SmPC- Temozolomide Accord 140mg Hard Capsules: Change history
View Summary of Product Characteristics (SmPC- Temozolomide Accord 140mg Hard Capsules)
Last updated on this site: 12 Jul 2023
Description of update: To update section 4.2, 4.8, 4.9, 5.1 and 5.3 of the SmPC, section 1, 2, 3, and 4 of the PIL and section C and D of the annex-II information in line with the information of reference product (Temodal 5mg, 20mg, 100mg, 140mg, 180mg, 250mg hard capsules; MAH: Merck Sharp & Dohme B.V. The Netherlands; EU procedure reference number:
EMEA/H/C/000229 - IA/0099 updated on date 21/02/2023) for Temozolomide Accord 5/20/100/140/180/250mg capsules. In addition, editorial updates have been made to sections 3, 4.2,
4.4, 4.6, 4.7 of SmPC and section 2 of leaflet with editorial changes in line with reference product Information.
SmPC sections updated: 4.4, 4.9, 5.3, 10.
Last updated on this site: 12 Jul 2023
Description of update: To update section 4.2, 4.8, 4.9, 5.1 and 5.3 of the SmPC, section 1, 2, 3, and 4 of the PIL and section C and D of the annex-II information in line with the information of reference product (Temodal 5mg, 20mg, 100mg, 140mg, 180mg, 250mg hard capsules; MAH: Merck Sharp & Dohme B.V. The Netherlands; EU procedure reference number:
EMEA/H/C/000229 - IA/0099 updated on date 21/02/2023) for Temozolomide Accord 5/20/100/140/180/250mg capsules. In addition, editorial updates have been made to sections 3, 4.2,
4.4, 4.6, 4.7 of SmPC and section 2 of leaflet with editorial changes in line with reference product Information.
SmPC sections updated: 4.4, 4.9, 5.3, 10.
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Changes: (Updated: 12 Jul 2023)
Description of update: To update section 4.2, 4.8, 4.9, 5.1 and 5.3 of the SmPC, section 1, 2, 3, and 4 of the PIL and section C and D of the annex-II information in line with the information of reference product (Temodal 5mg, 20mg, 100mg, 140mg, 180mg, 250mg hard capsules; MAH: Merck Sharp & Dohme B.V. The Netherlands; EU procedure reference number:
EMEA/H/C/000229 - IA/0099 updated on date 21/02/2023) for Temozolomide Accord 5/20/100/140/180/250mg capsules. In addition, editorial updates have been made to sections 3, 4.2,
4.4, 4.6, 4.7 of SmPC and section 2 of leaflet with editorial changes in line with reference product Information.
SmPC sections updated: 4.4, 4.9, 5.3, 10.
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Changes: (Updated: 22 Sep 2022)
initial upload