| Product name Brand name (INN) |
Company (Origin) |
Therapeutic Area (Indication) |
Presentation |
EMEA/CPMP Validation date |
Commission date of notification |
Registration number (NIP Budapest) |
| CEA SCan (Arcitumomab) |
Immunomedics B.V. (USA) |
V09IA02 (Diagnosis of colonic and rectal carcinoma) |
Powder for solution for injection
(for labelling with 99mTc) |
01/01/1995 |
07/10/1996 |
Ri-238 |
| Leucoscan (Sulesomab) |
Immunomedics B.V. (USA) |
V04CX (Diagnostic agent) |
Powder for solution for injection
(for labelling with 99mTc) |
12/09/1995 |
17/02/1997 |
Ri-237 |
| Helicobacter Test INFAI ([13C]-urea *) |
INFAI (Deutschland) |
V04CX (Diagnosis of helicobacter pylori infections) |
Powder for oral solution |
23/09/1996 |
15/08/1997< |
|
| Quadramet (Samarium [153Sm] lexidronam) |
CIS bio international (France) |
V10BX02 (Therapeutic radiopharmaceutical for pain pallition |
Solution for injection |
18/12/1996 |
10/02/1998 |
|
| Pylobactell ([13C]-urea *) |
Torbet (U.K.) |
V04CX (Diagnosis of helicobacter pylori infections) |
Soluble tablet |
18/12/1996 |
08/05/1998 |
|
| Datscan ([123I]-Ioflupane) |
Nycomed Amersham, (U.K.) |
V09AB03
(Diagnosis of Parkinson desease) |
V09AB03
(Diagnosis of Parkinson desease) |
Solution for injection |
02/08/2000 |
OGYI-T-8402/01-02 |
| Thyrogen
(Thyrotropin alfa) |
Genzyme B.V.
The Netherlands |
V04C J01
(Detection of thyroid cancer using [131I]-imaging) |
Powder for solution for injection |
19/12/1997 |
13/03/1999 |
|
| NeoSpect (Depreotide) |
Nycomed Imaging A/S (Norway) |
V09IA05
Scintigrafic imaging of suspected malignant tumours in the lung) |
Kit for radiopharmaacaeutical preparation
(for labelling with 99mTc) |
20/11/1998 |
04/12/2000 |
OGYI-T-8532/01-02 |
| Theryttrex (Yttrium [90Y] chloride) |
MDS Nordion S.A., (Belgium) |
V09X pending
(Radiolabelling of carrier molecules) |
Radiopharmacaeutical precursor, solution |
17/092001 |
09/01/2003 |
|
| Ytracis ([90Y]-Yttrium) |
CIS bio international, France |
V10X
(Radiolabelling of carrier molecules) |
Precursor solution |
22/10/2001 |
27/03/2003 |
|
| Zevalin (Ibritumomab tiuxetan) |
Schering AG
(Deutschland) |
L01X C
(Treatment of adult patients with rituximab relapsed or refractory
CD20+ follicular B-cell non-Hodgkin's lymphoma NHL) |
Kit for radiopharmaceutical preparation (for labelling with
[90Y] |
24/03/2003 |
21/01/2004 |
|
| Optison (perfultren) |
Amersham Health A/S (Deutschland) |
V08D (Ultrasound contrast agent for use in echocardiography) |
Suspension for injection |
21/03/1997 |
19/05/1998 |
|
| Teslascan (Mangafodipir) |
Nycomed Imaging A/S (Norway) |
V08C A05 (Detection and characterisation of liver lesions).
NMR agent. |
Solution for infusion |
22/07/1996 |
25/05/1997 |
|
| SonoVue
(Sulphur hexafluoride) |
Bracco International B.V.
Italy |
V08D A
(Ultrasound agent to enhance the echogenicity of the blood) |
Powder for injection |
27/08/1999 |
29/03/2001 |
|