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Fixed-dose combination

Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded

BiologicOrphan
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Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded is a medicine. It is available for export supply from India to licensed hospitals, importers and physicians, with the documents the destination country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
B05AX04 Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded · Blood substitutes and infusion solutions, subgroup B05A, subgroup B05AX
US FDA first approval
Not recorded
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Biologic
Yes
Fixed-dose combination of
Allogeneic umbilical cord-derived cd34- cells, Dorocubicel, Non-expanded

All presentations

No presentations of Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded are listed yet. Ask us to source it

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDANot recorded—
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026

Questions and answers

Is Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded available for export from India?

No presentation of Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded is listed yet, but our sourcing team can check licensed channels. Send a request with the strength, quantity and destination country.

Is Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded authorised in the European Union?

Yes. Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded need cold chain shipping?

No listed presentation of Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded in?

Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded is classified under ATC code B05AX04 (Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded).

References

  1. Zemcelpro: European public assessment report (EPAR). European Medicines Agency. Retrieved 16 July 2026

Request Allogeneic umbilical cord-derived cd34- cells, Dorocubicel and Non-expanded for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.