Medicines authorised in Romania

Kalydeco

Kalydeco is a medicine containing Ivacaftor, listed in the Romanian national register of medicines for human use with 8 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
IVACAFTORUM · all medicines with Ivacaftor
ATC code
R07AX02 Respiratory system
Therapeutic action
ALTE MED. PENTRU TRATAMENTUL AP. RESPIRATOR ALTE MED. PT. APARATUL RESPIRATOR
Prescription
Prescription required (register code PR)
Marketing authorisation holder
VERTEX PHARMACEUTICALS (IRELAND) LIMITED - IRLANDA
Manufacturer
ALMAC PHARMA SERVICES (IRELAND) LIMITED - IRLANDA
Pharmaceutical form
COMPR. FILM.
GRANULE

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
W65612001COMPR. FILM.150mgCutie cu 1 flac. HDPE x 56 compr.PR782/2012/014 ani
W65612002COMPR. FILM.150mgCutie cu blist. PCTFE/Al/Al x 56 compr.PR782/2012/024 ani
W65612003COMPR. FILM.150mgCard cu blist. PCTFE/Al x 28 compr.PR782/2012/054 ani
W65613001GRANULE50mgAmbalaj cu 56 plicuri (4x14) plicuri din BOPET/PE/folie aluminiu/PE)PR782/2012/034 ani
W65614001GRANULE75mgAmbalaj cu 56 plicuri (4x14) plicuri din BOPET/PE/folie aluminiu/PE)PR782/2012/044 ani
W65614002GRANULE75mgAmbalaj cu 28 de plicuri (contine 4 pliante individuale cu 7 plicuri per pliant)PR782/2012/054 ani
W67226001GRANULE25mgAmbalaj cu 56 plicuri (4x14) plicuri din BOPET/PE/folie aluminiu/PE)PR782/2012/064 ani
W67343001COMPR. FILM.75mgCard cu blist. PCTFE/Al x 28 compr.PR782/2012/074 ani

What it is used for

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

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

Other medicines with Ivacaftor

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.