PIL - Lopinavir/Ritonavir Accord 200 mg/50 mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL - Lopinavir/Ritonavir Accord 200 mg/50 mg Film-coated Tablets)
Last updated on this site: 22 Sep 2025
Description of update:
To submit type IB (C.I.2.a) variation to sections 4.3, 4.4, 4.5 of the SmPC and sections 2, 4 of the leaflet in-line with information of reference product (Kaletra 200 mg/50 mg film-coated tablets, EU procedure number: EU/1/01/172/001-006; MAH: AbbVie Deutschland GmbH & Co. KG, Germany) along with minor editorial changes.
In addition:
The carton Braille has been updated in line with the UEB Code, in order to correct the forward slash from ‘⠌’ to ‘⠸⠌’ and to include a number indicator before ‘50’.
The tablet description in PIL section 6 has been updated to align with SmPC section 3.
QRD updates have been made to the PIL.
Editorial and formatting updates have been made to SmPC sections 4.2, 4.3, 4.4, 4.5 and PIL.
Date of approval: 30/07/2025
PIL sections updated: Heading, Index, 1, 2, 4, 5 and 6
Last updated on this site: 22 Sep 2025
Description of update:
To submit type IB (C.I.2.a) variation to sections 4.3, 4.4, 4.5 of the SmPC and sections 2, 4 of the leaflet in-line with information of reference product (Kaletra 200 mg/50 mg film-coated tablets, EU procedure number: EU/1/01/172/001-006; MAH: AbbVie Deutschland GmbH & Co. KG, Germany) along with minor editorial changes.
In addition:
The carton Braille has been updated in line with the UEB Code, in order to correct the forward slash from ‘⠌’ to ‘⠸⠌’ and to include a number indicator before ‘50’.
The tablet description in PIL section 6 has been updated to align with SmPC section 3.
QRD updates have been made to the PIL.
Editorial and formatting updates have been made to SmPC sections 4.2, 4.3, 4.4, 4.5 and PIL.
Date of approval: 30/07/2025
PIL sections updated: Heading, Index, 1, 2, 4, 5 and 6
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Changes: (Updated: 22 Sep 2025)
Description of update:
To submit type IB (C.I.2.a) variation to sections 4.3, 4.4, 4.5 of the SmPC and sections 2, 4 of the leaflet in-line with information of reference product (Kaletra 200 mg/50 mg film-coated tablets, EU procedure number: EU/1/01/172/001-006; MAH: AbbVie Deutschland GmbH & Co. KG, Germany) along with minor editorial changes.
In addition:
The carton Braille has been updated in line with the UEB Code, in order to correct the forward slash from ‘⠌’ to ‘⠸⠌’ and to include a number indicator before ‘50’.
The tablet description in PIL section 6 has been updated to align with SmPC section 3.
QRD updates have been made to the PIL.
Editorial and formatting updates have been made to SmPC sections 4.2, 4.3, 4.4, 4.5 and PIL.
Date of approval: 30/07/2025
PIL sections updated: Heading, Index, 1, 2, 4, 5 and 6
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Changes: (Updated: 11 Apr 2023)
Description of update: To update SmPC and PIL in-line with the product information of reference product (Kaletra 200 mg/50 mg film-coated tablets, EU procedure number: EU/1/01/172/001-006; MAH: AbbVie Deutschland GmbH & Co. KG, Germany) for Lopinavir/Ritonavir 200mg/50mg film-coated tablets.
PIL sections updated: intro, 2, 3, 4, 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload