PIL - Gemcitabine 200 mg, 1 mg, 2 mg Powder for Solution for Infusion: Change history
View Patient Information Leaflet (PIL - Gemcitabine 200 mg, 1 mg, 2 mg Powder for Solution for Infusion)
Last updated on this site: 28 Mar 2024
Description of update:
The following change(s) has been notified: B.III.1.a.2, B.III.1.a.2, B.III.1.a.2, A.7
B.III.1.a.2 - QUALITY CHANGES - CEP/TSE/MONOGRAPHS - Submission of a new or updated Ph. Eur. Certificate of suitability or deletion of Ph. Eur. certificate of suitability: For an active substance For a starting material/reagent/intermediate used in the manufacturing process of the active substance For an excipient - European Pharmacopoeial Certificate of Suitability to the relevant Ph. Eur. Monograph - Updated certificate from an already approved manufacturer
Type IA To update CEP from Intas Pharmaceuticals Ltd; CEP update from “R1-CEP 2009-089-Rev 01” to “R1-CEP 2009-089-Rev 02”.
B.III.1.a.2 - QUALITY CHANGES - CEP/TSE/MONOGRAPHS - Submission of a new or updated Ph. Eur. Certificate of suitability or deletion of Ph. Eur. certificate of suitability: For an active substance For a starting material/reagent/intermediate used in the manufacturing process of the active substance For an excipient - European Pharmacopoeial Certificate of Suitability to the relevant Ph. Eur. Monograph - Updated certificate from an already approved manufacturer
Type IA To update CEP from Shilpa Medicare Ltd; CEP update from “R1-CEP 2006-222-Rev 00” to “R1-CEP 2006-222-Rev 01”.
B.III.1.a.2 - QUALITY CHANGES - CEP/TSE/MONOGRAPHS - Submission of a new or updated Ph. Eur. Certificate of suitability or deletion of Ph. Eur. certificate of suitability: For an active substance For a starting material/reagent/intermediate used in the manufacturing process of the active substance For an excipient - European Pharmacopoeial Certificate of Suitability to the relevant Ph. Eur. Monograph - Updated certificate from an already approved manufacturer
Type IA To update CEP from Hetero Labs Ltd; CEP update from “R1-CEP 2009-208-Rev 01” to “R1-CEP 2009-208-Rev 02”.
A.7 - ADMINISTRATIVE CHANGES - Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier)*
Type IA To delete Accord Healthcare B.V., Netherland as Batch release site.
There are product information updates.
PIL sections updated: Section 6 only.
Last updated on this site: 28 Mar 2024
Description of update:
The following change(s) has been notified: B.III.1.a.2, B.III.1.a.2, B.III.1.a.2, A.7
B.III.1.a.2 - QUALITY CHANGES - CEP/TSE/MONOGRAPHS - Submission of a new or updated Ph. Eur. Certificate of suitability or deletion of Ph. Eur. certificate of suitability: For an active substance For a starting material/reagent/intermediate used in the manufacturing process of the active substance For an excipient - European Pharmacopoeial Certificate of Suitability to the relevant Ph. Eur. Monograph - Updated certificate from an already approved manufacturer
Type IA To update CEP from Intas Pharmaceuticals Ltd; CEP update from “R1-CEP 2009-089-Rev 01” to “R1-CEP 2009-089-Rev 02”.
B.III.1.a.2 - QUALITY CHANGES - CEP/TSE/MONOGRAPHS - Submission of a new or updated Ph. Eur. Certificate of suitability or deletion of Ph. Eur. certificate of suitability: For an active substance For a starting material/reagent/intermediate used in the manufacturing process of the active substance For an excipient - European Pharmacopoeial Certificate of Suitability to the relevant Ph. Eur. Monograph - Updated certificate from an already approved manufacturer
Type IA To update CEP from Shilpa Medicare Ltd; CEP update from “R1-CEP 2006-222-Rev 00” to “R1-CEP 2006-222-Rev 01”.
B.III.1.a.2 - QUALITY CHANGES - CEP/TSE/MONOGRAPHS - Submission of a new or updated Ph. Eur. Certificate of suitability or deletion of Ph. Eur. certificate of suitability: For an active substance For a starting material/reagent/intermediate used in the manufacturing process of the active substance For an excipient - European Pharmacopoeial Certificate of Suitability to the relevant Ph. Eur. Monograph - Updated certificate from an already approved manufacturer
Type IA To update CEP from Hetero Labs Ltd; CEP update from “R1-CEP 2009-208-Rev 01” to “R1-CEP 2009-208-Rev 02”.
A.7 - ADMINISTRATIVE CHANGES - Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier)*
Type IA To delete Accord Healthcare B.V., Netherland as Batch release site.
There are product information updates.
PIL sections updated: Section 6 only.
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Changes: (Updated: 28 Mar 2024)
Description of update:
The following change(s) has been notified: B.III.1.a.2, B.III.1.a.2, B.III.1.a.2, A.7
B.III.1.a.2 - QUALITY CHANGES - CEP/TSE/MONOGRAPHS - Submission of a new or updated Ph. Eur. Certificate of suitability or deletion of Ph. Eur. certificate of suitability: For an active substance For a starting material/reagent/intermediate used in the manufacturing process of the active substance For an excipient - European Pharmacopoeial Certificate of Suitability to the relevant Ph. Eur. Monograph - Updated certificate from an already approved manufacturer
Type IA To update CEP from Intas Pharmaceuticals Ltd; CEP update from “R1-CEP 2009-089-Rev 01” to “R1-CEP 2009-089-Rev 02”.
B.III.1.a.2 - QUALITY CHANGES - CEP/TSE/MONOGRAPHS - Submission of a new or updated Ph. Eur. Certificate of suitability or deletion of Ph. Eur. certificate of suitability: For an active substance For a starting material/reagent/intermediate used in the manufacturing process of the active substance For an excipient - European Pharmacopoeial Certificate of Suitability to the relevant Ph. Eur. Monograph - Updated certificate from an already approved manufacturer
Type IA To update CEP from Shilpa Medicare Ltd; CEP update from “R1-CEP 2006-222-Rev 00” to “R1-CEP 2006-222-Rev 01”.
B.III.1.a.2 - QUALITY CHANGES - CEP/TSE/MONOGRAPHS - Submission of a new or updated Ph. Eur. Certificate of suitability or deletion of Ph. Eur. certificate of suitability: For an active substance For a starting material/reagent/intermediate used in the manufacturing process of the active substance For an excipient - European Pharmacopoeial Certificate of Suitability to the relevant Ph. Eur. Monograph - Updated certificate from an already approved manufacturer
Type IA To update CEP from Hetero Labs Ltd; CEP update from “R1-CEP 2009-208-Rev 01” to “R1-CEP 2009-208-Rev 02”.
A.7 - ADMINISTRATIVE CHANGES - Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier)*
Type IA To delete Accord Healthcare B.V., Netherland as Batch release site.
There are product information updates.
PIL sections updated: Section 6 only.
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Changes: (Updated: 31 Jan 2024)
Description of update: To implement the outcome of PSUSA/00001519/202301: Update section 4.4 of the SmPC with a general warning regarding SCARs. Update of section 4.8 of the SmPC under SOC Skin and subcutaneous tissue disorders to add the adverse reaction AGEP with a frequency Not known. Consequential PIL updates.
PIL sections updated: 2, 4 and 6.
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Changes: (Updated: 22 Sep 2022)
Initial upload