Medicines for Children
Many medicines, even essential medicines, are not licensed for paediatric use. The use of unlicensed and off-label medicines for children has been common practice for years, meaning that children often may not receive the same quality, safety and efficacy from their medicines as adults. Many drugs used in children have not been adequately developed in paediatric indications resulting in “off label” use of unlicensed adult medicines in children.
Additional challenges that specifically relate to the development of paediatric formulations include the necessity to avoid certain excipients that are not suitable for children, swallowing difficulties in some patients and the need for accurate dose administration and often titration for varying ages and weights. Many medicines are manipulated by pharmacists, parents and carers who may have to crush tablets, mix granules, open capsules to disperse in food or drinks therefore creating a risk of under or over dosage as well as inconsistent dosing.
Paediatric-Use Marketing Authorisation (PUMA)
In 2007, European Paediatric Regulation came into force to improve the health of children by increasing research, development and authorisation of medicines based on specific paediatric experience.1 The Paediatric Regulation introduced the Paediatric-Use Marketing Authorisation (PUMA), a dedicated marketing authorisation for medicines developed exclusively for use in the paediatric population. As part of the pathway to PUMA, a Paediatric Investigation Plan (PIP) must first be agreed by the European Medicine Agency’s Paediatric Committee.
Proveca Ltd specialises in identifying, developing and facilitating the licensing of off-patent medicines for children where priority healthcare needs exist.
Proveca has worked with the European Medicine Agency’s Paediatric Committee to gain a PUMA for the symptomatic treatment for severe sialorrhoea (chonic pathological drooling) in children and adolescents with chronic neurological disorders.
(1) European Medicines Agency. Better medicines for children. Available at: https://www.ema.europa.eu/en/documents/leaflet/better-medicines-children_en.pdf
‘We are a Family of Passionate Pioneers’
In Proveca our vision is to provide licensed medicines which have been designed specifically for children.
Our Research and Development programs evaluate novel pharmaceutical formulations to provide improved dose flexibility, easy administration and therefore better acceptance of drugs by children.
We care about your child and want to ensure they receive the right licenced medication.
The Proveca for children charity fund raising.
Welcome to the Proveca Values:
- In 2018, after Proveca had been a commercial organisation for a little over a year, it was felt that it would be beneficial for the company to reflect on who it was, what it had become and what it wanted to be in the future.
- The initial research involved an expert (Tim Reid) interviewing 16 people from across the business and across the EU to get a feel for what Proveca meant to them.
- From those interviews, the information gained was boiled down to a “strapline” that encompassed three core values:
Family, Passion, Pioneering
So, what do these three core values really mean to us?
What Family means to us
While many business cultures are about co-operation between individuals who may be ultimately competing with each other, being in a family is about having a vested interest in each other’s success and wellbeing.
Creating a family requires deep (not superficial or fleeting) relationships, a real interest in individuals as whole people (not just roles or skills) and a healthy blurring of the lines
between work and play.
The payoff is real trust, unquestioning support, no hidden agendas and genuine enjoyment of each other’s company.
What Passion means to us
Being passionate means truly believing in what you do and why you do it.
It’s a rare and special organisation that can claim its teams are passionate about their work and their Company.
Having a complete emotional commitment to your job means remaining passionate about it long after 5:30pm
What Pioneering means to us
Being pioneers is about leading the way, doing things that haven’t been done before, being first.
But in order to achieve that, pioneering needs to be a way of being, not a one-off act. Pioneers need to be comfortable not having evidence of previous success or established protocols to follow.
They need to have a clear plan but adapt or even abandon that plan in the face of what they encounter.
They need a ‘learner’ mindset – the curiosity to try things out and understand what they don’t know.
While pioneers have a drive to be first, they are also happy to be followed by others and to celebrate being a catalyst for change.
Created March 2020