Novaminsulfon Sintetica 500 mg/ml
As listed in the register: Novaminsulfon Sintetica 500 mg/ml, soluzione iniettabile
500 mg/ml ·
- Prescription only
- Pain, sleep, mood, epilepsy and the brain
- Active substance
- Metamizolum
- Made by
- Sintetica SA
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
Regulator safety notice · 2024-09-18
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
Measures to minimise serious outcomes of known side effect with painkiller metamizole
On 18 September 2024, the CMDh endorsed the measures recommended by EMA’s safety committee, PRAC, to minimise the serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole.
Agranulocytosis involves a sudden and sharp decrease in granulocytes, a type of white blood cell, that can lead to serious or even fatal infections.
The committee recommended that healthcare professionals must inform patients to stop taking these medicines and seek immediate medical attention if they develop symptoms of agranulocytosis.
These include fever, chills, sore throat and painful sores on the moist, inner body surfaces (mucosa), especially in the mouth, nose and throat or in the genital or anal regions.
Patients must remain alert for these symptoms both during and shortly after stopping treatment.
The PRAC concluded that the benefits of metamizole medicines continue to outweigh the risks.
Quoted from: European Medicines Agency — Metamizole-containing medicinal products, referral · retrieved 2026-09-30
What it is for
- Analgesico
From the official label · 2026-09-30 · Swissmedic
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
BulgariaNo exact match for this strength and form
SpainNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | Sintetica SA |
|---|---|
| Active substance | Metamizolum |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Strength | 500 mg/ml |
| Classification | N02BB02 · Pain, sleep, mood, epilepsy and the brain |
| Dispensing (as stated by the register) | Abgabekategorie B |
| Name in the register | Novaminsulfon Sintetica 500 mg/ml, soluzione iniettabile |
| Packs | 10 x 2 ml Ampulle(n) · 10 x 5 ml Ampulle(n) |
| Zulassungsnummer | 56541 |
| Dosisstärke | 1 |
Source: Zugelassene Packungen Humanarzneimittel · 2026-09-30 · not reviewed by a clinician
Quelle: Swissmedic. The publisher’s terms do not grant reproduction, so text is shortened and linked. Publisher’s terms.