SmPC - Metoclopramide 10mg Tablets: Change history
View Summary of Product Characteristics (SmPC - Metoclopramide 10mg Tablets)
Last updated on this site: 13 Jul 2023
Description of update: To update sections 4.2, 4.6, 4.8, 5.1 and 5.3 of the SmPC in line with reference product Maxolon Tablets 10mg (PL 20072/0048; MAH: Amdipharm UK Limited; dated 12/10/2022). No consequential update to the PIL. Additional editorial updates to SmPC sections 4.1, 4.2 and 4.8. Additional updates to the headings of SmPC sections 4.1, 5.1, 6.6, 7, 8 and 9 in line with the QRD template (version 10.3).
SmPC sections updated – 4.1, 4.2, 4.6, 4.8, 5.1, 5.3, 6.6, 7, 8, 9 and 10.
Last updated on this site: 13 Jul 2023
Description of update: To update sections 4.2, 4.6, 4.8, 5.1 and 5.3 of the SmPC in line with reference product Maxolon Tablets 10mg (PL 20072/0048; MAH: Amdipharm UK Limited; dated 12/10/2022). No consequential update to the PIL. Additional editorial updates to SmPC sections 4.1, 4.2 and 4.8. Additional updates to the headings of SmPC sections 4.1, 5.1, 6.6, 7, 8 and 9 in line with the QRD template (version 10.3).
SmPC sections updated – 4.1, 4.2, 4.6, 4.8, 5.1, 5.3, 6.6, 7, 8, 9 and 10.
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Changes: (Updated: 13 Jul 2023)
Description of update: To update sections 4.2, 4.6, 4.8, 5.1 and 5.3 of the SmPC in line with reference product Maxolon Tablets 10mg (PL 20072/0048; MAH: Amdipharm UK Limited; dated 12/10/2022). No consequential update to the PIL. Additional editorial updates to SmPC sections 4.1, 4.2 and 4.8. Additional updates to the headings of SmPC sections 4.1, 5.1, 6.6, 7, 8 and 9 in line with the QRD template (version 10.3).
SmPC sections updated – 4.1, 4.2, 4.6, 4.8, 5.1, 5.3, 6.6, 7, 8, 9 and 10.
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Changes: (Updated: 10 May 2023)
Single Variation
Variation type: IB, B.II.e.1.z
Variation Description: To register a module 32p7 covering the PVC blister lidded with aluminium. SmPC section 6.5 has been updated deleting obsolete packing.
Note: Additionally, details of heat seal lacquer have been removed from SmPC Section 6.5.
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Changes: (Updated: 27 Apr 2023)
Wrong SPC originally uploaded
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Changes: (Updated: 21 Oct 2022)
Update
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Changes: (Updated: 21 Sep 2022)
Initial upload