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Portugal: Infarmed releases three new ACMs for cannabis derivatives

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Infarmed gave the green light to three new cannabis derivatives in Portugal, which are now available in pharmacies and are part of the arsenal of medical prescription options. According to data available on the portal infomed, three new therapeutic options were approved: a flower and two oral solutions (oils), one of which predominantly contains CBD (cannabidiol). These products should enter the market very soon. 

The list of cannabis-based substances and preparations approved in Portugal increased last week, with three submissions receiving the green light from Infarmed, which issued three marketing authorizations (ACM) on March 7th. Among the approved medicines are two oral solutions (from Ferraz Lynce “Satalliv” and from Tilray Portugal “Tilray Oral Solution THC 5 CBD 20”) and a flower from PortoCanna, called “Hexacan – Hexa 01 Alto THC 20%”.

The medicine that presents the most information is “Satalliv”, which is produced by the Portuguese pharmaceutical company Ferraz Lynce. The oral solution is predominant in cannabidiol (CBD), and has a concentration of 10mg/ml. Despite being a formulation achieved through an extract rich in CBD, the information leaflet states that the medicine is not intended for pediatric patients and should be considered carefully in extreme cases.

CBD extract | Tilray THC

Satalliv will have four presentations, two of 30ml and two of 50ml, and should arrive in pharmacies soon, as the Summary of Product Characteristics and Information Leaflet on the InfoMed portal.

Tilray Oral Solution “Tilray THC 5 CBD 20 Oral Solution” is a formulation with a ratio of THC to CBD of 1 to 4, that is, it is also predominant in CBD, and is already sold in other countries such as Germany (see image ), however there is still no information available on Infomed, other than the packaging size, which will be 25ml, and with a concentration of 6.7 mg/ml of Delta-9-tetrahydrocannabinol and 28.6 mg/ml Cannabidiol.

PortoCanna flowers

Also PortoCanna flowers, “Hexacan – Hexa 01 Alto THC 20%” with a THC concentration of 20%, do not have any additional information available. They will be sold in 300ml packages containing 10 grams of dry flower for vaporization.

With this approval, Portugal now has 4 medicines approved through the national ACM route (Tilray Flor Seca 18, Hexacan – Hexa 01 Alto THC 20%, Satalliv and Tilray Oral Solution THC 5 CBD 20) as well as 2 medicines approved through AIM ( Sativex and Epidyolex).

 

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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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Editor-in-Chief

I am one of the directors of CannaReporter, which I founded together with Laura Ramos. I am from the unique Island of Madeira, where I currently reside. While I was in Lisbon at FCUL studying Physical Engineering, I became involved in the national hemp and cannabis scene and participated in several associations, some of which I am still a member of. I follow the global industry and especially legislative advances regarding the different uses of cannabis.

I can be contacted by email at joao.costa@cannareporter.eu

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