National
Infarmed approves 3 Portocanna ACMs: two flowers and the first sublingual solution with high levels of THC
Infarmed — the Portuguese National Authority for Medicines and Health Products (IP) has approved three more cannabis preparations, which will soon be available in Portuguese pharmacies. The new ACMs — Marketing Authorizations are all variations of Portocanna’s Hexacan, predominantly in Delta-9-tetrahydrocannabinol (THC), with levels between 20 and 25% of this cannabinoid.
Portocanna, which already sold these products in other countries, such as the United Kingdom, has now been authorized to sell them in Portuguese pharmacies. With a high THC content, the three products now approved have the same commercial name, Hexacan. Two are vaporizable flowers and the third is a sublingual solution.
According to infomed (Infarmed's database of medicinal products for human use), the compositions of these three new ACMs are as follows:
1 - Hexacan – Hexa 01 High THC 22% — Delta-9-tetrahydrocannabinol (THC) + Cannabidiol (CBD), Cannabis sativa flower Substance of plant origin for inhalation by vaporization — 22% + <= 1.0 %
2 - Hexacan – Hexa 01 High THC 25% — Delta-9-tetrahydrocannabinol (THC) + Cannabidiol (CBD), Cannabis sativa flower Substance of plant origin for inhalation by vaporization 25% + <= 1.0 % Portocanna SA
3 - Hexacan – Hexa 01, Cannabis Oil Extract, THC 20% — Delta-9-tetrahydrocannabinol (THC) + Cannabidiol (CBD), Cannabis sativa flower Sublingual solution 20% + <= 1.0% Portocanna SA
According to Helena Correia, a pharmacist and consultant specializing in regulatory matters, licensing and quality in the cannabis sector, “the sublingual solution is a pharmaceutical form that allows an active substance to be absorbed directly into the bloodstream via the sublingual route” and, as such, has a faster effect compared to the oral route of administration. “It is the first preparation based on the cannabis plant to be approved for sublingual administration in Portugal”, she explained to CannaReporter®.
With these three new ACMs, Portuguese patients now have 14 different options of cannabis-derived preparations to help treat the seven pathologies defined by Infarmed, in different proportions of cannabinoids and forms of administration (flowers and oral solutions).
However, it will still take some time before they are actually available for prescription and available to patients in Portuguese pharmacies, as the price will still have to be negotiated and approved by Infarmed. It should be noted that, paradoxically, and according to the latest Infarmed report, the number of prescriptions decreased from 1157 in 2023 to 757 by the 3rd quarter of 2024, falling by around 33%.
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[Disclaimer: Please note that this text was originally written in Portuguese and is translated into English and other languages using an automatic translator. Some words may differ from the original and typos or errors may occur in other languages.]____________________________________________________________________________________________________
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With a degree in Journalism from the University of Coimbra, Laura Ramos has a postgraduate degree in Photography and has been a Journalist since 1998. Winner of the Business of Cannabis Awards in the category "Journalist of the Year 2024", Laura was a correspondent for Jornal de Notícias in Rome, Italy, and Press Officer in the Office of the Minister of Education of the 21st Portuguese Government. She has an international certification in Permaculture (PDC) and created the street-art photography archive “Say What? Lisbon” @saywhatlisbon. Co-founder and Editor of CannaReporter® and coordinator of PTMC - Portugal Medical Cannabis, Laura directed the documentary “Pacientes” and was part of the steering group of the first Postgraduate Course in GxP's for Medicinal Cannabis in Portugal, in partnership with the Military Laboratory and the Faculty of Pharmacy of the University of Lisbon.
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