SmPC - Pantoprazole 20mg Gastro-resistant Tablets: Change history
View Summary of Product Characteristics (SmPC - Pantoprazole 20mg Gastro-resistant Tablets)
Last updated on this site: 24 May 2023
Variation Description:
IB C.I.2.a: to update sections 4.4, 4.5, 4.6 (40mg only), 4.8 and 5.2 for Pantoprazole 20 mg and 40 mg gastro-resistant tablets in line with the reference products Pantoprazole 20 mg, 40mg gastro-resistant tablets PL 16189/0034, 0035 (MAH: Takeda UK Limited) dated 18/07/2022.
In addition, the PIL has been updated in line with the excipient guideline and QRD template. The spelling of ‘Sodium lauryl sulfate’ has been corrected to ‘sodium laurilsulfate’ in PIL section 6.
IB C.I.z: PIL section 2 for the above-listed MAs have been updated in line with the MHRA letter dated 16th December 2022 on reduced vitamin B12 absorption. The SPCs are not affected.
SmPC sections updated: 4.4, 4.5, 4.6 (40mg only), 4.8, 5.2 and 10.
Last updated on this site: 24 May 2023
Variation Description:
IB C.I.2.a: to update sections 4.4, 4.5, 4.6 (40mg only), 4.8 and 5.2 for Pantoprazole 20 mg and 40 mg gastro-resistant tablets in line with the reference products Pantoprazole 20 mg, 40mg gastro-resistant tablets PL 16189/0034, 0035 (MAH: Takeda UK Limited) dated 18/07/2022.
In addition, the PIL has been updated in line with the excipient guideline and QRD template. The spelling of ‘Sodium lauryl sulfate’ has been corrected to ‘sodium laurilsulfate’ in PIL section 6.
IB C.I.z: PIL section 2 for the above-listed MAs have been updated in line with the MHRA letter dated 16th December 2022 on reduced vitamin B12 absorption. The SPCs are not affected.
SmPC sections updated: 4.4, 4.5, 4.6 (40mg only), 4.8, 5.2 and 10.
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Changes: (Updated: 24 May 2023)
Variation Description:
IB C.I.2.a: to update sections 4.4, 4.5, 4.6 (40mg only), 4.8 and 5.2 for Pantoprazole 20 mg and 40 mg gastro-resistant tablets in line with the reference products Pantoprazole 20 mg, 40mg gastro-resistant tablets PL 16189/0034, 0035 (MAH: Takeda UK Limited) dated 18/07/2022.
In addition, the PIL has been updated in line with the excipient guideline and QRD template. The spelling of ‘Sodium lauryl sulfate’ has been corrected to ‘sodium laurilsulfate’ in PIL section 6.
IB C.I.z: PIL section 2 for the above-listed MAs have been updated in line with the MHRA letter dated 16th December 2022 on reduced vitamin B12 absorption. The SPCs are not affected.
SmPC sections updated: 4.4, 4.5, 4.6 (40mg only), 4.8, 5.2 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload