natgillin/translations-raw huggingface dataset:
2
- 24.09.1999 - 17.02.2000 - 116 days
- Datscan - ioflupane - B
- 23.03.2000 - 27.06.2000 - 28.06.2000
Nycomed Amersha m UK
GmbH
- -
- 28 days
V09AB03 Diagnosis of Parkinson disease
- OJ C 216,
- - -
-D
Solution for injection 74 MBq/ ml 1 presentation
4
- 18. 12. 1998 - 16. 03. 2000 - 178 days - 272 days
- Nyracta - rosiglitazone -B
10
- -
EMEA/ MB/ 050/ 00 Årsberetning 2000
SmithKline Beecham Pharmaceuticals UK
- Ciba - L01XX - Powder for solution for - 27. 08.
A10BG02 Combination treatment of Type II diabetes mellitus
- Visudyne - Ciba -
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
L01XX - Powder for solution for
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
- Visudyne - Ciba - L01XX -
- - - -
- Visudyne - Ciba - L01XX - Powder for solution for -
2
- Visudyne - Ciba - L01XX - Powder for solution for - 27. 08. 1999 -
- Avandia - rosiglitazone -B
Vision - Treatment of age - infusion - 12. 0
SmithKline Beecham Pharmaceuticals UK
- verteporfin Vision -
- -
Treatment of age -
A10BG02 Combination treatment of Type II diabetes mellitus
- verteporfin Vision - Treatment of age - infusion -
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
- verteporfin Vision - Treatment of age - infusion - 12. 04. 2000 -
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
B
4
- CH
- -
related macular
SmithKline Beecham Pharmaceuticals UK
- 15
- -
- B - CH related macular - 15 mg - 138 days -
A10BG02 Combination treatment of Type II diabetes mellitusus
- 1
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
presentation
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
63 days -
2
10
- Myocet - doxorubicin -B
NovoMix 30 insulin aspart A
The Liposome Company US
Novo - Nordisk - DK
- Powder and pre-admixtures for concentrate for, liposomal dispersion for infusion - 50 mg - 1 presentation
A10AD Diabetes mellitus
- 30.07.1999 - 12.04.2000 - 167 days - 91 days
Suspension for injection 100 IU/ ml 8 presentations
2
24. 09. 1999 - 12. 04. 2000 - 144 days - 55 days -
Nycomed Amersham UK
Kogenate
V09AB03 Diagnosis of Parkinson disease
- Bayer - B02BD02 - Powder and solvent for - 26. 02.
- Solution for injection - 74 MBq/ml - 1 presentation
- Kogenate - Bayer -
- 18.12.1998 - 16.03.2000 - 178 days - 272 days
- Kogenate - Bayer - B02BD02 -
- - - -
- Kogenate - Bayer - B02BD02 - Powder and solvent for - 26. 02. 1999 -
10
05. 06. 2000
73 EMEA General Report 2000
Bayer
Product - Brandname - INN - Part A/B
Treatment and
Company - Name - Origin
solution for injection
Therapeutic area - ATC - Indication
16. 03. 2000 -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
04. 08. 2000
Commission - Opinion received - Date of Decision - Notification - Official Journal
- -
- Visudyne - verteporfin -B
octocog alfa A
- Ciba Vision - CH
prophylaxis of bleeding in haemophilia A
L01XX Treatment of age - related macular degeneration
250 IU, 500 IU, 1000 IU 3 presentations
- 27.08.1999 - 12.04.2000 - 138 days - 63 days
07. 08. 2000 OJ C 244, 25. 08. 2000, p.
15.05.2000 27.07.2000 31.07.2000 OJ C 244, 25.08.2000, p.
-
- NovoMix 30 - Novo Nordisk - insulin aspart - DK -A
Helixate NexGen
- A10AD - Diabetes mellitus
-
- Suspension for injection - 100 IU/ml - 8 presentations
Bayer AG
- 24.09.1999 - 12.04.2000 - 144 days - 55 days
B02BD02 Treatment and
10
Powder and solvent for solution for infusion
Kogenate Bayer octocog alfa
- -
- Bayer AG -D
26. 02. 1999 - 16. 03. 2000 -
- -
05. 06. 2000 04. 08. 2000
B02BD02 Treatment and prophylaxis of bleeding
octocog alfa A
- 26.02.1999 - 16.0 3.2000 - 182 days
-
- 05.06.2000 - 04.08.2000 - 07.08.2000
D
-A
prophylaxis of bleeding in haemophilia A
in haemophilia A
250 IU, 500 IU, 1000 IU 3 presentations
- 3 presentations
182 days - 201 days -
- 201 days
07. 08. 2000 OJ C 244, 25. 08. 2000, p.
OJ C 244, 25.08.2000, p.
Hepacare triple antigen hepatitis B
Helixate NexGen octocog alfa
-
- Bayer AG -D
J07BC Immunisation against hepatitis B
B02BD02 Treatment and prophylaxis of bleeding
Suspension for injection Monodose preparation of 1 ml contains Hepatitis B
Powder and solvent for solution for infusion 250 IU, 500 IU, 1000 IU
- - -
- 26.02.1999 - 16.0 3.2000 - 182 days
23. 10. 1998 - 16. 03. 2000 - 210 days -
- 05.06.2000 - 04.08.2000 - 07.08.2000
vaccine A
in haemophilia A
virus in adults
- 3 presentations
-
- 201 days
OJ C 244, 25. 08. 2000, p.
OJ C 244, 25.08.2000, p.
Herceptin trastuzumab A
Hepacare triple antigen hepatitis B vaccine
Roche Registrati on Ltd CH
Medeva Pharma Ltd UK
L01XC03 Treatment of patients with metastatic breast cancer whose tumour overexpress HER2
J07BC Immunisation against hepatitis B virus in adults
Powder for concentrate for solution for infusion 150 mg 1 presentation
Suspension for injection Monodose preparation of 1 ml contains Hepatitis B surface antigen S, pre -S1 and
- - - -
- 23.10.1998 - 16.03.2000 - 210 days - 293 days
26. 02. 1999 - 25. 05. 2000 - 147 days - 305 days -
- 16.05.2000 - 04.08.2000 - 07.08.2000 - OJ C 244,
14
-A
Keppra levetiracetam B
pre S2 20 µg 2 presentations
- -
10
US
- Herceptin - trastuzumab -A
N03A Adjunctive therapy in the partial onset seizures in epilepsy
Roche Registration Ltd CH
Film coated tablet 250 mg, 500 mg, 750 mg, 1000 mg 26 presentations
L01XC03 Treatment of patients with metastatic breast cancer whose tumour overexpress HER2
- - - -
- - -
26. 02. 1999 - 29. 06. 2000 - 187 days - 300 days -
Powder for concentrate for solution for infusion 150 mg 1 presentation
12
- 26.02.1999 - 25.05.2000 - 147 days - 305 days
Panretin alitretinoin B
- Keppra - levetiracetam -B
- -
- UCB S.A. - US
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi' s sarcoma
N03A Adjunctive therapy in the partial onset seizures in epilepsy
Gel 0. 1% w/ w 1 presentation
Film coated tablet 250 mg, 500 mg, 750 mg, 1000 mg 26 presentations
- - - -
- 26.02.1999 - 29.06.2000 - 187 days - 300 days
26. 02. 1999 - 29. 06. 2000 - 174 days - 313 days -
- - - -
2
31.07.2000 29.09.2000 11.10.2000 OJ C 308, 27.10.2000, p.
- - -
12
Glustin pioglitazone B
- Panretin - alitretinoin -B
Takeda Europe JP
Ligand Pharmaceuticals Ltd US
A10BG03 Combination treatment of Type II Diabetes mellitus
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi's sarcoma
- - -
- Gel - 0.1 %w/w - 1 presentation
Tablet 15 mg, 30 mg 6 presentations
- 26.02.1999 - 29.06.2000 - 174 days - 313 days
31. 07. 2000 11. 10. 2000 17. 10. 2000 OJ C 337, 28. 11. 2000. p.
31.07.2000 11.10.2000 18.10.2000 OJ C 337, 28.11.2000. p.
Actos pioglitazone B
- Glustin - pioglitazone -B
Takeda Europe JP
Takeda Europe JP
A10BG03 Combination treatment of Type II Diabetes mellitus
A10BG03 Combination treatment of Type II Diabetes mellitus
Tablet 15 mg, 30 mg 6 presentations
- Tablet - 15 mg, 30 mg - 6 presentations
- - - -
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
23. 04. 1999 - 29. 06. 2000 - 178 days - 251 days -
- - - -
31. 07. 2000 13. 10. 2000 19. 10. 2000 OJ C 337, 28. 11/ 00. p.
31.07.2000 11.10.2000 17.10.2000 OJ C 337, 28.11.2000. p.
- - -
- Actos - pioglitazone -B
Glaxo Group UK
Takeda Europe JP
J05AE05 Treatment of HIV infected adults and children
A10BG03 Combination treatment of Type II Diabetes mellitus
- - -
- Tablet - 15 mg, 30 mg - 6 presentations
Capsule, soft, Oral solution 50 mg, 150 mg, 15 mg/ ml 4 presentations
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
09. 08. 2000 20. 10. 2000 25. 10. 2000 OJ C 337, 28. 11. 2000. p.
31.07.2000 13.10.2000 19.10.2000 OJ C 337, 28.11/00. p.
EMEA/ MB/ 050/ 00 Årsberetning 2000
- Agenerase - amprenavir -B
Side 75/ 93
- Glaxo Group - UK
Infanrix hexa - - JO7CA - Powder and suspension for - 30. 07. 1999 - 09. 08.
J05AE05 Treatment of HIV infected adults and children
- Infanrix hexa - -
- Capsule, soft, Oral solution - 50 mg, 150 mg, 15 mg/ml - 4 presentations
JO7CA - Powder and suspension f
- 20.11.1998 - 29.06.2000 - 219 days - 324 days
- Infanrix hexa - - JO7CA -
- - - -
- Infanrix hexa - - JO7CA - Powder and suspension for - 30. 07. 1999 -
2
09. 08. 2000
74 EMEA General Report 2000
-
Product - Brandname - INN - Part A/B
Hep B- IPV
Company - Name - Origin
SmithKli - Immunisation suspension for injection - 29. 0
Therapeutic area - ATC - Indication
- Hep B- IPV SmithKli -
Presentation - Form - Dosage - Number of presentations
- Hep B- IPV SmithKli - Immunisation suspension for injection -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- Hep B- IPV SmithKli - Immunisation suspension for injection - 29. 06. 2000 -
Commission - Opinion received - Date of Decision - Notification - Official Journal
23. 10. 2000
- -
HIB vacci
Infanrix hexa Hep B-IPV HIB vaccine
ne ne
-
against
SmithKline Beecham Biologicals
Diphtheria toxoid, adsorbed - 201 days - 26. 10
JO7CA Immunisation against Haemophilus influenza,
- Diphtheria toxoid, adsorbed -
30IU
- Diphtheria toxoid, adsorbed - 201 days -
- 30.07.1999 - 29.06.2000 - 201 days
26. 10. 2000
- 09.08.2000 - 23.10.2000 - 26.10.2000
A
-A
Beecham
S.A.
Haemophilus
Diphtheria, Pertussis,
- A Beecham Haemophilus ≥ 30IU -
Tetanus toxoid, adsorbed ≥
- A Beecham Haemophilus ≥ 30IU - 132 days -
- 132 days
OJ C 337,
- OJ C 337,
Biologica ls S. A.
-B
influenza, Diphtheria,
Tetanus, HepB and Poliomyelitis
Tetanus toxoid, adsorbed ≥ 40IU
40IUPertussis toxoid, adsorbed 25 µg Filamentous haemagglutinin, adsorbed 25 µg Pertactin, adsorbed 8 µg Recombinant Hepatitis B surface Antigen (S protein), adsorbed 10 µg Inactivated type 1 Poliovirus 40 DU Inactivated type 2 Poliovirus 8 DU Inactivated type 3 Poliovirus 32 DU Conjugate of Haemophilus influenzae type b capsular polysaccharide (PRP) 10 µg and Tetanus toxoid (T), adsorbed (PRP-T) 20-40 µg
28. 11. 2000. p.
28.11.2000. p.
16 presentations
16 presentations
Infanrix penta Hep B- IPV vaccine
Infanrix penta - Hep B-IPV vaccine
-
SmithKline Beecham Biologicals
- SmithKli - ne
- -
JO7CA Primary and booster
JO7CA Primary and booster immunisation of infants
Suspension for injection Diphtheria toxoid, adsorbed ≥ 30IU
- Suspension for injection - Diphtheria toxoid, adsorbed ≥ 30IU
30. 07. 1999 - 29. 06. 2000 - 201 days -
- 30.07.1999 - 29.06.2000 - 201 days
09. 08. 2000 23. 10. 2000 26. 10. 2000
- 09.08.2000 - 23.10.2000 - 26.10.2000
A
S.A.
immunisation of infants against Diphtheria,
against Diphtheria,
Tetanus toxoid, adsorbed ≥ 40IU Pertussis toxoid, adsorbed
Tetanus toxoid, adsorbed ≥
132 days -
- 132 days
OJ C 337, 28. 11. 2000. p.
- OJ C 337,
8 presentations
8 presentations
Hexavac Comb vaccine A
Pasteur
- -
- JO7CA
Pasteur - Merieux - MSD F
Merieux MSD - -F
JO7CA Immunisation Diphtheria, pertussis, Tetanus, HepB, Poliomyelitis, Haemophilus influenza
Immunisation Diphtheria, pertussis, Tetanus, HepB, Poliomyelitis, Haemophilus influenza
Suspension for injection Purified diphtheria toxoid, adsorbed ≥ 20 IU, Purified tetanus toxoid, adsorbed ≥ 40 IU Purified pertussis toxoid, adsorbed 25 µg Purified pertussis filamentous haemagglutinin adsorbed 25 µg Recombinant hepatitis B surface antigen 5. 0 µg Inactivated poliomyelitis virus: type 1 40 D units type 2 8 D units type 3 32 D units Haemophilus influenzae polysaccharide type b 12 µg conjugated to tetanus toxoid (24 µg)
Purified diphtheria toxoid, adsorbed ≥ 20 IU, Purified tetanus toxoid, adsorbed ≥ 40 IU Purified pertussis toxoid, adsorbed 25 µg Purified pertussis filamentous haemagglutinin adsorbed 25 µg Recombinant hepatitis B surface antigen 5.0 µg Inactivated poliomyelitis virus: type 1 40 D units type 2 8 D units type 3 32 D units Haemophilus influenzae polysaccharide type b 12 µg conjugated to tetanus toxoid (24 µg)
30. 07. 1999 - 26. 06. 2000 - 180 days - 153 days -
- 26.06.2000 - 180 days - 153 days
10. 08. 2000 23. 10. 2000 26. 10. 2000 OJ C 337, 28. 11. 2000. p.
23.10.2000 26.10.2000 OJ C 337, 28.11.2000. p.
- Luveris -
- Luveris - lutropin alfa -A
- Luveris - Ares -
- -
- Luveris - Ares - G03G -
Ares Serono (Europe) Ltd CH
follicular development in women with servere Leng HEng and FSH deficiency
G03G Stimulation of follicular development in women - 75 with servere Leng HEng and FSH deficiency
75 IU - 6 presentations -
- Powder and solvent for solution for injection IU - 6 presentations
192 days - 200 days -
- 25.06.1999 - 27.07.2000 - 192 days - 200 days
30. 11. 2000 OJ C 2, 05. 01. 2001, p.
07.09.2000 29.11.2000 30.11.2000 OJ C 2, 05.01.2001, p.
-
75 EMEA General Report 2000
NeoSpect - - V09IA05 - Kit for - 20. 11. 1998 - 28. 08.
Product - Brandname - INN - Part A/B
- NeoSpect - -
Company - Name - Origin
V09IA05 - Kit for
Therapeutic area - ATC - Indication
- NeoSpect - - V09IA05 -
Presentation - Form - Dosage - Number of presentations
- NeoSpect - - V09IA05 - Kit for -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- NeoSpect - - V09IA05 - Kit for - 20. 11. 1998 -
Commission - Opinion received - Date of Decision - Notification - Official Journal
28. 08. 2000
- NeoSpect - depreotide
Nycomed - Scintigraphic radiopaharmaceutical - 27. 07
Nycomed Imaging A/S
- depreotide Nycomed -
- -
Scintigraphic
V09IA05 Scintigraphic imaging
- depreotide Nycomed - Scintigraphic radiopaharmaceutical -
-
- depreotide Nycomed - Scintigraphic radiopaharmaceutical - 27. 07. 2000 -
Kit for radiopaharmaceutical preparation
29. 11. 2000
- 20.11.1998 - 27.07.2000
B
-B
A/ S NO
NO
suspected malignant tumours in the lung
of suspected malignant tumours in the lung
47 µg 2 presentations
47 µg 2 presentations
404 days
- 204 days - 404 days
OJ C 2, 05. 01. 2001, p.
04.12.2000 OJ C 2, 05.01.2001, p.
Trizivir lamivudine zidovudine abacavir B
- Trizivir - lamivudine zidovudine abacavir -B
Glaxo - Group - UK
Glaxo Group UK
J05AF30 Treatment of HIV- 1 infected patients
J05AF30 Treatment of HIV -1 infected patients
Film coated tablet 150/ 300/ 300 mg 3 presentations
Film coated tablet 150/300/300 mg 3 presentations
21. 01. 2000 29. 06. 2000 158 days 0 days
- 21.01.2000 - 29.06.2000 - 158 days - 0 days
13. 10. 2000 08. 12. 2000
13.10.2000 08.12.2000
Nutropin AQ somatropin A
- Nutropin AQ - - somatropin
Schwarz - Pharma - AG D
Schwarz Pharma AG
H01AC01 Treatment of growth failure
- H01AC01 - Treatment of growth
- - -
- 21.10.1999 - 21.09.2000
Solution for injection 5 mg/ ml 2 presentations
- 05.1 2.2000 -
- - - -
- D
21. 10. 1999 21. 09. 2000 174 days 186 days
failure
- - - -
- 2 presentations
05. 12. 2000
- 174 days - 186 days
Neurobloc botulinum toxin type B B
- Neurobloc - botulinum
Elan - Pharma - Internatio nal Ltd UK
Elan Pharma International
M03AX01 Treatment of cervical dystonia
M03AX01 Treatment of cervical
Solution for injection 5000 IU/ ml 3 presentations
- Solution for injection - 5000 IU/ml
- - - -
- 27.08.1999 - 21.09.2000
- - - -
- 21.11.2000 -
21. 11. 2000
toxin type B
- -
Ltd
-
cancer
- Boehring -
- 3 presentations
B01AD Treatment of
- 187 days
Powder and solvent for solution for injection
-B
- -
- UK
24. 09. 1999 21. 09. 2000
- 229 days
27. 11. 2000
- Tenecteplase - tenecteplase -A
er Ingelhei m Internatio nal GmbH
Boehringer Ingelheim International GmbH
suspected myocardial infarction
B01AD Treatment of suspected myocardial infarction
6000 IU, 8000 IU, 10000 IU 3 presentations
Powder and solvent for solution for injection 6000 IU, 8000 IU, 10000 IU 3 presentations
176 days 215 days
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
- -
- 27.11.2000 - - -
D
-D
Metalyse tenecteplase
- Metalyse - tenecteplase -A
Powder and solvent for solution for injection
Boehringer Ingelheim International GmbH
- -
-D
Azomyr desloratadine
- Azomyr - desloratadine -B
SP - Europe -
- SP Europe - US
symptoms associated with seasonal allergic rhinitis
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
13 presentations
- Film coated tablet - 5 mg - 13 presentations
201 days 159 days
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
- -
- 06.11.2000 - - -
Opulis desloratadine
- Opulis - desloratadine -B
Allex desloratadine
- Allex - desloratadine -B
Aerius desloratadine
- Aerius - desloratadine -B
- SP - R06AX27 - Film coated tablet - 24. 09. 1
- 06.11.2000 - - -
- Neoclarityn - SP -
- Neoclarityn - desloratadine -B
- Neoclarityn - SP - R06AX27 -
- SP Europe - US
- desloratadine Europe - Relief of -
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
- desloratadine Europe - Relief of - 5 mg -
- Film coated tablet - 5 mg - 13 presentations
- B - US symptoms -
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
- B - US symptoms - 13 presentations -
- 06.11.2000 - - -
Xeloda -
- Xeloda - capecitabine -B
Roche -
- Roche Registration Ltd - CH
Registrati - treatment of - 150 mg, 500 mg
L01BC treatment of metastatic colorectal cancer
- capecitabine Registrati -
- Film coated tablet - 150 mg, 500 mg - 2 presentations
- capecitabine Registrati - treatment of -
- 21.10.1999 - 21.09.2000 - 201 days - 159 days
- capecitabine Registrati - treatment of - 150 mg, 500 mg -
- 20.11.2000 - - -
- B on Ltd metastatic - 2 presentations -
Ovidrelle chorio- gonadotropin alfa
colorectal cancer
Ares Serono (Europe) Ltd CH
159 days
G03GA01 Assisted reproductive techniques sus as in vitro fertilisation (IVF)
-
- - -
-
Powder and solvent for solution for injection 250 µg 6 presentations
- Ares -
- 21.10.1999 - 21.09.2000 - 174 days - 186 days
G03GA01 -
- 23.11.2000 - - -
23. 11. 2000
76 EMEA General Report 2000
chorio -
Company - Name - Origin
Serono - Assisted solution for injection
Therapeutic area - ATC - Indication
- chorio - Serono -
Presentation - Form - Dosage - Number of presentations
- chorio - Serono - Assisted solution for injection -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
reproductive techniques sus as in vitro fertilisation (IVF)
Commission - Opinion received - Date of Decision - Notification - Official Journal
Prevenar Prevenarpneu mococcal conjugate vaccine A
- Prevenar - Prevenarp- neumococcal conjugate vaccine -A
US
- Wyeth- Lederle Vaccines S.A. - US
J07AL Active immunisation of infants and children against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae
- J07AL - Active immunisation of infants and children against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae
Suspension for injection A monodose preparation of 0. 5 ml contains Streptococcus pneumoniae: saccharide suspension of Serotype 4 2 µg Serotype 9V 2 µg Serotype 14 2 µg Serotype 18C 2 µg Serotype 19F 2 µg Serotype 23F 2 µg Serotype 6B 4 µg Conjugated to CRM197 carrier protein ∼ 20 µg
- Suspension for injection - A monodose preparation of 0.5 ml contains Streptococcus pneumoniae: saccharide suspension of Serotype 4 2 (gSerotype 9V 2 µg Serotype 14 2 µg Serotype 18C 2 µg Serotype 19F 2 µg Serotype 23F 2 µg Serotype 6B 4 µg Conjugated to CRM197 carrier protein - 20 µg - 2 presentations
19. 11. 1999 21. 09. 2000 205 days 125 days
- 19.11.1999 - 21.09.2000 - 205 days - 125 days
- - - -
- 21.11.2000 - - -
Prandin replaglinide B
- Prandin - replaglinide -B
Novo Nordisk DK
Novo Nordisk DK
A10BX02 Treatment of Type II diabetes mellitus
A10BX02 Treatment of Type II diabetes mellitus
Tablet 0. 5 mg, 1. 0 mg, 2. 0 mg, 18 presentations
- Tablet - 0.5 mg, 1.0 mg, 2.0 mg, - 18 presentations
30. 06. 2000 21. 09. 2000 91 days 0 days
- 30.06.2000 - 21.09.2000 - 91 days - 0 days
- - - -
- 26.10.2000 - - -
Rapamune sirolimus B
- Rapamune - sirolimus -B
Wyeth Europe Ltd US
Wyeth Europe Ltd US
L04AA10 Prophylaxis of organ rejection in patient receiving renal transplants
L04AA10 rophylaxis of organ rejection in patient receiving renal transplants
Oral solution 1 mg/ ml 5 presentations
- Oral solution - 1 mg/ml - 5 presentations
29. 01. 1999 16. 11. 2000 214 days 393 days
- 29.01.1999 - 16.11.2000 - 214 days - 393 days
- - - -
- 08.01.2001 - - -
Targretin bexarotene B
- Targretin - bexarotene -B
Ligand Pharmac euticals Ltd US
Ligand Pharmaceuticals Ltd US
L01XX25 Treatment of skin manifestations of advanced stage of cutaneous T- cell Lymphoma
L01XX25 Treatment of skin manifestations of advanced stage of cutaneous T -cell Lymphoma
Capsule, soft 75 mg 1 presentation
- Capsule, soft - 75 mg - 1 presentation
17. 12. 1999 16. 11. 2000 197 days 159 days
- Fasturtec
- - - -
-
Fasturtec rasburicase A
- Powder and solvent for
Sanofi F
- rasburicase -A
V03AF07 Treatment of tumor induced hpreuricemia
Treatment of tumor induced hpreuricemia
Powder and solvent for solution for infusion 1. 5 mg/ ml 1 presentation
solution for infusion 1.5 mg/ml 1 presentation
21. 01. 2000 16. 11. 2000 177 days 118 days
- 16.11.2000 - 177 days - 118 days
Trazec nateglinide B
- Trazec - nateglinide -B
Novartis Europhar m Ltd CH
Novartis Europharm Ltd CH
A10B03 Combination treatment of diabetes mellitus Type II
A10B03 Combination treatment of diabetes mellitus Type II
Film coated tablet 60 mg, 120 mg, 180 mg 21 presentations
- Film coated tablet - 60 mg, 120 mg, 180 mg - 21 presentations
31. 10. 2000 14. 12. 2000 58 days 0 days
- 31.10.2000 - 14.12.2000 - 58 days - 0 days
Vaniqa eflornithine B
- Vaniqa - eflornithine -B
Bristol Myers Squibb Pharma EEIG
Bristol Myers Squibb Pharma EEIG US
D11AX Treatment of facial hirsutism
D11AX Treatment of facial hirsutism
Cream 11. 5% 3 presentations
- Cream - 11.5% - 3 presentations
03. 01. 2000 14. 12. 2000 182 days 157 days
- 03.01.2000 - 14.12.2000 - 182 days - 157 days
Starlix nateglinide B
- Starlix - nateglinide -B
A10BX03 Combination treatment of diabetes mellitus Type II
A10BX03 Combination treatment of diabetes mellitus Type II
21. 01. 2000 14. 12. 2000 179 days 144 days
- 21.01.2000 - 14.12.2000 - 179 days - 144 days
Zometa zoledronic acid
- Zometa - zoledronic
Novartis Europhar m Ltd
Novartis Europharm
M05BA08 Treatment of tumour induced
M05BA08 Treatment of tumour
Powder and solvent for solution for infusion 4 mg
induced hypercalcaemia - 4 mg
21. 01. 2000 14. 12. 2000 177 days
- 177 days
-
- B
CH
- CH
3 presentations
- 3 presentations
146 days
- 146 days
- Kaletra -
- Kaletra
Abbott -
- Abbott
J05A
- J05A
- Capsule, soft, Oral solution -
- Capsule, soft, Oral solution
18. 07. 2000
- 18.07.2000
- lopinavir / Laborato -
lopinavir/ ritonavir
ritonavir
Laboratories US
ries
-
treatment in
Combination treatment - 133.3/33.3 mg, 80/20 mg/ml in combination of HIV- - 3 presentations
145 days
- 14.12.2 000 - 145 days
-
-B
combination of HIV- 1 infected patients
1 infected patients
0 days
- 0 days
SonoVue sulphur hexafluoride B
- SonoVue - sulphur hexafluoride -B
I
- Bracco S.P.A. -I - V08DA
V08DA Ultrasound agent to enhance the echogenicity of the blood
Ultrasound agent to enhance the echogenicity of the blood
Powder for injection 8 µl/ ml 2 presentations
- Powder for injection - 8 µl/ml - 2 presentations
27. 08. 1999 14. 12. 2000 194 days 276 days
- 27.08.1999 - 14.12.2000 - 194 days - 276 days
Osteogenis Protein 1
Osteogenis Protein 1 Howmedia International Osteogenic Protein-1 BMP-7
Stryker - Biotech
Stryker - Biotech US
union of tibia of at least 9 month duration
M09AX Treatment of non-union of tibia of at least 9 month duration
3. 5 mg 1 presentation
- Powder for suspension for implantation - 3.5 mg - 1 presentation
201 days 297 days
- 30.07.1999 - 14.12.2000 - 201 days - 297 days
EMEA/ MB/ 050/ 00 Årsberetning 2000 Bilag 9 CVMP- udtalelser i 2000 om veterinærlægemidler
77 EMEA General Report 2000
Side 79/ 93
Annex 9:
Centraliserede ansøgninger
CVMP opinions in 2000 on medicinal products for veterinary use Centralised applications
Lægemiddel - Handelsnavn
Product - Brandname - INN - Part A/B
Firma - Navn
Company - Name - Origin
Behandlingsomr. - Målarter
Therapeutic area - Target species - Indication
Præsentation - Form
Presentation - Form - Dosage - Number of presentations
Kommissionen - Udtalelse modtaget
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
- Antal præsentationer
Commission - Opinion received - Date of Decision - Notification - Official Journal
Ibraxion Inactivated vaccine Part A
Ibraxion Inactivated vaccine Part A
Merial F
Merial F
Cattle Vaccine against IBR (QJ57DA)
Cattle Vaccine against IBR (QJ57DA)
Emulsion for injection 2 ml 1
Emulsion for injection 2 ml 1
- 17. 11. 1998 - 10. 11. 1999 - 210 days - 176 days
- 17.11.1998 - 10.11.1999 - 210 days - 176 days
- 10. 12. 1999 - 09. 03.
- - - -
00 - 10. 03.
10.12.1999 09.03.
00 - OJ C 95, 04. 04. 2000
00 OJ C 95, 04.04.2000
Metacam Meloxicam Part B extension
Metacam Meloxicam Part B extension
Boehringer Ingelheim D
Boehringer Ingelheim D
Dogs Initiation therapy for alleviation of pain and inflammation (QM01AC06)
Dogs Initiation therapy for alleviation of pain and inflammation (QM01AC06)