Medicines authorised in Romania

Xolair

Xolair is a medicine containing Omalizumab, listed in the Romanian national register of medicines for human use with 11 presentations.

General information from the official register, not medical advice. Anpheros does not diagnose and does not recommend medicines. Read the package leaflet and ask your doctor or pharmacist before taking any medicine.

At a glance

Active substance
OMALIZUMABUM · all medicines with Omalizumab
ATC code
R03DX05 Respiratory system
Therapeutic action
ALTE MED. PT. TRAT. BOLILOR OBSTRUCTIVE ALE C.R, SISTEMICE ALTE MED. PT. TRAT. BOLILOR OBSTRUCTIVE ALE C.R, SISTEMICE
Prescription
Prescription required (register code PR)
Marketing authorisation holder
NOVARTIS EUROPHARM LIMITED - IRLANDA
Manufacturer
NOVARTIS PHARMA GMBH - GERMANIA
Pharmaceutical form
SOL. INJ.
SOL. INJ. IN STILOU INJECTOR PREUMPLUT

Presentations and codes

CIM is the code of each pack in the Romanian register; the Anpheros app saves it when it recognises the box.

CIM codeFormStrengthPackPrescriptionAuthorisationShelf life
W65486001SOL. INJ.75mgCutie cu 1 seringa preumpluta x 0.5 ml sol. inj. (cu ac fix de marimea 26)PR319/2005/0518 luni
W65486002SOL. INJ.75mgCutie cu 4 seringi preumplute x 0.5 ml sol. inj.PR319/2005/0618 luni
W65486003SOL. INJ.75mgCutie cu 10 seringi preumplute x 0.5 ml sol. inj.PR319/2005/0718 luni
W65486004SOL. INJ.75mgCutie cu 1 seringa preumpluta x 0.5 ml sol. inj. (cu ac fix de marimea 27)PR319/2005/1818 luni
W65487001SOL. INJ.150mgCutie cu 1 seringa preumpluta x 1 ml sol. inj. (cu ac fix de marimea 26)PR319/2005/0818 luni
W65487002SOL. INJ.150mgCutie cu 4 seringi preumplute x 1 ml sol. inj.PR319/2005/0918 luni
W65487003SOL. INJ.150mgCutie cu 10 seringi preumplute x 1 ml sol. inj.PR319/2005/1018 luni
W65487004SOL. INJ.150mgCutie cu 1 seringa preumpluta x 1 ml sol. inj. (cu ac fix de marimea 27)PR319/2005/2418 luni
W69858001SOL. INJ. IN STILOU INJECTOR PREUMPLUT75mgCutie cu 1 stilou injector preumplut x 0.5 ml sol. inj.PR319/2005/2118 luni
W69859001SOL. INJ. IN STILOU INJECTOR PREUMPLUT150mgCutie cu 1 stilou injector preumplut x 1 ml sol. inj.PR319/2005/2718 luni
W69861001SOL. INJ. IN STILOU INJECTOR PREUMPLUT300mgCutie cu 1 stilou injector preumplut x 2 ml sol. inj.PR319/2005/1518 luni

What it is used for

The official indications for Omalizumab, quoted from the European Medicines Agency and the US FDA, are on Omalizumab in Anpheros Search.

The package leaflet and the summary of product characteristics are published by ANMDMR: search for “Xolair” in the national register.

Other medicines with Omalizumab

Scan the box in Anpheros

In the Anpheros Daily app, photograph the medicine box: the app reads the name and strength, matches them against this register and adds the medicine to your list, with its code. From your list you can come back to this page.

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Source: ANMDMR — National Agency for Medicines and Medical Devices of Romania, Nomenclatorul medicamentelor de uz uman (register updated 29 October 2026). Shown as published, in Romanian where the register is in Romanian.