The Brazilian Health Authorities, ANVISA has approved Probiokid for use in infants and children (from 3 to 36-month-old), reinforcing Lallemand Health Solutions “privileged position in the country.”
“We are beyond proud! Our product, supported by decades of scientific, marketing and regulatory accomplishments, has achieved the almost impossible nowadays: getting an approval in Brazil! It is the first one this year,” said Solange Henoud, VP of Regulatory and Compliance at Lallemand Health Solutions.
Henoud continued: “It’s been a while since anyone from the industry has made it this far, but with a documented product such as Probiokid, with its extensive marketing journey and various regulatory acknowledgements across the globe for infants and children, we felt confident. We hope this approval paves the way for further probiotic approvals to unfold, for the greater benefit of the Brazilian population.”
“Indeed, the last two years were tough on the Brazilian regulatory ground. We are definitely proud of this achievement, happy for Lallemand and for the Brazilians to have such a great product now at their reach,” added Daniela Tomei, owner of Meta Regulatória.
The world’s bestselling probiotic supplement for children, Probiokid is a unique combination bringing together three of Lallemand Health Solutions probiotic strains L. helveticus Rosell-52, B. infantis Rosell-33, B. bifidum Rosell-71.
These strains have gained several recognitions worldwide, whether individually or combined. They have been successfully notified as Generally Recognised as Safe (GRAS) to the United States (US) Food and Drug Administration (FDA) for non-exempt infant formula, from birth. They have been listed on the very narrow list of strains allowed in infant food in China.
Probiokid efficacy is supported by 28 clinical studies in pediatric populations, including two safety studies and is proven efficient to support immune system maturation (eight studies) and gut health (twelve studies). Its efficacy was confirmed in a recent literature review of clinical studies.
In Canada the probiotic combination has been granted health claims in babies (from 3-month-old and children) and the single strains have also gained claims for the support of infants' microbiome and immune development.
- Helps to reinforce the body’s natural defenses in children.
- Participates to a healthy intestinal balance.
- Source of probiotics for 3-month-old and over and could promote a favourable gut flora in babies 3-month-old and over.