Ulcerative Colitis

- TachoSil (Human fibrinogen and human thrombin), Nycomed Austria GmbH, to amend the indication by deleting the following statement: 'Efficacy has only been demonstrated in liver surgery'.

TachoSil was first authorised in the European Union on 8 June 2004 and is approved for supportive treatment in surgery for improvement of haemostasis where standard techniques are insufficient.

The CHMP also recommended the approval of Bondenza (ibandronic acid) and Bonviva (ibandronic acid) 3mg/3ml solution for injection.

Bondenza and Bonviva were first authorised in the European Union on 23 February 2004 and are both indicated for the treatment of osteoporosis.

This strength is for intravenous administration once every 3 months compared to once daily and once monthly oral administrations previously authorised.

Summaries of opinions for all these products are available and can be found here emea.eu.int/htms/human/opinion/opinion.htm.

Re-examination procedure concluded Following the re-examination of the negative opinion adopted on 13 October 2005, the Committee adopted a final positive opinion to recommend the extension of indication for Exelon and Prometax, from Novartis Europharm Ltd, to add the symptomatic treatment of mild to moderately severe dement...

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