54 tracked ATMP cases. gold = no Danish (Medicinrådet) decision yet
⚠ 1 source needs attention: jca_ongoing — see admin.
Nordic decisions
34| Product | Indication | Sverige | Norge | Danmark |
|---|---|---|---|---|
| Abecma | MM | — | Avbestilt | — |
| Alofisel | Crohn perianal fistula | — | Innføres | Ikke anbefalet |
| Aucatzyl | ALL | avvakta | — | — |
| Breyanzi | FL | använd inte | — | — |
| Breyanzi | DLBCL | — | Innføres | — |
| Breyanzi | MCL | kan användas | — | — |
| Breyanzi | DLBCL 2L | — | — | Anbefalet |
| Breyanzi | DLBCL 3L | kan användas | — | Anbefalet |
| Carvykti | MM 2L | kan användas | — | — |
| Carvykti | MM | — | Innføres ikke | Anbefalet |
| Casgevy | TDT | — | — | Anbefalet |
| Casgevy | SCD | avvakta | — | Anbefalet |
| Ebvallo | EBV+ PTLD | bör användas | Innføres | — |
| Hemgenix | Hemophilia | använd inte | Innføres | — |
| Holoclar | Limbal stem cell deficiency | — | — | Delvist anbefalet |
| Imlygic | Melanoma | — | Innføres ikke | — |
| Kymriah | DLBCL | — | Innføres ikke | — |
| Kymriah | FL | använd inte | Avbestilt | — |
| Kymriah | DLBCL 3L | använd inte | — | — |
| Kymriah | ALL | kan användas | Innføres | Anbefalet |
| lenadogene nolparvovec | LHON | — | Avbestilt | — |
| Libmeldy | MLD | bör användas | Innføres | — |
| Luxturna | RPE65 retinal dystrophy | bör användas | Videreføres | Anbefalet |
| Roctavian | Hemophilia | — | Ikke lansert i Norge | — |
| Tecartus | ALL | kan användas | Innføres | — |
| Tecartus | MCL | kan användas | Innføres | Ikke anbefalet |
| Upstaza | AADC deficiency | bör användas | Innføres ikke | — |
| Vyjuvek | DEB | avvakta | — | — |
| Yescarta | DLBCL | — | Innføres | — |
| Yescarta | DLBCL 3L | kan användas | — | — |
| Yescarta | FL | kan användas | Innføres ikke | — |
| Yescarta | DLBCL 2L | kan användas | — | Anbefalet |
| Zolgensma | SMA | bör användas | Under revurdering | Anbefalet |
| Zynteglo | TDT | — | Innføres ikke | — |
Horizon
8Upstream EU pipeline (PRIME / JCA / CHMP) — detected early, not yet authorised.
| Product | Indication | ATMP | Latest signal | Stage |
|---|---|---|---|---|
| rebisufligene etisparvovec | Treatment of Mucopolysaccharidosis Type IIIA, MPS IIIA... | CONFIRMED |
EMA-CHMP · under evaluation 2026-10-13
|
3 |
| bilayer engineered skin composed of autologous keratinocytes and allogeneic fibroblasts embedded in an allogeneic plasma matrix | Treatment of adults and children with partial deep... | CONFIRMED |
EMA-CHMP · under evaluation 2026-10-13
|
3 |
| living bilayered bioengineered skin made of an epithelium of autologous keratinocytes and a dermal matrix of bovine collagen hydrogel containing fibroblasts | Treatment of adults and children with partial deep... | CONFIRMED |
EU-JCA · ongoing 2026-07-16
|
2 |
| lunsotogene parvec | Treatment of biallelic OTOF variant-associated hearing... | CONFIRMED |
EMA-CHMP · under evaluation 2026-10-13
|
3 |
| zamtocabtagene autoleucel | Treatment of adults with large B-cell lymphoma | CONFIRMED |
EMA-CHMP · under evaluation · PRIME 2026-10-13
|
3 |
| zopapogene imadenovec | Treatment of respiratory papillomatosis in adults | CONFIRMED |
EMA-CHMP · under evaluation 2026-10-13
|
3 |
| bilayer engineered skin composed of autologous keratinocytes and allogeneic fibroblasts embedded in an allogeneic plasma matrix No longer listed | Treatment of adults and children with partial deep... | CONFIRMED |
EMA-CHMP · no longer listed 2026-09-15
|
3 |
| autologous melanoma-derived tumor infiltrating lymphocytes, ex vivo-expanded No longer listed | Treatment of melanoma | CONFIRMED |
EMA-CHMP · no longer listed 2026-08-05
|
3 |
Authorised — pending national assessment
12EU-authorised ATMPs with no Nordic verdict yet — sorted by time waiting (longest first).
| Product | Indication | ATMP | Latest signal | Stage | Since EU auth |
|---|---|---|---|---|---|
|
ChondroCelect
Withdrawn
TiGenix N.V.
|
Cartilage Diseases | CONFIRMED |
EMA · withdrawn 2026-10-20
|
4 | 17.1 yr |
|
Glybera
Expired
uniQure biopharma B.V.
|
Hyperlipoproteinemia Type I | CONFIRMED |
EMA · expired 2026-10-20
|
4 | 14.0 yr |
|
Maci
Expired
Vericel Denmark ApS
|
Fractures, Cartilage | CONFIRMED |
EMA · expired 2026-10-20
|
4 | 13.3 yr |
|
Provenge
Withdrawn
Dendreon UK Ltd
|
Prostatic Neoplasms | CONFIRMED |
EMA · withdrawn 2026-10-20
|
4 | 13.1 yr |
|
Strimvelis
Fondazione Telethon ETS
|
Severe Combined Immunodeficiency | CONFIRMED |
EMA · authorised 2026-10-20
|
4 |
10.4 yr
no DK decision
|
|
Zalmoxis
Withdrawn
MolMed SpA
|
Hematopoietic Stem Cell Transplantation;Graft vs Host Disease | CONFIRMED |
EMA · withdrawn 2026-10-20
|
4 | 10.2 yr |
|
Spherox
CO.DON Gmbh
|
Cartilage Diseases | CONFIRMED |
EMA · authorised 2026-10-20
|
4 |
9.3 yr
no DK decision
|
|
Skysona
Withdrawn
bluebird bio (Netherlands) B.V.
|
Adrenoleukodystrophy | CONFIRMED |
EMA · withdrawn 2026-10-20
|
4 | 5.3 yr |
|
Beqvez (previously Durveqtix)
Withdrawn
Pfizer Europe MA EEIG
|
Hemophilia B | CONFIRMED |
EMA · withdrawn 2026-10-20
|
4 | 2.2 yr |
|
Zemcelpro
Cordex Biologics International Limited
|
Hematologic Neoplasms;Hematopoietic Stem Cell Transplantation | CONFIRMED |
EMA · authorised 2026-10-20
|
4 |
1.2 yr
no DK decision
|
|
Waskyra
Fondazione Telethon ETS
|
Wiskott-Aldrich Syndrome | CONFIRMED |
EMA · authorised 2026-10-20
|
4 |
0.8 yr
no DK decision
|
|
Adstiladrin
Ferring Pharmaceuticals A/S
|
Non-Muscle Invasive Bladder Neoplasms | CONFIRMED |
EMA · authorised 2026-10-20
|
4 |
0.4 yr
no DK decision
|