Intended for UK patients and members of the public
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 complaintProduct Documentation
Last updated on this site: 21 Sep 2022
Initial upload
Last updated on this site: 26 Jan 2026
To register the following changes to the ASMF for the active substance, Palonosetron Hydrochloride, held by Apitoria Pharma Private Limited, (Version - PA/ASMF/AP/RP - 01/04-15 Update-06/25).
1. To register minor changes to the restricted part of the ASMF (from version PA/ASMF/RP-01/04-15 Update-12/19 to version PA/ASMF/RP-01/04-15 Update-06/25).
2. To register the following changes to the applicant’s part Of the ASMF (from version PA/ASMF/AP-01/04-15 Update-12/19 to version PA/ASMF/AP-01/04-15 Update-06/25).
a) To register minor changes to the Palladium and Lithium Contents (BY ICP-OES) test procedure for the active substance to include the LOD of 0.17 micrograms per gram and the LOQ of 0.5 micrograms per gram.
b) To add Surface Resistivity (Ohms) to the immediate packaging specifications of the active substance. The limit is set to Between 10x08 and 10x11.
c) To tighten the specification limits for the immediate packaging of the active substance: Width from Between 400 and 440 to Between 195 and 211; Length from Between 580
and 620 to Between 290 and 313 and Thickness (micrometres) Between 98 and 102 to Between 73 and 77.
d) To change the name and to update the address of the site responsible for manufacturing and quality control testing of the active substance Palonosetron Hydrochloride supported by an ASMF from Aurobindo Pharma Limited, Unit-VIII, Survey No. 10 & 13 Gaddapotharam village to Apitoria Pharma Private Limited, Unit-II, Survey No. : 10 & 13 Gaddapotharam.
e) To change the name and address of the ASMF holder from Aurobindo Pharma Limited, Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana state, INDIA to Apitoria Pharma Private, Limited, Floor 22-24, Plot No. 1, Survey, No. 83/1, Galaxy Tower, Hyderabad Knowledge City, Raidurg Panmaktha, Hyderabad, Telangana-500032, India.
f) To register minor changes to (3aR, 3R)-Enantiomer content (By HPLC) test procedure for the active substance to add the integration parameter.
g) To register minor changes to Related substances (By HPLC) test procedure for the active substance to add the integration parameter.
h) To register minor changes to Assay (By HPLC) test procedure for the active substance to add the integration parameter.
i) To register minor changes to Residual solvents (By GC) (Method I) test procedure for the active substance to add the integration parameter.
j) To register minor changes to Residual solvents (By GC) (Method II) test procedure for the active substance to add the integration parameter.
3. To delete Accord Healthcare B.V., Utrecht, Winthontlaan, 200 3526 KV, Utrecht, The Netherlands as a site responsible for batch release of the finished product. Consequently, the PIL has been updated.
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 complaintA 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.
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.
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.
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.
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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.
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.
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.
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.
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.
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).
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