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Repaglinide

NovoNorm, Prandin · ATC code A10BX02

Also known as: Repaglinid · Brand names: NovoNorm, Prandin, Repaglinid Ratiopharm, Repaglinid Sandoz, Repaglinid Stada, Diafree, Repafix, Replic, Sergilex

Key facts
Active substance
Repaglinide
Drug class
Anti-diabetic medication
ATC code
A10BX02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
NovoNorm 0.5 mg tablets · NovoNorm 1 mg tablets · NovoNorm 2 mg tablets · Prandin 0.5 mg tablets · Prandin 1 mg tablets · Prandin 2 mg tablets
Marketing authorisation holder
Novo Nordisk A/S
Information as of
2026-10-27

Key facts

Repaglinide (NovoNorm, Prandin) is a short-acting insulin secretagogue used to lower meal-related blood glucose in adults with type 2 diabetes.

What it is used for

  • Type 2 diabetes in adults when diet, weight reduction and exercise are insufficient
  • In combination with metformin when metformin alone is insufficient

Dosing

  • Taken preprandially, titrated individually to blood glucose
  • Starting dose 0.5 mg; 1 mg when transferred from another oral hypoglycaemic
  • One to two weeks between titration steps
  • Maximum single dose 4 mg with main meals; total daily maximum 16 mg
  • Renal impairment: careful titration; debilitated or malnourished patients: conservative dosing

Contraindications

  • Hypersensitivity to repaglinide or any excipient
  • C-peptide negative type 1 diabetes
  • Diabetic ketoacidosis with or without coma
  • Severe hepatic function disorder
  • Concomitant gemfibrozil

Important warnings

  • Can produce hypoglycaemia
  • Stress (fever, trauma, infection, surgery) may cause loss of glycaemic control; temporary insulin may be needed
  • Loss of effect over time (secondary failure) possible
  • Combination with other insulin secretagogues not studied

Side effects

  • Common: hypoglycaemia, abdominal pain, diarrhoea
  • Very rare: allergic reactions, refraction disorders, vomiting, constipation, increased liver enzymes
  • Hypoglycaemic coma possible (frequency not known)

Interactions

  • Metabolised mainly by CYP2C8, also CYP3A4; special care with inhibitors of both
  • Gemfibrozil: markedly increased repaglinide exposure; contraindicated
  • Glucose-lowering effect enhanced by e.g. clarithromycin, itraconazole, ketoconazole, trimethoprim, ciclosporin, clopidogrel, MAOIs, non-selective beta blockers, ACE inhibitors, alcohol

Pregnancy and breastfeeding

  • Should be avoided during pregnancy and not used in breast-feeding women

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • Enyglid · genericKrka, d.d., Novo mesto · EMEA/H/C/001065
  • NovoNormNovo Nordisk A/S · EMEA/H/C/000187
  • PrandinNovo Nordisk A/S · EMEA/H/C/000362
  • Repaglinide Krka · genericKrka, d.d., Novo mesto · EMEA/H/C/001066
  • Repaglinide Teva · genericTeva Pharma B.V. · EMEA/H/C/001067

Source: European Medicines Agency (EMA), product information

Austria

  • Repaglinid RatiopharmTeva B.V · 1 register entry
  • Repaglinid SandozSandoz Gmbh · 1 register entry
  • Repaglinid StadaStada Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Repaglinid1 A Pharma Gmbh, Ratiopharm Gmbh, Holsten Pharma Gmbh, Stadapharm Gmbh, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 6 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • DiafreeBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • RepafixNEUTEC İLAÇ SAN. TİC. A.Ş · 6 register entries
  • ReplicVİTALİS İLAÇ SAN. TİC. A.Ş. · 6 register entries
  • SergilexİLKO İLAÇ SAN.VE TİC. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 21 more European countries
Belgium
Repaglinide Eg
Bulgaria
Индорин
Croatia
Reglinid, Repaglinid Pharmas
Cyprus
Theroflan
Czechia
Vatinid
Denmark
Repaglinid Doc Generici
Finland
Repaglinid Stada
France
Repaglinide Arrow Lab, Repaglinide Biogaran, Repaglinide Cristers, Repaglinide Eg, Repaglinide Evolugen, Repaglinide Sandoz, Repaglinide Viatris, Repaglinide Zentiva, Repaglinide Zydus
Greece
Theroflan
Iceland
Enyglid, Novonorm, Prandin, Repaglinide Krka, Repaglinide Teva
Italy
Glicam, Repaglinide Aurobindo, Repaglinide Doc Generici, Repaglinide Eg, Repaglinide Mylan Generics, Repaglinide Pensa, Repaglinide Sandoz, Repaglinide Zentiva, Theroflan
Latvia
Repaglinide Elvim
Liechtenstein
Repaglinide Teva
Luxembourg
Repaglinide Eg
Malta
Repaglinide Aurobindo
Netherlands
Repaglinide Stada
Norway
Enyglid, Novonorm, Prandin, Repaglinide Krka, Repaglinide Teva
Romania
Reneos, Repaglinida Arena, Repaglinidă Hf
Slovenia
Repaglinid Stada
Spain
Repaglinida Alter, Repaglinida Aurovitas, Repaglinida Cinfa, Repaglinida Combix, Repaglinida Kern Pharma, Repaglinida Normon, Repaglinida Pensa, Repaglinida Sandoz, Repaglinida Stada, Repaglinida Tarbis, Repaglinida Viatris
Sweden
Repaglinid Actavis, Repaglinid Stada

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. NovoNorm – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf
  2. European Medicines Agency. Prandin – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/prandin-epar-product-information_en.pdf
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  6. Wikidata (CC0): ATC A10BX.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.