natgillin/translations-raw huggingface dataset:
- 26.02.1999 - 16.0 3.2000 - 182 days
L01XX22
- 05.06.2000 - 04.08.2000 - 07.08.2000
26. 02. 1999 -
-A
31. 07. 2000
in haemophilia A
alitretinoin
- 3 presentations
- alitretinoin Pharmac -
- 201 days
Ttopical - 0. 1% w/ w
-
11. 10. 2000
- -
B
Hepacare triple antigen hepatitis B vaccine
euticals
- -
treatment of - 1 presentation
Medeva Pharma Ltd UK
- B euticals treatment of -
- -
- B euticals treatment of - 1 presentation -
J07BC Immunisation against hepatitis B virus in adults
- B euticals treatment of - 1 presentation - 174 days -
- -
18. 10. 2000
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
Ltd US
- 16.05.2000 - 04.08.2000 - 07.08.2000 - OJ C 244,
cutaneous lesions in AIDS related Kaposi' s sarcoma
pre S2 20 µg 2 presentations
Glustin pioglitazone
10
Takeda - Europe -
- Herceptin - trastuzumab -A
A10BG03 - Combination -
Roche Registration Ltd CH
23. 04. 1999 - 29. 06. 2000 -
- -
31. 07. 2000 11. 10. 2000
L01XC03 Treatment of patients with metastatic breast cancer whose tumour overexpress HER2
-
- - -
B
Powder for concentrate for solution for infusion 150 mg 1 presentation
-
- - - -
JP
14
treatment of Type - II Diabetes mellitus
- Keppra - levetiracetam -B
6 presentations
- UCB S.A. - US
178 days - 251 days -
Film coated tablet 250 mg, 500 mg, 750 mg, 1000 mg 26 presentations
Actos pioglitazone
- 26.02.1999 - 29.06.2000 - 187 days - 300 days
-
- - - -
Takeda - Europe -
31.07.2000 29.09.2000 11.10.2000 OJ C 308, 27.10.2000, p.
A10BG03 - Combination -
12
Tablet 15 mg, 30 mg
- Panretin - alitretinoin -B
23. 04. 1999 - 29. 06. 2000 -
- -
31. 07. 2000 13. 10. 2000
Ligand Pharmaceuticals Ltd US
B
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi's sarcoma
JP
- Gel - 0.1 %w/w - 1 presentation
treatment of Type - II Diabetes mellitus
- 26.02.1999 - 29.06.2000 - 174 days - 313 days
6 presentations
2
178 days - 251 days -
- Glustin - pioglitazone -B
2
Takeda Europe JP
Agenerase
A10BG03 Combination treatment of Type II Diabetes mellitus
- Glaxo - J05AE05 - Capsule, soft, Oral - 20. 11.
- Tablet - 15 mg, 30 mg - 6 presentations
- Agenerase - Glaxo -
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
J05AE05 - Capsule, soft, Oral
- - - -
- Agenerase - Glaxo - J05AE05 -
2
- Agenerase - Glaxo - J05AE05 - Capsule, soft, Oral -
- Actos - pioglitazone -B
- Agenerase - Glaxo - J05AE05 - Capsule, soft, Oral - 20. 11. 1998 -
- -
09. 08. 2000
A10BG03 Combination treatment of Type II Diabetes mellitus
amprenavir
- Tablet - 15 mg, 30 mg - 6 presentations
Group - Treatment of solution - 29. 0
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
- amprenavir Group -
- - - -
Treatment of
2
so
- Agenerase - amprenavir -B
- amprenavir Group - Treatment of solution -
- Glaxo Group - UK
- amprenavir Group - Treatment of solution - 29. 06. 2000 -
- -
20. 10. 2000
J05AE05 Treatment of HIV infected adults and children
HIV infected
- Capsule, soft, Oral solution - 50 mg, 150 mg, 15 mg/ml - 4 presentations
- B - UK HIV infected - 50 mg, 150 mg, 15 mg/ ml -
- 20.11.1998 - 29.06.2000 - 219 days - 324 days
- B - UK HIV infected - 50 mg, 150 mg, 15 mg/ ml - 219 days -
74 EMEA General Report 2000
25. 10. 2000
Product - Brandname - INN - Part A/B
adults and children
Company - Name - Origin
2
Therapeutic area - ATC - Indication
EMEA/ MB/ 050/ 00 Allmän rapport 2000
Presentation - Form - Dosage - Number of presentations
Infanrix hexa - - JO7CA - Powder and suspension for - 30. 07. 1999 - 09. 08.
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- Infanrix hexa - - JO7CA - Powder and suspension for -
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Infanrix hexa - - JO7CA - Powder and suspension for - 30. 07. 1999 -
Infanrix hexa Hep B-IPV HIB vaccine
- Hep B- IPV SmithKli -
-
23. 10. 2000
SmithKline Beecham Biologicals
HIB vacci
- -
ne ne
JO7CA Immunisation against Haemophilus influenza,
against
30IU
Diphtheria toxoid, - 201 days - 26. 10
- 30.07.1999 - 29.06.2000 - 201 days
- Diphtheria toxoid, -
- 09.08.2000 - 23.10.2000 - 26.10.2000
- Diphtheria toxoid, - 201 days -
-A
26. 10. 2000
S.A.
Beecham
Diphtheria, Pertussis,
Haemophilus
Tetanus toxoid, adsorbed ≥
- A Beecham Haemophilus -
- 132 days
- A Beecham Haemophilus - 132 days -
- OJ C 337,
OJ C 337,
-B
Tetanus toxoid, adsorbed ≥
Tetanus, HepB and Poliomyelitis
Biologic als S. A.
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
influenza, Diphtheria,
2
40IU
Infanrix penta - Hep B-IPV vaccine
Infanrix penta
SmithKline Beecham Biologicals
30. 07. 1999 - 29. 06. 2000 -
- -
09. 08. 2000 23. 10. 2000
JO7CA Primary and booster immunisation of infants
booster
- Suspension for injection - Diphtheria toxoid, adsorbed ≥ 30IU
Tetanus toxoid, adsorbed ≥
- 30.07.1999 - 29.06.2000 - 201 days
201 days -
S.A.
-
against Diphtheria,
vaccine A
Tetanus toxoid, adsorbed ≥
Beecham Biologic
- 132 days
immunisation of infants against
- OJ C 337,
40IU
2
132 days -
- Hexavac
Hexavac Comb
Pasteur
- Pasteur Merieux
- JO7CA
JO7CA Immunisation
- Suspension for injection
Suspension for injection Purified diphtheria toxoid, adsorbed ≥ 20 IU,
- 30.07.1999
30. 07. 1999 - 26. 06. 2000 -
- 10.08.2000
10. 08. 2000 23. 10. 2000
- Comb vaccine -A
vaccine
Merieux MSD - -F
MSD
Immunisation Diphtheria, pertussis, Tetanus, HepB, Poliomyelitis, Haemophilus influenza
180 days -
-
26. 10. 2000
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 tetanus toxoid, adsorbed ≥ 40 IU
- 26.06.2000 - 180 days - 153 days
153 days -
- - -
OJ C 337,
2
Tetanus, HepB, Poliomyelitis, Haemophilus influenza
- Luveris - lutropin alfa -A
Sida 70/ 84
Ares Serono (Europe) Ltd CH
Luveris - Ares - G03G - Powder and solvent for - 25. 06. 1999 - 07. 09.
- -
- Luveris -
G03G Stimulation of follicular development in women - 75 with servere Leng HEng and FSH deficiency
Ares - G03G - Powder and solvent for - 25. 0
- Powder and solvent for solution for injection IU - 6 presentations
G03G - Powder and solvent
- 25.06.1999 - 27.07.2000 - 192 days - 200 days
- Luveris - Ares - G03G -
- - - -
- Luveris - Ares - G03G - Powder and solvent for -
3
- Luveris - Ares - G03G - Powder and solvent for - 25. 06. 1999 -
75 EMEA General Report 2000
07. 09. 2000
Product - Brandname - INN - Part A/B
-
Company - Name - Origin
lutropin alfa
Therapeutic area - ATC - Indication
Serono - Stimulation of solution for injection - 27. 07
Presentation - Form - Dosage - Number of presentations
- lutropin alfa Serono -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
Stimulation of
Commission - Opinion received - Date of Decision - Notification - Official Journal
- lutropin alfa Serono - Stimulation of solution for injection -
- NeoSpect - depreotide
- lutropin alfa Serono - Stimulation of solution for injection - 27. 07. 2000 -
-
29. 11. 2000
Nycomed Imaging A/S
follicular
V09IA05 Scintigraphic imaging
- A (Europe) follicular - 75 IU -
-
30. 11. 2000
Kit for radiopaharmaceutical preparation
development in women with servere Leng HEng and FSH deficiency
- 20.11.1998 - 27.07.2000
6 presentations
28.08.2000 29.11.2000
200 days
NO
- -
of suspected malignant tumours in the lung
V09IA05 Scintigraphic imaging of suspected malignant tumours in the lung
47 µg 2 presentations
Kit for radiopaharmaceutical preparation 47 µg 2 presentations
- 204 days - 404 days
20. 11. 1998 27. 07. 2000 204 days 404 days
04.12.2000 OJ C 2, 05.01.2001, p.
28. 08. 2000 29. 11. 2000 04. 12. 2000 OJ C 2, 05. 01. 2001, s.
- 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
Nutropin AQ somatropin A
Schwarz Pharma AG
Schwarz - Pharma - AG
- H01AC01 - Treatment of growth
H01AC01 Treatment of growth failure
- Solution for injection - 5 mg/ml
Solution for injection 5 mg/ ml 2 presentations
- 21.10.1999 - 21.09.2000
21. 10. 1999 21. 09. 2000 174 days
- 05.1 2.2000 -
- - -
-A
05. 12. 2000
- D
- D
failure
186 days
- 2 presentations
Neurobloc botulinum toxin type B B
- 174 days - 186 days
- Elan - Pharma - Internati onal Ltd - UK
- Neurobloc - botulinum
27. 08. 1999 21. 09. 2000 187 days 229 days
-
21. 11. 2000
M03AX01 Treatment of cervical
Tenecteplase - - B01AD - Powder and solvent for - 24. 09. 1999 - 27. 11.
- Solution for injection - 5000 IU/ml
- Tenecteplase - -
- 27.08.1999 - 21.09.2000
B01AD - Powder and solvent
- 21.11.2000 -
- Tenecteplase - - B01AD -
toxin type B
- Tenecteplase - - B01AD - Powder and solvent for -
Ltd
- Tenecteplase - - B01AD - Powder and solvent for - 24. 09. 1999 -
- 3 presentations
27. 11. 2000
- 187 days
Treatment of
-
21. 09. 2000
-B
A
- UK
er
- 229 days
215 days
-
27. 11. 2000
- Tenecteplase - tenecteplase -A
tenecteplase
Boehringer Ingelheim International GmbH
- A er suspected - 6000 IU, 8000 IU, 10000 -
B01AD Treatment of suspected myocardial infarction
myocardial infarction
Powder and solvent for solution for injection 6000 IU, 8000 IU, 10000 IU 3 presentations
IU 3 presentations
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
215 days
- 27.11.2000 - - -
- Azomyr - SP -
-D
06. 11. 2000
- Metalyse - tenecteplase -A
- desloratadine Europe -
Boehringer Ingelheim International GmbH
-
B01AD Treatment of suspected myocardial infarction
B
- - -
- US
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
symptoms - 13 pr
- 27.11.2000 - - -
- B - US symptoms -
- Azomyr - desloratadine -B
- B - US symptoms - 13 presentations -
- SP Europe - US
201 days
- Opulis - desloratadine -B
Opulis desloratadine
- -
06. 11. 2000
- Allex - desloratadine -B
Allex desloratadine
- Aerius - desloratadine -B
Aerius desloratadine
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
R06AX27 - Relief of -
- Film coated tablet - 5 mg - 13 presentations
Film coated tablet 5 mg
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
- -
- 06.11.2000 - - -
24. 09. 1999 21. 09. 2000
- Neoclarityn - desloratadine -B
- -
- -
US
- Xeloda - capecitabine -B
EMEA/ MB/ 050/ 00 Allmän rapport 2000
- Roche Registration Ltd - CH
Sida 71/ 84
L01BC treatment of metastatic colorectal cancer
Neoclarityn
- Film coated tablet - 150 mg, 500 mg - 2 presentations
- SP - R06AX27 - Film coated tablet - 24. 09. 1
- 21.10.1999 - 21.09.2000 - 201 days - 159 days
- Neoclarityn - SP -
- 20.11.2000 - - -
R06AX27 - Film coated tablet
- -
- Neoclarityn - SP - R06AX27 -
Ovidrelle chorio- gonadotropin alfa
- Neoclarityn - SP - R06AX27 - Film coated tablet -
Ares Serono (Europe) Ltd CH
- Neoclarityn - SP - R06AX27 - Film coated tablet - 24. 09. 1999 -
G03GA01 Assisted reproductive techniques sus as in vitro fertilisation (IVF)
-
- - -
desloratadine
Powder and solvent for solution for injection 250 µg 6 presentations
Europe - Relief of - 5 mg
- 21.10.1999 - 21.09.2000 - 174 days - 186 days
- desloratadine Europe -
- 23.11.2000 - - -
Relief of - 5 mg
-A
- desloratadine Europe - Relief of - 5 mg -
76 EMEA General Report 2000
21. 09. 2000
Product - Brandname - INN - Part A/B
symptoms - 13 pre
Company - Name - Origin
- B - US symptoms -
Therapeutic area - ATC - Indication
- B - US symptoms - 13 presentations -
Presentation - Form - Dosage - Number of presentations
-
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
associated with seasonal allergic rhinitis
Commission - Opinion received - Date of Decision - Notification - Official Journal
-
- Prevenar - Prevenarp- neumococcal conjugate vaccine -A
159 days
- Wyeth- Lederle Vaccines S.A. - US
-
- 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 (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
Xeloda -
- 19.11.1999 - 21.09.2000 - 205 days - 125 days
Roche -
- 21.11.2000 - - -
L01BC -
- Prandin - replaglinide -B
Film coated tablet
Novo Nordisk DK
21. 10. 1999
- -
20. 11. 2000
A10BX02 Treatment of Type II diabetes mellitus
capecitabine
- Tablet - 0.5 mg, 1.0 mg, 2.0 mg, - 18 presentations
Registrat - treatment of - 150 mg, 500 mg
- 30.06.2000 - 21.09.2000 - 91 days - 0 days
- capecitabine Registrat -
- 26.10.2000 - - -
treatment of - 150 mg
- Rapamune - sirolimus -B
- capecitabine Registrat - treatment of -
- -
21. 09. 2000
Wyeth Europe Ltd US
-
L04AA10 rophylaxis of organ rejection in patient receiving renal transplants
B
- Oral solution - 1 mg/ml - 5 presentations
ion Ltd
- 29.01.1999 - 16.11.2000 - 214 days - 393 days
metastatic - 2 pres
- 08.01.2001 - - -
- B ion Ltd metastatic -
- Targretin - bexarotene -B
- B ion Ltd metastatic - 2 presentations -
- -
201 days
Ligand Pharmaceuticals Ltd US
-
- -
- CH
L01XX25 Treatment of skin manifestations of advanced stage of cutaneous T -cell Lymphoma
colorectal cancer
- Capsule, soft - 75 mg - 1 presentation
-
- 17.12.1999 - 16.11.2000 - 197 days - 159 days
159 days
- - - -
- Ares -
- Fasturtec
21. 10. 1999
-
23. 11. 2000
Sanofi
chorio -
V03AF07
(Europe) Ltd CH
- Powder and solvent for
250 µg 6 presentations
- 21.01.2000
19. 11. 1999 21. 09. 2000 205 days 125 days
- rasburicase -A
30. 06. 2000 21. 09. 2000 91 days 0 days
-F
- - - -
- Powder and solvent for solution for infusion
Powder and solvent for solution for infusion 4 mg
- 21.01.2000 - 14.12.2000
21. 01. 2000 14. 12. 2000 177 days
acid
-
Ltd
CH
induced hypercalcaemia - 4 mg
hypercalcaemia
- 177 days
3 presentations
- B
146 days
- CH
-
- 3 presentations
EMEA/ MB/ 050/ 00 Allmän rapport 2000
- 146 days
Sida 72/ 84
-
18. 07. 2000
-
14. 12. 2000
lopinavir/ ritonavir
ritonavir
-
ries
Laboratories US
treatment in
Combination treatment - 133.3/33.3 mg, 80/20 mg/ml in combination of HIV- - 3 presentations
133. 3/ 33. 3 mg, -
- SonoVue - sulphur hexafluoride -B
SonoVue
Osteogenis Protein 1 Howmedia International Osteogenic Protein-1 BMP-7
- Osteogenis - Stryker - - M09AX - Powder for suspension for -
Stryker - Biotech US
Biotech
- -
14. 12. 2000
77 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Allmän rapport 2000 Bilaga 9 CVMP: s yttranden under 2000 om veterinärmedicinska läkemedel
Annex 9:
Sida 73/ 84
CVMP opinions in 2000 on medicinal products for veterinary use Centralised applications
Centraliserade ansökningar
Product - Brandname - INN - Part A/B
Läkemedel - Namn - INN - Del A/ B
Company - Name - Origin
Företag - Namn - Land
Therapeutic area - Target species - Indication
Användningsområde - Måldjurarter - Indikation
Presentation - Form - Dosage - Number of presentations
Presentation - Form - Dosering - Antal presentationer
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
EMEA/ CVMP - Giltigförklaring - Yttrande - Aktiv tid - Inaktiv tid
Commission - Opinion received - Date of Decision - Notification - Official Journal
Kommissionen - Yttrandet inne - Beslutsdatum - Kungörelsedatum - EGT
Ibraxion Inactivated vaccine Part A
Ibraxion Inactivated vaccine
Cattle Vaccine against IBR (QJ57DA)
Cattle Vaccine against IBR
- 17.11.1998 - 10.11.1999 - 210 days - 176 days
- 17. 11. 1998 - 10. 11. 1999 - 210 days
10.12.1999 09.03.
- 10. 12. 1999 - 09. 03.
00 10.03.
00
00 OJ C 95, 04.04.2000
- OJ C 95, 04. 04. 2000
- - - -
- 07. 01. 2000 - 24. 03. 2000 - 29. 03. 2000 - OJ C 120, 28. 04. 2000
07.01.2000 24.03.2000 29.03.2000 OJ C 120, 28.04.2000
Rabigen SAG2 Live vaccine Part A
Rabigen SAG2 Virbac Live vaccine F Part A
Virbac F
- 12.01.1999 - 08.12.1999 - 183 days - 120 days
- 07. 01. 2000 - 13. 04. 2000 - 18. 04. 2000 - OJ C 120, 28. 04. 2000
- - - -
- 28. 04. 2000 - 15. 09. 2000 - 18. 09. 2000 - OJ C 277, 29. 09. 2000
- - - -
- 19. 05. 2000 - 15. 09. 2000 - 20. 09. 2000 - OJ C 308, 27. 10. 2000
07.04.2000 15.09.2000 20.09.2000 OJ No.
- 07. 04. 2000 - 15. 09. 2000 - 20. 09. 2000 - OJ No.
308, 27.10.2000
308, 27. 10. 2000
Econor Valnemulin Part B (extension)
EMEA/ MB/ 050/ 00 Allmän rapport 2000
Novartis A
Sida 74/ 84
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
Läkemedel - Namn - INN - Del A/ B
10%/50% premix various 2
Företag - Namn - Land
- 12.10.1999 - 08.03.2000 - 148 days -0
Användningsområde - Måldjurarter - Indikation
- - - -
Presentation - Form - Dosering - Antal presentationer
07.04.2000 15.09.2000 22.09.2000 OJ C 308, 27.10.2000
EMEA/ CVMP - Giltigförklaring - Yttrande - Aktiv tid - Inaktiv tid
78 EMEA General Report 2000
Kommissionen - Yttrandet inne - Beslutsdatum - Kungörelsedatum - EGT
Product - Brandname - INN - Part A/B
Econor Valnemulin Part B (extension)
Company - Name - Origin
Novartis A
Therapeutic area - Target species - Indication
Pigs Prevention / treatment of dysentery and treatment/ control of enzootic pneumonia (QJ01XX94)
Presentation - Form - Dosage - Number of presentations
10% / 50% premix various 2
- - - -
- 21. 07. 2000 - 24. 10. 2000 - 25. 10. 2000 - OJ C 337, 28. 11. 2000
Establishment of maximum residue limits for new substances
EMEA/ MB/ 050/ 00 Allmän rapport 2000 Fastställande av maximalt tillåtna restmängder för nya substanser
Substance - INN
Sida 75/ 84
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
Substans Behandlingsområde EMEA/ CVMP - INN - Måldjurart - Giltigförklaring - Yttrande - Aktiv tid - Inaktiv tid
Commission - Sent to Commission - Date of Regulation - Official Journal
Kommissionen - Sänt till kommissionen - Förordningens datum - EGT
Bismuth subnitrate (extension)
Bismuth subnitrate Bovine - 18. 06. 1999 (extension) - 13. 10. 1999 - 113 days - 0
- 13.07.1999 - 13.10.1999 - 92 days -0
Metylprednisolon Bovine - 13. 07. 1999 - 13. 10. 1999 - 92 days - 0
Deltamethrin (extension)
Deltamethrin Fin fish - 09. 12. 1999 (extension) - 08. 03. 2000 - 90 days - 0
Tylosin (extension)
Tylosin Eggs - 09. 11. 1999 (extension) - 08. 03. 2000 - 90 days - 0
Tilmicosin (extension)
Tilmicosin Rabbit - 16. 07. 1999 (extension) - 13. 10. 1999 - 86 days - 0
Tiamulin (extension)
Tiamulin Rabbit - 14. 10. 1999 (extension) - 12. 01. 2000 - 90 days - 0
- 14.10.1999 - 12.01.2000 - 90 days -0
- 11. 02. 2000 - 20. 10. 2000 - OJ L 269, 21. 10. 2000
Butafosfan (extension)
Butafosfan Milk cattle - 19. 01. 2000 (extension) - 19. 04. 2000 - 90 days - 0
Tilmicosin (extension)
Tilmicosin Bovine milk - 22. 02. 1999 (extension) - 19. 04. 2000 - 203 days - 210 days
Phoxim (extension)
Phoxim Ovine - 19. 01. 2000 (extension) - 19. 04. 2000 - 90 - 0
- 19.01.2000 - 19.04.2000 - 90 -0
- 19. 05. 2000 - 27. 10. 2000 - OJ L 276, 28. 10. 2000
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
Flumethrin Ovine - 19. 01. 2000 (extension) - 19. 04. 2000 - 90 days - 0
80 EMEA General Report 2000
- 19. 05. 2000 - 27. 10. 2000 - OJ L 276, 28. 10. 2000
Therapeutic area - Target species
Flunixin Equine - 23. 03. 2000 (extension) - 21. 06. 2000 - 90 days - 0 days
Commission - Sent to Commission - Date of Regulation - Official Journal
EMEA/ MB/ 050/ 00 Allmän rapport 2000
Flumethrin (extension)
Sida 76/ 84
Ovine
Substans
- 19.01.2000 - 19.04.2000 - 90 days -0
Behandlingsområde
Flunixin (extension)
Kommissionen
- 23.03.2000 - 21.06.2000 - 90 days -0
- Giltigförklaring - Yttrande - Aktiv tid - Inaktiv tid
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
- Sänt till kommissionen - Förordningens datum - EGT
81 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Allmän rapport 2000 Bilaga 10 COMP: s yttranden under 2000 om särläkemedel
Annex 10:
Sida 77/ 84
Product
Läkemedel
EMEA/COMP - Submission - Validation - Opinion - Active time
- Inlämning - Giltigförklaring - Yttrande - Aktiv tid
Commission - Opinion received - Date of Designation
- Yttrandet inne - Beslutsdatum
Ares-Serono (Europe) Ltd
Ares- Serono (Europe) Ltd
AIDS-wasting
AIDS- wasting
Treament of acute myeloid leukaemia
Treament of acute myeloid leukaemia Treatment of Gaucher disease
- 02.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
- 02. 05. 2000 - 31. 07. 2000 - 13. 09. 2000 - 45 days
Treatment of erythema nodosum leprosum or type II reactions in Hansen's disease
Treatment of erythema nodosum leprosum or type II reactions in Hansen’ s disease
-
- 07. 08. 2000 - 25. 08. 2000 - 21. 11. 2000 - 89 days
-
- 08. 08. 2000 - 22. 09. 2000 - 21. 11. 2000 - 61 days
Treatment of amyotrophic lateral sclerosis
...
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
Treatment of acute respiratory distress syndrome
-
- 01. 09. 2000 - 22. 09. 2000 - 21. 11. 2000 - 61 days
- -
- 09. 08. 2000 - 22. 09. 2000 - 19. 12. 2000 - 89 days
Treatment of acute promyelocytic leukaemia
Treatment of patent ductus arteriosus
- 08.08.2000
- 02. 05. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
-
- 10. 08. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 61 days
Treatment of acromegaly
- -
- 11. 08. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
Treatment of acute respiratory distress syndrome
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
- 01.09.2000
- 21. 08. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
-
- 06. 09. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 22.09.2000
-
- -
- 08. 09. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
Treatment of cystic fibrosis
Treatment of chronic myeloid leukaemia
- 09.08.2000
- 03. 10. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
-
- 04. 10. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 22.09.2000
Antaget i april 2000
- 19.12.2000
Antaget i juli 2000
- 89 days
Points to consider on xenogeneic cell therapy Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Note for Guidance on Comparability of medicinal products containing
- -
Antaget i november 2000 Utsänt på remiss i januari 2000
Treatment of patent ductus arteriosus
EMEA/ CPMP/ BWP/ 3207/ 00
- 02.05.2000
Utsänt på remiss i maj 2000
-
Utsänt på remiss i juli 2000
- 19.10.2000
Utsänt på remiss i juli 2000
- 19.12.2000
Utsänt på remiss i november 2000
- 62 days
Referensnummer
- -
Status
Treatment of glycogen storage disease type II
EMEA/ CPMP/ BPWG/ 575/ 99
- 10.08.2000
Antaget i juni 2000
-
Antaget i juni 2000
(Pompe's disease)
1
- 19.10.2000 - 19.12.2000 - 62 days
immunoglobulin for intravenous administration (IVIg) Core SPC for Human and anti- D
Treatment of acromegaly
EMEA/ CPMP/ BPWG/ 574/ 99 EMEA/ CPMP/ BPWG/ 859/ 95
- 11.08.2000 - 19.10.2000 - 19.12.2000 - 62 days
immunoglobulin for intravenous and/ or intramuscular use Core SPC for Human normal
- -
1
Treatment of pulmonary arterial hypertension and
immunoglobulin for intravenous administration (IVIg) Core SPC for Human plasma derived and
- 21.08.2000
Antaget i juni 2000
chronic thromboembolic pulmonary hypertension
EMEA/ CPMP/ BPWG/ 1625/ 99
- 19.10.2000 - 19.12.2000 - 62 days
recombinant coagulation factor IX products Note for Guidance on the Clinical
- -
Antaget i juni 2000
Treatment of haemorrhagic fever with renal syndrome
EMEA/ CPMP/ BPWG/ 198/ 95 rev. 1
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
investigation of human plasma derived factor VIII and IX products Note for Guidance on the Clinical
-
Antaget i oktober 2000
- -
EMEA/ CPMP/ BPWG/ 1561/ 99
Treatment of mucopolysaccharidosis type I
investigation of recombinant factor VIII and IX products
- 08.09.2000
Antaget i oktober 2000
- 19.10.2000
Utsänt på remiss i juni 2000
- 19.12.2000
Utsänt på remiss i juni 2000
- 62 days
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