natgillin/translations-raw huggingface dataset:
Treatment of elevated intraocular pressure (second- line)
Treatment of elevated intraocular pressure (second-line)
26. 07. 2001
• 26.07.2001
27. 11. 2001
• 27.11.2001
152 days
• 152 days • 58 days
29. 11. 2001
8
121/ 2000 Lægemiddel Handelsnavn INN Del A/ B
• Glivec # • imatinib mesilate
Indehaver af markedsføringstilladelse
•
Behandlingsområde ATC- kode Indikation
Novartis Europharm Ltd
EMEA/ CPMP Godkendelse Udtalelse Nettotid Urstop
• •
Europa - Kommissionen Udtalelse modtaget Dato for afgørelsen Meddelelse EFT nr.
L01XX28 (temporary) Treatment of patients with chronic myeloid leukemia (CML)
58 days
• 27.03.2001 • 26.07.2001
8
• 23.08.2001 • 07.11.2001
Glivec imatinib mesilate Part B
• Part B
27. 03. 2001 26. 07. 2001 119 days 0 days
• 119 days • 0 days
23. 08. 2001 07. 11. 2001 12. 11. 2001 OJ C 336, 30. 112001, p.
• 12.11.2001 • OJ C 336, 30.11.2001, p.
Viread tenofovir Part B
• Viread • tenofovir
Gilead Science International Ltd
Gilead Science International Ltd
J05A Ttreatment of HIV infected patients with early virological failure in combination with other anti HIV
J05A Treatment of HIV infected patients with early virological
22. 05. 2001 18. 10. 2001 83 days
• 22.05.2001 • 18.10.2001
products
failure in combination with other anti HIV products
63 days
• 83 days • 63 days
Protopy tacrolimus Part B
• Protopy • tacrolimus
Fujisawa GmbH
Fujisawa GmbH
D11AX14 (temporary) Treatment of moderate to severe atopic dermatitis
D11AX14 (temporary) Treatment of moderate to severe atopic dermatitis
16. 08. 2000 18. 10. 2001 204 days 218 days
• 204 days • 218 days
(♦) Trisenox
• •
Cell Therapeutics (UK)
• Trisenox # • arsenic trioxide
27. 02. 2001
•
arsenic trioxide
Cell Therapeutics (UK) Ltd
Ltd
• •
Induction for induction of remission and
L01XX27 (temporary) Induction for induction of remission and consolidation in adult patients
18. 10. 2001
• •
consolidation in adult patients with relapsed/ refractory acute promyelocytic leukaemia (APL),
with relapsed/ refractory acute promyelocytic leukaemia (APL)
180 days 51 days
• 180 days • 51 days
Protopic tacrolimus
• Protopic • tacrolimus
Fujisawa GmbH
• Fujisawa GmbH
D11AX14 (temporary) Treatment of moderate to severe atopic dermatitis
• D11AX14 (temporary) • Treatment of moderate to severe atopic dermatitis
16. 08. 2000 18. 10. 2001
• •
204 days 218 days
• 204 days • 218 days
Kineret anakinra Part A
• Kineret • anakinra
Amgen Europe
• Amgen Europe
L04AA14 Treatment of the signs and symptoms of rheumatoid arthritis
L04AA14 Treatment of the signs and symptoms of rheumatoid
18. 07. 2000 15. 11. 2001 204 days 273 days
• 204 days
Xapit parecoxib
• Xapit • parecoxib
G D Searle & Co Ltd
• G D Searle & Co Ltd
M01AH For the short- term treatment of postoperative pain
M01AH For the short-term treatment of postoperative pain
31. 10. 2000 15. 11. 2001
• •
204 days 171 days
• 204 days • 171 days
Dynastat parecoxib Part B
• Dynastat • parecoxib
31. 10. 2000 15. 11. 2001 204 days 171 days
• 204 days • 171 days
Rayzon parecoxib
• Rayzon • parecoxib
Lumigan bimatoprost Part B
• Lumigan • bimatoprost
Allergan Sales Ltd
• Allergan Sales Ltd
S01EX Reduction of elevated intraocular pressure in chronic open- angle glaucoma and ocular hypertension
S01EX Reduction of elevated intraocular pressure in chronic open-angle
26. 12. 2000 15. 11. 2001 192 days 127 days
• 192 days • 127 days
Arixtra fondaparinux
• Arixtra • fondaparinux
Sanofi- Synthelabo
• Sanofi-Synthelabo
B01AE Prevention of venous thromboembolic
B01AE Prevention of venous thromboembolic events in
27. 02. 2001 13. 12. 2001
• 27.02.2001 • 13.12.2001
121/ 2000.
• •
events in patients undergoing major orthopaedic surgery
patients undergoing major orthopaedic surgery
205 days 78 days
• 205 days • 78 days
Quixidar fondaparinux Part B
• Quixidar • fondaparinux
NV Organon
NV Organon
B01AE Prevention of venous thromboembolic events in patients undergoing major orthopaedic surgery
B01AE Prevention of venous thromboembolic events in
27. 02. 2001 13. 12. 2001 205 Days 78 Days
• 205 Days • 78 Days
Dynepo
• Dynepo
Aventis Pharma SA France
Aventis Pharma SA France
26. 09. 2000
•
epoetin delta
• epoetin delta
Treatment of anaemia in patients with chronic renal failure
Treatment of anaemia in patients with chronic renal failure
13. 12. 2001
•
206 Days 238 days
• 206 Days • 238 days
Vfend Voriconazole Part B Bilag 8
• Vfend • Voriconazole • Part B
Pfizer Ltd
• Pfizer Ltd
J02AC Antifungal agent
• J02AC • Antifungal agent
28. 11. 2000 13. 12. 2001 203 days 169 days
• 28.11.2000 • 13.12.2001 • 203 days • 1 69 days
CVMP- udtalelser i 2001 om veterinærlægemidler
Annex 8 CVMP opinions in 2001 on medicinal products for veterinary use
Centraliserede ansøgninger
Centralised applications
Lægemiddel Handelsnavn INN Del A/ B
Product • Brand name • INN • Part A/B
Indehaver af markedsføringstilladels e
Marketing authorisation holder
Behandlingsområde Dyrearter, som lægemidlet er beregnet til Indikation
Therapeutic area • Target species • Indication
EMEA/ CVMP Godkendelse Udtalelse Nettotid Urstop
EMEA/CVMP • Validation • Opinion • Active time • Clock stop
Poulflox Difloxacin
• Poulflox • difloxacin • Part B
Virbac
• Virbac
Antibacterial for systemic use
• Poultry • Antibacterial for systemic use
21. 06. 00 152 days 43 days
• 09.12.99 • 21.06.00 • 152 days • 43 days
16. 11. 00 20. 11. 00 OJ C 2, 05. 01. 2001, p.
• 21.07.00 • 16.11.00 • 20.11.00 • OJ C 2, 05.01.2001, p.
Porcilis AR- T DF inactivated vaccine Part A
• Porcilis AR-T DF • inactivated vaccine • Part A
Intervet International
• Intervet International
Pigs Vaccine against atrophic rhinitis
Pigs Vaccine against atrophic rhinitis
12. 01. 99 19. 07. 00 204 days 336 days
• 12.01.99 • 19.07.00 • 204 days • 336 days
18. 08. 00 13. 11. 00 20. 11. 00 OJ C 2, 05. 01. 2001, p.
• 18.08.00 • 13.11.00 • 20.11.00 • OJ C 2, 05.01.2001, p.
Pruban rescortol butyrate Part B
• Pruban • rescortol butyrate
Dogs Anti- inflammatory for cutaneous inflammatory disorders
Dogs Anti-inflammatory for cutaneous inflammatory disorders
15. 09. 98 19. 07. 00 196 days 477 days
• 196 days • 477 days
18. 08. 00 16. 11. 00 20. 11. 00 OJ C 2, 05. 01. 2001, p.
• 20.11.00 • OJ C 2, 05.01.2001, p.
Bayovac CSF Marker
• Bayovac CSF Marker • live vaccine
Bayer
• Bayer
29. 11. 00
• •
Marker vaccine against Classical Swine Fever
Pigs Marker vaccine against Classical Swine Fever
19. 07. 00 210 days
• 16.12.98 • 19.07.00
02. 02. 01 06. 02. 01
• 29.11.00 • 02.02.01
309 days
• 210 days • 309 days
OJ C 53, 20. 02. 2001, p.
• 06.02.01 • OJ C 53, 20.02.2001, p.
Pirsue pirlimycin Part B
• Pirsue • pirlimycin • Part B
Pharmacia Upjohn
• Pharmacia Upjohn
Dairy cattle Clinical & sub- clinical mastitis
Dairy cattle Clinical & sub-clinical mastitis
12. 01. 99 11. 10. 00 210 days 428 days
• 12.01.99 • 11.10.00 • 210 days • 428 days
10. 11. 00 29. 01. 01 31. 01. 01 OJ C 53, 20. 02. 2001, p.
• 10.11.00 • 29.01.01 • 31.01.01 • OJ C 53, 20.02.2001, p.
Zubrin tepoxalin Part B
• Zubrin • tepoxalin • Part B
Schering Plough
• Schering Plough
Dogs Treatment of pain & inflammation
• Dogs • Treatment of pain & inflammation
18. 05. 99 08. 11. 00 210 days 330 days
• 18.05.99 • 08.11.00 • 210 days • 330 days
08. 12. 00 13. 03. 01 14. 03. 01 OJ C 127, 27. 04. 2001, p.
• 08.12.00 • 13.03.01 • 14.03.01 • OJ C 127, 27.04.2001, p.
Eurican Herpes 205 inactivated vaccine
• Eurican Herpes 205 • inactivated vaccine • Part B
Merial
• Merial
Dogs Vaccine against canine herpes
• Dogs • Vaccine against canine herpes
13. 07. 99 08. 11. 00 209 days
• 13.07.99 • 08.11.00 • 209 days • 274 days
OJ C 127, 27. 04. 2001, p.
• 08.12.00 • 26.03.01 • 29.03.01 • OJ C 127, 27.04.2001, p.
Metacam meloxicam Part B extension
• Metacam • meloxicam • Part B extension
Boehringer Ingelheim
• Boehringer Ingelheim
Cattle Diarrhoea/ respiratory infections
Cattle Diarrhoea/respiratory infections
14. 09. 99 10. 01. 01 184 days 301 days
• 14.09.99 • 10.01.01 • 184 days • 301 days
09. 02. 01 23. 04. 01 25. 04. 01 OJ C 158, 31. 05. 2001, p.
• 09.02.01 • 23.04.01 • 25.04.01 • OJ C 158, 31.05.2001, p.
Virbagen Omega feline interferon
• Virbagen Omega • feline interferon
Dogs To reduce mortality and clinical signs of canine parvovirosis
Dogs To reduce mortality and clinical signs of canine parvovirosis
21. 12. 99 11. 07. 01
• 21.12.99 • 11.07.01
10. 08. 01 06. 11. 01
• 10.08.01 • 06.11.01
210 days 358 days
• 210 days • 358 days
08. 11. 01 OJ C 336, 30. 11. 2001, p.
• 08.11.01 • OJ C 336, 30.11.2001, p.
Lægemiddel Handelsnavn INN Del A/ B
• Eurifel RCP-FelV • vaccine
Behandlingsområde Dyrearter, som lægemidlet er beregnet til Indikation
• Merial
EMEA/ CVMP Godkendelse Udtalelse Nettotid Urstop
• •
Europa - Kommissionen Udtalelse modtaget Dato for afgørelsen Meddelelse EFT nr.
Cats Vaccine against feline rhinotracheitis, calcivirus,
Eurifel RCP FeLV vaccine
• 19.12.00 • 05.12.01
Merial
• •
Vaccine against feline rhinotracheitis, calcivirus, panleucopenia and leukaemiac
panleucopenia and leukaemiac
05. 12. 01 210 days 141 days
• 141 days
Fastsættelse af maksimalgrænseværdier for restkoncentrationer i nye stoffer
Establishment of maximum residue limits for new substances
Stoffets INN
Substance INN
Behandlingsområde Dyrearter, som lægemidlet er beregnet til
Therapeutic area • Target species
Europa- Kommissionen Udtalelse modtaget Dato for vedtagelse af forordningen EFT nr.
European Commission • Opinion received • Date of regulation • Official Journal
Linear dodecyl benzene sulfonic acid
• Linear dodecyl benzene sulfonic acid
kvæg
• Bovine
22. 01. 99
• 22.01.99
18. 08. 00
• 18.08.00
19. 07. 00 195 days 321 days
• 19.07.00 • 195 days • 321 days
25. 04. 01 OJ L118, 27. 04. 2001, p.
• 25.04.01 • OJ L118, 27.04.2001, p.
Phoxim (extension)
• Phoxim (extension)
Ovine
• Ovine
19. 01. 00 19. 07. 00 120 days 0
• 19.01.00 • 19.07.00 • 120 days •0
18. 08. 00 25. 04. 01 OJ L118, 27. 04. 2001, p.
• 18.08.00 • 25.04.01 • OJ L118, 27.04.2001, p.
Florfenicol (extension)
• Florfenicol (extension)
Fish
• Fish
29. 01. 96 11. 11. 00 212 days 1504 days
• 29.01.96 • 11.11.00 • 212 days • 1504 days
08. 11. 00 29. 06. 01 OJ L177, 30. 06. 2001, p.
• 08.11.00 • 29.06.01 • OJ L177, 30.06.2001, p.
Meloxicam (extension)
• Meloxicam (extension)
Porcine
• Porcine
07. 09. 00 06. 12. 00 90 days 0
• 07.09.00 • 06.12.00 • 90 days •0
04. 01. 01 27. 06. 01 OJ L175, 28. 06. 2001, p.
• 04.01.01 • 27.06.01 • OJ L175, 28.06.2001, p.
Tilmicosin (extension)
• Tilmicosin (extension)
Turkeys
• Turkeys
Doramectin (extension)
• Doramectin (extension)
Reindeer
• Reindeer
11. 12. 97 10. 01. 01 203 days 923 days
• 11.12.97 • 10.01.01 • 203 days • 923 days
09. 02. 01 18. 07. 01 OJ L195, 19. 07. 2001, p.
• 09.02.01 • 18.07.01 • OJ L195, 19.07.2001, p.
Rafoxanide
• Rafoxanide
Bovine and ovine
• Bovine and ovine
11. 02. 97 10. 01. 01 193 days 1236 days
• 11.02.97 • 10.01.01 • 193 days • 1236 days
Tiludronate
• Tiludronate
Equine
• Equine
12. 10. 00 10. 01. 01 90 days 0
• 12.10.00 • 10.01.01 • 90 days •0
Moxidectin (extension)
• Moxidectin (extension)
Bovine milk
• Bovine milk
09. 10. 00 14. 02. 01 90 days 0
• 09.10.00 • 14.02.01 • 90 days •0
16. 03. 01 30. 07. 01 OJ L205, 31. 07. 2001, p.
• 16.03.01 • 30.07.01 • OJ L205, 31.07.2001, p.
Tosychloramide sodium (extension)
Tosychloramide sodium (extension)
Dairy cows
• Dairy cows
20. 01. 00
• 20.01.00
06. 04. 01
• 06.04.01
14. 03. 01 120 days 298 days
• 14.03.01 • 120 days • 298 days
22. 08. 01 OJ L227, 23. 08. 2001, p.
• 22.08.01 • OJ L227, 23.08.2001, p.
Deltamethrin (extension)
Deltamethrin (extension)
Fin fish
• Fin fish
09. 11. 99 13. 06. 01 177 days 404 days
• 09.11.99 • 13.06.01 • 177 days • 404 days
06. 07. 01 07. 11. 01 OJ L291, 08. 11. 2001, p.
• 06.07.01 • 07.11.01 • OJ L291, 08.11.2001, p.
Bronopol (extension) Bilag 9
• Bronopol (extension)
Salmonidae
• Salmonidae
15. 03. 01 13. 06. 01 90 days 0
• 15.03.01 • 13.06.01 • 90 days •0
COMP- udtalelser i 2001 om udpegelse lægemidler til sjældne sygdomme Lægemidlets INN
Annex 9 COMP opinions in 2001 on designation of orphan medicinal products
EMEA/ COMP Godkendelse Udtalelse Nettotid Urstop
EMEA/COMP • Validation • Opinion • Active time • Clock stop
Europa - Kommissionen Udtalelse modtaget Dato for afgørelsen
European Commission • Opinion received • Date of decision
Xaliproden hydrochloride
• Xaliproden hydrochloride
Sanofi- Synthélabo
• Sanofi-Synthélabo
Treatment of amyotrophic lateral sclerosis
• Treatment of amyotrophic lateral sclerosis
07. 08. 2000 25. 08. 2000 21. 11. 2000 89 days
• 07.08.2000 • 25.08.2000 • 21.11.2000 • 89 days
23. 11. 2000 17. 01. 2001
• 23.11.2000 • 17.01.2001
Arsenic trioxide
• Arsenic trioxide
Pharmacie Centrale des Hôpitaux de Paris
Pharmacie Centrale des Hôpitaux de Paris
Treatment of acute promyelocytic leukaemia
Treatment of acute promyelocytic leukaemia
08. 08. 2000 22. 09. 2000 21. 11. 2000 61 days
• 08.08.2000 • 22.09.2000 • 21.11.2000 • 61 days
Lusupultide
• Lusupultide
Byk Gulden Lomberg Chemische Fabrik GmbH
Byk Gulden Lomberg Chemische Fabrik GmbH
Treatment of acute respiratory distress syndrome
Treatment of acute respiratory distress syndrome
01. 09. 2000 22. 09. 2000 21. 11. 2000 61 days
• 01.09.2000 • 22.09.2000 • 21.11.2000 • 61 days
L- Lysine- N- Acetyl- L - Cysteinate
L-Lysine-N-Acetyl-L- Cysteinate
SMB Technology S. A.
• SMB Technology S.A.
09. 08. 2000 22. 09. 2000 19. 12. 2000 89 days
• 22.09.2000 • 19.12.2000 • 89 days
03. 01. 2001 14. 02. 2001
• 14.02.2001
Ibuprofen
Ibuprofen
Orphan Europe Sarl
• Orphan Europe Sarl
02. 05. 2000 19. 10. 2000 19. 12. 2000 62 days
• 19.10.2000 • 19.12.2000 • 62 days
Recombinant human acid α- glucosidase
Recombinant human acid α-glucosidase
Genzyme B. V.
Genzyme B.V.
Treatment of glycogen storage disease type II (Pompe’ s disease)
Treatment of glycogen storage disease type II (Pompe’s disease)
10. 08. 2000 19. 10. 2000 19. 12. 2000 62 days
• 10.08.2000 • 19.10.2000 • 19.12.2000 • 62 days
03. 01. 2001 14. 02. 2001
• 03.01.2001 • 14.02.2001
Pegvisomant
Pegvisomant
Pharmacia Enterprises S. A
Pharmacia Enterprises S.A
11. 08. 2000 19. 10. 2000 19. 12. 2000 62 days
• 19.10.2000 • 19.12.2000 • 62 days
Bosentan
• Bosentan
Actelion Registration Ltd
• Actelion Registration Ltd
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary
Treatment of pulmonary arterial hypertension and chronic
21. 08. 2000 19. 10. 2000
• 19.10.2000
19. 12. 2000 62 days
• 19.12.2000 • 62 days
Ribavirin
• Ribavirin
ICN Pharmaceuticals Ltd
• ICN Pharmaceuticals Ltd
06. 09. 2000 19. 10. 2000 19. 12. 2000 62 days
• 19.10.2000 • 19.12.2000 • 62 days
Laronidase
• Laronidase
08. 09. 2000 19. 10. 2000 19. 12. 2000 62 days
• 19.10.2000 • 19.12.2000 • 62 days
Imatinib mesylate
• Imatinib mesylate
Novartis Europharm Ltd
• Novartis Europharm Ltd
03. 10. 2000 19. 10. 2000 19. 12. 2000 62 days
• 19.10.2000 • 19.12.2000 • 62 days
Lægemidlets INN
Product INN
Indikation
Therapeutic area • ATC code • Indication
Godkendelse Udtalelse Nettotid Urstop
EMEA/COMP • Validation • Opinion • Active time • Clock stop
Kommissionen Udtalelse modtaget Dato for afgørelsen
European Commission • Opinion received • Date of decision
N- acetylglactos amine- 4 - sulfatase
• N-acetylglactos amine- 4-sulfatase
ClinTrials Research Ltd
• ClinTrials Research Ltd
Mucopolysaccharidosis type VI (Maroteaux- Lamy Syndrome)
• Mucopolysaccharidosis type VI (Maroteaux-Lamy Syndrome)
04. 10. 2000 19. 10. 2000 19. 12. 2000 62 days
• 04.10.2000 • 19.10.2000 • 19.12.2000 • 62 days
Ibuprofen
• Ibuprofen
Prevention of patent ductus arteriosus in premature neonates of less than 34 weeks of gestational
of less than 34 weeks of
02. 05. 2000 19. 10. 2000
• 19.10.2000
19. 01. 2001 05. 03. 2001
• 05.03.2001
age
gestational age
15. 01. 2001 89 days
• 15.01.2001 • 89 days
Inolimomab
• Inolimomab
Opi Orphan Pharma International
Opi Orphan Pharma International
Treatment of Graft versus Host disease
Treatment of Graft versus Host disease
05. 09. 2000 19. 10. 2000 15. 01. 2001 89 days
• 05.09.2000 • 19.10.2000 • 15.01.2001 • 89 days
18. 01. 2001 05. 03. 2001
• 18.01.2001 • 05.03.2001
Treatment of adenovirus infection in immunocompromised patients
Treatment of adenovirus infection in
06. 09. 2000 19. 10. 2000 15. 01. 2001 89 days
• 19.10.2000 • 15.01.2001 • 89 days
18. 01. 2001 08. 03. 2001
• 08.03.2001
Ranpirnase
• Ranpirnase
Dr.
• Dr.
Erika Morgenstern
Erika Morgenstern
Treatment of malignant mesothelioma
Treatment of malignant mesothelioma
20. 10. 2000 22. 12. 2000 09. 02. 2001 50 days
• 22.12.2000 • 09.02.2001 • 50 days
13. 02. 2001 29. 03. 2001
• 29.03.2001
Gusperimus trihydrochloride
Gusperimus trihydrochloride
Euro Nippon Kayaku GmbH
Euro Nippon Kayaku GmbH
Treatment of Wegener’ s granulomatosis
Treatment of Wegener’s granulomatosis
27. 10. 2000 13. 11. 2000 09. 02. 2001 89 days
• 27.10.2000 • 13.11.2000 • 09.02.2001 • 89 days
13. 02. 2001 29. 03. 2001
• 13.02.2001 • 29.03.2001
Cell Therapeutics (UK) Ltd
Cell Therapeutics (UK) Ltd
Treatment of myelodysplastic syndromes
Treatment of myelodysplastic syndromes
02. 10. 2000 22. 12. 2000 09. 02. 2001 50 days
• 02.10.2000 • 22.12.2000 • 09.02.2001 • 50 days
Treatment of multiple myeloma
• Treatment of multiple myeloma
02. 10. 2000
• 02.10.2000
13. 02. 2001
• 13.02.2001
22. 12. 2000 09. 02. 2001 50 days
• 22.12.2000 • 09.02.2001 • 50 days
29. 03. 2001
• 29.03.2001
8- cyclopentyl- 1, 3- dipropyl xanthine
8-cyclopentyl-1,3- dipropyl xanthine
SciClone Pharmaceuticals Italy S. r. l.
SciClone Pharmaceuticals Italy S.r.l.
Treatment of Cystic fibrosis
• Treatment of Cystic fibrosis
07. 12. 2000 22. 12. 2000 09. 02. 2001 50 days
• 07.12.2000 • 22.12.2000 • 09.02.2001 • 50 days
13. 12. 2001 29. 03. 2001
• 13.12.2001 • 29.03.2001
Levodopa and carbidopa (Gastroenteral Use)
Levodopa and carbidopa (Gastroenteral Use)
NeoPharma Production AB
NeoPharma Production AB
26. 03. 2001 10. 05. 2001
•
responding to oral treatment.
Treatment of advanced idiopathic Parkinson’s disease with severe motor fluctuations and not responding to oral treatment
20. 03. 2001 89 days
• 04.10.2000 • 22.12.2000 • 20.03.2001 • 89 days
Recombinant human C1 - inhibitor
Recombinant human C1-inhibitor
Pharming NV
Pharming NV
Treatment of angioedema caused by C1 inhibitor deficiency
Treatment of angioedema caused by C1 inhibitor deficiency
09. 10. 2000 22. 12. 2000 20. 03. 2001 89 days
• 09.10.2000 • 22.12.2000 • 20.03.2001 • 89 days
26. 03. 2001 11. 05. 2001
• 26.03.2001 • 11.05.2001
Anti- HM1. 24 monoclonal antibody (AHM)
Anti-HM1.24 monoclonal antibody (AHM)
Chugai Pharma Europe Ltd
Chugai Pharma Europe Ltd
Treatment of Multiple myeloma
• Treatment of Multiple myeloma
08. 02. 2001 23. 02. 2001 20. 03. 2001 26 days
• 08.02.2001 • 23.02.2001 • 20.03.2001 • 26 days
26. 03. 2001 10. 05. 2001
• 26.03.2001 • 10.05.2001
Fomepizole
• Fomepizole
Idis Ltd
• Idis Ltd
Treatment of methanol poisoning
• Treatment of methanol poisoning
15. 12. 2000 11. 01. 2001 10. 04. 2001 90 days
• 15.12.2000 • 11.01.2001 • 10.04.2001 • 90 days
11. 04. 2001 30. 05. 2001
• 11.04.2001 • 30.05.2001
Human engineered monoclonal antibody specific for Transforming
Human engineered monoclonal antibody specific for Transforming Growth Factor β2
Cambridge Antibody Technology Ltd
Cambridge Antibody Technology Ltd
Prevention of scarring in glaucoma filtration surgical procedures
Prevention of scarring in glaucoma filtration surgical procedures
18. 12. 2000 11. 01. 2001
• 18.12.2000 • 11.01.2001 • 10.04.2001 • 90 days
10. 04. 2001 90 days
•
Retroviral γc cDNA containing vector
Retroviral γc cDNA containing vector
Génopoïétic S. A.
Génopoïétic S.A.
Treatment of Severe Combined Immunodeficiency (SCID) - Xl Disease
Treatment of Severe Combined Immunodeficiency (SCID)-Xl Disease
29. 11. 2000 23. 02. 2001 10. 04. 2001 47 days
• 29.11.2000 • 23.02.2001 • 10.04.2001 • 47 days
Human Milk Fat Globule 1 / Human Milk Fat Globule
Human Milk Fat Globule 1 / Human Milk Fat Globule 1-
Antisoma plc
• Antisoma plc
Treatment of ovarian cancer
• Treatment of ovarian cancer
04. 12. 2000
• 04.12.2000
11. 04. 2001
• 11.04.2001
1 -
S-p-isothiocyanatobenzyl-
23. 02. 2001
• 23.02.2001
30. 05. 2001
• 30.05.2001
S- p- isothiocyanatobenzyl - diethylenetriaminepentaac etic acid for use with 90 Yttrium
diethylenetriaminepentaacet ic acid for use with 90Yttrium
10. 04. 2001 47 days
• 10.04.2001 • 47 days
Ecteinascidin 743
Ecteinascidin 743
Pharma Mar AS
• Pharma Mar AS
Treatment of soft tissue sarcoma
• Treatment of soft tissue sarcoma
05. 02. 2001 23. 02. 2001 10. 04. 2001 47 days
• 05.02.2001 • 23.02.2001 • 10.04.2001 • 47 days
Recombinant human alpha- 1- antitrypsin (Respiratory Use)
Recombinant human alpha-1-antitrypsin (Respiratory Use)
Bayer AG
• Bayer AG
Treatment of emphysema secondary to congenital alpha- 1 - antitrypsin deficiency
Treatment of emphysema secondary to congenital alpha-1- antitrypsin deficiency
06. 12. 2000 23. 02. 2001 10. 04. 2001 47 days
• 06.12.2000 • 23.02.2001 • 10.04.2001 • 47 days
Betaine anhydrous
Betaine anhydrous
Treatment of homocystinuria
Treatment of homocystinuria
02. 05. 2000 15. 03. 2001 23. 05. 2001 70 days
• 02.05.2000 • 15.03.2001 • 23.05.2001 • 70 days
28. 05. 2001 09. 07. 2001
• 28.05.2001 • 09.07.2001
Thalidomide
• Thalidomide
Laboratoires LAPHAL
• Laboratoires LAPHAL
Treatment of multiple myeloma
Treatment of multiple myeloma
01. 06. 2000 23. 02. 2001 23. 05. 2001 90 days
• 01.06.2000 • 23.02.2001 • 23.05.2001 • 90 days
Treatment of graft- versus- host disease
Treatment of graft-versus-host disease
01. 06. 2000 23. 02. 2001 23. 05. 2001 90 days
• 23.02.2001 • 23.05.2001 • 90 days
28. 05. 2001 09. 07. 2001
• 09.07.2001
Alpha1- Proteinase Inhibitor (Respiratory use)
Alpha1-Proteinase Inhibitor (Respiratory use)
Aventis Behring GmbH
Aventis Behring GmbH
Treatment of emphysema secondary to congenital alpha1 - antitrypsin deficieny
Treatment of emphysema secondary to congenital alpha 1- antitrypsin deficieny
02. 10. 2000 15. 03. 2001 23. 05. 2001 70 days
• 02.10.2000 • 15.03.2001 • 23.05.2001 • 70 days
Ziconotide (Intraspinal Use)
Ziconotide (Intraspinal Use)
Elan Pharma International Ltd
Elan Pharma International Ltd
Treatment of chronic pain requiring intraspinal analgesia
Treatment of chronic pain requiring intraspinal analgesia
04. 12. 2000 23. 02. 2001 23. 05. 2001 90 days
• 04.12.2000 • 23.02.2001 • 23.05.2001 • 90 days
Ramoplanin
• Ramoplanin
Biosearch Italia S. p. A
• Biosearch Italia S.p.A
Prevention of invasive infections due to Vancomycin resistant enterococci (VRE) in colonised
Prevention of invasive infections due to Vancomycin resistant
10. 08. 2000 23. 02. 2001
• 10.08.2000
28. 05. 2001 09. 07. 2001
• 28.05.2001
patients deemed at risk of infection
patients deemed at risk of infection
23. 05. 2001 90 days
• 23.05.2001 • 90 days
?
• 1,3-Propanedisulfonic acid, disodium salt (Fibrillex)
Quintiles Ltd
• Quintiles Ltd
Treatment of Systemic Secondary Amyloidosis
• Treatment of Systemic Secondary Amyloidosis
10. 10. 2000 13. 11. 2000 12. 06. 2001 116 days *
• 10.10.2000 • 13.11.2000 • 12.06.2001 • 116 days #
18. 06. 2001 31. 07. 2001
• 18.06.2001 • 31.07.2001
Seocalcitol
• Seocalcitol
Leo Pharmaceutical Products
Leo Pharmaceutical Products
Treatment of hepatocellular carcinoma
Treatment of hepatocellular carcinoma
05. 01. 2001 20. 04. 2001 12. 06. 2001 54 days
• 05.01.2001 • 20.04.2001 • 12.06.2001 • 54 days
Zinc acetate dihydrate
• Zinc acetate dihydrate
Treatment of Wilson’ s disease
Treatment of Wilson’s disease
02. 05. 2000 20. 04. 2001 12. 06. 2001 54 days
• 02.05.2000 • 20.04.2001 • 12.06.2001 • 54 days
Sinapultide, dipalmitoylphos - phatidylcholine, palmitoyl -
Sinapultide, dipalmitoylphos- phatidylcholine, palmitoyl-
Discovery Laboratories, Inc
Discovery Laboratories, Inc
Treatment of Meconium Aspiration Syndrome (MAS)
Treatment of Meconium Aspiration Syndrome (MAS)
27. 03. 2001 20. 04. 2001
• 27.03.2001 • 20.04.2001
25. 07. 2001 19. 09. 2001
• 25.07.2001 • 19.09.2001
oleoyl phosphatidylglyc - erol and palmitic acid (Surfaxin)
oleoyl phosphatidylglyc-erol and palmitic acid (Surfaxin)
18. 07. 2001 90 days
• 18.07.2001 • 90 days
Beraprost sodium
Beraprost sodium
Aventis Pharma SA
Aventis Pharma SA
21. 05. 2001 11. 06. 2001
• 11.06.2001
25. 07. 2001 18. 09. 2001
• 18.09.2001
18. 07. 2001 38 days
• 18.07.2001 • 38 days
Cladribine
Cladribine
Lipomed GmbH
• Lipomed GmbH
Treatment of indolent non- Hodgkin lymphoma
Treatment of indolent non- Hodgkin lymphoma
01. 03. 2001 20. 04. 2001 18. 07. 2001 90 days
• 20.04.2001 • 18.07.2001 • 90 days