SmPC - Risperidone 2mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Risperidone 2mg Film-coated Tablets)
Last updated on this site: 03 May 2023
Variation Description: To update sections 4.8 and 4.9 of the SmPC and PIL in line with the reference product RISPERDAL 0.5mg film-coated tablets (PL 00242/0347, MAH: Janssen-Cilag Ltd) dated 31st August 2022. In addition, editorial changes have been made in section 4.8 of the SmPC and PIL.
SmPC sections updated – 4.8, 4.9 and 10.
View Summary of Product Characteristics (SmPC - Risperidone 2mg Film-coated Tablets)
Last updated on this site: 03 May 2023
Variation Description: To update sections 4.8 and 4.9 of the SmPC and PIL in line with the reference product RISPERDAL 0.5mg film-coated tablets (PL 00242/0347, MAH: Janssen-Cilag Ltd) dated 31st August 2022. In addition, editorial changes have been made in section 4.8 of the SmPC and PIL.
SmPC sections updated – 4.8, 4.9 and 10.
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Changes: (Updated: 03 May 2023)
Variation Description: To update sections 4.8 and 4.9 of the SmPC and PIL in line with the reference product RISPERDAL 0.5mg film-coated tablets (PL 00242/0347, MAH: Janssen-Cilag Ltd) dated 31st August 2022. In addition, editorial changes have been made in section 4.8 of the SmPC and PIL.
SmPC sections updated – 4.8, 4.9 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload