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Shelf life

3 years.

Incompatibilities

Not applicable.

Date of revision of the text

14 February 2017

Marketing authorisation holder

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle

F-92800 Puteaux

France

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

White HDPE bottle with a polypropylene and HDPE closure and contains a filler (cotton coil). Each bottle contains 250 capsules.

Marketing authorisation number(s)

EU/1/04/286/001

Special precautions for disposal and other handling

No special requirements

Date of first authorisation/renewal of the authorisation

Date of first authorisation: 13 October 2004

Date of latest renewal: 13 October 2009