Elvanse (active substance Lisdexamfetamine dimesylate) is a long-acting stimulant medication indicated for attention deficit hyperactivity disorder (ADHD). In Europe it is marketed under the brand name Elvanse and has gradually gained approval in several countries. Fierce Pharma+4takeda.com+4RxReasoner+4

- Initial approval in the UK in February 2013 for children aged 6 and over when previous methylphenidate treatment was considered inadequate. takeda.com+1
- A 2015 press release noted that Elvanse Adult (for adults with ADHD) had received a positive response via the European decentralised procedure for the UK, Denmark and Sweden. takeda.com+1
- The drug is available in multiple European countries (children/adolescents, and some adult approvals) under strict regulation. catalogues.ema.europa.eu
- Despite its availability, regulatory bodies have sometimes questioned whether it offers significantly added clinical benefit compared to existing therapies (e.g., the German IQWiG found no proven added benefit in 2013). iqwig.de+1
- Like all stimulant medications, Elvanse carries high potential for abuse and dependence, so prescribing and monitoring conditions are stringent. takeda.com
For patients and pharmacies across Europe, awareness of national approval status, reimbursement, specialist‐prescribing requirements and supply issues (e.g., shortages flagged by the European Medicines Agency) is critical. European Medicines Agency (EMA)
Which ADHD Meds Are Legal in Europe?
ADHD treatment in Europe typically uses stimulant or non-stimulant medications. Some key medications and regulatory notes:
- Methylphenidate (brands like Ritalin®, Concerta®) has been used widely across Europe for ADHD in children aged 6 years and over. The EMA affirmed that the benefit–risk balance remains favourable in 2013. European Medicines Agency (EMA)+1
- Lisdexamfetamine (Elvanse) is one of the more recent stimulant approvals in Europe (see previous section).
- Non-stimulant medications (e.g., Atomoxetine) may also be authorised, though their availability and use vary widely between countries.
- Availability and prescribing conditions vary by member state: licensing procedures, specialist prescribing, age limits, and reimbursement status differ.
- Supply issues: The EMA has reported shortages of ADHD medicines including methylphenidate, lisdexamfetamine and atomoxetine in some EU states due to increased demand and manufacturing constraints. European Medicines Agency (EMA)
Thus, when considering ADHD medications in Europe, one must check the national marketing authorisations, age indications, treatment guidelines, and local reimbursement/coverage.
Is Elvanse Illegal in the UK?
No — Elvanse is not illegal in the United Kingdom; rather, it is a prescription‐only medicine regulated under controlled substances rules.
- According to the UK prescribing information, Elvanse (lisdexamfetamine) is available for children aged 6 and over when previous methylphenidate therapy is inadequate. takeda.com+1
- In the UK, lisdexamfetamine is classified as a “Prescription-Only Medicine (POM)” and is being treated by pharmacists as if it were a Schedule 2 controlled drug (reflecting its stimulant nature) in guidance documents. mims.co.uk
- Because it is a controlled stimulant, strict prescribing, dispensing, storage and monitoring rules apply in the UK.
Therefore, while Elvanse is legal under licence, it is highly regulated — misuse, off-label use without prescription or import without appropriate authorisation would be illegal.
What Does France Prescribe for ADHD?
France has a notably more restrictive approach compared to some other European countries when it comes to pharmacotherapy for ADHD.
- In France, methylphenidate (MPH) is currently the only psychostimulant approved for the treatment of children (aged 6 and over) with ADHD—under brand names like Ritalin®, Concerta®, Quasym®, Medikinet®. PubMed Central+1
- Prescription and distribution of stimulant medications in France are subject to strict controls: only specific specialists (paediatricians, child & adolescent psychiatrists, neurologists) may initiate treatment; initial prescription was historically hospital-based, with renewal protocols and tight monitoring. PubMed Central+1
- Reports indicate that adult ADHD pharmacotherapy in France remains limited and physician practices are cautious; monitoring and regulation are more conservative compared with other European states. fractions4kids.com
- Recent regulatory developments suggest changes may be underway, but as of several studies the only approved stimulant remains methylphenidate.
For pharmacies operating in or supplying to France, awareness of these restrictions, the need for specialist prescribing, and national insurance/coverage rules is essential.