Accord Logo

Intended for UK patients and members of the public

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Gemcitabine Powder

Active Ingredients

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Gemcitabine 1g Powder for solution for infusion

PL Number:
20075/0026
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Discontinued

Product Documentation

  • 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.

    SmPC Sections updated: 4.4, 4.8 and 10.

  • 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Gemcitabine 200mg Powder for solution for infusion

PL Number:
20075/0025
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Discontinued

Product Documentation

  • 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.

    SmPC Sections updated: 4.4, 4.8 and 10.

  • 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Gemcitabine 2g Powder for solution for infusion

PL Number:
20075/0262
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Discontinued

Product Documentation

  • 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.

    SmPC Sections updated: 4.4, 4.8 and 10.

  • 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

General FAQs

For any further assistance, please get in touch.

View product information as a: