Pharmacovigilance

Pharmacovigilance (PV) describes the processes of identifying and responding to safety issues arising with medicines, whether before or after they have been licensed.

PV reporting is vital to ensure that the healthcare profession is made aware of any potential side-effects of medicines and the likelihood of their occurrence.

The Medical Information department operates a PV service, for Sun Pharmaceuticals products covering the United Kingdom. We liaise closely with the MHRA and Corporate PV Group in the Netherlands to ensure that adverse events /reactions concerning our products are correctly documented and acted on appropriately.

Initially, you will need to provide Sun Pharmaceuticals UK Limited with the following information:

  • A specific patient identifier (hospital number, patient initials or sex)
  • An identifiable event/reaction associated with any of Sun Pharmaceutical products
  • Your identity as a healthcare professional
  • Name of product

We will then ask a series of questions over the telephone concerning the event/reaction. This will be followed up with a posted form and it would be greatly appreciate if this could be completed with as much information as possible and returned promptly. All information provided is treated in the strictest confidence, but may be required by the Government Regulatory Authorities. Any subsequent action will be determined by the nature of the event/reaction.



Healthcare Professional Reporting Form


Fields Marked with an Asterix (*) are Mandatory





Did you contact Sun previously about this adverse event?*:







If yes please provide the reference number:



Did you report the event to MHRA:







If yes please provide the MHRA reference number:





1. Reporter's (Your) Details:


















2. Patient Details:












3. Suspected drug(s)


Brand name of drug, Batch number if known, Route of administration, Dosage, Date started, Date stopped, Prescribed for:









4. Other medicines


Please tell us about any other medicines or remedies used within three months of having adverse reaction(s).











5. Suspect Reaction(s)








Did the patient require hospitalisation?








If yes please provide dates






Any further reaction details?




Do you consider the reaction to be serious?








Did the patient die?








Was the reaction life-threatening?








Was the patient incapacitated or disabled?








Did a congenital abnormality occur?








Did you consider the reaction medically significant?










6. Other information



Please add any further medical history, test results, known allergies, rechallenge(if performed), suspected drug interactions.