natgillin/translations-raw huggingface dataset:
A16AA05 Treatment of hyperammonaemia due to N-acetylglutamate
A16AA05 Treatment of hyperammonaemia due
• 22.10.2001 • 17.10.2002
22. 10. 2001 17. 10. 2002
synthase deficiency
to N- acetylglutamate synthase deficiency
• 191 days
191 days 164 days
•
Bayer
• 164 days
G04B E09 Treatment of erectile dysfunction
•
22. 4. 2002 21. 11. 2002
53
Part B
Marketing authorisation holder
96 days 115 days
• Vivanza • vardenafil • Part B
Levitra Vardenafil
• G04B E09 • Treatment of erectile dysfunction
G04B E09 Treatment of erectile dysfunction
• •
28. 1. 2002 21. 11. 2002
G04B E09 Treatment of erectile dysfunction
Part B
• 28.1.2002 • 21.11.2002 • 180 days • 115 days
180 days 115 days
• Ytracis • yttrium(Y-90)
Ytracis yttrium( Y- 90)
• CIS bio International
CIS bio International
V10X Radiolabelling of carrier molecules, specifically developed
V10X Radiolabelling of carrier molecules, specifically
• 22.10.2001 • 21.11.2002
22. 10. 2001 21. 11. 2002
• 209 days
176 days 209 days
• Hepsera • adefovir dipivoxil
Hepsera Adefovir dipivoxil
• Gilead Science
Gilead Science
• •
22. 4. 2002 21. 11. 2002
• 152 days • 59 days
152 days 59 days
• Forsteo • teriparatide
Forsteo Teriparatide
• Eli Lilly
Eli Lilly
Treatment of established osteoporosis in postmenopausal
Treatment of established osteoporosis in postmenopausal women
• 19.6.2001 • 18.12.2002
19. 6. 2001 18. 12. 2002 207 days 339 days
• •
# Viittaa asetuksen (EY) N: o 121/ 2000 mukaisesti nimettyyn harvinaislääkkeeseen.
•
Liite 8 CVMP: n lausunnot eläinlääkkeistä vuonna 2002
• 339 days
Sivu 73/ 90
54 EMEA Annual Report 2002
Keskitetyt hakemukset
Product • Brand name • INN • Part A or B
Tuote Kauppanimi INN
Therapeutic area • Target species • Summary of indication
Hoitoala Kohde- eläinlajit Tiivistelmä käyttöaiheesta
EMEA/CVMP • Validation • Opinion • Active time • Clock stop
EMEA/ CVMP Validointi Lausunto
• Eurifel RCP-FelV • Vaccine
Eurifel RCP- FelV Vaccine
• Mérial
Mérial
• Cats • Vaccine against feline rhinotracheitis, calcivirus,
Cats Vaccine against feline rhinotracheitis,
• 19.12.2000 • 5.12.2001
19. 12. 2000 5. 12. 2001
• 4.1.2002 • 8.3.2002
4. 1. 2002 8. 3. 2002
panleucopenia and leukaemiac
calcivirus, panleucopenia and leukaemiac
• 210 days
210 days 141 days
• 12.3.2002
12. 3. 2002 OJ C 77, 28. 3. 2002, p.
Porcilis Porcoli Diluvac Forte
Porcilis Porcoli Diluvac Forte Vaccine Part A extension
Vaccine against neonatal diarrhoea
Pigs (sows & gilts) Vaccine against neonatal diarrhoea
• 13.2.2002 • 210 days • 183 days
16. 1. 2001 13. 2. 2002 210 days 183 days
• 22.5.2002 • 24.5.2002 • OJ C 157, 2.7.2002, p.
15. 3. 2002 22. 5. 2002 24. 5. 2002 OJ C 157, 2. 7. 2002, p.
Quadrisol Vedaprofen
Quadrisol Vedaprofen
• 12.4.2002 • 10.7.2002
13. 2. 2001 13. 3. 2002
•
12. 4. 2002 10. 7. 2002
Part B extension
Part B extension
• 210 days • 183 days
210 days 183 days
• 15.7.2002 • OJ C 178, 26.7.2002, p.
15. 7. 2002 OJ C 178, 26. 7. 2002, p.
• Metacam • Meloxicam
Metacam Meloxicam
• 13.6.2001 • 17.4.2002
13. 6. 2001 17. 4. 2002
• 17.5.2002 • 9.8.2002
17. 5. 2002 9. 8. 2002
• Part B extension
Part B extension
• 210 days • 99 days
210 days 99 days
• 13.8.2002 • OJ C 206, 30.8.2002, p.
13. 8. 2002 OJ C 206, 30. 8. 2002, p.
• Gallivac HVT IBD • Live vaccine
Gallivac HVT IBD Live vaccine
Chickens Infectious Bursal disease/ Marek's disease
Chickens Infectious Bursal disease/ Marek’ s disease
• 12.7.2000 • 17.4.2002
12. 7. 2000 17. 4. 2002
• 210 days • 436 days
210 days 436 days
• Dexdomitor • Dexmedetonidine • Part B
Dexdomitor Dexmedetonidine
• Orion Pharma
Orion Pharma
• •
14. 6. 2002 30. 8. 2002
Dogs and cats Restraint, sedation and analgesia
Part B
• 15.5.2001 • 15.5.2002 • 210 days • 155 days
210 days 155 days
• 14.6.2002 • 30.8.2002 • 5.9.2002 • OJ C 237, 2.10.2002, p.
05. 9. 2002 OJ C 237, 2. 10. 2002, p.
• Nobivac Bb • Vaccine
Nobivac Bb Vaccine
• 13.2.2001 • 12.6.2002
13. 2. 2001 12. 6. 2002
• 12.7.2002 • 10.9.2002
12. 7. 2002 10. 9. 2002
• 210 days • 274 days
210 days 274 days
• 12.9.2002 • OJ C 237, 2.10.2002 p.
12. 9. 2002 OJ C 237, 2. 10. 2002 p.
• Sevoflo • Sevoflurane • Part B
Sevoflo Sevoflurane Part B
• Cyton Biosciences
Cyton Biosciences
• 11.7.2001 • 4.9.2002 • 210 days • 211 days
11. 7. 2001 4. 9. 2002 210 days 211 days
• 5.10.2002 • 11.12.2002 • 13.12.2002 • OJ C 2, 7.1.2003, p.
5. 10. 2002 11. 12. 2002 13. 12. 2002 OJ C 2, 7. 1. 2003, p.
• Nobilis OR inac • Vaccine
Nobilis OR inac Vaccine
• •
1. 11. 2002
Chickens Immunisation against ornithobacterium rhinotracheale
rhinotracheale
• 18.1.2000 • 2.10.2002
206 days 783 days
• 1.11.2002 •
Proteqflu Vaccine Part A
• Part B
Merial
• 206 days • 783 days
13. 11. 2001 13. 11. 2002
• •
13. 12. 2002
• Proteqflu • Vaccine • Part A
Proteqflu- Te Vaccine Part A
• Horses • Vaccine against equine influenza
Horses Vaccine against equine influenza and tetanus
• 13.11.2001 • 13.11.2002 • •
13. 11. 2001 13. 11. 2002
• 13.12.2002 • • •
13. 12. 2002
55
Sivu
Therapeutic area • Target species • Summary of indication
Hoitoalue Kohde- eläinlajit Tiivistelmä käyttöaiheesta
• Merial
Osa A tai B
• 13.11.2001 • 13.11.2002
Aktiivinen aika Kellon pysäytys
• 13.12.2002 •
Ilmoituspäivämäärä EYVL
Advocate Imidacloprid/ Moxidectin
Advocate Imidacloprid / Moxidectin Part B
• Dogs and cats • Antiparasitic
Dogs and cats Antiparasitic
• 210 days • 149 days
18. 12. 2001 11. 12. 2002 210 days 149 days
• Dogs • Antibacterial
Dogs Antibacterial
• 7.8.2001 • 11.12.2002 • 210 days • 267 days
7. 8. 2001 11. 12. 2002 210 days 267 days
• • • •
Uusien aineiden jäämien enimmäispitoisuuksien vahvistaminen Vaikuttavan aineen kansainvälinen yleisnimi (INN)
Establishment of maximum residue limits for new substances
Hoitoala Kohde- eläinlajit
Substance INN
EMEA/ CVMP Validointi
Therapeutic area • Target species
Euroopan komissio Lausunto saatu
EMEA/CVMP • Validation • Opinion • Active time • Clock stop
Lausunto Aktiivinen aika Kellon pysäytys
European Commission • Opinion received • Date of regulation • Official Journal
Asetuksen päivämäärä EYVL
• Methylprednisolone
Methylprednisolone
• 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 L 16, 18.1.2002
2. 8. 2001 17. 1. 2002 OJ L16, 18. 1. 2002
• 12.4.2001
12. 4. 2001 11. 7. 2001 84 days 0
• 3.8.2001
03. 8. 2001 17. 1. 2002 OJ L16, 18. 1. 2002
• 11.7.2001 • 84 days •0
Abamectin (extension)
• 17.1.2002 • OJ L 16, 18.1.2002
23. 4. 1999 5. 12. 2001 283 days 674 days
•
3. 1. 2002 24. 5. 2002 OJ L137, 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 L 137, 25.5.2002
8. 11. 2001 24. 5. 2002 OJ L137, 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 L 137, 25.5.2002
29. 11. 2001 24. 5. 2002 OJ L137, 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 L 230, 28.8.2002
8. 4. 2002 27. 8. 2002 OJ L230, 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 L 230, 28.8.2002
11. 3. 2002 27. 8. 2002 OJ L230, 28. 8. 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
• 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
Hydroxyethylsalicylate (extension)
Hydroxyethylsalicylate (extension)
• Extension of evaluation for salicylate
Extension of evaluation for salicylate
• 6.9.2001
6. 9. 2001 17. 4. 2002 114 days 109 days
• 13.5.2002
13. 5. 2002 1. 10. 2002 OJ L 264, 2. 10. 2002
• Xylazine (extension)
Xylazine (extension)
• Fenvalerate
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
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
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
•
12. 7. 2002 30. 10. 2002 OJ L 297, 31. 10. 2002
Trichlormethiazide (extension)
Trichlormethiazide (extension)
• 10.7.2002 • 90 days •0
11. 4. 2002 10. 7. 2002 90 days 0
•
1. 8. 2002
Bacitracin (extension)
Bacitracin (extension)
• Rabbits
Rabbits
• 16.8.2002 • 13.11.2002 • 86 days •0
16. 8. 2002 13. 11. 2002 86 days 0
Annex 9 COMP opinions in 2002 on designation of orphan medicinal products
Liite 9 COMP: n harvinaislääkkeeksi nimeämistä koskevat lausunnot vuonna 2002
Positive COMP designation opinions
COMP: n myönteiset lausunnot
Product INN
Valmisteen kansainvälinen yleisnimi (INN)
EMEA/COMP • Submission • Start Date • Opinion • Active Time
EMEA/ COMP Hakemus jätetty Aloituspäivä määrä Lausunto Aktiivinen aika
• 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
Beclomethasone 17, 21- dipropionate
Beclomethasone 17, 21 - dipropionate
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
• 30.11.2001 • 23.1.2002 • 54 days
14. 11. 2001 30. 11. 2001 23. 1. 2002 54 days
GM-CSF receptor antagonist
GM- CSF receptor antagonist
British Biotech Pharmaceuticals Ltd
British Biotech Pharmaceuticals Ltd -
• 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 19. 3. 2002
Chimeric IgG monoclonal antibody
Chimeric IgG monoclonal
• Wilex AG
Wilex AG
• Treatment of renal cell carcinoma
Treatment of renal cell carcinoma
• 3.9.2001
3. 9. 2001
• 31.1.2002
31. 1. 2002
cG250 for use with
antibody cG250 for use with 131Iodine
• 23.1.2002 • 89 days
26. 10. 2001 23. 1. 2002 89 days
•
19. 3. 2002
Chimeric IgG monoclonal antibody
Chimeric IgG monoclonal antibody cG250
• 26.10.2001 • 23.1.2002 • 89 days
3. 9. 2001 26. 10. 2001 23. 1. 2002 89 days
TGF-ß2-specific phosphorothioate
TGF- ß2- specific
• Antisense Pharma GmbH
Antisense Pharma GmbH
• Treatment of high-grade glioma
Treatment of high - grade glioma
• 14.11.2001
14. 11. 2001
oligodeoxynucleotide (Oncomun)
phosphorothioate antisense oligodeoxynucleotide (Oncomun)
• 23.1.2002 • 54 days
30. 11. 2001 23. 1. 2002 54 days
•
22. 3. 2002
Humanized anti-KSA monoclonal antibody -
Humanized anti- KSA
• Merck KGaA
Merck KGaA
• 11.10.2001
11. 10. 2001
fusion protein (EMD 273066)
monoclonal antibody – human interleukin- 2- fusion protein (EMD 273066)
• 11.10.2001 • 26.10.2001 • 23.1.2002 • 89 days
11. 10. 2001 26. 10. 2001 23. 1. 2002 89 days
• 16.1.2002
31. 1. 2002 22. 3. 2002
Interleukin 13 chimeric
Pseudomonas exotoxin (domains II/ III) - Interleukin 13 chimeric protein
• 30.4.2002
PPD Global Ltd.
• 26.3.2002 • 54 days
Treatment of glioma
•
16. 1. 2002 31. 1. 2002 26. 3. 2002 54 days
•
28. 3. 2002 30. 4. 2002
• 11.1.2002
EMEA 2003 EMEA: n vuosikertomus 2002 EMEA/ MB/ 055/ 02/ fi/ lopull.
• 28.3.2002
Tiivistelmä
• 31.1.2002 • 26.3.2002 • 54 days
Päätöksen päivämäärä
• 30.4.2002
GPC Biotech AG
•
11. 1. 2002 31. 1. 2002 26. 3. 2002 54 days
Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
Recombinant human alpha- 1 antitrypsin
• 10.8.2001 • 31.1.2002 • 26.3.2002 • 54 days
Treatment of emphysema secondary to congenital alpha- 1 antitrypsin deficiency
• 28.3.2002 • 30.4.2002
10. 8. 2001 31. 1. 2002 26. 3. 2002 54 days
• HemeBiotech A/S
HemeBiotech A/ S
• 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
• Zentaris AG
Zentaris AG
• 31.1.2002 • 30.4.2002 • 89 days
15. 11. 2001 31. 1. 2002 30. 4. 2002 89 days
•
14. 1. 2002 31. 2. 2002 30. 4. 2002 89 days
Treatment of adrenal cortical carcinoma
Treatment of cystic fibrosis
• 14.1.2002
07. 2. 2002 25. 2. 2002 22. 5. 2002 86 days
•
30. 5. 2002 26. 6. 2002
Carbamic acid, [[4-[[3-[[4- [1-(4-hydroxyphenyl)-1-
Treatment of hepatocellular carcinoma
•
4. 4. 2002 22. 4. 2002 27. 6. 2002 66 days
•
3. 7. 2002 30. 7. 2002
Treatment of cystic fibrosis
Antisense NF -? Bp65
• 7.2.2002
InDex Pharmaceuticals AB
• 30.5.2002
Treatment of
• 26.6.2002
12. 3. 2002
•
3. 7. 2002
Thymalfasin (Zadaxin)
active ulcerative colitis
•
25. 3. 2002 27. 6. 2002 94 days
•
30. 7. 2002
Treatment of hepatocellular carcinoma
Oregovomab (OvaRex)
• 4.4.2002 • 22.4.2002 • 27.6.2002 • 66 days
Dorian Regulatory Affairs
• 3.7.2002 • 30.7.2002
Treatment of ovarian cancer
•
5. 4. 2002 22. 4. 2002 27. 6. 2002 66 days
InDex Pharmaceuticals AB
Adprotech Ltd.
•
8. 3. 2002 25. 3. 2002 27. 6. 2002 94 days
Oregovomab (OvaRex)
Keith Judkins
• Dorian Regulatory Affairs
Treatment of partial deep dermal and full thickness burns
•
6. 3. 2002 25. 3. 2002 27. 6. 2002 94 days
Myristolated-peptidyl- recombinant SCR1-3 of human complement
Benzoic acid, sodium salt (Benzoate)
• Adprotech Ltd
Ethicare GmbH
•
5. 4. 2002 17. 6. 2002 17. 7. 2002 30 days
•
24. 7. 2002 11. 9. 2002
EMEA Annual Report 2002
Sivu 78/ 90
EMEA/COMP • Submission • Start Date • Opinion • Active Time
EMEA/ COMP Hakemus jätetty Aloituspäiväm äärä Lausunto Aktiivinen aika
• Benzoic acid, sodium salt (Benzoate)
Doxorubicin iron/ carbon
• Ethicare GmbH
Interface International Consultancy Ltd
• Treatment of non-ketotic hyperglycinaemia
Treatment of
•
27. 5. 2002
•
24. 7. 2002
Interface International Consultancy Ltd
hepatocellular carcinoma
•
17. 6. 2002
•
11. 9. 2002
Myristolated-peptidyl- recombinant Human CD59
microparticles (MTC- DOX for Injection)
•
17. 7. 2002 30 days
Adprotech Ltd
Adprotech Ltd.
•
5. 4. 2002 22. 4. 2002 17. 7. 2002 86 days
•
5. 4. 2002 17. 6. 2002
de Santé
Équipements et Produits de Santé
(-)-17(cyclopropylmethyl)-1,14
(-) - 17( cyclopropylmethyl) - 1, 14
•
5. 4. 2002
•
5. 8. 2002
ß-dihydroxy-4,5 alpha-epoxy- 6ß-[N-methyl-trans-3-(3-furyl)
ß- dihydroxy- 4, 5 alpha- epoxy - 6ß - [N- methyl- trans- 3 - (3- furyl) acrylamido] morphinan hydrochloride (Nalfurafine)
• 17.6.2002
17. 6. 2002 01. 8. 2002 45 days
• 11.9.2002
11. 9. 2002
• Autologous Renal Cell Tumor Vaccine
Autologous Renal Cell Tumor Vaccine
• Liponova GmbH
Liponova GmbH
• 17.6.2002 • 12.9.2002 • 87 days
31. 5. 2002 17. 6. 2002 12. 9. 2002 87 days
•
23. 9. 2002 21. 10. 2002
• Pharmasan GmbH
Pharmasan GmbH
•
6. 2. 2002 17. 6. 2002 12. 9. 2002 87 days
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 disorders
Prevention of post - transplantation lympho - proliferative disorders
• 23.9.2002 • 22.10.2002
9. 8. 2001 17. 6. 2002 12. 9. 2002 88 days
•
23. 9. 2002 22. 10. 2002
Anti-CD 147 murine monoclonal IgM
Anti- CD 147 murine monoclonal IgM
• SangStat UK Limited
SangStat UK Limited
•
2. 8. 2002 19. 8. 2002 09. 10. 2002 52 days
•
16. 10. 2002 14. 11. 2002
• SERB
SERB
•
29. 7. 2002 19. 8. 2002 9. 10. 2002 52 days
•
16. 10. 2002 13. 11. 2002
• Treatment of cystic fibrosis
Treatment of cystic fibrosis
• 16.10.2002 • 13.11.2002
29. 7. 2002 19. 8. 2002 9. 10. 2002 52 days
Iodine 131 radiolabeled anti-nucleohistone H1 chimeric biotinylated
Iodine 131 radiolabeled anti -
• Treatment of glioma
Treatment of glioma
•
26. 7. 2002
•
16. 10. 2002
OPi Orphan Pharma International
nucleohistone H1 chimeric biotinylated monoclonal antibody (Cotara)
•
19. 8. 2002 9. 10. 2002 52 days
•
13. 11. 2002
Recombinant inhibitor of human plasma
5- Aminolevulinic acid hydrochloride
•
26. 7. 2002 19. 8. 2002 9. 10. 2002 52 days
Treatment of angioedema
Monoclonal antibody to human interleukin- 6
kallikrein (DX-88)
OPi Orphan Pharma International
• 19.8.2002 • 15.11.2002 • 89 days
Treatment of post - transplantation lymphoproliferative disorders
•
5. 9. 2002 16. 9. 2002 15. 11. 2002 61 days
•
20. 11. 2002 18. 12. 2002
Treatment of inborn errors of primary bile acid synthesis
Sivu 79/ 90
• 27.6.2002 • 19.8.2002
Valmisteen kansainvälinen
• 20.11.2002 • 18.12.2002
Rahoittaja
de Santé
Tiivistelmä
• 15.11.2002 • 89 days
EMEA/ COMP
•
Euroopan
3,4 diaminopyridine phosphate
komissio
•
yleisnimi (INN)
AGEPS-EPHP Agence Générale des Équipements et Produits
käyttöaiheesta
•
Hakemus
Treatment of Lambert-Eaton myasthenic syndrome
jätetty Aloituspäiväm äärä Lausunto Aktiivinen aika
• 29.8.2002 • 16.9.2002
Päätöksen päivämäärä
• 20.11.2002 • 18.12.2002
Recombinant inhibitor of human
de Santé
Dyax s. a.
• 15.11.2002 • 67 days
Treatment of angioedema
•
20. 11. 2002
• Treatment of narcolepsy
plasma kallikrein (DX- 88)
•
19. 8. 2002 15. 11. 2002 89 days
•
18. 12. 2002
•
27. 6. 2002 19. 8. 2002 15. 11. 2002 89 days
Orion Clinical Service Limited
3, 4 diaminopyridine phosphate
• Treatment of gastric cancer
AGEPS- EPHP Agence Générale des Équipements et Produits de Santé
• 27.9.2002 • 14.10.2002 • 13.12.2002 • 61 days
Treatment of Lambert- Eaton myasthenic syndrome
• •
29. 8. 2002 16. 9. 2002 15. 11. 2002 67 days
G17(9) gastrin- Diphtheria Toxoid Conjugate
Treatment of narcolepsy
•
28. 8. 2002 16. 9. 2002 13. 12. 2002 89 days
•
27. 9. 2002 14. 10. 2002 13. 12. 2002 61 days
Treatment of pancreatic cancer
G17( 9) gastrin- Diphtheria Toxoid Conjugate
• 27.9.2002 • 14.10.2002 • 13.12.2002 • 61 days
Orion Clinical Service Limited
• •
Treatment of pancreatic cancer
Adjunctive treatment in patients at risk of methotrexate toxicity
Adjunctive treatment in patients at risk of methotrexate toxicity
•
30. 8. 2002 16. 9. 2002 13. 12. 2002 89 days
Negative COMP designation opinions
COMP: n kielteiset lausunnot
• Chlorproguanil hydrochloride and dapsone (LAPDAP)
Chlorproguanil hydrochloride
• SmithKline Beecham plc
SmithKline Beecham plc
• Treatment of acute uncomplicated Plasmodium falciparum malaria
30. 5. 2002
• 5.9.2001 • 20.9.2001 • 22.5.2002 • 244 days (including appeal)
uncomplicated Plasmodium falciparum malaria
• 30.5.2002 • 26.7.2002
20. 9. 2001 22. 5. 2002 244 days (including appeal)
• Bioniche Teoranta
Bioniche Teoranta
•
24. 5. 2002 17. 6. 2002 12. 9. 2002 88 days
• 16.10.2002 • 18.12.2002
16. 10. 2002 18. 12. 2002
62 EMEA Annual Report 2002
EMEA 2003 EMEA: n vuosikertomus 2002 EMEA/ MB/ 055/ 02/ fi/ lopull.
Annex 10 Guidelines and working documents in 2002
Liite 10 Ohjeet ja työasiakirjat vuonna 2002
CPMP Biotechnology Working Party
Sivu 80/ 90
Reference number
CPMP: n bioteknologian työryhmä
Document title
Viitenumero Asiakirjan nimi
CPMP/BWP/2490/00
CPMP/ 146/ 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)
Adopted January 2002
Hyväksytty tammikuussa 2002
EMEA /CPMP/571/02
EMEA/ CPMP/ 571/ 02
Adopted February 2002
Hyväksytty helmikuussa 2002
CPMP/BWP/6622/02
CPMP/ BWP/ 1793/ 01 CPMP/ BWP/ 6622/ 02
Concept Paper on the Development of a CPMP Note for Guidance on requirements for the Evaluation of New Adjuvants in Vaccines
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
Adopted April 2002
Toimitettu lausuntoa varten huhtikuussa 2002 Hyväksytty huhtikuussa 2002
CPMP/BWP/1412/02
CPMP/ BWP/ 1412/ 02 CPMP/ BWP/ 1571/ 02
Testing for SV40 in Polio Virus Vaccines
Testing for SV40 in Polio Virus Vaccines CPMP Position Statement on the Quality of Water used in the production of Vaccines for parenteral use
Adopted April 2002
Hyväksytty huhtikuussa 2002 Hyväksytty huhtikuussa 2002
CPMP/BWP/1571/02
CPMP/ BWP/ 764/ 02
CPMP Position Statement on the Quality of Water used in the production of Vaccines for parenteral use
Points to Consider on Quality Aspects of Medicinal Products containing Active Substances Produced by Stable Transgene Experession in Higher Plants
Adopted April 2002
Toimitettu lausuntoa varten toukokuussa 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
Adopted May 2002
Hyväksytty toukokuussa 2002
CPMP/BWP/337/02
CPMP/ BWP/ 337/ 02
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
EMEA/22314/02 rev.
CPMP/ BWP/ 2758/ 02
1
EMEA/ 22314/ 02/ Rev 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
Adopted October 2002
Hyväksytty lokakuussa 2002
Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products
CPMP: n verivalmisteiden erityistyöryhmä Viitenumero CPMP/ BPWG/ 2220/ 99
Points to Consider on Quality Aspects of Medicinal Products containing Active Substances Produced by Stable Transgene Experession in Higher Plants
Asiakirjan nimi Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products
Released for consultation May 2002
Tilanne Hyväksytty tammikuussa 2002
CPMP/BWP/2758/02
CPMP/ BPWG/ 3226/ 99 CPMP/ BPWG/ 283/ 00
Note for Guidance on Pharmaceutical Aspects of the Product Literature for Human Vaccines
Core SPC for Human Plasma derived Antithrombin Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular use
Adopted for release for consultation July 2002 EMEA Annual Report 2002
Hyväksytty tammikuussa 2002 Hyväksytty heinäkuussa 2002
CPMP/BPWG/2220/99
CPMP/ BPWG/ 282/ 00
Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products
Core SPC for Human Normal Immunoglobulin for Subcutaneous and Intramuscular use
Adopted January 2002
Hyväksytty heinäkuussa 2002
CPMP/BPWG/3226/99
CPMP: n tehokkuustyöryhmä Viitenumero (CPMP/ EWP/ 1412/ 01)
Core SPC for Human Plasma derived Antithrombin
Asiakirjan nimi 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)
Adopted January 2002
Tilanne Hyväksytty tammikuussa 2002
Adopted July 2002
(CPMP/ EWP/ 226/ 02) EMEA: n vuosikertomus 2002
Core SPC for Human Normal Immunoglobulin for Subcutaneous and Intramuscular use
Concept paper on the development of a CPMP Note for Guidance on the clinical pharmacokinetic investigation of
Adopted July 2002
Hyväksytty maaliskuussa 2002 EMEA 2003
CPMP Efficacy Working Party
EMEA/ MB/ 055/ 02/ fi/ lopull.
Document title
Sivu 81/ 90
CPMP/EWP/226/02
Viitenumero
Concept paper on the development of a CPMP Note for Guidance on the clinical pharmacokinetic investigation of the pharmacokinetics of peptides and proteins
Asiakirjan nimi the pharmacokinetics of peptides and proteins.
Adopted March 2002
Tilanne
CPMP/EWP/225/02
(CPMP/ EWP/ 225/ 02)