PIL - Aripiprazole 10mg, 15mg Orodispersible Tablets: Change history
View Patient Information Leaflet (PIL - Aripiprazole 10mg, 15mg Orodispersible Tablets)
Last updated on this site: 13 Sep 2023
To update sections 4.8 and 5.1 of the SmPC in line with the
reference product, ABILIFY 10mg orodispersible tablets (PLGB
50697/0002, MAH: Otsuka Pharmaceutical Netherlands B.V.).
Consequently, the PIL has been updated.
Last updated on this site: 13 Sep 2023
To update sections 4.8 and 5.1 of the SmPC in line with the
reference product, ABILIFY 10mg orodispersible tablets (PLGB
50697/0002, MAH: Otsuka Pharmaceutical Netherlands B.V.).
Consequently, the PIL has been updated.
-
Changes: (Updated: 13 Sep 2023)
To update sections 4.8 and 5.1 of the SmPC in line with the
reference product, ABILIFY 10mg orodispersible tablets (PLGB
50697/0002, MAH: Otsuka Pharmaceutical Netherlands B.V.).
Consequently, the PIL has been updated.
-
Changes: (Updated: 10 Aug 2023)
Variation Description: To register the addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, UK as a manufacturing site responsible for batch control testing for Microbiological testing (non-sterility) of the finished product.
-
Changes: (Updated: 20 Sep 2022)
Initial upload