Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
CIMA — Centro de Información de Medicamentos · Spain
- Updated
- Not provided for this source record
- Synchronized
- Oct 2, 2026
Medicine · Spain
KALYDECO 75 MG GRANULADO EN SOBRE
Powder
Home Med Cabinet
Updated · Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) — Not provided for this source record
Synchronized
At a glance
- Active ingredient
- IVACAFTOR — 75 mg
- Pharmaceutical form Home Med Cabinet grouping
- Powder
- Availability in Spain
- All 2 packs marketed
Packs
KALYDECO 75 MG GRANULADO EN SOBRE, 56 (4 x 14) sobres (multipack)
56 pcs
National code
Marketed711571Strength of this pack 75 mg
KALYDECO 75 MG GRANULADO EN SOBRE, 28 (4 x 7) sobres (multipack)
28 pcs
National code
Marketed764252Strength of this pack 75 mg
“Marketed” means the authority records the pack as placed on the market. It is not a statement about pharmacy stock.
Official documents
Documents open on the authority’s own site. Home Med Cabinet links to them and hosts no copy.
- Official
Opens on the authority’s own site
- Official
Summary of product characteristics
Opens on the authority’s own site
Registration
- Registration number
- 112782004Official data
- Marketing authorisation holder
- VERTEX PHARMACEUTICALS (IRELAND) LIMITEDOfficial data
- Authorised
- Jul 8, 2016Official data
- Authority form code
- 1324Official data
Classification
ATC classification is not published here yet
Publication rights for ATC codes and labels are still under review, and no classification is inferred for this record.