natgillin/translations-raw huggingface dataset:
S01EX Reduction of elevated intraocular pressure in chronic open-angle
S01EX Reduction of elevated intraocular pressure in chronic open- angle glaucoma
• 26.12.2000 • 15.11.2001
26. 12. 2000 15. 11. 2001
glaucoma and ocular hypertension
and ocular hypertension
• 192 days • 127 days
192 days 127 days
• Arixtra • fondaparinux
Arixtra fondaparinux
• Sanofi-Synthelabo
Sanofi- Synthelabo
B01AE Prevention of venous thromboembolic events in
B01AE Prevention of venous thromboembolic events in patients undergoing major
• •
27. 02. 2001 13. 12. 2001
patients undergoing major orthopaedic surgery
orthopaedic surgery
• 205 days • 78 days
205 days 78 days
• •
(♦) Ilmaisee harvinaislääkkeeksi nimeämistä Säädöksen (EC) No 121/ 2000 mukaisesti.
• Quixidar • fondaparinux
69 Valmiste Merkin nimi
•
Myyntiluvan haltija
NV Organon
Hoitoalue ATC- koodi
• •
EMEA/ CPMP
B01AE Prevention of venous thromboembolic events in
Euroopan komissio
• 27.02.2001 • 13.12.2001
INN Osa A/ B
• •
Käyttöaihe
• Part B
Validointi Lausunto Aktiivinen aika Kellon pysäytys
patients undergoing major orthopaedic surgery
Lausunto saatu Päätöksen päivämäärä Ilmoituspäiväm äärä EYVL
• 205 Days • 78 Days
Quixidar Fondaparinux
• •
NV Organon
• Dynepo
B01AE
Aventis Pharma SA France
Part B
•
13. 12. 2001 205 Days 78 Days
B03XA
Dynepo
• 26.09.2000
Aventis Pharma SA France
•
B03XA
• epoetin delta
epoetin delta
•
13. 12. 2001
• 206 Days • 238 days
206 Days 238 days
• Vfend • Voriconazole • Part B
Vfend Voriconazole Part B
• Pfizer Ltd
Pfizer Ltd
• J02AC • Antifungal agent
J02AC Antifungal agent
• 28.11.2000 • 13.12.2001 • 203 days • 1 69 days
28. 11. 2000 13. 12. 2001 203 days 169 days
Annex 8 CVMP opinions in 2001 on medicinal products for veterinary use
70 Liite 8 CVMP: n lausunnot eläinlääkevalmisteista vuonna 2001
Product • Brand name • INN • Part A/B
Keskitetyt hakemukset Valmiste Merkin nimi INN Osa A/ B
Therapeutic area • Target species • Indication
Hoitoalue Kohde- eläinlaji Käyttöaihe
EMEA/CVMP • Validation • Opinion • Active time • Clock stop
EMEA/ CVMP Validointi Lausunto Aktiivinen aika Kellon pysäytys
European Commission • Opinion received • Date of decision • Notification • Official Journal
Euroopan komissio Lausunto saatu Päätöksen päivämäärä Ilmoituspäiväm äärä EYVL
• Poulflox • difloxacin • Part B
Poulflox Difloxacin Part B
• Virbac
Virbac
• Poultry • Antibacterial for systemic use
Poultry Antibacterial for systemic use
• 09.12.99 • 21.06.00 • 152 days • 43 days
09. 12. 99 21. 06. 00 152 days 43 days
• 21.07.00 • 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
• Intervet International
Intervet International
• 12.01.99 • 19.07.00 • 204 days • 336 days
204 days 336 days
• 18.08.00 • 13.11.00 • 20.11.00 • OJ C 2, 05.01.2001, p.
20. 11. 00 OJ C 2, 05. 01. 2001, p.
• Pruban • rescortol butyrate
Pruban Rescortol butyrate Part B
Dogs Anti-inflammatory for cutaneous inflammatory disorders
Dogs Anti- inflammatory for cutaneous inflammatory disorders
• 15.09.98 • 19.07.00
15. 09. 98 19. 07. 00 196 days
• 18.08.00 • 16.11.00
18. 08. 00 16. 11. 00 20. 11. 00
• 196 days • 477 days
477 days
• 20.11.00 • OJ C 2, 05.01.2001, p.
OJ C 2, 05. 01. 2001, p.
• Bayovac CSF Marker • live vaccine
Bayovac CSF Marker live vaccine Part A
• Bayer
Bayer
Pigs Marker vaccine against Classical Swine Fever
Pigs Marker vaccine against Classical Swine Fever
• 210 days • 309 days
16. 12. 98 19. 07. 00 210 days 309 days
• 06.02.01 • OJ C 53, 20.02.2001, p.
29. 11. 00 02. 02. 01 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 • Part B
Eurican Herpes 205 Inactivated
• Merial
Merial
• Dogs • Vaccine against canine herpes
Dogs Vaccine against canine herpes
• 13.07.99 • 08.11.00 • 209 days • 274 days
274 days
• 08.12.00 • 26.03.01 • 29.03.01 • OJ C 127, 27.04.2001, p.
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
• 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.
• Eurifel RCP-FelV • vaccine
71 Valmiste Merkin nimi INN Osa A/ B
• Merial
Myyntiluvan haltija
• •
Hoitoalue Kohde- eläinlaji Käyttöaihe
Cats Vaccine against feline rhinotracheitis, calcivirus,
EMEA/ CVMP Validointi Lausunto Aktiivinen aika Kellon pysäytys
• 19.12.00 • 05.12.01
Eurifel RCP FeLV
• •
Merial
• Part A
Cats
panleucopenia and leukaemiac
19. 12. 00
• 210 days
vaccine Part A
•
Vaccine against feline rhinotracheitis, calcivirus, panleucopenia and leukaemiac
• 141 days
05. 12. 01 210 days 141 days
Establishment of maximum residue limits for new substances
Uusien aineiden jäämien enimmäispitoisuuksien vahvistaminen Vaikuttavan aineen kansainvälinen yleisnimi (INN)
Therapeutic area • Target species
Hoitoalue Kohde- eläinlaji
European Commission • Opinion received • Date of regulation • Official Journal
Euroopan komissio Lausunto saatu Asetuksen päivämäärä EYVL
• Linear dodecyl benzene sulfonic acid
Linear dodecyl benzene sulfonic acid
• Bovine
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
• 16.03.01 • 30.07.01 • OJ L205, 31.07.2001, p.
16. 03. 01 30. 07. 01 OJ L205, 31. 07. 2001, p.
•
Euroopan komissio Lausunto saatu Asetuksen päivämäärä EYVL
• 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.
• 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)
Bronopol (extension)
• Salmonidae
Salmonidae
• 15.03.01 • 13.06.01 • 90 days •0
15. 03. 01 13. 06. 01 90 days 0
Annex 9 COMP opinions in 2001 on designation of orphan medicinal products
73 Liite 9 COMP: n harvinaislääkkeeksi nimeämistä koskevat lausunnot vuonna 2001 Valmisteen kansainvälinen yleisnimi (INN)
Product INN
Rahoittaja
EMEA/COMP • Validation • Opinion • Active time • Clock stop
EMEA/ COMP Validointi Lausunto Aktiivinen aika Kellon pysäytys
European Commission • Opinion received • Date of decision
Euroopan komissio Lausunto saatu Päätöksen päivämäärä
• 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
• 08.08.2000 • 22.09.2000 • 21.11.2000 • 61 days
08. 08. 2000 22. 09. 2000 21. 11. 2000 61 days
• Lusupultide
Lusupultide
• 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.
• 22.09.2000 • 19.12.2000 • 89 days
09. 08. 2000 22. 09. 2000 19. 12. 2000 89 days
•
03. 01. 2001 14. 02. 2001
• Orphan Europe Sarl
Orphan Europe Sarl
• 19.10.2000 • 19.12.2000 • 62 days
02. 05. 2000 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
Pharmacia Enterprises S.A
Pharmacia Enterprises S. A
• 19.10.2000 • 19.12.2000 • 62 days
11. 08. 2000 19. 10. 2000 19. 12. 2000 62 days
• 14.02.2001
03. 01. 2001 14. 02. 2001
• Bosentan
Bosentan
• Actelion Registration Ltd
Actelion Registration Ltd
Treatment of pulmonary arterial hypertension and chronic
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
• 19.10.2000
21. 08. 2000 19. 10. 2000 19. 12. 2000 62 days
• Ribavirin
Ribavirin
• ICN Pharmaceuticals Ltd
ICN Pharmaceuticals Ltd
• 19.10.2000 • 19.12.2000 • 62 days
06. 09. 2000 19. 10. 2000 19. 12. 2000 62 days
• Laronidase
Laronidase
• Genzyme B.V.
Genzyme B. V.
• 19.10.2000 • 19.12.2000 • 62 days
08. 09. 2000 19. 10. 2000 19. 12. 2000 62 days
• Imatinib mesylate
Imatinib mesylate
• Novartis Europharm Ltd
Novartis Europharm Ltd
• 19.10.2000 • 19.12.2000 • 62 days
03. 10. 2000 19. 10. 2000 19. 12. 2000 62 days
Product INN
74 Valmisteen kansainvälinen ylesinimi INN
Therapeutic area • ATC code • Indication
Käyttöaihe
European Commission • Opinion received • Date of decision
Euroopan komissio Lusunto saatu Päätöksen pävämäärä
• 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
• 02.05.2000
Ibuprofen
• 19.01.2001
Orphan Europe Sarl
of less than 34 weeks of
Prevention of patent ductus arteriosus in premature neonates of less than 34 weeks of gestational age
• 19.10.2000
02. 05. 2000 19. 10. 2000 15. 01. 2001 89 days
•
19. 01. 2001 05. 03. 2001
• 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
• 06.09.2000
Ribavirin
• 18.01.2001
ICN Pharmaceuticals Ltd
immunocompromised patients
Treatment of adenovirus infection in immunocompromised patients
• 19.10.2000 • 15.01.2001 • 89 days
06. 09. 2000 19. 10. 2000 15. 01. 2001 89 days
• 08.03.2001
18. 01. 2001 08. 03. 2001
• Ranpirnase
Ranpirnase
• Dr.
Dr.
• 22.12.2000 • 09.02.2001 • 50 days
20. 10. 2000 22. 12. 2000 09. 02. 2001 50 days
•
13. 02. 2001 29. 03. 2001
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
• 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
• 22.12.2000 • 09.02.2001 • 50 days
02. 10. 2000 22. 12. 2000 09. 02. 2001 50 days
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
Treatment of advanced idiopathic Parkinson’s disease with severe motor fluctuations and not responding to oral treatment
Treatment of advanced idiopathic Parkinson’ s disease with severe motor fluctuations and not responding to oral treatment.
• 04.10.2000 • 22.12.2000 • 20.03.2001 • 89 days
04. 10. 2000 22. 12. 2000 20. 03. 2001 89 days
•
26. 03. 2001 10. 05. 2001
Recombinant human C1-inhibitor
Recombinant human C1 - inhibitor
•
26. 03. 2001 11. 05. 2001
Treatment of angioedema caused by C1 inhibitor deficiency
Anti- HM1. 24 monoclonal antibody (AHM)
• 09.10.2000 • 22.12.2000 • 20.03.2001 • 89 days
Chugai Pharma Europe Ltd
• 26.03.2001 • 11.05.2001
Treatment of Multiple myeloma
•
08. 02. 2001 23. 02. 2001 20. 03. 2001 26 days
Product INN
75 Valmisteen kansainvälinen yleisnimi (INN)
• 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
Human engineered monoclonal antibody specific for Transforming Growth Factor β2
Human engineered monoclonal antibody specific for Transforming Growth Factor β2
• 18.12.2000 • 11.01.2001 • 10.04.2001 • 90 days
18. 12. 2000 11. 01. 2001 10. 04. 2001 90 days
Retroviral γc cDNA containing vector
Retroviral γc cDNA
•
11. 04. 2001
Génopoïétic S.A.
containing vector
•
23. 02. 2001 10. 04. 2001 47 days
•
30. 05. 2001
Human Milk Fat Globule 1 / Human Milk Fat Globule 1-
Human Milk Fat Globule 1 / Human Milk Fat Globule
• Antisoma plc
Antisoma plc
• Treatment of ovarian cancer
Treatment of ovarian cancer
• 04.12.2000
11. 04. 2001
• 11.04.2001
23. 02. 2001 10. 04. 2001
• 30.05.2001
30. 05. 2001
diethylenetriaminepentaacet ic acid for use with 90Yttrium
diethylenetriaminepentaac etic acid for use with 90 Yttrium
• 10.04.2001 • 47 days
47 days
• 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
Treatment of emphysema secondary to congenital alpha-1- antitrypsin deficiency
Recombinant human alpha- 1- antitrypsin (Respiratory Use)
• 06.12.2000 • 23.02.2001 • 10.04.2001 • 47 days
Treatment of emphysema secondary to congenital alpha- 1- antitrypsin deficiency
• 11.04.2001 • 30.05.2001
06. 12. 2000 23. 02. 2001 10. 04. 2001 47 days
• 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
Treatment of multiple myeloma
Thalidomide
• 28.05.2001 • 09.07.2001
Laboratoires LAPHAL
• Thalidomide
Treatment of multiple myeloma
• Laboratoires LAPHAL
01. 06. 2000 23. 02. 2001 23. 05. 2001 90 days
Treatment of graft-versus-host disease
Thalidomide
• 01.06.2000
Laboratoires LAPHAL
• 28.05.2001
Treatment of graft- versus- host disease
• 23.02.2001 • 23.05.2001 • 90 days
01. 06. 2000 23. 02. 2001 23. 05. 2001 90 days
Alpha1-Proteinase Inhibitor (Respiratory use)
Alpha1- Proteinase Inhibitor (Respiratory use)
Treatment of emphysema secondary to congenital alpha 1- antitrypsin deficieny
Treatment of emphysema secondary to congenital alpha1- antitrypsin deficieny
• 02.10.2000 • 15.03.2001 • 23.05.2001 • 70 days
02. 10. 2000 15. 03. 2001 23. 05. 2001 70 days
• 04.12.2000 • 23.02.2001 • 23.05.2001 • 90 days
04. 12. 2000 23. 02. 2001 23. 05. 2001 90 days
• 10.08.2000
Ramoplanin
• 28.05.2001
Biosearch Italia S. p. A
enterococci (VRE) in colonised
Prevention of invasive infections due to Vancomycin resistant enterococci (VRE) in colonised patients deemed at risk of infection
• 23.02.2001
10. 08. 2000 23. 02. 2001 23. 05. 2001
• 23.05.2001 • 90 days
28. 05. 2001 09. 07. 2001
Product INN
76 90 days Valmisteen kansainvälinen yleisnimi (INN)
• 1,3-Propanedisulfonic acid, disodium salt (Fibrillex)
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
•
05. 01. 2001 20. 04. 2001 12. 06. 2001 54 days
Treatment of Wilson’s disease
Zinc acetate dihydrate
• 02.05.2000 • 20.04.2001 • 12.06.2001 • 54 days
Treatment of Wilson’ s disease
• 18.06.2001 • 31.07.2001
02. 05. 2000 20. 04. 2001 12. 06. 2001 54 days
Sinapultide, dipalmitoylphos- phatidylcholine, palmitoyl-
Treatment of Meconium Aspiration Syndrome (MAS)
•
27. 03. 2001 20. 04. 2001 18. 07. 2001
•
25. 07. 2001 19. 09. 2001
oleoyl phosphatidylglyc-erol and palmitic acid (Surfaxin)
erol and palmitic acid (Surfaxin)
• 18.07.2001 • 90 days
90 days
•
21. 05. 2001
•
25. 07. 2001
thromboembolic pulmonary
thromboembolic pulmonary hypertension
• 18.09.2001
11. 06. 2001 18. 07. 2001 38 days
•
18. 09. 2001
• Lipomed GmbH
Lipomed GmbH
• 18.09.2001
01. 03. 2001 20. 04. 2001 18. 07. 2001 90 days
•
25. 07. 2001 18. 09. 2001
• Genzyme BV
Genzyme BV
•
26. 02. 2001 11. 06. 2001 18. 07. 2001 38 days
Dompé s.p.a.
Dompé s. p. a.
•
05. 04. 2001 20. 04. 2001 18. 07. 2001 90 days
• 05.04.2001
25. 07. 2001 19. 09. 2001
• 25.07.2001
Porcine lung surfactant
• 20.04.2001 • 18.07.2001 • 90 days
Leo Pharmaceutical Products
• Porcine lung surfactant
Treatment of Acute Lung Injury
•
23. 05. 2001 11. 06. 2001 18. 07. 2001 38 days
• Dexrazoxane
Dexrazoxane
• TopoTarget A/S
TopoTarget A/ S
•
24. 05. 2001 11. 06. 2001 18. 07. 2001 38 days
• 25.05.2001
Pemetrexed disodium
• 25.07.2001
Eli Lilly Nederland B. V.
• 11.06.2001 • 18.07.2001 • 54 days
Treatment of malignant mesothelioma
•
25. 05. 2001 11. 06. 2001 18. 07. 2001 54 days
•
25. 07. 2001 17. 09. 2001
# Includes time for appeal
* Sisältää valitusajan
Product INN
77 Valmisteen kansainvälinen yleisnimi (INN)
• Idebenone
- {} -- {} -- {} -
• Laboratoires Takeda
Voisin Consulting SARL
• Treatment of Friedreich’s ataxia
Treatment of chronic lymphocytic leukaemia
•
23. 05. 2001 30. 07. 2001 07. 09. 2001 40 days
• 13.07.2001
17. 09. 2001 20. 11. 2001
• 17.09.2001
Laboratoires Takeda
• 30.07.2001 • 07.09.2001 • 40 days
Treatment of Friedreich’ s ataxia
• 20.11.2001
12. 07. 2001 30. 07. 2001 07. 09. 2001 40 days
•
17. 09. 2001 20. 11. 2001
Treatment of Familial Adenomatous Polyposis (FAP)
Treatment of malignant gastrointestinal stromal tumours
• 04.04.2001
13. 07. 2001 30. 07. 2001 07. 09. 2001 40 days
• 17.09.2001
17. 09. 2001 20. 11. 2001
• 11.06.2001 • 07.09.2001 • 89 days
Treatment of Familial Adenomatous Polyposis (FAP)
• 20.11.2001
04. 04. 2001 11. 06. 2001 07. 09. 2001 89 days
• S.L.A Pharma (UK) Ltd
S. L. A Pharma (UK) Ltd
•
29. 09. 2001 11. 06. 2001 07. 09. 2001 89 days
• Pharmion Ltd
Pharmion Ltd
•
13. 07. 2001 30. 07. 2001 07. 09. 2001 40 days
• 13.07.2001
Thalidomide
• 17.09.2001
Pharmion Ltd
reactions
Treatment of erythema nodosum leprosum (ENL) or type II lepra reactions
• 25.05.2001
Abetimus sodium
• 17.09.2001
ICON Clinical Research UK Ltd
• 11.06.2001 • 07.09.2001 • 89 days
Treatment of lupus nephritis
• 20.11.2001
25. 05. 2001 11. 06. 2001 07. 09. 2001 89 days
Deoxyribose phosphorothioate (5’-
Deoxyribose phosphorothioate (5 ’ - tct - ccc- agc- gtg- cgc- cat- 3 ’)
• Voisin Consulting SARL
Voisin Consulting SARL
• 20.11.2001
23. 05. 2001 30. 07. 2001 07. 09. 2001 40 days
• NeuTec Pharma plc
NeuTec Pharma plc
•
11. 04. 2001 11. 06. 2001 07. 09. 2001 89 days
•
17. 09. 2001 05. 12. 2001
• 25.05.2001
Apomorphine
• 17.09.2001
Orion Corporation
responding to other oral
Treatment of off- periods in Parkinson’ s disease not responding to other oral treatment
• 11.06.2001
25. 05. 2001 11. 06. 2001 07. 09. 2001 89 days
• 05.12.2001
17. 09. 2001 05. 12. 2001
• Stiripentol
Stiripentol
• Laboratoires BIOCODEX
Laboratoires BIOCODEX
• 04.06.2001
04. 06. 2001 30. 07. 2001 07. 09. 2001 40 days
• 17.09.2001
17. 09. 2001 05. 12. 2001
• 30.07.2001 • 07.09.2001 • 40 days
78 Valmisteen kansainvälinen yleisnimi (INN)
• 05.12.2001
Rahoittaja
•
Käyttöaihe
• PPD Global Ltd
PPD Global Ltd
• Treatment of systemic sclerosis
Treatment of systemic sclerosis
• 12.07.2001
12. 07. 2001
• 05.11.2001
05. 11. 2001
• 11.12.2001
30. 07. 2001 26. 10. 2001 89 days
58 EMEA Annual Report 2001
11. 12. 2001
• Denileukin diftitox (Onzar)
Denileukin diftitox (Onzar)
• Ligand Pharmaceuticals
Ligand Pharmaceuticals
• Treatment of cutaneous T-cell Lymphoma
Treatment of cutaneous T- cell Lymphoma
•
12. 07. 2001 30. 07. 2001 26. 10. 2001 89 days
•
05. 11. 2001 11. 12. 2001
•
20. 07. 2001 24. 08. 2001 26. 10. 2001 64 days
gly2-Recombinant human glucagon-like peptide
gly2- Recombinant human glucagon- like peptide
•
09. 08. 2001 24. 08. 2001 26. 10. 2001 64 days
• Iduronate-2-sulfatase
Iduronate- 2- sulfatase
• TKT UK Ltd
TKT UK Ltd
•
05. 09. 2001 20. 09. 2001 26. 10. 2001 37 days
• 05.09.2001
05. 11. 2001 11. 12. 2001
• 05.11.2001
Thalidomide
(Hunter Syndrome)
Kendle International Ltd
• 20.09.2001 • 26.10.2001 • 37 days
Treatment of multiple myeloma
• 11.12.2001
23. 05. 2001
• Thalidomide
17. 09. 2001
•
30. 07. 2001 07. 09. 2001 40 days
•
19. 12. 2001
Treatment of acute lung injury
♣
•† •†
♣
•† •†
Treatment of acute lung injury
•
27. 03. 2001 24. 08. 2001 21. 11. 2001 90 days
• 29.05.2001
♣
•†
♣
microsporidial infection
Treatment of diarrhoea associated with intestinal microsporidial infection
•
29. 05. 2001 20. 09. 2001 21. 11. 2001 63 days
•† •†
Treatment of acute lymphoblastic leukaemia
•
09. 08. 2001 24. 08. 2001 21. 11. 2001 90 days
Treatment of systemic sclerosis
♣
•† •†
Treatment of systemic sclerosis
•
28. 08. 2001 20. 09. 2001 21. 11. 2001 62 days
• 04.09.2001
♣
ganciclovir sodium
Treatment of high- grade glioma with subsequent use of ganciclovir sodium
•
04. 09. 2001 20. 09. 2001 21. 11. 2001 62 days
† Awaiting adoption of European Commission decision
♣ Euroopan komissio ei vielä ole tehnyt päätöstä
Product INN
79 Valmisteen kansainvälinen yleisnimi (INN)
Indication
Käyttöaihe Treatment of myelodysplastic
• Treatment of Pseudomonas aeruginosa lung infection
syndromes
• 06.09.2001
05. 09. 2001 20. 09. 2001 21. 11. 2001 62 days
• 18.12.2001 • 54 days
Treatment of glioma
•
12. 10. 2001 26. 10. 2001 18. 12. 2001 54 days
Treatment of Familial Adenomatous Polyposis (FAP)
Treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic fibrosis
• 09.08.2001
06. 09. 2001 26. 10. 2001 18. 12. 2001 54 days
•† •†
Treatment of Familial Adenomatous Polyposis (FAP).
•
09. 08. 2001 26. 10. 2001 18. 12. 2001 54 days
Treatment of high-grade dysplasia in Barrett’s Esophagus
Treatment of high- grade dysplasia in Barrett’ s Esophagus
• 11.10.2001
11. 10. 2001 26. 10. 2001 18. 12. 2001 54 days
† Awaiting adoption of European Commission decision 60 EMEA Annual Report 2001
♣ Euroopan komissio ei vielä ole tehnyt päätöstä
Annex 10 Guidelines and working documents in 2001
80 Liite 10 Ohjeet ja työasiakirjat vuonna 2001
CPMP Biotechnology Working Party
CPMP: n bioteknologian työryhmä
CPMP/BWP/269/95 Rev.
Viitenumero CPMP/ BWP/ 269/ 95 Rev.
Note for guidance on plasma-derived medicinal products
Asiakirjan nimi Note for guidance on plasma- derived medicinal products