Medicines authorised in Romania

Orfadin

Orfadin is a medicine containing Nitisinonum, listed in the Romanian national register of medicines for human use with 3 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: NITISINONUM
ATC code: A16AX04 Alimentary tract and metabolism
Therapeutic action: ALTE PRODUSE PENTRU TRACTUL DIGESTIV SI METABOLISM DIFERITE PRODUSE PENTRU TRACT DIGESTIV SI METABOLISM
Prescription: Prescription required (register code P-RF/R)
Marketing authorisation holder: SWEDISH ORPHAN BIOVITRUM INTERNATIONAL AB - SUEDIA
Manufacturer: APOTEKET AB PRODUKTION &LABORATORIER - SUEDIA
Pharmaceutical form: CAPS.

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 code	Form	Strength	Pack	Prescription	Authorisation	Shelf life
W51622001	CAPS.	2mg	Cutie x 1 flac. din PEID x 60 caps.	P-RF/R	303/2005/01	18 luni
W51627001	CAPS.	5mg	Cutie x 1 flac. din PEID x 60 caps.	P-RF/R	303/2005/01	18 luni
W51629001	CAPS.	10mg	Cutie x 1 flac. din PEID x 60 caps.	P-RF/R	303/2005/01	18 luni

What it is used for

Anpheros does not have a page with official indications for this substance yet.

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

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.