Unlicensed medicines
Your partner for essential unlicensed medicines
Addeira Pharmaceuticals is a trusted supplier of licensed medicines to hospitals and pharmacies. We help when authorized medicines are not available - for example, when there are backorders or when specific treatments are only available in other countries.
We have our own GDP warehouse just outside Stockholm that can handle human, veterinary and narcotic drugs. Our own warehouse is optimized for larger deliveries. In addition, we also stock a large number of medicines through Oriola so that it is easily available for pharmacies to order every day.
With our background as pharmacists, we always put the patient's needs first. We strive to match the right product with the right medical need - quickly, safely and with professional advice. It goes without saying that all our medicines are covered by pharmaceutical insurance.
What does 'back-listing' of medicines mean?
A drug is backordered when the marketing authorization holder (MAH) is unable to deliver a drug for a certain period of time. This may be due to manufacturing problems, a shortage of active ingredients, or commercial decisions to withdraw the product from the market. In the event of a drug shortage, the goal is always to find another effective drug for the patient.
How to check if a medicine is back-ordered and how to find alternatives
You can easily check residual listings via:
- The Swedish Medical Products Agency's list of back-listed medicines
- FASS.se, which also shows stock status at pharmacies
Pharmacists can also provide information on available alternatives. Do you need support in finding a substitute?
Our pharmacists at Addeira can also help with alternatives and can be reached via the switchboard between 9 a.m. and 5 p.m. on 08-1220 75 50 or by email at requests@addeira.com. We will respond on the same day.
For prescribers and pharmacies
If an authorized medicine is not available in Sweden, a doctor can, according to EU Directive 2001/83/EC, prescribe an unlicensed medicine - i.e. a medicine that is authorized in other countries. This applies for example when:
- A medicine is back-listed or deregistered
- Patient does not respond to approved treatment in Sweden
Prescribers create an unlicense justification via KLAS (Communication solution for license application), which the pharmacy then completes with a license application to the Medical Products Agency. Once the license is approved, the patient can collect their medicine from any pharmacy.
More information about licensing and the application process can be found at The website of the Medical Products Agency.
Tips for prescribers of licensed medicines
Purpose & objectives of licensing
Licensed prescribing exists to ensure that patients can get the treatment they need - even when the medicine is not approved in Sweden. It is an important part of a flexible and personalized pharmaceutical supply, where patient safety and medical benefit are at the centre.
Ensuring access to treatment
Licensing is used when a medicine is not available on the Swedish market - for example, when it is back-listed, deregistered or has never been approved in Sweden. In this way, treatment can continue without interruption.
Personalized care
Not all patients respond to the same treatment. If a patient does not get enough effect or suffers side effects from approved medicines, a prescriber can apply for a license for an alternative that better meets the patient's needs.
Use of international medicines
Many medicines are authorized in other EU countries or internationally. The licensing system makes it possible to use these medicines in Sweden - provided they are medically justified and safe.
Medical and regulatory control
All license applications are reviewed by the Medical Products Agency. This means that the quality, efficacy and safety of the medicine are assessed before it can be used in Sweden. In this way, a high standard of drug prescribing is maintained.
Medicine declaration - peace of mind for patients and prescribers
Pharmaceutical insurance is an insurance scheme specifically created to protect patients who may have suffered harm or side effects due to their use of medicines.
We at Addeira Pharmaceuticals AB have taken the initiative to join Läkemedelsförsäkringen to cover any damage that may occur due to the use of our medicines. This also means that we as a company are responsible for complying with the Swedish Product Liability Act or other compensation regulations. Pharmaceutical insurance covers damage up to a certain amount. This means that if an injury or side effect occurs due to our medicines, the insurance
will cover the costs incurred up to the amount agreed in the insurance.
When you choose to procure unlicensed medicines through Addeira, you ensure that the patient is insured in case of injury.
