Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 44301 |
|---|---|
| 2: Name of authorisation holder | CURIUM PHARMA UK LIMITED |
| 3: Address(es) of manufacturing site(s) |
CURIUM PHARMA UK LIMITED, C/O CURIUM RADIOPHARMACY (ORP), BLOCK 4, CHURCHILL HOSPITAL, OLD ROAD, HEADINGTON, OXFORD, OX3 7LE, UNITED KINGDOM CURIUM PHARMA UK LIMITED, BURLINGTON DANES BUILDING, IMPERIAL COLLEGE LONDON, DU CANE ROAD WHITE CITY, LONDON, W12 0NN, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | CURIUM PHARMA UK LIMITED, C/O CURIUM RADIOPHARMACY (ORP), BLOCK 4, CHURCHILL HOSPITAL, OLD ROAD, HEADINGTON, OXFORD, OX3 7LE, UNITED KINGDOM |
| 5: Scope of authorisation and dosage forms | ANNEX 1 and/ or ANNEX 2 |
| 6: Legal Basis of authorisation | |
| 7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation | Confidential |
| 8: Authorisation Date | 11/09/2026 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
CURIUM PHARMA UK LIMITED, C/O CURIUM RADIOPHARMACY (ORP), BLOCK 4, CHURCHILL HOSPITAL, OLD ROAD, HEADINGTON, OXFORD, OX3 7LE, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) |
| [ 1.1.1.4 ] Small volume liquids Special Requirements Radiopharmaceuticals |
| [ 1.1.3 ] Batch certification |
| [ 1.4 ] Other products or manufacturing activity |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
CURIUM PHARMA UK LIMITED, BURLINGTON DANES BUILDING, IMPERIAL COLLEGE LONDON, DU CANE ROAD WHITE CITY, LONDON, W12 0NN, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) |
| [ 1.1.1.4 ] Small volume liquids Special Requirements Radiopharmaceuticals |
| [ 1.1.1.6 ] Other aseptically prepared products PET radiopharmaceuticals |
| [ 1.1.3 ] Batch certification |
| [ 1.4 ] Other products or manufacturing activity |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |