Gemcitabine Powder

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

Gemcitabine Powder

Active Ingredients

Gemcitabine

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

View Summary of Product Characteristics (SmPC - Gemcitabine 1 g Powder for Solution for Infusion)

Last updated on this site: 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.
SmPC Sections updated: 4.4, 4.8 and 10.

View 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.
View change history

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

View Summary of Product Characteristics (SmPC - Gemcitabine 200 mg Powder for Solution for Infusion)

Last updated on this site: 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.
SmPC Sections updated: 4.4, 4.8 and 10.

View 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.
View change history

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

View Summary of Product Characteristics (SmPC - Gemcitabine 2 g Powder for Solution for Infusion)

Last updated on this site: 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.
SmPC Sections updated: 4.4, 4.8 and 10.

View 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.
View change history

Report a side effect or a product complaint

General FAQs

What does Accord do with any personal details I provide?

The controller of your personal data is Accord-UK Ltd, with its registered office at Whiddon Valley, Barnstaple, EX32 8NS, United Kingdom. Your personal data will be processed for the purpose of correspondence, handling your enquiry and/or taking appropriate steps to conclude and perform the contract between the controller and the company you represent. For more information on the processing of personal data, including your rights, please see our Privacy Policy available on our website: https://www.accord-healthcare.com/uk/
What is a Summary of Product Characteristics (SmPC)?

A Summary of Product Characteristics (SmPC) is a document describing the properties and the approved conditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively, and are approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK and the European Medicines Agency (EMA) in the EU.
What is a Patient Information Leaflet (PIL)?

A Patient Information Leaflet (PIL) is a document included in the package of a medication that provides specific information about that medication and its use. It includes information about dose and administration of the medicine, warnings and precautions and potential side effects.
What is a Risk Minimisation Measure (RMM)?

All medicines have both risks and benefits of treatment, it is important to minimise the risks. Some products will have specific activities or materials that companies need to do or provide in order to make the risks of treatment with the medicine as small as possible, these are known as Risk Minimisation Measures or RMMs. Examples of risk minimisation measures could include written guides for patients or healthcare professionals, an alert card for patients or a requirement to ask specific questions if a patient experiences a particular adverse effect of treatment.
How do I print off documents on the Accord Product Website?

Search for the relevant product and click on it. Here, you will see all available strengths and their associated documents. Click on one of the links under the “Product Documentation” header to open the document in a new window in your browser. Right click on the document in this new window and select “Print” from the drop-down menu that appears by your cursor.
How do I search for a product?

There are two ways to search for a product on the Accord Product Website. The first is to use the search bar at the top of the screen to search by product name or PL number (e.g. 0142/0456). The second way to search for a product is to look at our full list by clicking on “Products” at the top of the screen, or by clicking one of the letter icons at the top of every page.
What is a generic medicine?

A generic drug is a medicine that is developed to be the same as a medicine that has already been authorised, and which is usually branded. Generic medications contain the same active ingredient as the original branded medication and work the same way but may differ in shape or size. Most Accord medications are generic medications.
What is a biosimilar medicine?

A biosimilar medication is a biological medication (one whose active substance is made by a living organism) that is highly similar to an already approved biological medicine. These biosimilar medications are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all medicines.
I am looking for a product that Accord sells, but which is not listed on your product site. Where can I find it?

As well as Accord products, Accord also sells medications that are licenced by other pharmaceutical companies. If you need information about a product, you may need to check who the marketing authorisation holder is, and this will be on the packaging. You may need to contact the other company for an answer to your query.
How can I tell two similarly-named products apart?

All Accord medicinal products have a Product Licence (PL) number. This is unique to each type of medicine and will differ by the strength of each medicine as well. PL numbers are listed under each product on this website. To find your medicine’s PL number, look on the carton or bottle label, as this will have the PL number on it (usually on the back – check beneath the dispensing label if necessary).
▼ What does a black triangle mean?

Medicines showing this symbol are subject to additional monitoring. This will allow quick identification of new safety information. The black triangle will appear on the Summary of Product Characteristics and the Patient Information Leaflet. You can help by reporting any side effects you may get. See yellowcard.mhra.gov.uk for how to report side effects or report to Accord by clicking on the Report a side effect or a product complaint button, or emailing medinfo@accord-healthcare.com.

For any further assistance, please get in touch.

General FAQs

What does Accord do with any personal details I provide?

What is a Summary of Product Characteristics (SmPC)?

What is a Patient Information Leaflet (PIL)?

What is a Risk Minimisation Measure (RMM)?

How do I print off documents on the Accord Product Website?

How do I search for a product?

What is a generic medicine?

What is a biosimilar medicine?

I am looking for a product that Accord sells, but which is not listed on your product site. Where can I find it?

How can I tell two similarly-named products apart?

▼ What does a black triangle mean?