medicinal product
ProdXYZ tablets
"Full Presentation Name" (AP.13.1) = ProdXYZ tablets
"Product Short Name" (AP.13.2) =
ProdXYZ
EXAMPLE 15
The SmPC of a medicinal product authorised in Italy states the following information:
1. DENOMINAZIONE DEL MEDICINALE
XYZ Plus 40 Compresse rivestite
The number "40" does refer to the strength (as section 2. Qualitative and Quantitative composition of
the SmPC indicates that the strength of the active ingredient is 40 mg), therefore, the following
approach has to be adopted:
"Full Presentation Name" (AP.13.1) = XYZ Plus 40 Compresse rivestite
"Product Short Name" (AP.13.2) =
XYZ Plus
EXAMPLE 16
The SmPC of a medicinal product authorised in the UK states the following information:
1. Name of the medicinal product
Maddalin® Insuline Porcine 30/70 Mix
"Full Presentation Name" (AP.13.1) =
"Product Short Name" (AP.13.2) =
Maddalin® Insuline Porcine 30/70 Mix
Maddalin Porcine 30/70 Mix
Detailed guidance on the electronic submission of information on medicinal products
for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 48/163