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Icelandic Medicines Agency

New Medicines Marketed in November 2026

5th November 2026

Summary of the medicines that were marketed November 1st 2026

ATC Class A – Alimentary Tract and Metabolism

Teduglutide Viatris 5 mg powder and solvent for solution for injection
Each vial contains 5 mg of teduglutide as powder. After reconstitution, each vial contains 5 mg of teduglutide in 0.5 ml of solution, corresponding to a concentration of 10 mg/ml.

Teduglutide Viatris is indicated for the treatment of:
Patients aged 4 months corrected for gestational age and older with Short Bowel Syndrome (SBS).

The medicine is a generic of Revestive and is prescription-only and specialist-restricted.

ATC Class B – Blood and Blood Forming Organs

Apixaban Zentiva 2.5 mg and 5 mg film-coated tablets
Each film-coated tablet contains 2.5 mg or 5 mg of apixaban.

Apixaban Zentiva is indicated for treatment in adults and children.

Adults

  • Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

  • Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) and one or more risk factors, such as a history of stroke or transient ischaemic attack (TIA), age ≥ 75 years, hypertension, diabetes mellitus, or symptomatic heart failure (NYHA Class ≥ II).

  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for patients with PE and haemodynamically unstable conditions).

Children

  • Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in children from 28 days of age to under 18 years.

The medicine is a generic of Eliquis and is prescription-only.

ATC Class C – Cardiovascular System

Hirudoid cream and gel
The medicine contains mucopolysaccharide polysulfate 3 mg/g.

Hirudoid is used for:

  • Superficial bruising.

  • Superficial thrombophlebitis, e.g., thrombophlebitis due to infusion and postpartum.

The medicine is sold over the counter.

ATC Class L – Antineoplastic and Immunomodulating Agents

Columvi 2.5 mg and 10 mg concentrate for solution for infusion
Each vial with 2.5 ml of concentrate contains 2.5 mg of glofitamab at a concentration of 1 mg/ml.
Each vial with 10 ml of concentrate contains 10 mg of glofitamab at a concentration of 1 mg/ml.

Columvi, in combination with gemcitabine and oxaliplatin, is indicated for the treatment of:

  • Diffuse large B-cell lymphoma (DLBCL) in adult patients, which is relapsed or refractory, without further specification (DLBCL NOS), where autologous stem cell transplantation (ASCT) is not applicable.

The medicine is prescription-only.

ATC Class R – Respiratory System

Fexofenadine Viatris 180 mg film-coated tablets
Each film-coated tablet contains 180 mg of fexofenadine hydrochloride, equivalent to 168 mg of fexofenadine.

Fexofenadine Viatris 180 mg is indicated to:

  • Relieve symptoms caused by chronic idiopathic urticaria in adults and children aged 12 years and older.

The medicine is a generic of Telfast and is prescription-only but available over the counter in smaller packages.

ATC-VET Class Q – Veterinary Medicines

Clavusan Vet 50 mg/12.5 mg tablet and 250 mg/62.5 mg tablet
Each tablet contains the active ingredients:

  • Amoxicillin (as amoxicillin trihydrate)

  • Clavulanic acid (as potassium clavulanate)

Indicated for the treatment of bacterial infections sensitive to amoxicillin and clavulanic acid, including:

  • Skin diseases (including deep and superficial pyodermas),

  • Infections of skin and soft tissues (abscesses and anal sacculitis),

  • Dental infections (e.g., gingivitis),

  • Urinary tract infections,

  • Respiratory diseases (affecting upper and lower respiratory tracts),

  • Enteritis.

The medicine is a generic of Synulox Palatable and is prescription-only.

Icthiovac ERM bath concentrate, suspension for Atlantic salmon
Each ml contains the active ingredients Yersinia ruckeri, serotype:

  • O1, biotype 1, strain 8363, inactivated

  • O2, biotype 1, strain 8365, inactivated

  • O1, biotype 2, strain 8302, inactivated

Icthiovac ERM is used for active immunisation of Atlantic salmon to reduce mortality caused by serotypes O1 (biotypes 1 and 2) and serotype O2 (biotype 1) of Yersinia ruckeri in freshwater.

The medicine is prescription-only.

ProZinc 40 IU/ml suspension for injection for dogs and cats
Each ml contains the active ingredient:

  • Human insulin 40 IU as protamine zinc insulin.

Indicated for the treatment of diabetes mellitus in cats and dogs to reduce hyperglycaemia and improve clinical symptoms associated with the disease.

The medicine is prescription-only.

Overview of new medicines launched in November 2026

Medicine Name

Dosage Form

Strength

Quantity

Controlled Substance

Apixaban Zentiva

Film-coated tablet

2.5 mg and 5 mg

60, 168, 100 pcs

No

Clavusan Vet

Tablet

50 mg/12.5 mg and 250 mg/62.5 mg

100 pcs

No

Columvi

Concentrate for infusion

2.5 mg and 10 mg

2.5 ml and 10 ml

No

Fexofenadine Viatris

Film-coated tablet

180 mg

100 pcs

No

Hirudoid

Gel and cream

3 mg/g

100 g

No

Icthiovac ERM

Bath concentrate, suspension

1000 ml

No

ProZinc

Suspension for injection

40 IU/ml

10 ml

No

Teduglutide Viatris

Powder and solvent for injection

5 mg

28 pcs

No

Further information about the medicines can be found in the Summary of Product Characteristics and the medicinal texts for each product in Sérlyfjaskrá.

The summary of new medicines only includes information about new medicines. It does not cover new dosage forms, new strengths, or new package sizes. Information on the aforementioned can be found in the list of new medicines for publication.