11.07.2015 Views

The GCC Guidance for Presenting the SPC, PIL and Labeling ...

The GCC Guidance for Presenting the SPC, PIL and Labeling ...

The GCC Guidance for Presenting the SPC, PIL and Labeling ...

SHOW MORE
SHOW LESS
  • No tags were found...

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

Patient In<strong>for</strong>mation Leaflet (<strong>PIL</strong>){(Invented) name strength pharmaceutical <strong>for</strong>m}{Active substance(s)}<strong>The</strong> (invented) name of <strong>the</strong> medicinal product (referred to as X throughout this document)followed by <strong>the</strong> strength <strong>and</strong> pharmaceutical <strong>for</strong>m (i.e. as it appears in <strong>the</strong> <strong>SPC</strong>) should bestated here in bold. This should be followed by <strong>the</strong> active substance(s) (as stated on <strong>the</strong>label section 1), which may be written on <strong>the</strong> line below.In this leaflet:1. What {product name}is <strong>and</strong> what it is used <strong>for</strong>2. Be<strong>for</strong>e you {product name}3. How to {product name}4. Possible side effects5. How to store {product name}6. Fur<strong>the</strong>r in<strong>for</strong>mationPage 12 of 52

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!