SmPC - Efavirenz Accord 600 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - 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.
SmPC sections updated: 4.5 and 10.
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.
SmPC sections updated: 4.5 and 10.
-
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.
SmPC sections updated: 4.5 and 10.
-
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.
-
Changes: (Updated: 06 Dec 2022)
Section 4.5 - addition of "PraziquantelConcomitant use of efavirenz with praziquantel is not recommended due to significant decrease in plasma concentrations of praziquantel, with risk of treatment failure due to increased hepatic metabolism by efavirenz. In case the combination is needed, an increased dose of praziquantel could be considered."
-
Changes: (Updated: 20 Sep 2022)
Initial upload