About licensed medicinal products

What can we add to an industry that is already doing everything to make it better?

Your partner for vital licensed medicines

Addeira supplies critical licensed medicines to hospitals and pharmacies all over Sweden. Our medicines often function as substitutes for drugs listed as remaining and include the latest FDA-approved cancer treatments that have not yet been launched in Sweden. We also provide substances used in clinical studies as well as tailor-made medicines for children with allergies to certain excipients. For elderly patients who have difficulty swallowing capsules and tablets, we offer alternatives such as oral solutions and suspensions.

With our background as pharmacists, the customer's well-being has of course always been most important. That the right medical need is matched with the right product and the right advice.


What does residual listing of medicines mean?

A medicine becomes back-listed when the marketing authorization holder (MAH) cannot deliver the preparation during a certain period. The reasons can be production problems, withdrawals or lack of the active substance. In some cases, the company may decide to stop selling and deregister the product from the Swedish market due to commercial reasons. In the event of a drug shortage, we always try to find a solution for the patients.


This is how you check if a medicine is backlisted and how to find alternatives

When prescribing medication, it is important to ensure that it is not over-listed. You can find information about backlogs on the Swedish Medicines Agency's list of backlogged drugs and at fass.se. These sources provide information on when backlogs occur, how long they are expected to last, any equivalent alternatives, and updates from drug companies. Pharmacies can also provide information on stock status and ordering options. On FASS you can also see which pharmacies have the product in stock.

Our pharmacists at Addeira can also help with alternatives and can be reached via the exchange between 9-17 on 08-1220 75 50 or via email requests@addeira.co . We will respond within 24 hours.


For prescribers and pharmacies

When there are no approved alternatives to a medicine, a doctor can, according to EU directive 2001/83/EC, prescribe medicines that are not available in Sweden but are approved in other countries. This is possible when an approved drug is backlisted, deregistered, or when the patient does not respond to existing treatment with approved drugs in Sweden.

Through KLAS (Communication solution for license application), prescribers can create justifications for licensed medicinal products. Pharmacy operators must then supplement these justifications with a license application to the Swedish Medicines Agency. If the license is granted, the patient can pick up his licensed medicine at any pharmacy of his choice. More information is available on the Swedish Medicines Agency's website .

Important tips when prescribing and applying for the granting of licensed medicinal products

  • Often fastest from the US and Canada: When available, lead times from the US and Canada are usually the fastest.
  • Longer lead times from Southern Europe: Orders from countries such as Spain and Italy may take 20-30 days, as smaller order volumes are not prioritized.
  • Limited volumes from Eastern Europe: Medicines from Eastern Europe can be in very limited volume and may not be enough to cover the need in Sweden.
  • Import and export permits for drugs classified as narcotics: These permits can take up to two months depending on the exporting country and authorities.
  • Sudden export bans: Many countries may introduce export bans to manage their own backlogs, which affects the availability of medicines internationally.
  • Global competition for medicines: Sweden is not the only country that deals with residual quotations, which means that competition for certain preparations can be high, especially from countries such as Germany.


Medicine insurance - a security for the patient

Medicines insurance is an insurance scheme created specifically to protect patients who may have suffered injuries or side effects due to their medication use.

We at Addeira Pharmaceuticals AB have taken the initiative to join the Läkemedelsförsäkringen to cover any damages that may arise 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 law regulations. Pharmaceutical insurance covers damage up to a certain amount. This means that should an injury or side effect occur due to our medicines, the insurance will cover it
to cover the costs incurred up to the amount agreed in the insurance.

When you choose to procure licensed medicines through Addeira, you ensure that the patient is insured in the event of any damage.


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