natgillin/translations-raw huggingface dataset:
- Keppra - levetiracetam -B
30. 07. 1999 - 29. 06. 2000 -
- UCB S.A. - US
09. 08. 2000 23. 10. 2000
N03A Adjunctive therapy in the partial onset seizures in epilepsy
Hep B- IPV
- - -
ne
Film coated tablet 250 mg, 500 mg, 750 mg, 1000 mg 26 presentations
booster
- 26.02.1999 - 29.06.2000 - 187 days - 300 days
Tetanus toxoid, adsorbed ≥
12
201 days -
- Panretin - alitretinoin -B
26. 10. 2000
Ligand Pharmaceuticals Ltd US
vaccine A
- -
Beecham Biologic
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi's sarcoma
immunisation of infants against
- Gel - 0.1 %w/w - 1 presentation
40IU
- 26.02.1999 - 29.06.2000 - 174 days - 313 days
-
- - - -
132 days -
31.07.2000 11.10.2000 18.10.2000 OJ C 337, 28.11.2000. p.
OJ C 337, 28. 11. 2000. p.
- Glustin - pioglitazone -B
als S. A. - B
Takeda Europe JP
8 presentations
A10BG03 Combination treatment of Type II Diabetes mellitus
Hexavac Comb
- Tablet - 15 mg, 30 mg - 6 presentations
- Pasteur Merieux
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
JO7CA Immunisation
31.07.2000 11.10.2000 17.10.2000 OJ C 337, 28.11.2000. p.
Suspension for injection Purified diphtheria toxoid, adsorbed ≥ 20 IU,
- Actos - pioglitazone -B
30. 07. 1999 - 26. 06. 2000 -
Takeda Europe JP
26. 10. 2000
A10BG03 Combination treatment of Type II Diabetes mellitus
- F
- Tablet - 15 mg, 30 mg - 6 presentations
pertussis,
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
Purified tetanus toxoid, adsorbed ≥ 40 IU
31.07.2000 13.10.2000 19.10.2000 OJ C 337, 28.11/00. p.
Tetanus, HepB, Poliomyelitis, Haemophilus influenza
- Agenerase - amprenavir -B
EMEA/ MB/ 050 Vuosikertomus 2000
- Glaxo Group - UK
sivu 71/ 85
J05AE05 Treatment of HIV infected adults and children
Luveris - Ares - G03G - Powder and solvent for - 25. 06. 1999 - 07. 09.
- Capsule, soft, Oral solution - 50 mg, 150 mg, 15 mg/ml - 4 presentations
Ares - G03G - Powder and solvent for - 25. 0
- 20.11.1998 - 29.06.2000 - 219 days - 324 days
- Luveris - Ares -
- - - -
- Luveris - Ares - G03G -
2
- Luveris - Ares - G03G - Powder and solvent for - 25. 06. 1999 -
74 EMEA General Report 2000
07. 09. 2000
Product - Brandname - INN - Part A/B
lutropin alfa
Company - Name - Origin
Serono - Stimulation of solution for injection - 27. 07
Therapeutic area - ATC - Indication
- lutropin alfa Serono -
Presentation - Form - Dosage - Number of presentations
Stimulation of
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- lutropin alfa Serono - Stimulation of solution for injection -
Commission - Opinion received - Date of Decision - Notification - Official Journal
- lutropin alfa Serono - Stimulation of solution for injection - 27. 07. 2000 -
Infanrix hexa Hep B-IPV HIB vaccine
29. 11. 2000
SmithKline Beecham Biologicals
A
- -
(Europe)
JO7CA Immunisation against Haemophilus influenza,
follicular
30IU
- A (Europe) follicular - 75 IU -
- 30.07.1999 - 29.06.2000 - 201 days
- A (Europe) follicular - 75 IU - 192 days -
- 09.08.2000 - 23.10.2000 - 26.10.2000
30. 11. 2000
S.A.
Ltd CH
Tetanus toxoid, adsorbed ≥
development in women with servere Leng HEng and FSH deficiency
- 132 days
-
- OJ C 337,
6 presentations
-B
-
Tetanus, HepB and Poliomyelitis
200 days
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
-
16 presentations
NeoSpect depreotide B
Infanrix penta - Hep B-IPV vaccine
- Nycome - d Imaging A/ S NO
SmithKline Beecham Biologicals
V09IA05 Scintigraphic imaging of suspected malignant tumours in the lung
- Suspension for injection - Diphtheria toxoid, adsorbed ≥ 30IU
Kit for radiopaharmaceutical preparation 47 µg 2 presentations
-A
- - - -
Tetanus toxoid, adsorbed ≥
20. 11. 1998 27. 07. 2000 204 days 404 days
- 132 days
- - - -
8 presentations
Trizivir lamivudine zidovudine abacavir B
- Hexavac
Glaxo - Group - UK
Pasteur
Film coated tablet 150/ 300/ 300 mg 3 presentations
- JO7CA
- - - -
- Suspension for injection
21. 01. 2000 29. 06. 2000 158 days 0 days
- 30.07.1999
- - - -
- 10.08.2000
13. 10. 2000 08. 12. 2000
- Comb vaccine -A
- - -
Merieux MSD - -F
Nutropin AQ somatropin A
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)
Schwarz - Pharma - AG
- 26.06.2000 - 180 days - 153 days
H01AC01 Treatment of growth failure
2
Solution for injection 5 mg/ ml 2 presentations
8 presentations
21. 10. 1999 21. 09. 2000 174 days
- Luveris - lutropin alfa -A
- - -
Ares Serono (Europe) Ltd CH
186 days
G03G Stimulation of follicular development in women - 75 with servere Leng HEng and FSH deficiency
Neurobloc botulinum toxin type B B
- Powder and solvent for solution for injection IU - 6 presentations
- Elan - Pharma - Internati onal Ltd - UK
- 25.06.1999 - 27.07.2000 - 192 days - 200 days
M03AX01 Treatment of cervical dystonia
3
Solution for injection - 5000 IU/ ml - 3 presentations - -
75 EMEA General Report 2000
21. 11. 2000
Product - Brandname - INN - Part A/B
- Tenecteplase - -
Company - Name - Origin
- Tenecteplase - - B01AD -
Therapeutic area - ATC - Indication
- Tenecteplase - - B01AD - Powder and solvent for -
Presentation - Form - Dosage - Number of presentations
- Tenecteplase - - B01AD - Powder and solvent for - 24. 09. 1999 -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- tenecteplase Boehring -
Commission - Opinion received - Date of Decision - Notification - Official Journal
- tenecteplase Boehring - Treatment of solution for injection -
- NeoSpect - depreotide
- A er suspected - 6000 IU, 8000 IU, 10000 -
Nycomed Imaging A/S
myocardial infarction
V09IA05 Scintigraphic imaging
IU 3 presentations
Kit for radiopaharmaceutical preparation
Metalyse - - B01AD - Powder and solvent for - 24. 09. 1999 - 27. 11.
- 20.11.1998 - 27.07.2000
- Metalyse - - B01AD -
28.08.2000 29.11.2000
- tenecteplase Boehring -
NO
er
of suspected malignant tumours in the lung
suspected
47 µg 2 presentations
Ingelhei m Internati onal GmbH
- 204 days - 404 days
myocardial infarction
3
IU 3 presentations
Glaxo Group UK
215 days
J05AF30 Treatment of HIV -1 infected patients
- SP - R06AX27 - Film coated tablet - 24. 09. 1
- - -
- Azomyr - SP -
Film coated tablet 150/300/300 mg 3 presentations
R06AX27 - Film coated tablet
- 21.01.2000 - 29.06.2000 - 158 days - 0 days
- Azomyr - SP - R06AX27 -
- - - -
- Azomyr - SP - R06AX27 - Film coated tablet -
13.10.2000 08.12.2000
06. 11. 2000
- Nutropin AQ - - somatropin
desloratadine
Schwarz Pharma AG
Europe - Relief of - 5 mg
- H01AC01 - Treatment of growth
- desloratadine Europe -
- Solution for injection - 5 mg/ml
Relief of - 5 mg
- 21.10.1999 - 21.09.2000
- desloratadine Europe - Relief of -
- 05.1 2.2000 -
- desloratadine Europe - Relief of - 5 mg -
- D
-
failure
symptoms - 13 pr
- 2 presentations
- B - US symptoms - 13 presentations -
- 174 days - 186 days
201 days
- Neurobloc - botulinum
associated with seasonal allergic rhinitis
Elan Pharma International
159 days
M03AX01 Treatment of cervical
Opulis desloratadine
- Solution for injection - 5000 IU/ml
-
- 27.08.1999 - 21.09.2000
SP - Europe -
- 21.11.2000 -
R06AX27 - Relief of -
toxin type B
Film coated tablet 5 mg
Ltd
- -
cancer
24. 09. 1999 21. 09. 2000
- 3 presentations
- -
- 187 days
06. 11. 2000
-B
B
- UK
-
- 229 days
13 presentations
- Tenecteplase - tenecteplase -A
201 days 159 days
B01AD Treatment of suspected myocardial infarction
Allex desloratadine
Powder and solvent for solution for injection 6000 IU, 8000 IU, 10000 IU 3 presentations
SP - Europe -
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
R06AX27 - Relief of -
- 27.11.2000 - - -
- -
-D
- -
- Metalyse - tenecteplase -A
06. 11. 2000
Boehringer Ingelheim International GmbH
B
B01AD Treatment of suspected myocardial infarction
symptoms - associated with seasonal allergic rhinitis
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
201 days 159 days
- Azomyr - desloratadine -B
Aerius desloratadine
- SP Europe - US
SP - Europe -
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
symptoms - associated with seasonal allergic rhinitis
- Film coated tablet - 5 mg - 13 presentations
13 presentations
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
201 days 159 days
- 06.11.2000 - - -
- -
- Opulis - desloratadine -B
EMEA/ MB/ 050 Vuosikertomus 2000
- SP Europe - US
sivu 72/ 85
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
- SP - R06AX27 - Film coated tablet - 24. 09. 1
- Film coated tablet - 5 mg - 13 presentations
R06AX27 - Film coated tablet
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
- Neoclarityn - SP - R06AX27 -
- 06.11.2000 - - -
- Neoclarityn - SP - R06AX27 - Film coated tablet -
- Allex - desloratadine -B
- Neoclarityn - SP - R06AX27 - Film coated tablet - 24. 09. 1999 -
- SP Europe - US
06. 11. 2000
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Europe - Relief of - 5 mg
- Film coated tablet - 5 mg - 13 presentations
- desloratadine Europe -
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
- desloratadine Europe - Relief of -
- 06.11.2000 - - -
- desloratadine Europe - Relief of - 5 mg -
- Aerius - desloratadine -B
- B - US symptoms -
- SP Europe - US
- B - US symptoms - 13 presentations -
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
associated with seasonal allergic rhinitis
- Film coated tablet - 5 mg - 13 presentations
-
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
159 days
- 06.11.2000 - - -
Xeloda -
- Neoclarityn - desloratadine -B
Roche -
- SP Europe - US
L01BC -
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Registrat - treatment of - 150 mg, 500 mg
- Film coated tablet - 5 mg - 13 presentations
- capecitabine Registrat -
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
- capecitabine Registrat - treatment of -
- 06.11.2000 - - -
- capecitabine Registrat - treatment of - 150 mg, 500 mg -
- Xeloda - capecitabine -B
- B ion Ltd metastatic -
- Roche Registration Ltd - CH
- B ion Ltd metastatic - 2 presentations -
L01BC treatment of metastatic colorectal cancer
colorectal cancer
- Film coated tablet - 150 mg, 500 mg - 2 presentations
Serono - Assisted solution for injection
- 21.10.1999 - 21.09.2000 - 201 days - 159 days
- chorio - Serono -
- 20.11.2000 - - -
- chorio - Serono - Assisted solution for injection -
Ovidrelle chorio- gonadotropin alfa
gonadotropin alfa A
Ares Serono (Europe) Ltd CH
(Europe) Ltd CH
G03GA01 Assisted reproductive techniques sus as in vitro fertilisation (IVF)
reproductive techniques sus as in vitro fertilisation (IVF)
Powder and solvent for solution for injection 250 µg 6 presentations
250 µg 6 presentations
- 21.10.1999 - 21.09.2000 - 174 days - 186 days
174 days 186 days
- 23.11.2000 - - -
- -
76 EMEA General Report 2000
Prevenar Prevenarpneu mococcal conjugate vaccine
Product - Brandname - INN - Part A/B
US
Company - Name - Origin
- -
Therapeutic area - ATC - Indication
J07AL Active immunisation of infants and children against
Presentation - Form - Dosage - Number of presentations
Suspension for injection A monodose preparation of 0. 5 ml contains Streptococcus pneumoniae: saccharide suspension of Serotype 4 2 µg
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- - - -
Commission - Opinion received - Date of Decision - Notification - Official Journal
19. 11. 1999 21. 09. 2000 205 days 125 days
- Prevenar - Prevenarp- neumococcal conjugate vaccine -A
invasive disease, pneumonia and otitis media caused by
- Wyeth- Lederle Vaccines S.A. - US
Serotype 9V 2 µg Serotype 14 2 µg Serotype 18C 2 µg
- J07AL - Active immunisation of infants and children against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae
Streptococcus pneumoniae
- 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
Serotype 19F 2 µg Serotype 23F 2 µg Serotype 6B 4 µg Conjugated to CRM197 carrier protein ∼ 20 µg
- 19.11.1999 - 21.09.2000 - 205 days - 125 days
2 presentations
- 21.11.2000 - - -
- - -
- Prandin - replaglinide -B
Prandin replaglinide B
- 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
L04AA10 rophylaxis of organ rejection in patient receiving renal transplants
L04AA10 Prophylaxis 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 Pharmaceuticals Ltd US
Ligand Pharmac euticals 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
- Fasturtec
17. 12. 1999 16. 11. 2000 197 days 159 days
- Powder and solvent for
Fasturtec rasburicase A
- rasburicase -A
Sanofi F
Treatment of tumor induced hpreuricemia
V03AF07 Treatment of tumor induced hpreuricemia
solution for infusion 1.5 mg/ml 1 presentation
Powder and solvent for solution for infusion 1. 5 mg/ ml 1 presentation
- 16.11.2000 - 177 days - 118 days
21. 01. 2000 16. 11. 2000 177 days 118 days
- Trazec - nateglinide -B
Trazec nateglinide B
Novartis Europharm Ltd CH
Novartis Europhar m Ltd CH
- 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 US
Bristol Myers Squibb Pharma EEIG
- 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
- 21.01.2000 - 14.12.2000 - 179 days - 144 days
21. 01. 2000 14. 12. 2000 179 days 144 days
- Zometa - zoledronic
Zometa zoledronic acid
Novartis Europharm
Novartis Europhar m Ltd
M05BA08 Treatment of tumour
M05BA08 Treatment of tumour induced
induced hypercalcaemia - 4 mg
Powder and solvent for solution for infusion 4 mg
- 177 days
21. 01. 2000 14. 12. 2000 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 -
- 18.07.2000
18. 07. 2000
lopinavir/ ritonavir
lopinavir /
Laboratories US
Combination
Combination treatment - 133.3/33.3 mg, 80/20 mg/ml in combination of HIV- - 3 presentations
treatment in
- 14.12.2 000 - 145 days
145 days
1 infected patients
combination of
- 0 days
0 days
- SonoVue - sulphur hexafluoride -B
- SonoVue - Bracco -
- Bracco S.P.A. -I - V08DA
- SonoVue - Bracco - V08DA -
Ultrasound agent to enhance the echogenicity of the blood
to enhance the - echogenicity of the blood
- Powder for injection - 8 µl/ml - 2 presentations
2 presentations - -
- 27.08.1999 - 14.12.2000 - 194 days - 276 days
194 days 276 days
Osteogenis Protein 1 Howmedia International Osteogenic Protein-1 BMP-7
Protein 1
Stryker - Biotech US
implantation -
M09AX Treatment of non-union of tibia of at least 9 month duration
non- union of tibia of at least 9 month duration
- Powder for suspension for implantation - 3.5 mg - 1 presentation
3. 5 mg - 1 presentation -
- 30.07.1999 - 14.12.2000 - 201 days - 297 days
201 days 297 days
-A
A
77 EMEA General Report 2000
EMEA/ MB/ 050 Vuosikertomus 2000 Liite 9 CVMP: n lausunnot eläinlääkevalmisteista vuonna 2000
Annex 9:
sivu 74/ 85
CVMP opinions in 2000 on medicinal products for veterinary use Centralised applications
Keskitetyt hakemukset
Product - Brandname - INN - Part A/B
Tuote - Kauppanimi - INN
Company - Name - Origin
Yhtiö - Nimi - Alkuperä
Therapeutic area - Target species - Indication
Hoitoalue - Kohdelaji - Indikaatio
Presentation - Form - Dosage - Number of presentations
Esittely - Muoto - Annostus
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
EMEA/ CVMP - Validointi - Lausunto
Commission - Opinion received - Date of Decision - Notification - Official Journal
Komissio - Lausunto saatu - Päätöksen päivämäärä
- 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.
10.12.1999 09.03.
00 - 10. 03.
00 OJ C 95, 04.04.2000
00 - OJ C 95, 04. 04. 2000
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
Intervet International NL
Intervet Internation al NL
Dogs Hormone-dependent urinary incontinence (QG03CA04)
Dogs Hormone - dependent urinary incontinence (QG03CA04)
- 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 Virbac Live vaccine F Part A
Rabigen SAG2 Live vaccine Part A
- 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
- 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
- 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
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
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
Econor Valnemulin Part B extension
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
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
- - - -
- 07. 04. 2000 - 15. 09. 2000 - 20. 09. 2000 - OJ No.
07.04.2000 15.09.2000 20.09.2000 OJ No.
Vuosikertomus 2000
308, 27.10.2000
sivu 75/ 85
Econor Valnemulin Part B (extension)
Tuote Yhtiö
Novartis A
Hoitoalue
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
Esittely
10%/50% premix various 2
EMEA/ CVMP
- 12.10.1999 - 08.03.2000 - 148 days -0
- Kauppanimi - INN
- - - -
- Nimi - Alkuperä
07.04.2000 15.09.2000 22.09.2000 OJ C 308, 27.10.2000
- Kohdelaji - Indikaatio
78 EMEA General Report 2000
- Muoto - Annostus
Product - Brandname - INN - Part A/B
- Validointi - Lausunto
Company - Name - Origin
- Lausunto saatu - Päätöksen päivämäärä
Therapeutic area - Target species - Indication
- Pakkaustapojen määrä
Presentation - Form - Dosage - Number of presentations
- Ilmoituspäivämäärä
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
- 12. 10. 1999 - 08. 03. 2000 - 148 days - 0
Commission - Opinion received - Date of Decision - Notification - Official Journal
- 07. 04. 2000 - 15. 09. 2000 - 22. 09. 2000 - OJ C 308, 27. 10. 2000
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
Virbac S.A.
Virbac S. A.
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
- 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 -T- DF Inactivated vaccine Part A
Porcilis AR - T- DF Inactivated vaccine Part A
- 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
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
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
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
- 13.07.1999 - 08.11.2000 - 209 days - 274 days
- 13. 07. 1999 - 08. 11. 2000 - 209 days - 274 days
79 EMEA General Report 2000
- 08. 12. 2000
Establishment of maximum residue limits for new substances
EMEA/ MB/ 050 Vuosikertomus 2000 Uusien aineiden jäämien enimmäispitoisuuksien vahvistaminen
Substance - INN
sivu 76/ 85
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
Aine Hoitoalue EMEA/ CVMP - INN - Kohdelaji - Validointi - Lausunto - Aktiivinen aika - Kellon pysäytys
Commission - Sent to Commission - Date of Regulation - Official Journal
Komissio - Toimitettu komissiolle - Asetuksen päivämäärä - EYVL
- 18.06.1999 - 13.10.1999 - 113 days -0
Bismuth subnitrate Bovine - 18. 06. 1999 (extension) - 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 tylosin tartrate
Acetyl isovaleryl Porcine - 18. 10. 1995 tylosin tartrate - 13. 10. 1999 - 195 days - 1260 days
- 13.07.1999 - 13.10.1999 - 92 days -0
Methylprednisolone Bovine - 13. 07. 1999 - 13. 10. 1999 - 92 days - 0
- 09.12.1999 - 08.03.2000 - 90 days -0
Deltamethrin Fin fish - 09. 12. 1999 (extension) - 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
- 09.11.1999 - 08.03.2000 - 90 days -0
Tylosin Eggs - 09. 11. 1999 (extension) - 08. 03. 2000 - 90 days - 0
25.02.1997 - 08.03.2000 - 281 days - 825 days
Dicyclanil Ovine - 25. 02. 1997 - 08. 03. 2000 - 281 days - 825 days