Medicinal Products

Dáil Éireann Debate, Tuesday - 17 July 2012

Tuesday, 17 July 2012

Questions (732, 733)

Tom Fleming

Question:

740 Deputy Tom Fleming asked the Minister for Health if the cystic fibrosis drug kayldeco is covered under the medical card scheme; and if he will make a statement on the matter. [34448/12]

Tom Fleming

Question:

741 Deputy Tom Fleming asked the Minister for Health if the cystic fibrosis drug kayldeco is covered under the long-term illness scheme; and if he will make a statement on the matter. [34449/12]

Written answers

Minister of State at the Department of Health (Deputy Róisín Shortall)

I propose to take Questions Nos. 740 and 741 together.

Ivacaftor (Kalydeco) received a positive opinion from the Committee for Medicinal Products for Human Use at EU level in May 2012. Marketing authorisation issued by the EU Commission is anticipated in due course. Should the manufacturers make an application for inclusion of the product on the GMS and community drugs schemes, that application shall be considered in accordance with the relevant criteria.