Portugal: Doctors can now prescribe 8 cannabis derivatives – find out which ones

Last week, Infarmed – National Authority for Medicines and Health Products, IP approved two new ACMs (Authorization for Placing on the Market) for preparations based on the cannabis plant for medicinal purposes. There are now eight cannabis-based options that doctors can prescribe and that patients have at their disposal in Portuguese pharmacies, with different proportions of cannabinoids and forms of administration.

CannaReporter® has made a list of all substances, preparations and medicines based on medicinal cannabis that are now available for medical prescription in Portugal, to facilitate understanding for patients and healthcare professionals.

1. "Sativex"* – Oral spray » Dose: 100 microliters contain 2,7 mg of Delta-9-tetrahydrocannabinol (THC) and 2,5 mg of Cannabidiol (CBD). Excipients: ethanol, propylene glycol and mint oil. 10 ml spray. Produced by GW/Jazz Pharmaceuticals. Approved in 2010, revised in 2018.
2. epidyolex* – CBD (cannabidiol) » Oral solution. 100mg/ml of Cannabidiol. Excipients: Refined sesame oil, anhydrous ethanol, sucralose (E955) strawberry flavor (including benzyl alcohol). Subject to restricted medical prescription and only available in hospital pharmacies. Produced by GW/Jazz Pharmaceuticals. Approved in 2019 by the European Medicines Agency (EMA) as an orphan medicine (only prescribed for rare diseases, such as Dravet and Lennox-Gastaut syndromes or Tuberous Sclerosis).* Editor's Note: Sativex and Epidyolex are considered medicines and have AIMs (Marketing Authorization) from Infarmed, which means they underwent clinical trials before their approval, unlike substances and preparations, which have an ACM, authorization It does not require the presentation of clinical trials, as it is considered that there is sufficient scientific evidence to support its prescription, attesting to its efficacy and safety. 
3. Tilray 18 THC » Dried flower with 18% Delta-9-tetrahydrocannabinol and less than 1% Cannabidiol (CBD). 15g packaging. Produced and marketed by Tilray Medical Europe. Approved in January 2021.
4. Hexacan – Hexa01 THC 20% » Dried flower with 20% Delta-9-tetrahydrocannabinol and less than 1% Cannabidiol (CBD). 10g packaging. Processed and marketed by Portocanna. Approved in March 2024.
5. Tilray THC 5 | CBD 20 » Broad-spectrum oral solution 5 mg/ml Delta-9-tetrahydrocannabinol and 20 mg/ml Cannabidiol (CBD); Excipients: medium chain triglyceride oil (MCT oil). 30 ml bottle. Produced and marketed by Tilray Medical Europe.
   Approved in March 2024.
6. Satalliv 10 mg/ml - CBD » Oral solution, 10 mg/ml Cannabidiol obtained from flowers; Excipients: medium chain triglyceride oil (MCT oil) and peppermint flavor. Processed and marketed by Ferraz, Lynce, Especialidades Farmacêuticas, SA.
   Approved in March 2024.
7. Satalliv, Delta 9-tetrahydrocannabinol (THC) » Oral Solution 10 mg/ml, Processed and marketed by Ferraz, Lynce, Especialidades Farmacêuticas, SA. Approved in July 2024;
8. Tilray THC 10 CBD 10 » Oral Solution with 10 mg/ml Delta-9-tetrahydrocannabinol (THC PFV) + 10 mg/ml Cannabidiol (CBD PFV).
   Approved in July 2024.

Therapeutic indications
On the extranet infomed, on the Infarmed website, you can search for information leaflets for each of these options, with the appropriate instructions for use. In Portugal, healthcare professionals can prescribe these medicines, preparations or substances in seven therapeutic indications:

1) Spasticity associated with Multiple Sclerosis or spinal cord injuries;

2) Nausea, vomiting (resulting from chemotherapy, radiotherapy and combined therapy for HIV and hepatitis C medication);

3) Stimulation of appetite in palliative care for patients undergoing oncological treatments or with AIDS;

4) Chronic pain (associated with oncological diseases or the nervous system, such as neuropathic pain caused by nerve damage, phantom limb pain, trigeminal neuralgia or after herpes zoster);

5) Gilles de la Tourette syndrome;

6) Epilepsy and treatment of severe convulsive disorders in childhood, such as Dravet and Lennox-Gastaut syndromes;

7) Therapy-resistant glaucoma.

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Laura Ramos

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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 2018st Portuguese Government. She has an international certification in Permaculture (PDC) and created the street-art photography archive “What does Lisbon say?” @saywhatlisbon. Co-founder and Editor of CannaReporter® and coordinator of PTMC - Portugal Medical Cannabis, Laura made the documentary “Pacientes” in XNUMX 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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