SmPC - Donepezil Hydrochloride 5 mg Film-coated Tablets (20075/0107): Change history
View Summary of Product Characteristics (SmPC - Donepezil Hydrochloride 5 mg Film-coated Tablets (20075/0107))
Last updated on this site: 20 Nov 2023
Description of update: Type IB (C.I.2.a) variation to update sections 4.2, 4.4, 4.6, 4.8 and 5.1 of the SmPC and sections 2, 3 and 4 of the leaflet in line with the information of Reference product (ARICEPT 5 mg film coated tablets MAH: Pfizer Healthcare Ireland; Approved through EU procedure number: AT/H/0983/001-002)
SmPC Sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.3 and 10.
Last updated on this site: 20 Nov 2023
Description of update: Type IB (C.I.2.a) variation to update sections 4.2, 4.4, 4.6, 4.8 and 5.1 of the SmPC and sections 2, 3 and 4 of the leaflet in line with the information of Reference product (ARICEPT 5 mg film coated tablets MAH: Pfizer Healthcare Ireland; Approved through EU procedure number: AT/H/0983/001-002)
SmPC Sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.3 and 10.
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Changes: (Updated: 20 Nov 2023)
Description of update: Type IB (C.I.2.a) variation to update sections 4.2, 4.4, 4.6, 4.8 and 5.1 of the SmPC and sections 2, 3 and 4 of the leaflet in line with the information of Reference product (ARICEPT 5 mg film coated tablets MAH: Pfizer Healthcare Ireland; Approved through EU procedure number: AT/H/0983/001-002)
SmPC Sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.3 and 10.
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Changes: (Updated: 10 Jan 2023)
Variation application to update SPC and PIL in-line with the wordings of PSUSA/00001160/202111.
Updates to SmPC sections 4.2, 4.8 & 10.
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Changes: (Updated: 23 Sep 2022)
Unlinked from 0142
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Changes: (Updated: 20 Sep 2022)
Initial upload