ORFADIN
As listed in the register: ORFADIN 5 mg, gélule
5 mg · gélule
- Prescription only
- Active substance
- Nitisinone
- Made by
- SWEDISH ORPHAN BIOVITRUM INTERNATIONAL (SUEDE)
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
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
United States5 matching products
European UnionNo exact match for this strength and form
Canada2 matching products
Details
| Made by | SWEDISH ORPHAN BIOVITRUM INTERNATIONAL (SUEDE) |
|---|---|
| Active substance | Nitisinone |
| Strength | 5 mg |
| Form | gélule |
| Route | orale |
| Dispensing (as stated by the register) | prescription hospitalière · liste I |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/04/303 |
| Name in the register | ORFADIN 5 mg, gélule |
| Packs | 1 flacon(s) polyéthylène haute densité (PEHD) de 60 gélule(s) |
| CIS | 60459499 |
| CIP13 | 3400936593893 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).
Other strengths and forms
5 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.