SmPC- Lenalidomide Accord 15 mg Hard Capsules: Change history
View Summary of Product Characteristics (SmPC- Lenalidomide Accord 15 mg Hard Capsules)
Last updated on this site: 07 Aug 2024
1) To update section 4.4, 4.8 and 5.1 of SmPC in line with the reference product (Revlimid; 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsule, hard; EU procedure reference number: EMEA/H/C/000717/II/0126; MAH: Bristol Myers Squibb Pharma EEIG).
2) To update sections 4.4 of SmPC and updating RMP in line with the reference product (Revlimid; 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsule, hard; EU procedure reference number: EMEA/H/C/000717/II/0123; MAH: Bristol Myers Squibb Pharma EEIG).
Last updated on this site: 07 Aug 2024
1) To update section 4.4, 4.8 and 5.1 of SmPC in line with the reference product (Revlimid; 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsule, hard; EU procedure reference number: EMEA/H/C/000717/II/0126; MAH: Bristol Myers Squibb Pharma EEIG).
2) To update sections 4.4 of SmPC and updating RMP in line with the reference product (Revlimid; 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsule, hard; EU procedure reference number: EMEA/H/C/000717/II/0123; MAH: Bristol Myers Squibb Pharma EEIG).
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Changes: (Updated: 07 Aug 2024)
1) To update section 4.4, 4.8 and 5.1 of SmPC in line with the reference product (Revlimid; 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsule, hard; EU procedure reference number: EMEA/H/C/000717/II/0126; MAH: Bristol Myers Squibb Pharma EEIG).
2) To update sections 4.4 of SmPC and updating RMP in line with the reference product (Revlimid; 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsule, hard; EU procedure reference number: EMEA/H/C/000717/II/0123; MAH: Bristol Myers Squibb Pharma EEIG).
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Changes: (Updated: 27 Jun 2023)
Description of update:
1) To update sections 4.2 and 4.4 of SmPC and section 2 of leaflet in-line with the reference product (Revlimid; 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsule, hard; EU procedure reference number: EMEA/H/C/000717/II/0122; MAH: Bristol Myers Squibb Pharma EEIG).
2) To update section 5.1 of the SmPC in-line with the reference product (Revlimid; 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Capsule, hard; EU procedure reference number: EMEA/H/C/000717/II/0124; MAH: Bristol Myers Squibb Pharma EEIG). Additionally, editorial updates have been made to sections 4.2, 4.4, 4.5, 4.8, 5.1 of SmPC and section 2, 3 and 4 of PIL in line with reference products.
SmPC sections updated: 4.2, 4.4, 4.6, 4.8, 5.1, 10.
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Changes: (Updated: 22 Sep 2022)
initial upload