Supply bottleneck Imurek
Situation in Austria
Imurek-50 mg Film-Coated Tablets are currently temporarily unavailable due to increased demand beyond national borders, and associated capacity constraints at the manufacturer. This information is publicly available on the website of the Federal Office for Safety in Health Care (BASG) at www.basg.gv.at in the so-called Sales Restriction Register: https://medicineshortage.basg.gv.at
The anticipated resupply date announced by the marketing authorization holder is Sept. 17, 2019.
According to the marketing authorization holder, Austria has therefore already received larger deliveries of Italian goods as of calendar week 30, which will be placed on the market in accordance with the law in the course of the import of medicinal products, in accordance with the provisions of the Medicinal Products Import Act 2010. The first half of this quantity has already been repackaged and provided with Austrian instructions for use to enable problem-free use by healthcare professionals and patients. As a result, delivery is expected in the course of calendar week 30. According to the marketing authorization holder, this delivery of 20,000 packs is sufficient to cover Austrian demand until the product is resupplied in Austrian packaging.
In Austria, the following drug is affected by the above-mentioned supply shortage:
Name Approval number Active ingredient
Imurek - 50 mg film-coated tablets 13362Azathioprine
Marketing Authorization Holder:
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland
The BASG would like to point out that there are also approved alternatives in Austria with the same active ingredient, which can be used as an equivalent substitute for Imurek after consultation with the treating physician. However, these alternatives have a smaller market share.
For this reason, the Federal Office for Safety in Health Care has undertaken efforts to bring Imurek from Italy to Austria, as indicated above.
Alternatives with the same active ingredient:
In Austria, the following drugs with the same active ingredient are approved and may also be considered as alternative preparations* for treatment after consultation with the attending physician:
NameApproval number Active ingredient
Immunoprin 100 mg FT 953769 Azathioprine (fractional groove 50mg divisible)
Immunoprin 75 mg FT 953768 Azathioprine
Immunoprin 50 mg FT 949023 Azathioprine (currently not available)
Azafalk 50 mg FT 959093 Azathioprine (currently not available)
Azafalk 100 mg FT 956124 Azathioprine (currently not available)
Azafalk 75 mg FT 956123 Azathioprine (currently not available)
Azathioprine Hexal 50 mg FT 946267 Azathioprine
* Not all of these drugs may be currently or consistently available due to market conditions.
Information on the drug affected by the shortage:
Imurek (active ingredient: azathioprine) is indicated, alone or in combination with other agents, following organ transplantation, such as kidney, heart, and liver transplantation. Other indications include treatment of inflammatory bowel disease such as Crohn's disease or ulcerative colitis, severe rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, chronic active autoimmune hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune hemolytic anemia, and chronic refractory idiopathic thrombocytopenic purpura.
Indications (according to the SmPC):
Azathioprine is used as an immunosuppressive antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and procedures that affect the immune response. Therapeutic effects may not become apparent for weeks or months and may include a steroid-sparing effect, reducing toxicity associated with high dosage and prolonged use of corticosteroids.
Azathioprine, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated for prolonging the survival of organ transplants-for example, kidney transplants, heart transplants, and liver transplants. It also reduces the need for corticosteroids in kidney transplant recipients.
Azathioprine is indicated for the treatment of moderate to severe inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis, when corticosteroid therapy is required and in patients who cannot tolerate corticosteroid therapy or in patients whose disease is refractory to standard first-line therapy.
Azathioprine is used either alone or, more commonly, in combination with corticosteroids and/or other drugs and procedures of clinical benefit (including dose reduction or corticosteroid discontinuation) in a subset of patients with the following conditions:
- severe rheumatoid arthritis
- systemic lupus erythematosus;
- dermatomyositis and polymyositis;
- chronic active autoimmune hepatitis;
- pemphigus vulgaris;
- polyarteritis nodosa;
- autoimmune hemolytic anemia;
- chronic refractory idiopathic thrombocytopenic purpura.
Additional Information:
Imurek Specialty Information:
https://aspregister.basg.gv.at/aspregister
Tasks that fall to the BASG in connection with distribution restrictions:
Queries (technical): Dr. Christoph Baumgärtel, Tel.: +43 505 55-36004 E-mail: christoph.baumgaertel@ages.at Queries (for media): Communications Management, Tel.: +43 505 55-25000 E-mail: presse@ages.at
