Solensia NOAH and SPC Product Information
Vets’ Advice: Solensia NOAH and SPC Product Information
Solensia solution for injection is a fairly new treatment for managing osteoarthritis in cats. It contains the active ingredient frunevetmab, which is a particular type of drug called a monoclonal antibody. Solensia is licensed in the UK for the alleviation of pain associated with osteoarthritis in cats, and It is only available on veterinary prescription.
Vets Advice: Solensia NOAH and SPC Product Information
What the official information about a medicine like Solensia can tell you
You might wonder “exactly what do you mean by 'official information'?”. To answer this question it is first helpful to understand how veterinary medicines get to market in the UK. In order to be able to market a veterinary medicine, a company must first obtain a marketing authorisation (commonly known as a licence) from the Veterinary Medicines Directorate, which is the veterinary medicines regulatory agency in the UK.
What constitutes a veterinary medicine (and therefore what requires a marketing authorisation), is defined in law in the Veterinary Medicines Regulations - the current version of which dates from 2013. In short, a product is a veterinary medicine if it contains an ingredient that has an action in the body. A product is also considered to be a veterinary medicine if communications about it (labelling, advertising etc.) give the impression that the product can be used to treat a veterinary disease (whether or not it contains an active ingredient).
Vets Advice: Solensia NOAH and SPC Product Information
What companies have to do to get a marketing authorisation
To receive authorisation for marketing, a company must prove to the regulator that their product meets a high quality standard, that the product does what it is claimed to do (this is usually shown in clinical trials, but sometimes it is enough to provide proof through published evidence), and that it is safe. This can add up to a huge amount of information, which all needs to be assessed by the regulator. However, once the regulator judges the product has proven quality, efficacy and acceptable safety, it grants a marketing authorisation.
Vets Advice: Solensia NOAH and SPC Product Information
What happens to all the information?
The information gathered during the authorisation process is summarised in a document called the 'Summary of Product Characteristics', or SPC - a legal document that is presented in a standard format. The SPC contains all of the information needed to enable safe and effective use of the medicine. It sets out the authorised use(s), the dose and other instructions for administering the medicine, the known side effects, and information about how to avoid them (e.g. not using the medicine in certain types of animal).
Vets Advice: Solensia NOAH and SPC Product Information
The SPC is the basis for other sources of information
The SPC is the official informational document regarding a veterinary medicine such as Solensia. However, the information in the SPC can also be used to produce information in other formats. For instance, it may serve as the basis for the package leaflet that comes with a given medicine, and it is also the basis for NOAH datasheets.
Vets Advice: Solensia NOAH and SPC Product Information
What is a Solensia NOAH datasheet?
NOAH, a representative organisation for the veterinary pharmaceutical industry, publishes product ‘datasheets’ in the NOAH online Compendium as a service to the veterinary profession. It is a known resource within the veterinary medicines community, and pharmaceutical companies will often voluntarily add datasheets to the Compendium.
You might wonder if there is any difference between the Solensia SPC and Solensia NOAH datasheet - and the answer to that question is actually quite nuanced. The current Solensia SPC can be found in full on the VMD’s website, in the 'Product Information Database'. The NOAH online Compendium contains a Solensia NOAH datasheet which in broad terms carries the same information from the SPC but presents it in a different format.
It should be noted however that not all UK authorised veterinary medicines are included in NOAH Compendium, whereas the VMD Product Information Database contains every authorised veterinary medicine. Likewise, NOAH datasheets sometimes leave out some of the information that is in the SPC (such as pharmacology details). However many veterinary professionals find that the NOAH datasheet can be easier to use compared to the original SPC, because it is presented in sections - allowing the reader to go directly to the area that's relevant to any question or query that they may have rather than having to scroll through the whole document to find the information they're looking for.
Vets Advice: Solensia NOAH and SPC Product Information
How often is the Solensia NOAH datasheet updated?
The VMD updates the Solensia SPC when there are significant changes, such as new side effects that have come to light, or new authorised uses for the medicine. When this happens, the company that markets the product must then ensure that the Solensia NOAH datasheet is updated in a timely fashion as well.
Other ways in which Veterinary Prescriber can help
Of course we hope that you've found this piece on the Solensia NOAH datasheet and NOAH datasheets in general useful and informative. However, don't forget that when you sign up to the Veterinary Prescriber site you will get access to a wealth of other articles just like these. We've covered Thyronorm, Nexgard and other medicines in articles just like these, but in our members' area you'll find many other articles that are just as informative, but which cover topics in many other areas of veterinary medicine. To sign up today, click here, or to learn more about us first, click here.