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sofosbuvir

Sovaldi · ATC code J05AX15

Key facts
Active substance
sofosbuvir
Drug class
Enisamium iodide
ATC code
J05AX15
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Sovaldi 400 mg film-coated tablets / Sovaldi 200 mg film-coated tablets · Sovaldi 150 mg coated granules in sachet / Sovaldi 200 mg coated granules in sachet
Marketing authorisation holder
Gilead Sciences Ireland UC
Information as of
2026-10-27

Key facts

Sofosbuvir is a nucleotide prodrug that inhibits the HCV NS5B polymerase (direct-acting antiviral). It is used in combination with other medicines to treat chronic hepatitis C.

What it is used for

  • Chronic hepatitis C in adults and children aged 3 years and above, always in combination with other medicines

Dosing

  • Adults: one 400 mg tablet once daily with food
  • Children aged 3 years and above: dose based on weight; granules for children who have difficulty swallowing tablets
  • Partner medicines (e.g. ribavirin, peginterferon alfa) and duration depend on genotype, e.g. 12 or 24 weeks; regimens in the full text
  • No monotherapy; if partner medicines are permanently stopped, sofosbuvir should also be stopped
  • Mild to moderate renal impairment: no adjustment; severe renal impairment: limited data

Contraindications

  • Hypersensitivity to the active substance or excipients
  • Strong intestinal P-gp inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort)

Important warnings

  • Life-threatening severe bradycardia and heart block with amiodarone; use only if alternatives are not possible, with cardiac monitoring
  • Hepatitis B reactivation, some cases fatal; screen for HBV before starting
  • Consult the product information of the partner medicines

Side effects

  • Most common with ribavirin (± peginterferon): fatigue, headache, nausea, insomnia
  • No adverse reactions specific to sofosbuvir have been identified

Interactions

  • Amiodarone: risk of severe bradycardia
  • Strong P-gp inducers: contraindicated (loss of efficacy)

Pregnancy and breastfeeding

  • With ribavirin: extreme care to avoid pregnancy in female patients and partners of male patients; effective contraception
  • Should not be used during breast-feeding

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)

  • SovaldiGilead Sciences Ireland UC · EMEA/H/C/002798

Source: European Medicines Agency (EMA), product information

Turkey

  • SovaldiGİLEAD SCİENCES İLAÇ TİC. LTD. ŞTİ. · 2 register entries

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

Brand names in 3 more European countries
Iceland
Sovaldi
Liechtenstein
Sovaldi
Norway
Sovaldi

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

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Sovaldi – 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/sovaldi-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC J05AX.

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.