natgillin/translations-raw huggingface dataset:
Lægemiddel Indehaver af Handelsnavn markedsføringstilladelse INN Del A eller B
• •
Behandlingsområde Tilsigtede dyrearter Resumé af indikation
• •
EMEA/ CVMP Godkendelse Udtalelse Nettotid Urstop
Advocate Imidacloprid/ Moxidectin
Advocate Bayer Imidacloprid / Moxidectin Part B
• Bayer
Dogs and cats Antiparasitic
• Dogs and cats • Antiparasitic
18. 12. 2001 11. 12. 2002 210 days 149 days
• 210 days • 149 days
Ibaflin Intervet International Ibafloxacin Part B extension
Ibaflin Ibafloxacin Part B extension
Dogs Antibacterial
• Dogs • Antibacterial
7. 8. 2001 11. 12. 2002 210 days 267 days
• 7.8.2001 • 11.12.2002 • 210 days • 267 days
Fastsættelse af maksimalgrænseværdier for restkoncentrationer for nye stoffer Stoffets INN
Establishment of maximum residue limits for new substances
Behandlingsområde Tilsigtede dyrearter
Therapeutic area • Target species
Europa- Kommissionen Udtalelse modtaget Dato for vedtagelse af forordningen EFT
European Commission • Opinion received • Date of regulation • Official Journal
Methylprednisolone
• Methylprednisolone
Bovine
• Bovine
13. 7. 1999 11. 7. 2001 177 days 535 days
• 13.7.1999 • 11.7.2001 • 177 days • 535 days
2. 8. 2001 17. 1. 2002 OJ L16, 18. 1. 2002
• 2.8.2001 • 17.1.2002 • OJ L 16, 18.1.2002
Acetyllisovaleryltylosin (extension)
Acetyllisovaleryltylosin (extension)
12. 4. 2001 11. 7. 2001 84 days 0
• 11.7.2001 • 84 days •0
03. 8. 2001 17. 1. 2002 OJ L16, 18. 1. 2002
• 17.1.2002 • OJ L 16, 18.1.2002
Abamectin (extension)
Abamectin (extension)
23. 4. 1999 5. 12. 2001 283 days 674 days
• 23.4.1999 • 5.12.2001 • 283 days • 674 days
3. 1. 2002 24. 5. 2002 OJ L137, 25. 5. 2002
• 3.1.2002 • 24.5.2002 • OJ L 137, 25.5.2002
Allantoin
• Allantoin
All food producing species
• All food producing species
12. 7. 2001 10. 10. 2001 90 days 0
• 12.7.2001 • 10.10.2001 • 90 days •0
8. 11. 2001 24. 5. 2002 OJ L137, 25. 5. 2002
• 8.11.2001 • 24.5.2002 • OJ L 137, 25.5.2002
Benzocaine (extension)
• Benzocaine (extension)
12. 10. 2000 7. 11. 2001 120 days 271 days
• 12.10.2000 • 7.11.2001 • 120 days • 271 days
29. 11. 2001 24. 5. 2002 OJ L137, 25. 5. 2002
• 29.11.2001 • 24.5.2002 • OJ L 137, 25.5.2002
Equidae
• Equidae
13. 12. 2001 13. 3. 2002 90 days 0
• 13.12.2001 • 13.3.2002 • 90 days •0
8. 4. 2002 27. 8. 2002 OJ L230, 28. 8. 2002
• 8.4.2002 • 27.8.2002 • OJ L 230, 28.8.2002
Azagly- nafarelin
• Azagly-nafarelin
21. 2. 2001 13. 2. 2002 120 days 237 days
• 21.2.2001 • 13.2.2002 • 120 days • 237 days
11. 3. 2002 27. 8. 2002 OJ L230, 28. 8. 2002
56 EMEA Annual Report 2002
Deslorelin acetate
• Deslorelin acetate
15. 11. 2001 13. 2. 2002 90 days 0
• 15.11.2001 • 13.2.2002 • 90 days •0
11. 3. 2002 27. 8. 2002 OJ L230, 28. 8. 2002
• 11.3.2002 • 27.8.2002 • OJ L 230, 28.8.2002
Ceftiofur (modification)
Ceftiofur (modification)
To permit intramammary administration
• To permit intramammary administration
17. 1. 2002 17. 4. 2002 90 days 0
• 17.1.2002 • 17.4.2002 • 90 days •0
13. 5. 2002 1. 10. 2002 OJ L 264, 2. 10. 2002
• 13.5.2002 • 1.10.2002 • OJ L 264, 2.10.2002
EMEA 2003 Side 72/ 88
Hydroxyethylsalicylate (extension)
Stoffets INN Behandlingsområde Tilsigtede dyrearter
• Extension of evaluation for salicylate
EMEA/ CVMP Godkendelse Udtalelse Nettotid Urstop
• 6.9.2001
Europa- Kommissionen Udtalelse modtaget Dato for vedtagelse af forordningen EFT
• 13.5.2002
6. 9. 2001 17. 4. 2002 114 days 109 days
• 17.4.2002 • 114 days • 109 days
13. 5. 2002 1. 10. 2002 OJ L 264, 2. 10. 2002
• 1.10.2002 • OJ L 264, 2.10.2002
Xylazine (extension) Dairy cows
• Dairy cows
Fenvalerate Bovine
• Fenvalerate
13. 7. 2001 15. 5. 2002 87 days 219 days
• 13.7.2001 • 15.5.2002 • 87 days • 219 days
13. 6. 2002 30. 10. 2002 OJ L 297, 31. 10. 2002
• 13.6.2002 • 30.10.2002 • OJ L 297, 31.10.2002
Omeprazole Equidae
• Omeprazole
12. 4. 2001 12. 6. 2002 120 days 306 days
• 12.4.2001 • 12.6.2002 • 120 days • 306 days
12. 7. 2002 30. 10. 2002 OJ L 297, 31. 10. 2002
• 12.7.2002 • 30.10.2002 • OJ L 297, 31.10.2002
Tulathromycin Bovine and swine
• Bovine and swine
9. 8. 2001 12. 6. 2002 120 days 187 days
• 9.8.2001 • 12.6.2002 • 120 days • 187 days
Trichlormethiazide Bovine milk (extension)
• Bovine milk
11. 4. 2002 10. 7. 2002 90 days 0
• 10.7.2002 • 90 days •0
1. 8. 2002
• •
Bacitracin (extension) Rabbits
Bacitracin (extension)
16. 8. 2002 13. 11. 2002 86 days 0
• 16.8.2002 • 13.11.2002 • 86 days •0
Bilag 9 COMP- udtalelser i 2002 om udpegelse af lægemidler til sjældne sygdomme
Annex 9 COMP opinions in 2002 on designation of orphan medicinal products
Positive COMP- udtalelser om udpegelse
Positive COMP designation opinions
EMEA/ COMP Indgivelse Startdato Udtalelse Nettotid
EMEA/COMP • Submission • Start Date • Opinion • Active Time
Europa- Kommissionen Udtalelse modtaget Dato for afgørelsen
European Commission • Opinion received • Date of decision
4 - (3, 5- Bis( hdroxy- phenyl) - 1, 2, 4) triazol- 1- yl) benzoic acid (ICL670)
• 4-(3,5-Bis(hdroxy-phenyl) -1,2,4) triazol-1-yl) benzoic acid (ICL670)
Novartis Europharm Limited
• Novartis Europharm Limited
Treatment of chronic iron overload requiring chelation therapy
• Treatment of chronic iron overload requiring chelation therapy
10. 10. 2001 26. 10. 2001 23. 1. 2002 89 days
• 10.10.2001 • 26.10.2001 • 23.1.2002 • 89 days
31. 1. 2002 13. 3. 2002
• 31.1.2002 • 13.3.2002
Beclomethasone 17, 21 - dipropionate
Beclomethasone 17, 21- dipropionate
Voisin Consulting SARL
Voisin Consulting SARL
Treatment of intestinal Graft - versus- Host Disease
Treatment of intestinal Graft- versus-Host Disease
11. 7. 2001 26. 10. 2001 23. 1. 2002 89 days
• 11.7.2001 • 26.10.2001 • 23.1.2002 • 89 days
Treatment of alkaptonuria
Treatment of alkaptonuria
14. 11. 2001 30. 11. 2001 23. 1. 2002 54 days
• 30.11.2001 • 23.1.2002 • 54 days
31. 1. 2002 13. 3. 2002
• 13.3.2002
GM- CSF receptor antagonist
GM-CSF receptor antagonist
British Biotech Pharmaceuticals Ltd -
British Biotech Pharmaceuticals Ltd
Treatment of juvenile myelomonocytic leukaemia
Treatment of juvenile myelomonocytic leukaemia
15. 11. 2001 30. 11. 2001 23. 1. 2002 54 days
• 15.11.2001 • 30.11.2001 • 23.1.2002 • 54 days
31. 1. 2002 18. 3. 2002
• 31.1.2002 • 18.3.2002
Human transferrin conjugated to mutant diptheria toxin
Human transferrin conjugated to mutant diptheria toxin
KS Biomedix Holdings PLC
KS Biomedix Holdings PLC
Treatment of gliomas
Treatment of gliomas
31. 1. 2002 19. 3. 2002
• 31.1.2002 • 19.3.2002
Chimeric IgG monoclonal antibody cG250 for use with 131Iodine
Chimeric IgG monoclonal antibody
Wilex AG
• Wilex AG
Treatment of renal cell carcinoma
• Treatment of renal cell carcinoma
3. 9. 2001 26. 10. 2001 23. 1. 2002 89 days
• 23.1.2002 • 89 days
31. 1. 2002 19. 3. 2002
•
Chimeric IgG monoclonal antibody cG250
Chimeric IgG monoclonal antibody
3. 9. 2001 26. 10. 2001 23. 1. 2002 89 days
• 26.10.2001 • 23.1.2002 • 89 days
31. 1. 2002 19. 3. 2002
• 19.3.2002
TGF- ß2- specific phosphorothioate antisense oligodeoxynucleotide (Oncomun)
TGF-ß2-specific phosphorothioate
Antisense Pharma GmbH
• Antisense Pharma GmbH
Treatment of high - grade glioma
• Treatment of high-grade glioma
14. 11. 2001 30. 11. 2001 23. 1. 2002 54 days
• 23.1.2002 • 54 days
31. 1. 2002 22. 3. 2002
•
Humanized anti- KSA monoclonal antibody – human interleukin- 2- fusion protein (EMD 273066)
Humanized anti-KSA monoclonal antibody -
Merck KGaA
• Merck KGaA
11. 10. 2001 26. 10. 2001 23. 1. 2002 89 days
• 23.1.2002 • 89 days
Epothilone B (EPO 906 A)
Epothilone B (EPO 906 A)
11. 10. 2001 26. 10. 2001 23. 1. 2002 89 days
• 11.10.2001 • 26.10.2001 • 23.1.2002 • 89 days
31. 1. 2002 22. 3. 2002
58 EMEA Annual Report 2002
Pseudomonas exotoxin (domains II/ III) - Interleukin 13 chimeric protein
• Pseudomonas exotoxin (domains II/III)-
PPD Global Ltd.
• PPD Global Ltd
28. 3. 2002 30. 4. 2002
• 16.1.2002
EMEA 2003
• 28.3.2002
EMEA/ MB/ 055/ 02/ da/ Endelig udg.
Interleukin 13 chimeric
Side 74/ 88
• 31.1.2002
Lægemidlets INN
• 30.4.2002
Sponsor
protein
Resumé af indikation
• 26.3.2002 • 54 days
EMEA/ COMP Indgivelse Startdato Udtalelse Nettotid
•
Bryostatin- 1
Bryostatin-1
GPC Biotech AG
• GPC Biotech AG
Treatment of oesophageal cancer
Treatment of oesophageal cancer
11. 1. 2002 31. 1. 2002 26. 3. 2002 54 days
• 31.1.2002 • 26.3.2002 • 54 days
28. 3. 2002 30. 4. 2002
• 30.4.2002
Recombinant human alpha- 1 antitrypsin
Recombinant human alpha-1 antitrypsin
Treatment of emphysema secondary to congenital alpha- 1
•
antitrypsin deficiency
Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
54 days
• 10.8.2001 • 31.1.2002 • 26.3.2002 • 54 days
Recombinant human porphobilinogen deaminase
Recombinant human porphobilinogen deaminase
HemeBiotech A/ S
• HemeBiotech A/S
Treatment of acute intermittent porphyria
Treatment of acute intermittent porphyria
12. 12. 2001 31. 1. 2002 30. 4. 2002 89 days
• 12.12.2001 • 31.1.2002 • 30.4.2002 • 89 days
6. 5. 2002 12. 6. 2002
• 6.5.2002 • 12.6.2002
Miltefosine
Miltefosine
Zentaris AG
• Zentaris AG
Treatment of visceral leishmaniasis
Treatment of visceral leishmaniasis
15. 11. 2001 31. 1. 2002 30. 4. 2002 89 days
• 31.1.2002 • 30.4.2002 • 89 days
6. 5. 2002 12. 6. 2002
• 12.6.2002
Mitotane (Lysodren)
Mitotane (Lysodren)
Laboratoire HRA Pharma
Laboratoire HRA Pharma
Treatment of adrenal cortical carcinoma
Treatment of adrenal cortical carcinoma
14. 1. 2002 31. 2. 2002 30. 4. 2002 89 days
• 31.2.2002 • 30.4.2002 • 89 days
Carbamic acid, [[4 - [[3 - [[4 - [1 - (4 - hydroxyphenyl) - 1- methyl - ethyl] phenoxy] methyl] phenyl] m ethoxy] - phenyl] iminomethyl] -
Carbamic acid, [[4-[[3-[[4- [1-(4-hydroxyphenyl)-1-
Boehringer Ingelheim International GmbH
Boehringer Ingelheim International GmbH
07. 2. 2002 25. 2. 2002 22. 5. 2002
• 25.2.2002 • 22.5.2002
30. 5. 2002 26. 6. 2002
• 26.6.2002
, ethyl ester (Amelubant)
,ethyl ester (Amelubant)
86 days
• 86 days
Thymalfasin (Zadaxin)
Thymalfasin (Zadaxin)
4. 4. 2002 22. 4. 2002 27. 6. 2002 66 days
• 4.4.2002 • 22.4.2002 • 27.6.2002 • 66 days
3. 7. 2002 30. 7. 2002
• 3.7.2002 • 30.7.2002
Antisense NF -? Bp65 Oligonucletide (Kappaproct)
Antisense NF-KBp65 Oligonucletide (Kappaproct)
InDex Pharmaceuticals AB
InDex Pharmaceuticals AB
Treatment of active ulcerative colitis
Treatment of active ulcerative colitis
12. 3. 2002 25. 3. 2002 27. 6. 2002 94 days
• 12.3.2002 • 25.3.2002 • 27.6.2002 • 94 days
Oregovomab (OvaRex)
Oregovomab (OvaRex)
Dorian Regulatory Affairs
• Dorian Regulatory Affairs
Treatment of ovarian cancer
Treatment of ovarian cancer
5. 4. 2002 22. 4. 2002 27. 6. 2002 66 days
• 5.4.2002 • 22.4.2002 • 27.6.2002 • 66 days
Myristolated- peptidyl - recombinant SCR1- 3 of human complement receptor type I
Myristolated-peptidyl- recombinant SCR1-3 of human complement
Adprotech Ltd.
• Adprotech Ltd
Prevention of post transplantation graft dysfunction
Prevention of post transplantation graft dysfunction
8. 3. 2002 25. 3. 2002 27. 6. 2002 94 days
• 27.6.2002 • 94 days
3. 7. 2002 30. 7. 2002
•
Purified bromelain (Debrase Gel Dressing)
Purified bromelain (Debrase Gel Dressing)
Prof.
• Prof.
Keith Judkins
Keith Judkins
Treatment of partial deep dermal and full thickness burns
Treatment of partial deep dermal and full thickness burns
6. 3. 2002 25. 3. 2002 27. 6. 2002 94 days
• 6.3.2002 • 25.3.2002 • 27.6.2002 • 94 days
24. 7. 2002 11. 9. 2002
• 3.7.2002 • 30.7.2002
EMEA 2003
Product INN
EMEA/ MB/ 055/ 02/ da/ Endelig udg.
Summary of indication
Side 75/ 88
European Commission • Opinion received • Date of decision
Lægemidlets INN
• Benzoic acid, sodium salt (Benzoate)
Sponsor
• Ethicare GmbH
Resumé af indikation
• Treatment of non-ketotic hyperglycinaemia
EMEA/ COMP Indgivelse Startdato Udtalelse Nettotid
• 5.4.2002 • 17.6.2002 • 17.7.2002 • 30 days
Europa- Kommissionen Udtalelse modtaget Dato for afgørelsen
• 24.7.2002 • 11.9.2002
Doxorubicin iron/ carbon magnetically targeted microparticles (MTC- DOX for Injection)
Doxorubicin iron/carbon magnetically targeted
Interface International Consultancy Ltd
Interface International Consultancy Ltd
27. 5. 2002 17. 6. 2002 17. 7. 2002 30 days
• 17.7.2002 • 30 days
24. 7. 2002 11. 9. 2002
•
Myristolated- peptidyl - recombinant Human CD59
Myristolated-peptidyl- recombinant Human CD59
Adprotech Ltd.
Adprotech Ltd
Treatment of paroxysmal nocturnal haemoglobinuria
Treatment of paroxysmal nocturnal haemoglobinuria
5. 4. 2002 22. 4. 2002 17. 7. 2002 86 days
• 5.4.2002 • 22.4.2002 • 17.7.2002 • 86 days
24. 7. 2002 11. 9. 2002
• 24.7.2002 • 11.9.2002
Mitotane (Lysodren 500 mg Tablets)
Mitotane (Lysodren 500 mg Tablets)
AGEPS- EPHP Agence Générale des Équipements et Produits de Santé
AGEPS-EPHP Agence Générale des Équipements et Produits
5. 4. 2002 17. 6. 2002 17. 7. 2002 30 days
• 17.7.2002 • 30 days
24. 7. 2002 11. 9. 2002
(-)-17(cyclopropylmethyl)-1,14
(-) - 17( cyclopropylmethyl) - 1, 14 ß- dihydroxy- 4, 5 alpha- epoxy - 6ß - [N- methyl- trans- 3 - (3- furyl) acrylamido] morphinan
•
Toray Europe Limited
Toray Europe Limited
Treatment of uremic pruritus
Treatment of uremic pruritus
5. 4. 2002 17. 6. 2002 01. 8. 2002
• 17.6.2002
5. 8. 2002 11. 9. 2002
• 11.9.2002
hydrochloride (Nalfurafine)
acrylamido] morphinan hydrochloride (Nalfurafine)
45 days
• 1.8.2002 • 45 days
Autologous Renal Cell Tumor Vaccine
• Autologous Renal Cell Tumor Vaccine
Liponova GmbH
• Liponova GmbH
31. 5. 2002 17. 6. 2002 12. 9. 2002 87 days
• 17.6.2002 • 12.9.2002 • 87 days
23. 9. 2002 21. 10. 2002
• 21.10.2002
Boswellia serrata resin dry extract (Boswelan)
Boswellia serrata resin dry extract (Boswelan)
Pharmasan GmbH
• Pharmasan GmbH
Treatment of peritumoral edema derived form brain tumour
Treatment of peritumoral edema derived form brain tumour
6. 2. 2002 17. 6. 2002 12. 9. 2002 87 days
• 6.2.2002 • 17.6.2002 • 12.9.2002 • 87 days
23. 9. 2002 21. 10. 2002
• 23.9.2002 • 21.10.2002
Recombinant glycoprotein gp350 of Epstein- Barr Virus (Henogen 350)
Recombinant glycoprotein gp350 of Epstein-Barr Virus (Henogen 350)
Henogen SA
• Henogen SA
Prevention of post - transplantation lympho - proliferative
Prevention of post- transplantation lympho- proliferative disorders
88 days
• 9.8.2001 • 17.6.2002 • 12.9.2002 • 88 days
Anti- CD 147 murine monoclonal IgM
Anti-CD 147 murine monoclonal IgM
SangStat UK Limited
• SangStat UK Limited
Treatment of Graft versus Host Disease
Treatment of Graft versus Host Disease
2. 8. 2002 19. 8. 2002 09. 10. 2002 52 days
• 2.8.2002 • 19.8.2002 • 9.10.2002 • 52 days
16. 10. 2002 14. 11. 2002
• 16.10.2002 • 14.11.2002
Etilefrine
Etilefrine
SERB
• SERB
Treatment of low flow priapism
Treatment of low flow priapism
29. 7. 2002 19. 8. 2002 9. 10. 2002 52 days
• 29.7.2002 • 19.8.2002 • 9.10.2002 • 52 days
16. 10. 2002 13. 11. 2002
• 16.10.2002 • 13.11.2002
Duramycin
Duramycin
Gerd Döring
Gerd Döring
Treatment of cystic fibrosis
• Treatment of cystic fibrosis
Iodine 131 radiolabeled anti - nucleohistone H1 chimeric biotinylated monoclonal antibody
Iodine 131 radiolabeled anti-nucleohistone H1 chimeric biotinylated
26. 7. 2002 19. 8. 2002 9. 10. 2002
• 26.7.2002 • 19.8.2002
(Cotara)
monoclonal antibody (Cotara)
52 days
• 9.10.2002 • 52 days
5- Aminolevulinic acid hydrochloride
• 5-Aminolevulinic acid hydrochloride
Medac Gesellschaft fuer klinische Spezialpräparate mbH
• Medac Gesellschaft fuer klinische Spezialpräparate mbH
Intra- operative photodynamic diagnosis of residual glioma
• Intra-operative photodynamic diagnosis of residual glioma
26. 7. 2002 19. 8. 2002 9. 10. 2002 52 days
• 26.7.2002 • 19.8.2002 • 9.10.2002 • 52 days
Monoclonal antibody to human interleukin- 6
Monoclonal antibody to human interleukin-6
OPi Orphan Pharma International
OPi Orphan Pharma International
Treatment of post - transplantation lymphoproliferative disorders
Treatment of post- transplantation lymphoproliferative disorders
5. 9. 2002 16. 9. 2002 15. 11. 2002 61 days
• 5.9.2002 • 16.9.2002 • 15.11.2002 • 61 days
EMEA’ s årsberetning for 2002
• 20.11.2002 • 18.12.2002
EMEA/ MB/ 055/ 02/ da/ Endelig udg.
Recombinant inhibitor of human plasma
Side 76/ 88
•
Lægemidlets INN
Dyax s.a.
Resumé af indikation
Treatment of angioedema
EMEA/ COMP Indgivelse Startdato Udtalelse Nettotid
• 1.8.2002
Dyax s. a.
• 20. 11.2002
Treatment of angioedema
kallikrein (DX-88)
1. 8. 2002 19. 8. 2002 15. 11. 2002 89 days
• 19.8.2002 • 15.11.2002 • 89 days
20. 11. 2002 18. 12. 2002
• 18.12.2002
Cholic Acid
Cholic Acid
Treatment of inborn errors of primary bile acid synthesis
Treatment of inborn errors of primary bile acid synthesis
27. 6. 2002 19. 8. 2002 15. 11. 2002 89 days
• 15.11.2002 • 89 days
20. 11. 2002 18. 12. 2002
•
3, 4 diaminopyridine phosphate
3,4 diaminopyridine phosphate
Treatment of Lambert- Eaton myasthenic syndrome
Treatment of Lambert-Eaton myasthenic syndrome
29. 8. 2002 16. 9. 2002 15. 11. 2002 67 days
• 15.11.2002 • 67 days
Sodium oxybate (Xyrem)
Sodium oxybate (Xyrem)
IDIS Ltd.
IDIS Ltd
Treatment of narcolepsy
• Treatment of narcolepsy
28. 8. 2002 16. 9. 2002 13. 12. 2002 89 days
• 16.9.2002 • 13.12.2002 • 89 days
G17( 9) gastrin- Diphtheria Toxoid Conjugate
G17(9) gastrin- Diphtheria Toxoid Conjugate
Orion Clinical Service Limited
Orion Clinical Service Limited
Treatment of gastric cancer
• Treatment of gastric cancer
27. 9. 2002 14. 10. 2002 13. 12. 2002 61 days
• 27.9.2002 • 14.10.2002 • 13.12.2002 • 61 days
Treatment of pancreatic cancer
Treatment of pancreatic cancer
Carboxypeptidase G2
Carboxypeptidase G2
Enact Pharma plc
Enact Pharma plc
Adjunctive treatment in patients at risk of methotrexate
Adjunctive treatment in patients at risk of methotrexate toxicity
30. 8. 2002 16. 9. 2002 13. 12. 2002
• 30.8.2002
toxicity
•
89 days
• 16.9.2002 • 13.12.2002 • 89 days
Negative COMP- udtalelser om udpegelse
Negative COMP designation opinions
Chlorproguanil hydrochloride and dapsone (LAPDAP)
• Chlorproguanil hydrochloride and dapsone (LAPDAP)
SmithKline Beecham plc
• SmithKline Beecham plc
Treatment of acute uncomplicated Plasmodium falciparum malaria
• Treatment of acute uncomplicated Plasmodium falciparum malaria
5. 9. 2001 20. 9. 2001 22. 5. 2002 244 days (including appeal)
• 5.9.2001 • 20.9.2001 • 22.5.2002 • 244 days (including appeal)
30. 5. 2002 26. 7. 2002
• 30.5.2002 • 26.7.2002
Mycobacterial cell wall complex (MCC)
Mycobacterial cell wall complex (MCC)
Bioniche Teoranta
• Bioniche Teoranta
Treatment of carcinoma in situ of the urinary bladder
Treatment of carcinoma in situ of the urinary bladder
24. 5. 2002 17. 6. 2002 12. 9. 2002 88 days
• 24.5.2002 • 17.6.2002 • 12.9.2002 • 88 days
16. 10. 2002 18. 12. 2002
• 16.10.2002 • 18.12.2002
EMEA’ s årsberetning for 2002
62 EMEA Annual Report 2002
Bilag 10 Retningslinjer og arbejdsdokumenter i 2002
Annex 10 Guidelines and working documents in 2002
Side 77/ 88
Document title
CPMP- arbejdsgruppe vedrørende bioteknologi
CPMP/BWP/2490/00
Referencenummer Titel på dokumentet CPMP/ BWP/ 2490/ 00 Note for guidance on Cell Culture Inactivated Influenza Vaccines Annex to NfG on Harmonisation of requirements for Influenza Vaccines (CPMP/ BWP/ 214/ 96)
Note for guidance on Cell Culture Inactivated Influenza Vaccines Annex to NfG on Harmonisation of requirements for Influenza Vaccines (CPMP/BWP/214/96)
Status Vedtaget i januar 2002
Adopted January 2002
EMEA/ CPMP/ 571/ 02 Public Statement on Lactose prepared using Calf Rennet:
Public Statement on Lactose prepared using Calf Rennet:
Risk Assessment in relation to Bovine Spongiform Encephalopathies (BSE)
Risk Assessment in relation to Bovine Spongiform Encephalopathies (BSE)
Vedtaget i februar 2002
Adopted February 2002
CPMP/ BWP/ 1793/ 01
CPMP/BWP/6622/02
Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products
Concept Paper on the Development of a CPMP Note for Guidance on requirements for the Evaluation of New Adjuvants in Vaccines
Sendt til høring i april 2002
Adopted April 2002
CPMP/ BWP/ 6622/ 02
CPMP/BWP/1412/02
Concept Paper on the Development of a CPMP Note for Guidance on requirements for the Evaluation of New Adjuvants in Vaccines
Testing for SV40 in Polio Virus Vaccines
Vedtaget i april 2002
Adopted April 2002
CPMP/ BWP/ 1412/ 02 CPMP/ BWP/ 1571/ 02
CPMP/BWP/1571/02
Testing for SV40 in Polio Virus Vaccines CPMP Position Statement on the Quality of Water used in the production of Vaccines for parenteral use
CPMP Position Statement on the Quality of Water used in the production of Vaccines for parenteral use
Sendt til høring i maj 2002
Adopted April 2002
CPMP/ BWP/ 852/ 02
CPMP/BWP/852/02
Committee for Proprietary Medicinal Products (CPMP), Final EU recommendations for the influenza vaccine composition for the season 2002/ 2003
Committee for Proprietary Medicinal Products (CPMP), Final EU recommendations for the influenza vaccine composition for the season 2002/2003
Vedtaget i maj 2002
Adopted May 2002
CPMP/ BWP/ 337/ 02
CPMP/BWP/337/02
Public Report on Risk and Regulatory Assessment of Lactose and other products prepared using CalfRennet
Public Report on Risk and Regulatory Assessment of Lactose and other products prepared using CalfRennet
CPMP/ BWP/ 1818/ 02
CPMP/BWP/1818/02
CPMP Position Statement on Non- Remunerated and Remunerated Donors:
CPMP Position Statement on Non-Remunerated and Remunerated Donors:
Safety and Supply of Plasma - derived Medicinal Products
Safety and Supply of Plasma-derived Medicinal Products
CPMP/ BWP/ 2758/ 02
EMEA/22314/02 rev.
EMEA/ 22314/ 02/ Rev 1
1
Position Paper on Re- establishment of Working Seeds and Working Cell Banks using TSE compliant materials
Position Paper on Re-establishment of Working Seeds and Working Cell Banks using TSE compliant materials
Vedtaget i oktober 2002
Adopted October 2002
CPMP’ s ad hoc- arbejdsgruppen vedrørende blodpræparater Referencenummer CPMP/ BPWG/ 2220/ 99
CPMP/BWP/1793/01
Titel på dokumentet Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products
Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products
Status Vedtaget i januar 2002
Released for consultation April 2002
CPMP/ BPWG/ 3226/ 99 CPMP/ BPWG/ 283/ 00
Released for consultation May 2002
Core SPC for Human Plasma derived Antithrombin Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular use
Note for Guidance on Pharmaceutical Aspects of the Product Literature for Human Vaccines
Vedtaget i januar 2002 Vedtaget i juli 2002
Adopted for release for consultation July 2002 EMEA Annual Report 2002
CPMP/ BPWG/ 282/ 00
CPMP/BPWG/2220/99
Core SPC for Human Normal Immunoglobulin for Subcutaneous and Intramuscular use
Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products
Vedtaget i juli 2002
Adopted January 2002
CPMP’ s arbejdsgruppe vedrørende virkninger Referencenummer (CPMP/ EWP/ 1412/ 01)
CPMP/BPWG/3226/99
Titel på dokumentet Concept paper for the development of the revision of the CPMP Note for Guidance on evaluation of new anti - bacterial medicinal products (CPMP/ EWP/ 558/ 95) and the CPMP Note for Guidance on the pharmacodynamic section of the SPC for anti- bacterial medicinal products (CPMP/ EWP/ 520/ 96)
Core SPC for Human Plasma derived Antithrombin
(CPMP/ EWP/ 226/ 02)
CPMP/BPWG/283/00
Concept paper on the development of a CPMP Note for Guidance on the clinical pharmacokinetic investigation of the pharmacokinetics of peptides and proteins.
Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular use
Vedtaget i marts 2002
Adopted July 2002
EMEA’ s årsberetning for 2002 EMEA/ MB/ 055/ 02/ da/ Endelig udg.
Adopted July 2002
Referencenummer Titel på dokumentet
CPMP Efficacy Working Party
EMEA 2003 Side 78/ 88
Adopted January 2002
(CPMP/ EWP/ 225/ 02)
Adopted March 2002
Concept paper on the development of a CPMP Note for Guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal failure.
Concept paper on the development of a CPMP Note for Guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal failure
Vedtaget i marts 2002
Adopted March 2002
(CPMP/ EWP/ 518/ 97 rev.
CPMP/EWP/518/97 rev.
1)
1
Note for Guidance on clinical investigation of medicinal products in the treatment of depression.
Note for Guidance on clinical investigation of medicinal products in the treatment of depression
(CPMP/ EWP/ 714/ 98 rev.
CPMP/EWP/714/98 rev.