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DE/H/3682/001/IA/020_approved_common_SPC

               Pack sizes:
               -     1 box of one 5 ml bottle.
               -     1 box of one 10 ml bottle.
               -     1 box of three 5 ml bottles.
               -     3 boxes of one 5 ml bottle wrapped with a foil.
               -     1 box of two 10 ml bottles.
               -     2 boxes of one 10 ml bottle wrapped with a foil.

               Not all pack sizes may be marketed.

               6.6  Special precautions for disposal and other handling

               No special requirements.


               7.    MARKETING AUTHORISATION HOLDER

               LABORATOIRES THEA
               12 RUE LOUIS BLERIOT
               63017 CLERMONT-FERRAND CEDEX 2
               France


               8.    MARKETING AUTHORISATION NUMBER(S)

               [To be completed nationally]

               9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

               [To be completed nationally]

               10.  DATE OF REVISION OF THE TEXT

               14/12/2022

               11.  DOSIMETRY

               Not applicable

               12.  INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

               Not applicable
               Detailed information on this medicinal product is available on the website of {name of
               MS/Agency}.













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