Herceptin Licence

Herceptin Licence

Herceptin Licence For info…

Hot off the press from the emeu

emea.eu.int/pdfs/human/press/pr/15260806en.pdf

(Herceptin is on p2)

and
emea.eu.int/pdfs/human/opinion/15430606en.pdf

Sandra

Thank you Thank you for pointing this out. It makes interesting reading. Do you know how long it takes from now to get the licence approved and for it to go through NICE?
Kate

Timing ???

I’ve seen a suggestion that it is "within next " 3 months to full marketing authorisation for this (a bit of a how long is a piece of string I guess).

nelm.nhs.uk/Record%20Viewing/vR.aspx?id=564193

NICE - anyones guess - my Onc earlier this week had heard rumours of July for issue of guidance (and May for licence - which may tie in with todays report). I couldn’t find anything on NICE site though. I know the first lot of info is in - in theory the draft guidance will go onto the website in the same way the taxane stuff has now appeared) at some point for more general “comment” - had a chance to look at these briefly ( I hadn’t done this when I posted the link in the other thread - need to think before I comment) - highlights the fact that NICE aren’t automatically going to approve (sorry - got cycnical head on tonight).

On the paclitaxel/docetaxel documents There is a mention of a herceptin review in August.