Extension of shelf life for Tamiflu 75 mg, 45 mg and 30 mg hard capsules
17.07.2009
The European Medicines Agency (EMEA) has recommended that the shelf life of Tamiflu capsules should be extended from 5 to 7 years. The Agency for Medicinal Products and Medical Devices approved this variation for all dosages of the Tamiflu hard capsules that have the marketing authorisation in the Republic of Croatia (Tamiflu 75 mg, 45 mg and 30 mg). The Summary of Product Characteristics, Medicinal Product Labelling and Patient Information Leaflet in all newly manufactured capsule series will be amended accordingly.
As for the Tamiflu capsules that are already on the market, in line with the recommendations of the EMEA's Committee for Medicinal Products for Human Use (CHMP), the Agency for Medicinal Products and Medical Devices of the Republic of Croatia advises to keep Tamiflu capsules for up to two more years beyond the stated five-year shelf life.
The patients who have Tamiflu capsules at home can use them for up to two more years after their current five-year expiry date stated on the packaging.
The full text of the CHMP's recommendations can be found below: (http://www.emea.europa.eu/humandocs/PDFs/EPAR/tamiflu/28497109en.pdf)
