PIL - Efavirenz Accord 600 mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL - Efavirenz Accord 600 mg Film-coated Tablets)
Last updated on this site: 31 Oct 2023
Description of update: Variation to update section 4.5 of SmPC and section 2 of leaflet in-line with the reference product (SUSTIVA 600 mg film-coated tablets; EU procedure number: EMEA/H/C/000249; MAH: Bristol Mayor Squibb) for Efavirenz Accord 600 mg Film-coated tablets.
PIL sections updated: 2 and 6.
Last updated on this site: 31 Oct 2023
Description of update: Variation to update section 4.5 of SmPC and section 2 of leaflet in-line with the reference product (SUSTIVA 600 mg film-coated tablets; EU procedure number: EMEA/H/C/000249; MAH: Bristol Mayor Squibb) for Efavirenz Accord 600 mg Film-coated tablets.
PIL sections updated: 2 and 6.
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Changes: (Updated: 31 Oct 2023)
Description of update: Variation to update section 4.5 of SmPC and section 2 of leaflet in-line with the reference product (SUSTIVA 600 mg film-coated tablets; EU procedure number: EMEA/H/C/000249; MAH: Bristol Mayor Squibb) for Efavirenz Accord 600 mg Film-coated tablets.
PIL sections updated: 2 and 6.
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Changes: (Updated: 27 Jul 2023)
The proposed change is:
C.I.2.a;
update section 4.4, 4.5, 4.6, 4.8 and 5.1 of SmPC and section 2 of leaflet in-line with the reference product (SUSTIVA 600 mg film-coated tablets; EU procedure number: EMEA/H/C/000249-IB/0160; MAH: Bristol Mayor Squibb) for Efavirenz Accord 600 mg Film-coated tablets.
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Changes: (Updated: 06 Dec 2022)
Updated in line with update to SmPC for this product
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Changes: (Updated: 20 Sep 2022)
Initial upload