Sovaldi 400 mg filmomhulde tabletten
As listed in the register: Sovaldi 400 mg filmomhulde tabletten
400 mg · filmomhulde tablet
- Prescription only
- Antibiotics, antivirals and antifungals taken into the body
- Active substance
- Sofosbuvir
- Made by
- Gilead Sciences Ireland UC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Sovaldi). It describes the substance, not this exact product.
Sofosbuvir is a direct-acting antiviral agent against the hepatitis C virus [see Microbiology (12.4) ].
Sofosbuvir is extensively metabolized in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203.
Effect of Food Relative to fasting conditions, the administration of a single dose of SOVALDI with a standardized high fat meal did not substantially affect the sofosbuvir C max or AUC 0–inf.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-12-26
Safety of the active substance
From the US prescribing label for the same active substance (Sovaldi). It describes the substance, not this exact product.
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with SOVALDI.
- When SOVALDI is used in combination with ribavirin or peginterferon alfa/ribavirin, the contraindications applicable to those agents are applicable to combination therapies.
- Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.
- When used in combination with peginterferon alfa/ribavirin or ribavirin alone, all contraindications to peginterferon alfa and/or ribavirin also apply to SOVALDI combination therapy.
The most common adverse events (incidence greater than or equal to 20%, all grades) observed with SOVALDI in combination with ribavirin were fatigue and headache.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
Spain1 matching products
SwitzerlandNo exact match for this strength and form
Details
| Made by | Gilead Sciences Ireland UC |
|---|---|
| Active substance | Sofosbuvir |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 400 mg |
| Form | filmomhulde tablet |
| Classification | J05AP08 · Antibiotics, antivirals and antifungals taken into the body |
| Route | oraal gebruik |
| Dispensing (as stated by the register) | Uitsluitend recept |
| RVG | EU/1/13/894 |
Source: Geneesmiddeleninformatiebank · 2026-09-30 · not reviewed by a clinician
Bron: College ter Beoordeling van Geneesmiddelen (CBG). De Rijksoverheid is het niet automatisch eens met de inhoud van deze site. Reuse terms: CC0 1.0 (CBG website).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.