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ocrelizumab

Ocrevus · ATC code L04AG08

Key facts
Active substance
ocrelizumab
Drug class
Immunosuppressive drug
ATC code
L04AG08
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Ocrevus 300 mg concentrate for solution for infusion · Ocrevus 920 mg solution for injection
Marketing authorisation holder
Roche Registration GmbH
Information as of
2026-10-27

Key facts

Ocrelizumab is an anti-CD20 monoclonal antibody (Ocrevus) that depletes B cells. It is used for relapsing and early primary progressive multiple sclerosis, given by infusion or subcutaneous injection.

What it is used for

  • Relapsing MS (RMS) with active disease: infusion in adults and children 10 years and older, injection in adults
  • Early primary progressive MS (PPMS) with imaging features of inflammatory activity in adults

Dosing

  • Infusion, adults: initial 600 mg dose as two 300 mg infusions 2 weeks apart, then 600 mg every 6 months
  • Infusion, children 10 years and older under 35 kg: two 150 mg infusions, then 300 mg every 6 months; 35 kg or more as adults
  • Subcutaneous injection (920 mg): 920 mg every 6 months, no division of the initial dose
  • Minimum interval of 5 months between doses
  • Premedication with IV methylprednisolone and an antihistamine before each infusion; an antipyretic may be considered

Contraindications

  • Hypersensitivity to the active substance or any of the excipients
  • Current active infection
  • Severely immunocompromised state
  • Known active malignancies

Important warnings

  • Infusion or injection reactions, mainly with the first dose, up to 24 hours afterwards
  • Hypotension during infusion; consider withholding antihypertensives
  • Hepatitis B reactivation: HBV screening before starting
  • Progressive multifocal leukoencephalopathy (PML): discontinue permanently if confirmed
  • Live vaccines: safety not studied

Side effects

  • Infusion-related reactions (34.3% in RMS, 40.1% in PPMS)
  • Infections (58.5% in RMS, 72.2% in PPMS), including upper respiratory tract infection, nasopharyngitis, influenza
  • COVID-19 (16.0% in PPMS)
  • Decreased blood immunoglobulin M

Interactions

  • No interactions expected via CYP450 or transporters
  • Other immunosuppressive therapies not recommended concomitantly, except corticosteroids for relapses

Pregnancy and breastfeeding

  • Contraception during treatment and for 4 months after the last dose
  • IgG crosses the placenta; postponing live vaccines in exposed newborns should be considered

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)

  • OcrevusRoche Registration GmbH · EMEA/H/C/004043

Source: European Medicines Agency (EMA), product information

Turkey

  • OcrevusROCHE MÜSTAHZARLARI SAN.A.Ş. · 2 register entries

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

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

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

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. Ocrevus – 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/ocrevus-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 L04AG.

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.