MedeliX
Start asking

Vosoritide

Voxzogo · ATC code M05BX

Also known as: Vosoritid

Key facts
Active substance
Vosoritide
ATC code
M05BX
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Voxzogo 0.4 mg powder and solvent for solution for injection / Voxzogo 0.56 mg powder and solvent for solution for injection / Voxzogo 1.2 mg powder and solvent for solution for injection
Marketing authorisation holder
BioMarin International Limited
Information as of
2026-10-28

Key facts

Vosoritide is a modified type C natriuretic peptide (CNP) that promotes bone growth. It is used to treat achondroplasia in children from 4 months of age whose epiphyses are not closed.

What it is used for

  • Treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed; the diagnosis should be confirmed by appropriate genetic testing.

Dosing

  • Voxzogo (powder and solvent for solution for injection): daily subcutaneous injection; the dose is weight-based, approximately between 15-30 µg/kg, with the higher dose given to the smallest children – single doses and volumes in the table in the full text.
  • Monitor body weight, growth and physical development every 3-6 months and adjust the dose to body weight.
  • Stop treatment when there is no further growth potential (growth velocity of < 1.5 cm/year and closure of epiphyses).
  • Missed dose: give within 12 hours; otherwise skip and continue with the next scheduled dose the following day.
  • Eat a light snack and drink adequate fluid about 30 minutes before injecting; administer within 3 hours of reconstitution. Not evaluated in renal or hepatic impairment.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.

Important warnings

  • Decreased blood pressure with dizziness, fatigue and/or nausea may occur; patients should be well hydrated at the time of injection.
  • Patients with significant cardiac or vascular disease and those on anti-hypertensives were excluded from clinical trials.
  • Caregivers should be trained in injection and in recognising signs of decreased blood pressure.
  • Record the name and batch number of the biological product.

Side effects

  • Most common: injection site reactions (85%), vomiting (27%) and decreased blood pressure (13%).
  • Others: syncope, pre-syncope, dizziness, nausea, hypertrichosis, fatigue, increased alkaline phosphatase.

Interactions

  • As a recombinant human protein, vosoritide is an unlikely candidate for interactions; CYP- or transporter-mediated interactions are not expected.

Pregnancy and breastfeeding

  • As a precaution, it is preferable to avoid use during pregnancy.
  • Should not be used during breast-feeding.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

This product has no separate US patient information.

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)

  • VoxzogoBioMarin International Limited · EMEA/H/C/005475

Source: European Medicines Agency (EMA), product information

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

EMA – Article 57 product data (EU/EEA), 2026-10-29

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

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Voxzogo – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/voxzogo-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-28 · 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.