natgillin/translations-raw huggingface dataset:
Solution for injection 5 mg/ ml 1
Solution for injection 5 mg/ml 1
- 12. 01. 1999 - 10. 11. 1999 - 210 days - 92 days
- 12.01.1999 - 10.11.1999 - 210 days - 92 days
- 10. 12. 1999 - 24. 03. 2000 - 27. 03. 2000 - OJ C 120, 28. 04. 2000
10.12.1999 24.03.2000 27.03.2000 OJ C 120, 28.04.2000
Incurin Oestriol Part B
Incurin Oestriol Part B
Intervet Internation al NL
Intervet International NL
Dogs Hormone - dependent urinary incontinence (QG03CA04)
Dogs Hormone-dependent urinary incontinence (QG03CA04)
Scored tablets 1 mg 1
Scored tablets 1 mg 1
- 14. 07. 1998 - 08. 12. 1999 - 210 days - 302 days
- 14.07.1998 - 08.12.1999 - 210 days - 302 days
- 07. 01. 2000 - 24. 03. 2000 - 29. 03. 2000 - OJ C 120, 28. 04. 2000
07.01.2000 24.03.2000 29.03.2000 OJ C 120, 28.04.2000
Rabigen SAG2 Live vaccine Part A
Rabigen SAG2 Virbac Live vaccine F Part A
Foxes Vaccine against rabies (QJ57HA)
Foxes Vaccine against rabies (QJ57HA)
Liquid within a blister pack embedded in a bait 8 log 10 CCID50 2
Liquid within a blister pack embedded in a bait 8 log 10 CCID50 2
- 23. 03. 1998 - 08. 12. 1999 - 196 days - 428 days
- 23.03.1998 - 08.12.1999 - 196 days - 428 days
- 07. 01. 2000 - 06. 04. 2000 - 10. 04. 2000 - OJ C 120, 28. 04. 2000
07.01.2000 06.04.2000 10.04.2000 OJ C 120, 28.04.2000
Eurifel FeLV Live vaccine Part A
Eurifel FeLV Live vaccine Part A
Cats Vaccine against feline leukaemis (QJ57BA04)
Cats Vaccine against feline leukaemis (QJ57BA04)
Pellet plus diluent 1 ml 3
Pellet plus diluent 1 ml 3
- 12. 01. 1999 - 08. 12. 1999 - 183 days - 120 days
- 12.01.1999 - 08.12.1999 - 183 days - 120 days
- 14. 07. 1998 - 13. 10. 1999 - 210 days - 246 days
- - - -
- 12. 11. 1999 - 09. 06. 2000 - 14. 06. 2000 - OJ C 183, 30. 06. 2000
12.11.1999 09.06.2000 14.06.2000 OJ C 183, 30.06.2000
Ibaflin Ibafloxacin Part B
Ibaflin Ibafloxacin Part B
Dogs Pyoderma (QG51AC)
Dogs Pyoderma (QG51AC)
Tablet 150 & 300mg 1
Tablet 150 & 300mg 1
- 12. 01. 1999 - 09. 02. 2000 - 210 days - 184 days
- 12.01.1999 - 09.02.2000 - 210 days - 184 days
- 10. 03. 2000 - 13. 06. 2000 - 15. 06. 2000 - OJ C 183, 30. 06. 2000
10.03.2000 13.06.2000 15.06.2000 OJ C 183, 30.06.2000
Metacam Meloxicam Part B (extension)
Metacam Meloxicam Part B (extension)
Dogs Post- operative pain (QM01AC06)
Dogs Post-operative pain (QM01AC06)
Solution for injection 5mg/ ml 1
Solution for injection 5mg/ml 1
- 02. 01. 2000 - 19. 04. 2000 - 101 days - 7 days
- 02.01.2000 - 19.04.2000 - 101 days - 7 days
- 28. 04. 2000 - 15. 09. 2000 - 18. 09. 2000 - OJ C 277, 29. 09. 2000
28.04.2000 15.09.2000 18.09.2000 OJ C 277, 29.09.2000
Econor Valnemulin Part B (extension)
Econor Valnemulin Part B (extension)
Novartis A
Novartis A
Pigs Prevention & treatment of dysentery (QJ01XX94)
Pigs Prevention & treatment of dysentery (QJ01XX94)
0. 5% premix various 2
0.5% premix various 2
- 10. 08. 1999 - 19. 04. 2000 - 210 days - 43 days
- 10.08.1999 - 19.04.2000 - 210 days - 43 days
- 19. 05. 2000 - 15. 09. 2000 - 20. 09. 2000 - OJ C 308, 27. 10. 2000
19.05.2000 15.09.2000 20.09.2000 OJ C 308, 27.10.2000
Econor Valnemulin Part B extension EMEA/ MB/ 050/ 00
Econor Valnemulin Part B extension
Pigs Prevention / treatment of dysentery and treatment/ control of
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
10% / 50% premix various 2
10%/50% premix various 2
- 12. 10. 1999 - 08. 03. 2000 - 148 days - 0
- 12.10.1999 - 08.03.2000 - 148 days -0
- Dosis
- - - -
- Dato for afgørelsen
07.04.2000 15.09.2000 20.09.2000 OJ No.
- Del A/ B
308, 27.10.2000
- Antal præsentationer
Econor Valnemulin Part B (extension)
- Nettotid
Novartis A
enzootic pneumonia (QJ01XX94)
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
EMEA/ MB/ 050/ 00 Årsberetning 2000
10%/50% premix various 2
Lægemiddel Firma - - Navn Handelsnavn
- 12.10.1999 - 08.03.2000 - 148 days -0
Præsentation - Form
- - - -
EMEA/ CVMP - Godkendelse
07.04.2000 15.09.2000 22.09.2000 OJ C 308, 27.10.2000
Kommissionen - Udtalelse modtaget
78 EMEA General Report 2000
- INN - Oprindelse
Product - Brandname - INN - Part A/B
- Indikation
Company - Name - Origin
- Udtalelse
Therapeutic area - Target species - Indication
- Dato for afgørelsen
Presentation - Form - Dosage - Number of presentations
- Antal præsentationer
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
- Dato for meddelelsen
Commission - Opinion received - Date of Decision - Notification - Official Journal
Econor Novartis Valnemulin A Part B (extension)
Dicural Difloxacin Part B (extension)
Dicural Fort Dodge Difloxacin Animal Part B Health (extension) NL
Fort Dodge Animal Health NL
Cattle & pigs Antibacterial for systemic use (QJ01MA)
Cattle & pigs Antibacterial for systemic use (QJ01MA)
Solution for injection 50 mg/ ml 3
Solution for injection 50 mg/ml 3
- 16. 12. 1998 - 21. 06. 2000 - 203 days - 351 days
- 16.12.1998 - 21.06.2000 - 203 days - 351 days
- 21. 07. 2000 - 24. 10. 2000 - 25. 10. 2000 - OJ C 337, 28. 11. 2000
21.07.2000 24.10.2000 25.10.2000 OJ C 337, 28.11.2000
Poulflox Virbac Difloxacin S. A.
Poulflox Difloxacin Part B
Part B F
F
Poultry Antibacterial for systemic use QJ01MA94)
Poultry Antibacterial for systemic use (QJ01MA94)
Oral solution 100 mg/ ml 3
Oral solution 100 mg/ml 3
- 09. 12. 1999 - 21. 06. 2000 - 152 days - 43 days
- 09.12.1999 - 21.06.2000 - 152 days - 43 days
- 21. 07. 2000 - 16. 11. 2000 - OJ C 2, 05. 01. 2001
- 21.07.2000 - 16.11.2000 - OJ C 2, 05.01.2001
Bayovac CSF Bayer Marker D Live vaccine Part A
Bayovac CSF Marker Live vaccine Part A
Pigs Marker vaccine against Classical Swine Fever (QJ57EA)
Pigs Marker vaccine against Classical Swine Fever (QJ57EA)
Emulsion for injection E2 glycoprotein of Classical Swine Fever virus 4
Emulsion for injection E2 glycoprotein of Classical Swine Fever virus 4
- 16. 12. 1998 - 19. 07. 2000 - 210 days - 309 days
- 16.12.1998 - 19.07.2000 - 210 days - 309 days
- 07. 08. 2000
- 07.08.2000
Porcilis AR - Intervet T- DF Internation Inactivated al vaccine NL Part A
Porcilis AR -T- DF Inactivated vaccine Part A
Pigs Vaccine against atrophic rhinitis (QJ57EA)
Pigs Vaccine against atrophic rhinitis (QJ57EA)
Suspension for injection 2 ml 2
Suspension for injection 2 ml 2
- 12. 01. 1999 - 19. 07. 2000 - 204 days - 336 days
- 12.01.1999 - 19.07.2000 - 204 days - 336 days
- 18. 08. 2000 - 16. 11. 2000 - OJ C 2, 05. 01. 2001
- 18.08.2000 - 16.11.2000 - OJ C 2, 05.01.2001
Pruban Intervet Rescortol Internation butyrate al Part B NL
Pruban Rescortol butyrate Part B
Dogs Anti- inflammatory for cutaneous inflammatory disorders (QD07AC90)
Dogs Anti-inflammatory for cutaneous inflammatory disorders (QD07AC90)
Cream 1 mg/ g 1
Cream 1 mg/g 1
- 15. 09. 1998 - 19. 07. 2000 - 196 days - 477 days
- 15.09.1998 - 19.07.2000 - 196 days - 477 days
Pirsue Pharmacia Pirlimycin Upjohn Part B B
Pirsue Pirlimycin Part B
Dairy cattle Clinical & sub - clinical mastitis (QJ51FF90)
Dairy cattle Clinical & sub-clinical mastitis (QJ51FF90)
Sterile solution for intramammary use 5 mg/ ml 4
Sterile solution for intramammary use 5 mg/ml 4
- 12. 01. 1999 - 11. 10. 2000 - 210 days - 428 days
- 12.01.1999 - 11.10.2000 - 210 days - 428 days
- 10. 11. 2000
- 10.11.2000
Zubrin Schering - Tepoxalin Plough Part B UK
Zubrin Tepoxalin Part B
Dogs Treatment of pain & inflammation
Dogs Treatment of pain & inflammation
Oral lyophilisate 30, 50, 100 & 200 mg/ ml 39
Oral lyophilisate 30,50,100 & 200 mg/ml 39
- 18. 05. 1999 - 08. 11. 2000 - 210 days - 330 days
- 18.05.1999 - 08.11.2000 - 210 days - 330 days
- 08. 12. 2000
- 08.12.2000
Eurican Merial herpes 205 F Inactivated vaccine Part B
Eurican herpes 205 Inactivated vaccine Part B
Dogs Vaccine against canine herpes
Dogs Vaccine against canine herpes
Powder plus solvent for emulsion for injection 1 ml 2
Powder plus solvent for emulsion for injection 1 ml 2
- 13. 07. 1999 - 08. 11. 2000 - 209 days - 274 days
- 13.07.1999 - 08.11.2000 - 209 days - 274 days
- 08. 12. 2000
79 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Årsberetning 2000 Fastsættelse af maksimalgrænseværdier for restkoncentrationer
Establishment of maximum residue limits for new substances
i nye stoffer
Substance - INN
Side 82/ 93
Therapeutic area - Target species
Stof Behandlingsområde EMEA/ CVMP - INN - Målarter - Godkendelse - Udtalelse - Nettotid - Urstop
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
Kommissionen - Sendt til Kommissionen - Dato for vedtagelse af forordningen - EFT nr.
Commission - Sent to Commission - Date of Regulation - Official Journal
Bismuth subnitrate Bovine - 18. 06. 1999 (extension) - 13. 10. 1999 - 113 days - 0
- 18.06.1999 - 13.10.1999 - 113 days -0
- 12. 11. 1999 - 19. 06. 2000 - OJ L 145, 20. 06. 2000
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
Acetyl isovaleryl Porcine - 18. 10. 1995 tylosin tartrate - 13. 10. 1999 - 195 days - 1260 days
Acetyl isovaleryl tylosin tartrate
Methylprednisolone Bovine - 13. 07. 1999 - 13. 10. 1999 - 92 days - 0
- 13.07.1999 - 13.10.1999 - 92 days -0
Deltamethrin Fin fish - 09. 12. 1999 (extension) - 08. 03. 2000 - 90 days - 0
- 09.12.1999 - 08.03.2000 - 90 days -0
- 07. 04. 2000 - 15. 09. 2000 - OJ L 234, 16. 09. 2000
- 07.04.2000 - 15.09.2000 - OJ L 234, 16.09.2000
Tylosin Eggs - 09. 11. 1999 (extension) - 08. 03. 2000 - 90 days - 0
- 09.11.1999 - 08.03.2000 - 90 days -0
Dicyclanil Ovine - 25. 02. 1997 - 08. 03. 2000 - 281 days - 825 days
25.02.1997 - 08.03.2000 - 281 days - 825 days
Tilmicosin Rabbit - 16. 07. 1999 (extension) - 13. 10. 1999 - 86 days - 0
- 16.07.1999 - 13.10.1999 - 86 days -0
- 12. 11. 1999 - 20. 10. 2000 - OJ L 269, 21. 10. 2000
- 12.11.1999 - 20.10.2000 - OJ L 269, 21.10.2000
Flumequine Bovine milk & turkey - 27. 07. 1999 (extension) - 10. 11. 1999 - 89 days - 0
Bovine milk & turkey
- 09. 12. 1999 - 20. 10. 2000 - OJ L 269, 21. 10. 2000
- 09.12.1999 - 20.10.2000 - OJ L 269, 21.10.2000
Tiamulin Rabbit - 14. 10. 1999 (extension) - 12. 01. 2000 - 90 days - 0
- 14.10.1999 - 12.01.2000 - 90 days -0
- 11. 02. 2000 - 20. 10. 2000 - OJ L 269, 21. 10. 2000
- 11.02.2000 - 20.10.2000 - OJ L 269, 21.10.2000
Dicyclanil Sheep fat - 23. 02. 2000 (modification) - 17. 05. 2000 - 84 days - 0
- 23.02.2000 - 17.05.2000 - 84 days -0
- 16. 06. 2000 - 27. 10. 2000 - OJ L 276, 28. 10. 2000
- 16.06.2000 - 27.10.2000 - OJ L 276, 28.10.2000
Butafosfan Dairy cattle - 19. 01. 2000 (extension) - 19. 04. 2000 - 90 days - 0
- 19.01.2000 - 19.04.2000 - 90 days -0
- 19. 05. 2000 - 27. 10. 2000 - OJ L 276, 28. 10. 2000
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
Tilmicosin Bovine milk - 22. 02. 1999 (extension) - 19. 04. 2000 - 203 days - 210 days
- 22.02.1999 - 19.04.2000 - 203 days - 210 days
Phoxim Ovine - 19. 01. 2000 (extension) - 19. 04. 2000 - 90 - 0
Phoxim (extension)
- 19. 05. 2000 - 27. 10. 2000 - OJ L 276, 28. 10. 2000
Ovine
Flumethrin Ovine - 19. 01. 2000 (extension) - 19. 04. 2000 - 90 days - 0
- 19.01.2000 - 19.04.2000 - 90 -0
Flunixin Equine - 23. 03. 2000 (extension) - 21. 06. 2000 - 90 days
80 EMEA General Report 2000
- 21. 07. 2000 - 29. 12. 2000 - OJ L 336, 30. 12. 2000
Substance - INN
EMEA/ MB/ 050/ 00 Årsberetning 2000
Therapeutic area - Target species
-
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
Side 83/ 93
Commission - Sent to Commission - Date of Regulation - Official Journal
EMEA/ MB/ 050/ 00 Årsberetning 2000
Flumethrin (extension)
Side 84/ 93
Ovine
Stof - INN
- 19.01.2000 - 19.04.2000 - 90 days -0
Behandlingsområde - Målarter
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
EMEA/ CVMP - Godkendelse - Udtalelse - Nettotid - Urstop
- 23.03.2000 - 21.06.2000 - 90 days -0
Kommissionen - Sendt til Kommissionen - Dato for vedtagelse af forordningen - EFT nr.
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
Toltrazuril (extension)
Toltrazuril (extension)
Porcine
Porcine
- 16. 02. 1999 - 21. 06. 2000 - 206 days - 284 days
- 16.02.1999 - 21.06.2000 - 206 days - 284 days
- 21. 07. 2000 - 29. 12. 2000 - OJ L 336, 30. 12. 2000
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
Thiamphenicol (extension)
Thiamphenicol (extension)
Porcine, Ovine, Turkey, Fish
Porcine, Ovine, Turkey, Fish
- 15. 05. 1998 - 21. 06. 2000 - 206 days - 562 days
- 15.05.1998 - 21.06.2000 - 206 days - 562 days
- 08. 11. 2000
- 08.11.2000
Difloxacin (extension)
Difloxacin (extension)
Bovine, Porcine
Bovine, Porcine
- 14. 07. 1998 - 21. 06. 2000 - 205 days - 503 days
- 14.07.1998 - 21.06.2000 - 205 days - 503 days
Bovine
Bovine
- 10. 12. 1996 - 21. 06. 2000 - 281 days - 1008 days
- 10.12.1996 - 21.06.2000 - 281 days - 1008 days
Linear dodecyl benzene sulfonic acid
Linear dodecyl benzene sulfonic acid
- 22. 01. 1999 - 19. 07. 2000 - 195 days - 321 days
- 22.01.1999 - 19.07.2000 - 195 days - 321 days
- 18. 08. 2000
- 18.08.2000
Phoxim (extension)
Phoxim (extension)
Ovine
Ovine
- 19. 01. 2000 - 19. 07. 2000 - 120 days - o
- 19.01.2000 - 19.07.2000 - 120 days -0
Acetyl isovaleryl tylosin tartrate
Acetyl isovaleryl tylosin tartrate
- 18. 01. 1995 - 13. 09. 2000 - 274 days - 1790 days
- 18.01.1995 - 13.09.2000 - 274 days - 1790 days
- 18. 02. 2000
- 18.02.2000
Florfenicol (extension)
Florfenicol (extension)
Fish
Fish
- 29. 01. 1996 - 11. 11. 2000 - 212 days - 1504 days
- 29.01.1996 - 11.11.2000 - 212 days - 1504 days
Meloxicam (extension)
Meloxicam (extension)
- 07. 09. 2000 - 06. 12. 2000 - 90 days - 0 days
- 07.09.2000 - 06.12.2000 - 90 days - 0 days
- 04. 01. 2001
- 04.01.2001
Tilmicosin z( extension)
Tilmicosin z(extension)
Turkey
Turkey
EMEA/ MB/ 050/ 00 Årsberetning 2000 Bilag 10 COMP- udtalelser i 2000 om lægemidler til sjældne sygdomme
81 EMEA General Report 2000
Side 85/ 93
Annex 10:
Sponsor
Sponsor
EMEA/ COMP - Indgivelse - Godkendelse - Udtalelse - Nettotid
EMEA/COMP - Submission - Validation - Opinion - Active time
Kommissionen - Udtalelse modtaget - Dato for udpegelse
Commission - Opinion received - Date of Designation
Ares- Serono (Europe) Ltd
Ares-Serono (Europe) Ltd
AIDS- wasting
AIDS-wasting
- 28. 04. 2000 - 15. 06. 2000 - 11. 07. 2000 - 27 days
- 28.04.2000 - 15.06.2000 - 11.07.2000 - 27 days
- 17. 07. 2000 - 08. 08. 2000
- 17.07.2000 - 08.08.2000
Alpha- Galactosidase A
Alpha - Galactosidase A
TKT Europe- 5S AB
TKT Europe- 5S AB
Treatment of Fabry disease
Treatment of Fabry disease
- 03. 05. 2000 - 15. 06. 2000 - 11. 07. 2000 - 27 days
- 03.05.2000 - 15.06.2000 - 11.07.2000 - 27 days
Genzyme BV
Genzyme BV
- 12. 05. 2000 - 15. 06. 2000 - 11. 07. 2000 - 27 days
- 12.05.2000 - 15.06.2000 - 11.07.2000 - 27 days
Fluorouracil
Fluorouracil
Ethypharm S. A.
Ethypharm S.A.
Treatment of glioblastoma
Treatment of glioblastoma
- 26. 05. 2000 - 31. 07. 2000 - 13. 09. 2000 - 45 days
- 26.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
- 18. 09. 2000 - 18. 10. 2000
- 18.09.2000 - 18.10.2000
Gemtuzumab ozogamicin
Gemtuzumab ozogamicin
Wyeth- Ayerst Research
Wyeth-Ayerst Research
Treament of acute myeloid leukaemia
Treament of acute myeloid leukaemia
- 07. 06. 2000 - 31. 07. 2000 - 13. 09. 2000 - 45 days
- 07.06.2000 - 31.07.2000 - 13.09.2000 - 45 days
1, 5 - (Butylimino) - 1, 5- dideoxy, D - glucitol
1,5 -(Butylimino)- 1,5-dideoxy, D-glucitol
Oxford GlycoSciences Ltd
Oxford GlycoSciences Ltd
Treatment of Gaucher disease
Treatment of Gaucher disease
N- carbamyl- L - glutamic acid
N -carbamyl-L- glutamic acid
Orphan Europe Sarl
Orphan Europe Sarl
Treatment of N- acetylglutamate synthetase (NAGS) deficiency
Treatment of N-acetylglutamate synthetase (NAGS) deficiency
- 02. 05. 2000 - 31. 07. 2000 - 13. 09. 2000 - 45 days
- 02.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
Arsenic trioxide
Arsenic trioxide
Treatment of acute promyelocytic leukaemia
Voisin Consulting Treatment of acute promyelocytic leukaemia Sarl
- 08. 05. 2000 - 15. 06. 2000 - 13. 09. 2000 - 90 days
- 08.05.2000 - 15.06.2000 - 13.09.2000 - 90 days
Thalidomide
Thalidomide
Laboratoires LAPHAL
Laboratoires LAPHAL
Treatment of erythema nodosum leprosum or type II reactions in Hansen’ s disease
Treatment of erythema nodosum leprosum or type II reactions in Hansen's disease
- 01. 06. 2000 - 25. 08. 2000 - 27. 10. 2000 - 64 days
- 01.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
- 6. 11. 2000 - 29. 12. 2000
- 6.11.2000 - 29.12.2000
Anagrelide hydrochloride
Anagrelide hydrochloride
Shire Pharmaceutical Development Ltd
Shire Pharmaceutical Development Ltd
Treatment of essential thrombocythaemia
Treatment of essential thrombocythaemia
- 31. 05. 2000 - 31. 07. 2000 - 27. 10. 2000 - 89 days
- 31.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
Busulfan (intravenous use)
Busulfan (intravenous use)
Pierre Fabre Médicament
Pierre Fabre Médicament
Intravenous conditioning treatment prior to hematopoietic progenitor cell transplantation
Intravenous conditioning treatment prior to hematopoietic progenitor cell transplantation
- 09. 06. 2000 - 31. 07. 2000 - 27. 10. 2000 - 89 days
- 09.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
Nitisinone
Nitisinone
Swedish Orphan AB
Swedish Orphan AB
Treatment of tyrosinaemia type 1
Treatment of tyrosinaemia type 1
- 05. 06. 2000 - 25. 08. 2000 - 27. 10. 2000 - 64 days
- 05.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
Ethyl eicosopentaenoate
Ethyl eicosopentaenoate
Laxdale Ltd
Laxdale Ltd
Treatment of Huntington’ s disease
Treatment of Huntington's disease
- 05. 06. 2000 - 31. 07. 2000 - 27. 10. 2000 - 89 days
- 05.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
Iloprost
Iloprost
Schering AG
Schering AG
Treatment of primary and of the following forms of secondary pulmonary hypertension: connective tissue disease pulmonary hypertension, drug- induced pulmonary hypertension, portopulmonary hypertension, pulmonary hypertension associated with congenital heart disease and chronic thromboembolic pulmonary hypertension
Treatment of primary and of the following forms of secondary pulmonary hypertension: connective tissue disease pulmonary hypertension, drug -induced pulmonary hypertension, portopulmonary hypertension, pulmonary hypertension associated with congenital heart disease and chronic thromboembolic pulmonary hypertension
- 10. 05. 2000 - 31. 07. 2000 - 27. 10. 2000 - 89 days
- 10.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
...
-
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
Side 86/ 93
- -
Lægemiddel
Treatment of acute promyelocytic leukaemia
Sponsor
- 08.08.2000
Indikation
-
EMEA/ COMP - Indgivelse - Godkendelse - Udtalelse - Nettotid
- 22.09.2000
Kommissionen - Udtalelse modtaget - Dato for udpegelse
- 21.11.2000
...
- 61 days
...
- -
Treatment of acute promyelocytic leukaemia
Treatment of acute respiratory distress syndrome
- 08. 08. 2000 - 22. 09. 2000 - 21. 11. 2000 - 61 days
- 01.09.2000
...
- 22.09.2000
...
- 21.11.2000
- 01. 09. 2000 - 22. 09. 2000 - 21. 11. 2000 - 61 days
- 61 days
Treatment of cystic fibrosis
Treatment of cystic fibrosis
- 09. 08. 2000 - 22. 09. 2000 - 19. 12. 2000 - 89 days
- 09.08.2000
...
- 89 days
Treatment of patent ductus arteriosus
Treatment of patent ductus arteriosus
- 02. 05. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 02.05.2000
...
- 62 days
Treatment of glycogen storage disease type II (Pompe’ s disease)
Treatment of glycogen storage disease type II
- 10. 08. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 10.08.2000
...
- 19.10.2000 - 19.12.2000 - 62 days
Treatment of acromegaly
Treatment of acromegaly
- 11. 08. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 11.08.2000 - 19.10.2000 - 19.12.2000 - 62 days
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Treatment of pulmonary arterial hypertension and
- 21. 08. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 21.08.2000
Treatment of haemorrhagic fever with renal syndrome
Treatment of haemorrhagic fever with renal syndrome
- 06. 09. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
Treatment of mucopolysaccharidosis type I
Treatment of mucopolysaccharidosis type I
- 08. 09. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 08.09.2000
Treatment of chronic myeloid leukaemia
Treatment of chronic myeloid leukaemia
- 03. 10. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 03.10.2000
Mucopolysaccharidosis type VI (Maroteaux - Lamy Syndrome)
Mucopolysaccharidosis type VI (Maroteaux -Lamy
- 04. 10. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 04.10.2000
Side 87/ 93
Syndrome)
CPMP- arbejdsgruppe vedrørende bioteknologi
- 19.10.2000 - 19.12.2000 - 62 days
Referencenummer EMEA/ CPMP/ BWP/ 840/ 00
83 EMEA General Report 2000
Guidelines Final EU recommendations for the Influenza vaccine composition for the season 2000/ 2001
Annex 11:
Status Vedtaget i april 2000
EMEA guidelines in 2000
EMEA/ CPMP/ BWP/ 1244/ 00
EMEA/ CPMP/ BWP/840/00
Vedtaget i juli 2000
Final EU recommendations for the Influenza vaccine composition for the season 2000/2001 Adopted April 2000
EMEA/ CPMP/ BWP/ 3326/ 99
EMEA/ CPMP/ BWP/1244/00
Concept paper on the Development of a Points to consider on xenogeneic cell therapy
Report of the EMEA Expert Workshop on human TSEs and plasma-derived medicinal products, 15-16 May 2000 Adopted July 2000
Vedtaget i november 2000
Concept paper on the Development of a Points to consider on xenogeneic cell therapy Adopted November 2000
EMEA/ CPMP/ BWP/ 3354/ 99 Draft
EMEA/ CPMP/ BWP/3354/99 Draft
Sendt til høring i januar 2000
Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Released for consultation January 2000
EMEA/ CPMP/ BWP/ 3207/ 00
EMEA/ CPMP/ BWP/3207/00
Note for Guidance on Comparability of medicinal products containing biotechnology- derived proteins as active substances
Note for Guidance on Comparability of medicinal products containing biotechnology-derived proteins as active substances Released for consultation May 2000
EMEA/ CPMP/ BWP/ 1143/ 00
EMEA/CPMP/BWP/1143/00
Sendt til høring i juli 2000
Position statement on the Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products Released for consultation July 2000
EMEA/ CPMP/ BWP/ 269/ 95 rev.
EMEA/CPMP/BWP/269/95rev.
Sendt til høring i juli 2000
Revision of section 3.2.5 of CPMP Note for guidance on Plasma-derived medicinal products Released for consultation July 2000
EMEA/ CPMP/ BWP/ 2571/ 00
EMEA/CPMP/BWP/2571/00
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines Released for consultation November 2000
Sendt til høring i november 2000
CPMP Blood and Plasma Working Group
CPMP- arbejdsgruppe vedrørende blodpræparater
Reference number
Referencenummer EMEA/ CPMP/ BPWG/ 575/ 99
Guidelines/Status
Guidelines Note for guidance on the Clinical investigation of human anti- D immunoglobulin for intravenous and/ or intramuscular use
EMEA/CPMP/BPWG/575/99
Status Vedtaget i juni 2000
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
EMEA/ CPMP/ BPWG/ 388/ 95 rev.
EMEA/CPMP/BPWG/388/95 rev.
Vedtaget i juni 2000
Note for guidance on the Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
EMEA/ CPMP/ BPWG/ 574/ 99
EMEA/CPMP/BPWG/574/99
Vedtaget i juni 2000
Core SPC for Human and anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
EMEA/ CPMP/ BPWG/ 859/ 95 rev.
EMEA/CPMP/BPWG/859/95 rev.
Vedtaget i juni 2000
Core SPC for Human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
EMEA/ CPMP/ BPWG/ 1619/ 99
EMEA/ CPMP/ BPWG/1619/99
Vedtaget i juni 2000
Core SPC for Human plasma derived and recombinant coagulation factor VIII products Adopted June 2000
EMEA/ CPMP/ BPWG/ 1625/ 99
EMEA/ CPMP/ BPWG/1625/99
Vedtaget i juni 2000
Core SPC for Human plasma derived and recombinant coagulation factor IX products Adopted June 2000
EMEA/ CPMP/ BPWG/ 198/ 95 rev. 1
EMEA/CPMP/BPWG/198/95 rev.1
Vedtaget i oktober 2000
Note for Guidance on the Clinical investigation of human plasma derived factor VIII and IX products Adopted October 2000
Vedtaget i oktober 2000
EMEA/CPMP/BPWG/ 1561/99
Årsberetning 2000
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adopted October 2000
Vedtaget i oktober 2000
84 EMEA General Report 2000