qanastek/EMEA-V3 huggingface dataset:
Company - Name - Origin
Powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU 3 presentations
Therapeutic area - ATC - Indication
- - - -
Presentation - Form - Dosage - Number of presentations
26.2.1999 - 16.3.2000 - 182 days - 201 days -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
10
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Helixate NexGen - octocog alfa - A
- Orgalutran
- Bayer AG - D
- N.V.
- -
Organon - H01CC01
B02BD02 Treatment and prophylaxis of bleeding in haemophilia A
- Orgalutran - N.V.
- - -
Organon - H01CC01 - Solution for injection -
Powder and solvent for solution for infusion 250 IU, 500 IU, 1000 IU 3 presentations
- Orgalutran - N.V.
- - - -
Organon - H01CC01 - Solution for injection - 29.01.1999 -
26.2.1999 - 16.3.2000 - 182 days - 201 days -
22.02.2000
10
- ganirelix
- - -
- NL
- -
- Prevention of
Medeva Pharma Ltd UK
- ganirelix - NL - Prevention of - 0.5 mg/ml -
J07BC Immunisation against hepatitis B virus in adults
- ganirelix - NL - Prevention of - 0.5 mg/ml - 19.01.2000 -
Suspension for - injection - Monodose preparation - of 1 ml contains - Hepatitis B surface antigen S, pre-S1 and pre S2 20 µg
17.05.2000
23.10.1998 - 16.3.2000 - 210 days - 293 days -
-B
10
premature luteinising
-
-B premature luteinising - 2 presentations -
2 presentations
-B premature luteinising - 2 presentations - 162 days -
- Herceptin - trastuzumab - A
22.05.2000
Roche Registration Ltd CH
hormone surges in conteolled ovarian hyperstimulation
L01XC03 Treatment of patients with metastatic breast
189 days -
305 days -
OJ C 183, 30.06.2000, p.
OJ C 277, 29.9.2000, p.
Pegintron peginterferon alfa -2b
26.2.1999 - 29.6.2000 - 187 days - 300 days -
- SP Europe - US
- Panretin - alitretinoin - B
L03AB10 Treatment of chronic hepatitis C
Ligand Pharmaceuticals Ltd US
Powder and solvent for solution for injection 50 µg/0.5 ml, 80 µg/0.5 ml,
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi’s sarcoma
- 26.03.1999 - 17.02.2000 - 189 days
- Gel - - 0.1 %w/w - - 1 presentation - -
- 27.03.2000 - 25.05.2000 - 05.06.2000
26.2.1999 - 29.6.2000 - 174 days - 313 days -
100 µg/0.5 ml 120 µg/0.5 ml, 150µg/0.5 ml 25 presentations
A10BG03 Combination treatment of Type II Diabetes mellitus
- 139 days
- Tablet - 15 mg, 30 mg - 6 presentations
OJ C 183, 30.06.2000, p.
31.7.2000 11.10.2000 17.10.2000 OJ C 337, 28.11.2000, p.
- Viraferon PEG - peginterferon alfa -2b -A
- Actos - pioglitazone - B
- SP Europe - US
- Takeda Europe - JP
L03AB10 Treatment of chronic hepatitis C
A10BG03 Combination treatment of Type II Diabetes mellitus
Powder and solvent for solution for injection 50 µg/0.5 ml, 80 µg/0.5 ml, 100 µg/0.5 ml 120 µg/0.5 ml, 150µg/0.5 ml 25 presentations
2
- 03.01.2000 - 17.02.2000 - 43 days - 0 days
- Agenerase - amprenavir - B
3
J05AE05 Treatment of HIV infected adults and children
Lantus insulin glargine
Capsule, soft, Oral solution 50 mg, 150 mg, 15 mg/ml 4 presentations
Aventis Pharma Deutschland
74 Informe General EMEA 2000
- A10AE - Diabetes mellitus
Producto - Nombre comercial - DCI - Parte A/B
- Solution for injection - 100 IU/ml - 7 presentations
Compañía - Nombre - Origen
- 23.04.1999 - 17.02.2000 - 215 days
Área terapéutica - ATC - Indicación
- 23.03.2000 - 06.06.2000 - 14.06.2000
Presentación - Forma - Dosis - Número de presentaciones
-A
EMEA/CPMP - Validación - Dictamen - Tiempo activo - Tiempo inactivo
GmbH
Comisión - Dictamen recibido el - Fecha de la decisión - Fecha de la notificación - Diario Oficial
- 8 3 days
- Infanrix hexa
- OJ C 183,
- SmithKline
-D
- JO7CA - Powder and suspension for su
3
- Infanrix hexa - SmithKline - JO7CA -
- -
Powder and suspension for suspension -
Optisulin insulin glargine
- Infanrix hexa - SmithKline - JO7CA - Powder and suspension for suspension - 30.7.1999 -
-
9.8.2000
Aventis Pharma Deutschland
- Hep B-IPV HIB
- A10AE - Diabetes mellitus
Beecham
- Solution for injection - 100 IU/ml - 7 presentations
- Immunisation against
- 24.09.1999 - 17.02.2000 - 116 days
- Hep B-IPV HIB Beecham - Immunisation against for injection -
- 23.03.2000 - 27.06.2000 - 28.06.2000
- Hep B-IPV HIB Beecham - Immunisation against for injection - 29.6.2000 -
-A
23.10.2000
GmbH
vaccine
- 28 days
Biologicals S.A.
- OJ C 216,
Haemophilus influenza,
4
Diphtheria toxoid, adsorbed ≥ 30IU -
- Nyracta - rosiglitazone -B
201 days -
SmithKline Beecham Pharmaceuticals UK
A
A10BG02 Combination treatment of Type II diabetes mellitus
B
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
Diphtheria, Pertussis, Tetanus, HepB and Poliomyelitis
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
Tetanus toxoid, adsorbed ≥ 40IU - Pertussis 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
17.04.2000 11.07.2000 26.07.2000 OJ C 244, 25.08.2000, p.
OJ C 337, 28.11.2000, p.
- Avandia - rosiglitazone -B
- Infanrix penta
- -
- SmithKline
SmithKline Beecham Pharmaceuticals UK
- Infanrix penta - SmithKline - JO7CA -
- -
- Hep B-IPV
A10BG02 Combination treatment of Type II diabetes mellitus
- Primary and booster -
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
- Hep B-IPV Beecham - Primary and booster - Diphtheria toxoid, -
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
- Hep B-IPV Beecham - Primary and booster - Diphtheria toxoid, - 29.6.2000 -
- - - -
vaccine
17.04.2000 11.07.2000 28.06.2000 OJ C 216, 28.07.2000, p.
immunisation of infants
- Venvia - rosiglitazone -B
201 days -
A10BG02 Combination treatment of Type II diabetes mellitusus
B
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
against Diphtheria, Tetanus, Pertussis, Hepatitis B and Poliomyelitis
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
Tetanus toxoid, adsorbed ≥ 40IU Pertussis 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
- Myocet - doxorubicin -B
- Pasteur Merieux - JO7CA
- -
- Comb vaccine
The Liposome Company US
- Purified diphtheria toxoid, -
- -
- F
L01DB Treatment of metastatic breast cancer
Diphtheria, pertussis,
- Powder and pre-admixtures for concentrate for, liposomal dispersion for infusion - 50 mg - 1 presentation
- A - F Diphtheria, pertussis, adsorbed ≥ 20 IU, -
- 30.07.1999 - 12.04.2000 - 167 days - 91 days
- A - F Diphtheria, pertussis, adsorbed ≥ 20 IU, - 180 days -
17.05.2000 13.07.2000 26.07.2000 OJ C 244, 25.08.2000, p.
OJ C 337, 28.11.2000, p.
- Datscan - ioflupane -B
- 8 presentations
- -
- Luveris
Nycomed Amersham UK
Powder and solvent for -
- -
- lutropin alfa
V09AB03 Diagnosis of Parkinson disease
- Stimulation of follicular
- Solution for injection - 74 MBq/ml - 1 presentation
solution for injection -
- 18.12.1998 - 16.03.2000 - 178 days - 272 days
- A - CH development in women - 75 IU - 192 days -
05.05.2000 27.07.2000 02.08.2000 OJ C 244, 25.08.2000, p.
OJ C 2, 5.1.2001, p.
10
3
73 EMEA General Report 2000
75 Informe General EMEA 2000
Product - Brandname - INN - Part A/B
Producto - Nombre comercial - DCI - Parte A/B
Company - Name - Origin
Compañía - Nombre - Origen
Therapeutic area - ATC - Indication
Área terapéutica - ATC - Indicación
Presentation - Form - Dosage - Number of presentations
Presentación - Forma - Dosis - Número de presentaciones
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
EMEA/CPMP - Validación - Dictamen - Tiempo activo - Tiempo inactivo
Commission - Opinion received - Date of Decision - Notification - Official Journal
Comisión - Dictamen recibido el - Fecha de la decisión - Fecha de la notificación - Diario Oficial
- Visudyne - verteporfin -B
- NeoSpect - depreotide - B
- Ciba Vision - CH
- -
L01XX Treatment of age - related macular degeneration
V09IA05 Scintigraphic imaging of suspected malignant tumours in the lung
Powder for solution for infusion 15 mg 1 presentation
Kit for - radiopaharmaceutical - preparation - 47 µg - 2 presentations
- 27.08.1999 - 12.04.2000 - 138 days - 63 days
20.11.1998 - 27.7.2000 - 204 days - 404 days -
15.05.2000 27.07.2000 31.07.2000 OJ C 244, 25.08.2000, p.
Trizivir lamivudine zidovudine abacavir B
- NovoMix 30 - Novo Nordisk - insulin aspart - DK -A
- Film coated tablet - - 150/300/300 mg - - 3 presentations - -
- A10AD - Diabetes mellitus
21.1.2000 29.6.2000 158 days 0 days
- Suspension for injection - 100 IU/ml - 8 presentations
- 13.10.2000 - 8.12.2000 - -
- 24.09.1999 - 12.04.2000 - 144 days - 55 days
- Nutropin AQ - somatropin - A
17.05.2000 01.08.2000 01.08.2000 OJ C 244, 25.08.2000, p.
Schwarz Pharma AG D
Kogenate Bayer octocog alfa
21.10.1999 21.9.2000 174 days 186 days
- Bayer AG -D
- 5.12.2000 - - -
B02BD02 Treatment and prophylaxis of bleeding
Neurobloc botulinum toxin type B B
Powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU
Elan Pharma International Ltd UK
- 26.02.1999 - 16.0 3.2000 - 182 days
M03AX01 Treatment of cervical dystonia
- 05.06.2000 - 04.08.2000 - 07.08.2000
- Solution for injection - - 5000 IU/ml - - 3 presentations - -
-A
27.8.1999 21.9.2000 187 days 229 days
in haemophilia A
- 21.11.2000 - - -
- 3 presentations
- Tenecteplase
- 201 days
- Boehringer
-
- B01AD
10
- Powder and solvent for -
- -
24.9.1999
Helixate NexGen octocog alfa
- 27.11.2000
- Bayer AG -D
- tenecteplase - A
B02BD02 Treatment and prophylaxis of bleeding
Ingelheim International GmbH D
Powder and solvent for solution for infusion 250 IU, 500 IU, 1000 IU
Treatment of suspected solution for injection - myocardial infarction - 6000 IU, 8000 IU, - 10000 IU - - 3 presentations
- 26.02.1999 - 16.0 3.2000 - 182 days
21.9.2000 176 days 215 days
- 05.06.2000 - 04.08.2000 - 07.08.2000
- Boehringer
-A
- B01AD
in haemophilia A
- Powder and solvent for -
- 3 presentations
- 27.11.2000
- 201 days
- tenecteplase - A
10
Ingelheim International GmbH D
Hepacare triple antigen hepatitis B vaccine
21.9.2000 176 days 215 days
Medeva Pharma Ltd UK
- Azomyr - desloratadine - B
J07BC Immunisation against hepatitis B virus in adults
- Film coated tablet - 5 mg - 13 presentations
Suspension for injection Monodose preparation of 1 ml contains Hepatitis B surface antigen S, pre -S1 and
24.9.1999 21.9.2000 201 days 159 days
- 23.10.1998 - 16.03.2000 - 210 days - 293 days
- 6.11.2000 - - -
- 16.05.2000 - 04.08.2000 - 07.08.2000 - OJ C 244,
- Opulis - desloratadine - B
-A
- SP Europe - US
pre S2 20 µg 2 presentations
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
- Herceptin - trastuzumab -A
- Film coated tablet - 5 mg - 13 presentations
Roche Registration Ltd CH
24.9.1999 21.9.2000 201 days 159 days
- -
- 6.11.2000 - - -
L01XC03 Treatment of patients with metastatic breast cancer whose tumour overexpress HER2
- Allex - desloratadine - B
Powder for concentrate for solution for infusion 150 mg 1 presentation
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
- 26.02.1999 - 25.05.2000 - 147 days - 305 days
- Film coated tablet - 5 mg - 13 presentations
03.07.2000 28.08.2000 04.09.2000 OJ C 277, 29.09.2000, p.
24.9.1999 21.9.2000 201 days 159 days
14
- 6.11.2000 - - -
- Keppra - levetiracetam -B
- Aerius - desloratadine - B
- UCB S.A. - US
- SP Europe - US
N03A Adjunctive therapy in the partial onset seizures in epilepsy
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Film coated tablet 250 mg, 500 mg, 750 mg, 1000 mg 26 presentations
24.9.1999 21.9.2000 201 days 159 days
- 26.02.1999 - 29.06.2000 - 187 days - 300 days
- 6.11.2000 - - -
31.07.2000 29.09.2000 11.10.2000 OJ C 308, 27.10.2000, p.
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
12
- - - -
- Panretin - alitretinoin -B
- Xeloda - capecitabine - B
Ligand Pharmaceuticals Ltd US
Roche Registration Ltd CH
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi's sarcoma
L01BC treatment of metastatic colorectal cancer
- Gel - 0.1 %w/w - 1 presentation
- Film coated tablet - 150 mg, 500 mg - 2 presentations
- 26.02.1999 - 29.06.2000 - 174 days - 313 days
21.10.1999 21.9.2000 201 days 159 days
- - - -
- 20.11.2000 - - -
2
- - -
- Glustin - pioglitazone -B
Ovidrelle chorio- gonadotropin alfa A
Takeda Europe JP
Ares Serono (Europe) Ltd CH
A10BG03 Combination treatment of Type II Diabetes mellitus
G03GA01 Assisted reproductive techniques sus as in vitro fertilisation (IVF)
- Tablet - 15 mg, 30 mg - 6 presentations
Powder and solvent for - solution for injection - 250 µg - 6 presentations -
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
21.10.1999 21.9.2000 174 days 186 days
- - - -
- 23.11.2000 - - -
2
76 Informe General EMEA 2000
- Actos - pioglitazone -B
Producto - Nombre comercial - DCI - Parte A/B
- -
Compañía - Nombre - Origen
Takeda Europe JP
Área terapéutica - ATC - Indicación
A10BG03 Combination treatment of Type II Diabetes mellitus
Presentación - Forma - Dosis - Número de presentaciones
- Tablet - 15 mg, 30 mg - 6 presentations
EMEA/CPMP - Validación - Dictamen - Tiempo activo - Tiempo inactivo
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
Comisión - Dictamen recibido el - Fecha de la decisión - Fecha de la notificación - Diario Oficial
2
Prevenar Prevenarpneumo - coccal conjugate vaccine A
- Agenerase - amprenavir -B
- -
- Glaxo Group - UK
US
J05AE05 Treatment of HIV infected adults and children
J07AL Active immunisation of - infants and children against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae
- Capsule, soft, Oral solution - 50 mg, 150 mg, 15 mg/ml - 4 presentations
Suspension for injection - A monodose preparation- of 0.5 ml contains - Streptococcus pneumoniae: - saccharide suspension of Serotype 4 2 mg Serotype 9V 2 mg Serotype 14 2 mg Serotype 18C 2 mg Serotype 19F 2 mg Serotype 23F 2 mg Serotype 6B 4 mg Conjugated to CRM197 carrier protein ~ 20 mg
- 20.11.1998 - 29.06.2000 - 219 days - 324 days
19.11.1999 21.9.2000 205 days 125 days
2
2 presentations
74 EMEA General Report 2000
- Prandin
Product - Brandname - INN - Part A/B
- Novo Nordisk
Company - Name - Origin
- A10BX02
Therapeutic area - ATC - Indication
- Prandin - Novo Nordisk - A10BX02 - Tablet -
Presentation - Form - Dosage - Number of presentations
- 26.10.2000
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- replaglinide - B
Commission - Opinion received - Date of Decision - Notification - Official Journal
- 0.5 mg, 1.0 mg, 2.0 mg - 18 presentations
Infanrix hexa Hep B-IPV HIB vaccine
21.9.2000 91 days 0 days
SmithKline Beecham Biologicals
- Rapamune - sirolimus - B
JO7CA Immunisation against Haemophilus influenza,
Wyeth Europe Ltd US
Powder and suspension for suspension for injection Diphtheria toxoid, adsorbed ≥.
L04AA10 Prophylaxis of organ rejection in patient receiving renal transplants
30IU
- - - -
- 30.07.1999 - 29.06.2000 - 201 days
- 8.1.2001 - - -
- 09.08.2000 - 23.10.2000 - 26.10.2000
- Targretin - Ligand - L01XX25 - Capsule, soft -
S.A.
- bexarotene
Diphtheria, Pertussis,
Pharmaceuticals - Treatment of skin
Tetanus toxoid, adsorbed ≥
- bexarotene Pharmaceuticals - Treatment of skin - 75 mg -
- OJ C 337,
- B
-B
Ltd
Tetanus, HepB and Poliomyelitis
manifestations of
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
- B Ltd manifestations of - 1 presentation -
28.11.2000. p.
197 days
-
- US
16 presentations
159 days
Infanrix penta - Hep B-IPV vaccine
- Fasturtec - rasburicase - A
SmithKline Beecham Biologicals
- Sanofi - F
JO7CA Primary and booster immunisation of infants
V03AF07 Treatment of tumor induced hpreuricemia
- Suspension for injection - Diphtheria toxoid, adsorbed ≥ 30IU
Powder and solvent for - solution for infusion - 1.5 mg/ml - 1 presentation -
- 30.07.1999 - 29.06.2000 - 201 days
21.1.2000 16.11.2000 177 days 118 days
- 09.08.2000 - 23.10.2000 - 26.10.2000
- - - -
-A
- Trazec
S.A.
- Novartis
against Diphtheria,
- A10B03 - Film coa
Tetanus toxoid, adsorbed ≥
- Trazec - Novartis - A10B03 -
- OJ C 337,
- nateglinide
-B
Europharm Ltd - Combination treatment -
Tetanus, Pertussis, Hepatitis B and Poliomyelitis
- nateglinide Europharm Ltd - Combination treatment - 60 mg, 120 mg, -
40IU Pertussis 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
14.12.2000
8 presentations
of diabetes mellitus
- Hexavac
- B - CH of diabetes mellitus 180 mg -
Pasteur
Type II
- JO7CA
-
- Suspension for injection
21 presentations - 0 day
- 30.07.1999
- 21 presentations -
- 10.08.2000
-
- Comb vaccine -A
- Vaniqa
Merieux MSD - -F
- Bristol Myers
-
- D11AX
- 26.06.2000 - 180 days - 153 days
- Vaniqa - Bristol Myers - D11AX - Cream -
- - -
3.1.2000
-
- eflornithine
8 presentations
Squibb Pharma
- Luveris - lutropin alfa -A
- Treatment of facial
- -
- eflornithine Squibb Pharma - Treatment of facial - 11.5% -
Ares Serono (Europe) Ltd CH
14.12.2000
G03G Stimulation of follicular development in women - 75 with servere Leng HEng and FSH deficiency
- B
- Powder and solvent for solution for injection IU - 6 presentations
EEIG
- - - -
hirsutism
3
- B EEIG hirsutism - 3 presentations -
75 EMEA General Report 2000
157 days
Product - Brandname - INN - Part A/B
- Starlix - nateglinide - B
Therapeutic area - ATC - Indication
Novartis Europharm Ltd CH
Presentation - Form - Dosage - Number of presentations
A10BX03 Combination treatment of diabetes mellitus Type II
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
Film coated tablet - 60 mg, 120 mg, - 180 mg - 21 presentations -
Commission - Opinion received - Date of Decision - Notification - Official Journal
21.1.2000 14.12.2000 179 days 144 days
- NeoSpect - depreotide
- Zometa - zoledronic acid
Nycomed Imaging A/S
Novartis Europharm Ltd
V09IA05 Scintigraphic imaging
M05BA08 Treatment of tumour
Kit for radiopaharmaceutical preparation
Powder and solvent for - solution for infusion -
- 20.11.1998 - 27.07.2000
21.1.2000 14.12.2000
-B
- B
-
- CH
NO
induced hypercalcaemia -
of suspected malignant tumours in the lung
- B - CH induced hypercalcaemia - 4 mg -
3
3 presentations -
- Trizivir - lamivudine zidovudine abacavir -B
146 days
Glaxo Group UK
- Kaletra
- -
- Abbott
J05AF30 Treatment of HIV -1 infected patients
- J05A
Film coated tablet 150/300/300 mg 3 presentations
Capsule, soft, Oral -
- 21.01.2000 - 29.06.2000 - 158 days - 0 days
18.7.2000
- Nutropin AQ - - somatropin
- lopinavir/
Schwarz Pharma AG
Laboratories
- H01AC01 - Treatment of growth
- Combination treatment
- Solution for injection - 5 mg/ml
- lop inavir/ Laboratories - Combination treatment solution -
- 21.10.1999 - 21.09.2000
14.12.2000
- 05.1 2.2000 -
-
- D
- US
failure
in combination of HIV -- 1 infected patients -
- 2 presentations
133.3/33.3 mg, - 80/20 mg/ml - 3 presentations
- 174 days - 186 days
145 days 0 days
- Neurobloc - botulinum
- Bracco S.P.A.
-
- V08DA
Elan Pharma International
- SonoVue - Bracco S.P.A. - V08DA - Powder for injection -
M03AX01 Treatment of cervical
- sulphur
- Solution for injection - 5000 IU/ml
- I
- 27.08.1999 - 21.09.2000
- Ultrasound agent to
- 21.11.2000 -
- sulphur - I - Ultrasound agent to - 8 µl/ml -
toxin type B
14.12.2000
Ltd
-
cancer
enhance the
- 3 presentations
- 2 presentations -
- 187 days
194 days
- 229 days
276 days
- Tenecteplase - tenecteplase -A
- Osteogenis Protein - Stryker-Biotech - M09AX
Boehringer Ingelheim International GmbH
1 Howmedia International
B01AD Treatment of suspected myocardial infarction
Treatment of non- union of tibia of at
Powder and solvent for solution for injection 6000 IU, 8000 IU, 10000 IU 3 presentations
for implantation - 3.5 mg -
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
14.12.2000 201 days
- Metalyse - tenecteplase -A
Osteogenic Protein -1 BMP-7
Boehringer Ingelheim International GmbH
1 presentation -
Powder and solvent for solution for injection 6000 IU, 8000 IU, 10000 IU 3 presentations
A
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
77 Informe General EMEA 2000
- 27.11.2000 - - -
Anexo 9.
- Azomyr - desloratadine -B
Producto - Nombre comercial - DCI - Parte A/B
- SP Europe - US
Compañía - Nombre - Origen
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Área terapéutica - Especies de destino - Indicación
- Film coated tablet - 5 mg - 13 presentations
Presentación - Forma - Dosis - Número de presentaciones
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
EMEA/CPMP - Validación - Dictamen - Tiempo activo - Tiempo inactivo
- 06.11.2000 - - -
Comisión - Dictamen recibido el - Fecha de la decisión - Fecha de la notificación - Diario Oficial
- Opulis - desloratadine -B
- Ibraxion - Inactivated vaccine - Part A
- SP Europe - US
- Merial - F
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Cattle Vaccine against IBR (QJ57DA)
- Film coated tablet - 5 mg - 13 presentations
- Emulsion for injection - 2 ml - 1
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
- - - -
- 06.11.2000 - - -
17.11.1998 - 10.11.1999 - 210 days - 176 days - 10.12.1999
- Allex - desloratadine -B
- Metacam
- SP Europe - US
- Boehringer
- -
- Dogs
- Film coated tablet - 5 mg - 13 presentations
- Metacam - Boehringer - Dogs - Solution for injection -
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
- Metacam - Boehringer - Dogs - Solution for injection - 12.1.1999 -
- 06.11.2000 - - -
10.12.1999
- Aerius - desloratadine -B
- Meloxicam - Part B extension
- SP Europe - US
Ingelheim D
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Initiation therapy for - 5 mg/ml alleviation of pain and - 1 inflammation (QM01AC06)
- Film coated tablet - 5 mg - 13 presentations
- - -
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
10.11.1999 - 210 days - 92 days - 10.12.1999
- 06.11.2000 - - -
24.3.2000 27.3.2000 OJ C 120, 28.4.2000
- Neoclarityn - desloratadine -B
- Incurin - Oestriol - Part B
- SP Europe - US
- -
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Dogs Hormone -dependent urinary incontinence (QG03CA04)
- Film coated tablet - 5 mg - 13 presentations
- Scored tablets - 1 mg - 1
- 06.11.2000 - - -
14.7.1998 - 8.12.1999 - 210 days - 302 days -
- Xeloda - capecitabine -B
- Rabigen SAG2 - Live vaccine - Part A
- Roche Registration Ltd - CH
- Virbac - F
L01BC treatment of metastatic colorectal cancer
Foxes Vaccine against rabies (QJ57HA)
- Film coated tablet - 150 mg, 500 mg - 2 presentations
- - -
- 21.10.1999 - 21.09.2000 - 201 days - 159 days
Liquid within a blister - pack embedded in a - bait - 8 log 10 CCID50 - 2
- 20.11.2000 - - -
23.3.1998 - 8.12.1999 - 196 days - 428 days -
- -
7.1.2000 6.4.2000 10.4.2000 OJ C 120, 28.4.2000
Ovidrelle chorio- gonadotropin alfa
- Eurifel FeLV - Live vaccine - Part A
- -
- Merial - F
G03GA01 Assisted reproductive techniques sus as in vitro fertilisation (IVF)
Cats Vaccine against feline leukaemis (QJ57BA04)
- - -
- Pellet plus diluent - 1 ml - 3
- 21.10.1999 - 21.09.2000 - 174 days - 186 days
- - - -
- 23.11.2000 - - -
12.1.1999 - 8.12.1999 - 183 days - 120 days -
76 EMEA General Report 2000
7.1.2000 13.4.2000 18.4.2000 OJ C 120, 28.4.2000
Product - Brandname - INN - Part A/B
- Porcilis Pesti
Company - Name - Origin
- Intervet
Therapeutic area - ATC - Indication
- Pigs
Presentation - Form - Dosage - Number of presentations
- Porcilis Pesti - Intervet - Pigs - Water in oil emulsion -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- Porcilis Pesti - Intervet - Pigs - Water in oil emulsion - 14.7.1998 -
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Inactivated vaccine International - Part A - NL
- Prevenar - Prevenarp- neumococcal conjugate vaccine -A
Marker vaccine against CSF (QJ57EA)
- Wyeth- Lederle Vaccines S.A. - US
- 120 Elisa Units/2ml - 3
- J07AL - Active immunisation of infants and children against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae
- - -
- 19.11.1999 - 21.09.2000 - 205 days - 125 days
13.10.1999 - 210 days - 246 days -
- 21.11.2000 - - -
9.6.2000 14.6.2000 OJ C 183, 30.6.2000
- Prandin - replaglinide -B
- Ibaflin - Ibafloxacin - Part B
Novo Nordisk DK
Intervet International NL
A10BX02 Treatment of Type II diabetes mellitus
Dogs Pyoderma (QG51AC)
- Tablet - 0.5 mg, 1.0 mg, 2.0 mg, - 18 presentations
- Tablet - 150 & 300mg - 1
- 30.06.2000 - 21.09.2000 - 91 days - 0 days
- - - -
- 26.10.2000 - - -
12.1.1999 - 9.2.2000 - 210 days - 184 days -
- Rapamune - sirolimus -B
- Metacam - Meloxicam - Part B extension
Wyeth Europe Ltd US
Boehringer Ingelheim D
L04AA10 rophylaxis of organ rejection in patient receiving renal transplants
Dogs Post -operative pain (QM01AC06)
- Oral solution - 1 mg/ml - 5 presentations
- Solution for injection - 5mg/ml - 1
- 29.01.1999 - 16.11.2000 - 214 days - 393 days
2.1.2000 - 19.4.2000 - 101 days - 7 days -
- 08.01.2001 - - -
- Econor - Valnemulin - Part B extension
- Targretin - bexarotene -B
- Novartis - A
Ligand Pharmaceuticals Ltd US
- 0.5% premix - various - 2
L01XX25 Treatment of skin manifestations of advanced stage of cutaneous T -cell Lymphoma
10.8.1999 - 19.4.2000 - 2 10 days - 43 days -
- Capsule, soft - 75 mg - 1 presentation
- Econor - Valnemulin - Part B extension
- 17.12.1999 - 16.11.2000 - 197 days - 159 days
- Novartis - A
- Fasturtec
- 10 %/50% premix - various - 2
Sanofi
12.10.1999 - 8.3.2000 - 148 days - 0 -
-
7.4.2000 15.9.2000 20.9.2000 OJ C 308, 27.10.2000
V03AF07
78 Informe General EMEA 2000
- Powder and solvent for
Producto - Nombre comercial - DCI - Parte A/B
- 21.01.2000
Compañía - Nombre - Origen
-
Área terapéutica - Especies de destino - Indicación
- rasburicase -A
Presentación - Forma - Dosis - Número de presentaciones
-F
Comisión - Dictamen recibido el - Fecha de la decisión - Fecha de la notificación - Diario Oficial
-
- Econor
Treatment of tumor induced hpreuricemia
- Novartis
- -
- Pigs
solution for infusion 1.5 mg/ml 1 presentation
- Econor - Novartis - Pigs - 10 %/50% premix -
- 16.11.2000 - 177 days - 118 days
- Econor - Novartis - Pigs - 10 %/50% premix - 12.10.1999 -
- - -
7.4.2000
- Trazec - nateglinide -B
- Valnemulin
- -
- A
Novartis Europharm Ltd CH
- Prevention/treatment
- -
- Part B extension
A10B03 Combination treatment of diabetes mellitus Type II
- Part B extension of dysentery and - 2 -
- Film coated tablet - 60 mg, 120 mg, 180 mg - 21 presentations
- Part B extension of dysentery and - 2 - 148 days -
- 31.10.2000 - 14.12.2000 - 58 days - 0 days
0 -
- - - -
- Dicural
- Vaniqa - eflornithine -B
- Fort Dodge
- -
- Cattle & pigs
Bristol Myers Squibb Pharma EEIG US
- Dicural - Fort Dodge - Cattle & pigs - Solution for injection -
- -
- Difloxacin
D11AX Treatment of facial hirsutism
Animal Health
- Cream - 11.5% - 3 presentations
- Antibacterial for
- 03.01.2000 - 14.12.2000 - 182 days - 157 days
- Difloxacin Animal Health - Antibacterial for - 50 mg/ml -
- Starlix - nateglinide -B
- Difloxacin Animal Health - Antibacterial for - 50 mg/ml - 21.6.2000 -
- -
24.10.2000
Novartis Europharm Ltd CH
- Part B extension
A10BX03 Combination treatment of diabetes mellitus Type II
systemic use
- Film coated tablet - 60 mg, 120 mg, 180 mg - 21 presentations
- Part B extension - NL systemic use - 3 -
- 21.01.2000 - 14.12.2000 - 179 days - 144 days
- Part B extension - NL systemic use - 3 - 203 days -
- - - -
25.10.2000
- Zometa - zoledronic
(QJ01MA)
Novartis Europharm
OJ C 337, 28.11.2000
- -
- Poulflox
M05BA08 Treatment of tumour
- Virbac S.A.
- Powder and solvent for solution for infusion
- Poultry
- 21.01.2000 - 14.12.2000
- Poulflox - Virbac S.A. - Poultry - Oral solution -
- -
- 21.7.2000
acid
- Difloxacin
Ltd
- F
induced hypercalcaemia - 4 mg
- Antibacterial for
- 177 days
21.6.2000
-
- 16.11.2000
- B
- Part B
- 3 presentations
- Part B systemic use - 3 -
- 146 days
152 days
- Kaletra
43 days
- Abbott
- Bayovac CSF
- J05A
- Bayer
- Capsule, soft, Oral solution
- Pigs - Emulsion for inj
- 18.07.2000
- Bayovac CSF - Bayer - Pigs -
-
- 7.8.2000
lopinavir/ ritonavir
Marker Live vaccine Part A
-
- D
Combination treatment - 133.3/33.3 mg, 80/20 mg/ml in combination of HIV- - 3 presentations
E2 glycoprotein of - (CSF) virus - 4 -
- 14.12.2 000 - 145 days
- Porcilis AR-T-DF - Intervet
-B
- 18.8.2000
1 infected patients
- Vaccine against
- 0 days
- 16.11.2000
-
- Part A
- SonoVue - sulphur hexafluoride -B
- NL
- Bracco S.P.A. -I - V08DA
atrophic rhinitis
Ultrasound agent to enhance the echogenicity of the blood
- Part A - NL atrophic rhinitis - 2 ml -
- Powder for injection - 8 µl/ml - 2 presentations
- 2 -
- 27.08.1999 - 14.12.2000 - 194 days - 276 days
336 days
- - - -
- Pruban
Osteogenis Protein 1 Howmedia International Osteogenic Protein-1 BMP-7
- Anti-inflammatory for - 1 mg/g
- -
19.7.2000
Stryker - Biotech US
- 16.11.2000
- -
- Part B
M09AX Treatment of non-union of tibia of at least 9 month duration
- NL
- Powder for suspension for implantation - 3.5 mg - 1 presentation
cutaneous inflammatory- 1
- 30.07.1999 - 14.12.2000 - 201 days - 297 days
- Part B - NL cutaneous inflammatory- 1 -
- - - -
196 days
-A
- OJ C 2, 5.1.2001
77 EMEA General Report 2000
disorders (QD07AC90)
Annex 9:
477 days
Product - Brandname - INN - Part A/B
- Pirsue
Company - Name - Origin
- Pharmacia
Therapeutic area - Target species - Indication
- Dairy cattle
Presentation - Form - Dosage - Number of presentations
- Pirsue - Pharmacia - Dairy cattle - Sterile solution for -
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
12.1.1999
Commission - Opinion received - Date of Decision - Notification - Official Journal
- 10.11.2000
Ibraxion Inactivated vaccine Part A
- Pirlimycin
Merial F
Upjohn
Emulsion for injection 2 ml 1
- Clinical & sub-clinical
- 17.11.1998 - 10.11.1999 - 210 days - 176 days
- Pirlimycin Upjohn - Clinical & sub-clinical intramammary use -
00 10.03.
11.10.2000
Metacam Meloxicam Part B extension
- Part B
Boehringer Ingelheim D
- B
Dogs Initiation therapy for alleviation of pain and inflammation (QM01AC06)
mastitis
Solution for injection 5 mg/ml 1
- Part B - B mastitis - 5 mg/ml -
- 12.01.1999 - 10.11.1999 - 210 days - 92 days
210 days
- - - -
- 4 -
10.12.1999 24.03.2000 27.03.2000 OJ C 120, 28.04.2000
428 days
Incurin Oestriol Part B
- Zubrin
Intervet International NL
- Schering-Plough - Dogs
Dogs Hormone-dependent urinary incontinence (QG03CA04)
- Zubrin - Schering-Plough - Dogs - Oral lyophilisate -
Scored tablets 1 mg 1
18.5.1999
- 14.07.1998 - 08.12.1999 - 210 days - 302 days
- 8.12.2000
- - - -
- Tepoxalin
07.01.2000 24.03.2000 29.03.2000 OJ C 120, 28.04.2000
- UK
Foxes Vaccine against rabies (QJ57HA)
- Treatment of pain &
Liquid within a blister pack embedded in a bait 8 log 10 CCID50 2
- Tepoxalin - UK - Treatment of pain & - 30,50,100 & -
- 23.03.1998 - 08.12.1999 - 196 days - 428 days
8.11.2000
- - - -
- Part B
07.01.2000 06.04.2000 10.04.2000 OJ C 120, 28.04.2000
inflammation
Eurifel FeLV Live vaccine Part A
- Part B inflammation 200 mg/ml -
Merial F
210 days
Cats Vaccine against feline leukaemis (QJ57BA04)
- 39 -
Pellet plus diluent 1 ml 3
330 days
- 12.01.1999 - 08.12.1999 - 183 days - 120 days
- Eurican herpes 205 - Merial
- - - -
- Dogs - Powder plus solve
Ibaflin Ibafloxacin Part B
- Eurican herpes 205 - Merial - Dogs -
Intervet International NL
Powder plus solvent for -
Dogs Pyoderma (QG51AC)
13.7.1999
Tablet 150 & 300mg 1
- 8.12.2000
- 12.01.1999 - 09.02.2000 - 210 days - 184 days
- Inactivated vaccine - F - Part B
10.03.2000 13.06.2000 15.06.2000 OJ C 183, 30.06.2000
Vaccine against canine herpes
Metacam Meloxicam Part B (extension)
- -
Boehringer Ingelheim D
emulsion for injection - 1 ml - 2 -
Dogs Post-operative pain (QM01AC06)
8.11.2000 209 days 274 days
Solution for injection 5mg/ml 1
79 Informe General EMEA 2000
- 02.01.2000 - 19.04.2000 - 101 days - 7 days
Establecimiento de límites máximos de residuos para sustancias
- - - -
Sustancia - DCI
28.04.2000 15.09.2000 18.09.2000 OJ C 277, 29.09.2000
Área terapéutica - Especie de destino
Econor Valnemulin Part B (extension)
EMEA/CVMP - Validación - Dictamen - Tiempo activo - Tiempo inactivo
Novartis A
Comisión - Enviado a la Comisión - Fecha del Reglamento - Diario Oficial
Pigs Prevention & treatment of dysentery (QJ01XX94)
-
0.5% premix various 2
Bismuth subnitrate (extension)
- 10.08.1999 - 19.04.2000 - 210 days - 43 days
- Bovine
19.05.2000 15.09.2000 20.09.2000 OJ C 308, 27.10.2000
18.6.1999 13.10.1999 113 days 0
Econor Valnemulin Part B extension
- 12.11.1999 - 19.6.2000 - OJ L 145, 20.6.2000
Novartis A
-
10%/50% premix various 2
Acetyl isovaleryl tylosin tartrate
- 12.10.1999 - 08.03.2000 - 148 days -0
- Porcine
308, 27.10.2000
- 12.11.1999 - 19.6.2000 - OJ L 145, 20.6.2000
Econor Valnemulin Part B (extension)
- Methylprednisolone
Novartis A
- Bovine
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
- - - -
10%/50% premix various 2
13.7.1999 13.10.1999 92 days 0
- 12.10.1999 - 08.03.2000 - 148 days -0
- 12.11.1999 - 19.6.2000 - OJ L 145, 20.6.2000
07.04.2000 15.09.2000 22.09.2000 OJ C 308, 27.10.2000
Deltamethrin (extension)
78 EMEA General Report 2000
- Fin fish
Product - Brandname - INN - Part A/B
- - - -
Company - Name - Origin
9.12.1999 8.3.2000 90 days 0
Therapeutic area - Target species - Indication
- 7.4.2000 - 15.9.2000 - OJ L 234, 16.9.2000
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
Tylosin (extension)
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Eggs
Dicural Difloxacin Part B (extension)
- - - -
Fort Dodge Animal Health NL
9.11.1999 8.3.2000 90 days 0
Cattle & pigs Antibacterial for systemic use (QJ01MA)
- 7.4.2000 - 15.9.2000 - OJ L 234, 16.9.2000
Solution for injection 50 mg/ml 3
- Dicyclanil
- 16.12.1998 - 21.06.2000 - 203 days - 351 days
- Ovine
21.07.2000 24.10.2000 25.10.2000 OJ C 337, 28.11.2000
25.2.1997 8.3.2000 281 days 825 days
Poulflox Difloxacin Part B
- 7.4.2000 - 15.9.2000 - OJ L 234, 16.9.2000
F
-
Poultry Antibacterial for systemic use (QJ01MA94)
Tilmicosin (extension)
Oral solution 100 mg/ml 3
- Rabbit
- 09.12.1999 - 21.06.2000 - 152 days - 43 days
- - - -
- 21.07.2000 - 16.11.2000 - OJ C 2, 05.01.2001
16.7.1999 13.10.1999 86 days 0
Bayovac CSF Marker Live vaccine Part A
- 12.11.1999 - 20.10.2000 - DO L 269, 21.10.2000
Bayer D
-
Pigs Marker vaccine against Classical Swine Fever (QJ57EA)
Flumequine (extension)
Emulsion for injection E2 glycoprotein of Classical Swine Fever virus 4
- Bovine milk & turkey
- 16.12.1998 - 19.07.2000 - 210 days - 309 days
- - - -
- 07.08.2000
27.7.1999 10.11.1999 89 days 0
Porcilis AR -T- DF Inactivated vaccine Part A
- 9.12.1999 - 20.10.2000 - OJ L 269, 21.10.2000
Intervet International NL
Tiamulin (extension)
Pigs Vaccine against atrophic rhinitis (QJ57EA)
- Rabbit
Suspension for injection 2 ml 2
- - - -
- 12.01.1999 - 19.07.2000 - 204 days - 336 days
14.10.1999 12.1.2000 90 days 0
- 18.08.2000 - 16.11.2000 - OJ C 2, 05.01.2001
- 11.2.2000 - 20.10.2000 - OJ L 269, 21.10.2000
Pruban Rescortol butyrate Part B
-
Intervet International NL
Dicyclanil (modification)
Dogs Anti-inflammatory for cutaneous inflammatory disorders (QD07AC90)
- Sheep fat
Cream 1 mg/g 1
- - - -
- 15.09.1998 - 19.07.2000 - 196 days - 477 days
23.2.2000 17.5.2000 84 days 0
- 18.08.2000 - 16.11.2000 - OJ C 2, 05.01.2001
- 16.6.2000 - 27.10.2000 - OJ L 276, 28.10.2000
Pirsue Pirlimycin Part B
-
Pharmacia Upjohn B
Butafosfan (extension)
Dairy cattle Clinical & sub-clinical mastitis (QJ51FF90)
- Dairy cattle
Sterile solution for intramammary use 5 mg/ml 4
19.1.2000 19.4.2000 90 days 0
- 12.01.1999 - 11.10.2000 - 210 days - 428 days
- 19.5.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- 10.11.2000
-
Zubrin Tepoxalin Part B
Tilmicosin (extension)
Schering - Plough UK
- Bovine milk
Dogs Treatment of pain & inflammation
- - - -
Oral lyophilisate 30,50,100 & 200 mg/ml 39
22.2.1999 19.4.2000 203 days 210 days
- 18.05.1999 - 08.11.2000 - 210 days - 330 days
- 19.5.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- 08.12.2000
-
Eurican herpes 205 Inactivated vaccine Part B
Phoxim (extension)
Merial F
- Ovine
Dogs Vaccine against canine herpes
- - - -
Powder plus solvent for emulsion for injection 1 ml 2
19.1.2000 19.4.2000 90 0
- 13.07.1999 - 08.11.2000 - 209 days - 274 days
- 19.5.2000 - 27.10.2000 - OJ L 276, 28.10.2000
79 EMEA General Report 2000
80 Informe General EMEA 2000
Substance - INN
Sustancia - DCI
Therapeutic area - Target species
Área terapéutica - Especie de destino
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
EMEA/CVMP - Validación - Dictamen - Tiempo activo - Tiempo inactivo
Commission - Sent to Commission - Date of Regulation - Official Journal
Comisión - Enviado a la Comisión - Fecha del Reglamento - Diario Oficial
Bovine
- Flumethrin
- 18.06.1999 - 13.10.1999 - 113 days -0
- Ovine - 1
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
- Flumethrin - Ovine -
Porcine
19.1.2000
- 18.10.1995 - 13.10.1999 - 195 days - 1260 days
- 19.5.2000
Methylprednisolone
(extension)
Bovine
- - -
- 13.07.1999 - 13.10.1999 - 92 days -0
19.4.2000 90 days 0
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
- 27.10.2000 - OJ L 276, 28.10.2000
Deltamethrin (extension)
- Flunixin
Fin fish
- Equine - 2
- 09.12.1999 - 08.03.2000 - 90 days -0
- Flunixin - Equine -
- 07.04.2000 - 15.09.2000 - OJ L 234, 16.09.2000
- 21.7.2000
Tylosin (extension)
(extension)
Eggs
- - -
- 09.11.1999 - 08.03.2000 - 90 days -0
21.6.2000 90 days 0
- 07.04.2000 - 15.09.2000 - OJ L 234, 16.09.2000
- 29.12.2000 - OJ L 336, 30.12.2000
Dicyclanil
- Toltrazuril
Ovine
- Porcine - 1
25.02.1997 - 08.03.2000 - 281 days - 825 days
- Toltrazuril - Porcine -
Tilmicosin (extension)
(extension)
Rabbit
- - -
- 16.07.1999 - 13.10.1999 - 86 days -0
21.6.2000 206 days 284 days
- 12.11.1999 - 20.10.2000 - OJ L 269, 21.10.2000
- 29.12.2000 - OJ L 336, 30.12.2000
Flumequine (extension)
- Thiamphenicol
Bovine milk & turkey
- Porcine, Ovine, Turkey, - 1
- 27.07.1999 - 10.11.1999 - 89 days -0
- Thiamphenicol - Porcine, Ovine, Turkey, -
- 09.12.1999 - 20.10.2000 - OJ L 269, 21.10.2000
- 8.11.2000
Tiamulin (extension)
(extension)
Rabbit
- Fish
- 14.10.1999 - 12.01.2000 - 90 days -0
- - -
- 11.02.2000 - 20.10.2000 - OJ L 269, 21.10.2000
21.6.2000 206 days 562 days
Dicyclanil (modification)
- Difloxacin
Sheep fat
- Bovine, Porcine - 1
- 23.02.2000 - 17.05.2000 - 84 days -0
- Difloxacin - Bovine, Porcine -
- 16.06.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- 21.7.2000
Butafosfan (extension)
(extension)
Dairy cattle
- - -
- 19.01.2000 - 19.04.2000 - 90 days -0
21.6.2000 205 days 503 days
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- 29.12.2000 - OJ L 336, 30.12.2000
Tilmicosin (extension)
- Halofuginone
Bovine milk
- Bovine - 1
- 22.02.1999 - 19.04.2000 - 203 days - 210 days
- Halofuginone - Bovine -
Phoxim (extension)
10.12.1996
Ovine
- 21.7.2000
- 19.01.2000 - 19.04.2000 - 90 -0
- - -
80 EMEA General Report 2000
21.6.2000 281 days 1008 days
Substance - INN
- 29.12.2000 - DO L 336, 30.12.2000
Therapeutic area - Target species
- Linear dodecyl
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
- Bovine - 2
Commission - Sent to Commission - Date of Regulation - Official Journal
- Linear dodecyl - Bovine -
Flumethrin (extension)
22.1.1999
Ovine
- 18.8.2000
- 19.01.2000 - 19.04.2000 - 90 days -0
benzene sulfonic acid
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- - -
Flunixin (extension)
19.7.2000 195 days 321 days
Equine
- Phoxim
- 23.03.2000 - 21.06.2000 - 90 days -0
- Ovine - 1
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
- Phoxim - Ovine -
- 16.02.1999 - 21.06.2000 - 206 days - 284 days
- 18.8.2000
Thiamphenicol (extension)
(extension)
Porcine, Ovine, Turkey, Fish
- - -
- 15.05.1998 - 21.06.2000 - 206 days - 562 days
19.7.2000 120 days 0
- 08.11.2000
- Acetyl isovaleryl
Bovine, Porcine
- Porcine - 1
- 14.07.1998 - 21.06.2000 - 205 days - 503 days
- Acetyl isovaleryl - Porcine -
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
- 18.2.2000
Halofuginone
tylosin tartrate
- 10.12.1996 - 21.06.2000 - 281 days - 1008 days
13.9.2000 274 days 1790 days
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
- Florfenicol
Bovine
- Fish - 2
- 22.01.1999 - 19.07.2000 - 195 days - 321 days
- Florfenicol - Fish -
- 18.08.2000
- 8.11.2000
Phoxim (extension)
(extension)
Ovine
- - -
- 19.01.2000 - 19.07.2000 - 120 days -0
11.11.2000 212 days 1504 days
- 18.08.2000
- Meloxicam
Porcine
- Porcine -
- 18.01.1995 - 13.09.2000 - 274 days - 1790 days
- Meloxicam - Porcine -
- 18.02.2000
- 4.1.2001
Florfenicol (extension)
(extension)
Fish
- - -
- 29.01.1996 - 11.11.2000 - 212 days - 1504 days
6.12.2000 90 days 0
- 08.11.2000
- Tilmicosin
Porcine
- Turkey -
- 07.09.2000 - 06.12.2000 - 90 days - 0 days
- Tilmicosin - Turkey -
- 04.01.2001
4.1.2001
Tilmicosin z(extension)
z(extension)
Turkey
- - -
- 07.09.2000 - 06.12.2000 - 90 days - 0 days
6.12.2000 90 days 0
81 EMEA General Report 2000
81 Informe General EMEA 2000
Annex 10:
Anexo 10.
COMP opinions in 2000 on orphan medicinal products
Dictámenes del COMP en 2000 para medicamentos huérfanos
Product
Promotor
Sponsor
Indicación
Indication
EMEA/COMP - Presentación - Validación - Dictamen - Tiempo activo
EMEA/COMP - Submission - Validation - Opinion - Active time
Comisión - Dictamen recibido el - Fecha de la designación
Commission - Opinion received - Date of Designation
- Somatropin
Somatropin
Ares-Serono (Europe) Ltd
Ares-Serono (Europe) Ltd
- AIDS-wasting
AIDS-wasting
- - - -
- 28.04.2000 - 15.06.2000 - 11.07.2000 - 27 days
28.4.2000 15.6.2000 11.7.2000 27 days
- 17.07.2000 - 08.08.2000
- 17.7.2000 - 8.8.2000
Treatment of Fabry disease
- Treatment of Fabry disease
- 03.05.2000 - 15.06.2000 - 11.07.2000 - 27 days
3.5.2000 15.6.2000 11.7.2000 27 days
Genzyme BV
- Genzyme BV
- 12.05.2000 - 15.06.2000 - 11.07.2000 - 27 days
12.5.2000 15.6.2000 11.7.2000 27 days
Fluorouracil
- Fluorouracil
Ethypharm S.A.
- Ethypharm S.A. - Treatment of glioblastoma
Treatment of glioblastoma
- - - -
- 26.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
26.5.2000 31.7.2000 13.9.2000 45 days
- 18.09.2000 - 18.10.2000
- 18.9.2000 - 18.10.2000
Wyeth-Ayerst Research
Wyeth-Ayerst Research
Treament of acute myeloid leukaemia
- Treament of acute myeloid leukaemia
- 07.06.2000 - 31.07.2000 - 13.09.2000 - 45 days
7.6.2000 31.7.2000 13.9.2000 45 days
1,5 -(Butylimino)- 1,5-dideoxy, D-glucitol
1,5 -(Butylimino)- - 1,5-dideoxy, D- glucitol
Treatment of Gaucher disease
- Treatment of Gaucher disease
N -carbamyl-L- glutamic acid
N -carbamyl-L- glutamic acid
Orphan Europe Sarl
Orphan Europe - Sarl
Treatment of N-acetylglutamate synthetase (NAGS) deficiency
Treatment of N-acetylglutamate synthetase (NAGS) deficiency
- 02.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
2.5.2000 31.7.2000 13.9.2000 45 days
Arsenic trioxide
- Arsenic trioxide
- 08.05.2000 - 15.06.2000 - 13.09.2000 - 90 days
8.5.2000 15.6.2000 13.9.2000 90 days
Thalidomide
- Thalidomide
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
- 01.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
1.6.2000 25.8.2000 27.10.2000 64 days
- 6.11.2000 - 29.12.2000
- 6.11.2000 - 29.12.2000
Anagrelide hydrochloride
Anagrelide hydrochoride
- 31.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
31.5.2000 31.7.2000 27.10.2000 89 days
Pierre Fabre Médicament
- Pierre Fabre
Intravenous conditioning treatment prior to hematopoietic progenitor cell transplantation
Intravenous conditioning treatment - prior to hematopoietic progenitor cell transplantation
- 09.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
9.6.2000 31.7.2000 27.10.2000 89 days
Nitisinone
- Nitisinone
Swedish Orphan AB
-
Treatment of tyrosinaemia type 1
Swedish Orphan - Treatment of tyrosinaemia type 1 AB
- 05.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
5.6.2000 25.8.2000 27.10.2000 64 days
82 EMEA General Report 2000
82 Informe General EMEA 2000
Product
Producto
Sponsor
Promotor
EMEA/COMP - Submission - Validation - Opinion - Active time
EMEA/COMP - Presentación - Validación - Dictamen - Tiempo activo
Commission - Opinion received - Date of Designation
Comisión - Dictamen recibido el - Fecha de la designación
Ethyl eicosopentaenoate
- Ethyl
Laxdale Ltd
- Laxdale Ltd
Treatment of Huntington's disease
- Ethyl - Laxdale Ltd - Treatment of Huntington’s disease -
- 05.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
31.7.2000 27.10.2000 89 days
- 6.11.2000 - 29.12.2000
- 29.12.2000
Iloprost
-
Schering AG
Iloprost - Schering AG
Treatment of primary and of the following forms of secondary pulmonary hypertension: connective tissue disease pulmonary hypertension, drug -induced pulmonary hypertension, portopulmonary hypertension, pulmonary hypertension associated with congenital heart disease and chronic thromboembolic pulmonary hypertension
tissue disease pulmonary hypertension, drug -induced pulmonary hypertension, portopulmonary hypertension, pulmonary hypertension associated with congenital heart disease and chronic thromboembolic pulmonary hypertension
- 10.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
89 days
- 6.11.2000 - 29.12.2000
- Treatment of amyotrophic lateral -
-
7.8.2000
Treatment of amyotrophic lateral sclerosis
sclerosis
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
25.8.2000 21.11.2000 89 days
-
......
- 61 days
8.8.2000 22.9.2000 21.11.2000 61 days
Treatment of acute respiratory distress syndrome
- Treatment of acute respiratory -
- 01.09.2000
1.9.2000
- 22.09.2000
distress syndrome
- 21.11.2000
- - -
- 61 days
22.9.2000 21.11.2000 61 days
- 89 days
9.8.2000 22.9.2000 19.12.2000 89 days
Treatment of patent ductus arteriosus
- Treatment of patent ductus -
- 02.05.2000
2.5.2000
- 19.10.2000
arteriosus
- 19.12.2000
- - -
- 62 days
19.10.2000 19.12.2000 62 days
Treatment of glycogen storage disease type II
Treatment of glycogen storage disease type II (Pompe’s disease)
- 19.10.2000 - 19.12.2000 - 62 days
10.8.2000 19.10.2000 19.12.2000 62 days
Treatment of acromegaly
- Treatment of acromegaly -
- 11.08.2000 - 19.10.2000 - 19.12.2000 - 62 days
19.10.2000 19.12.2000 62 days
- 19.10.2000 - 19.12.2000 - 62 days
21.8.2000 19.10.2000 19.12.2000 62 days
Treatment of haemorrhagic fever with renal syndrome
- Treatment of haemorrhagic fever -
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
6.9.2000
Treatment of mucopolysaccharidosis type I
19.10.2000 19.12.2000 62 days
- 08.09.2000
......
- 19.10.2000
Treatment of mucopolysaccharidosis type I
- 19.12.2000
- - - -
- 62 days
8.9.2000 19.10.2000 19.12.2000 62 days
Treatment of chronic myeloid leukaemia
- Treatment of chronic myeloid -
- 03.10.2000
3.10.2000
- 19.10.2000
leukaemia
Mucopolysaccharidosis type VI (Maroteaux -Lamy
Mucopolysaccharidosis type VI (Maroteaux-Lamy Syndrome)
- 19.10.2000 - 19.12.2000 - 62 days
4.10.2000 19.10.2000 19.12.2000 62 days
83 EMEA General Report 2000
83 Informe General EMEA 2000
Annex 11:
Anexo 11.
EMEA guidelines in 2000
Directrices de la EMEA en 2000 Grupo de trabajo del CPMP «Biotecnología»
Reference number
Número de referencia
Guidelines/Status
Directrices/Situación
EMEA/ CPMP/ BWP/840/00
EMEA/ CPMP/ BWP/840/00
Final EU recommendations for the Influenza vaccine composition for the season 2000/2001 Adopted April 2000
Final EU recommendations for the Influenza vaccine composition for the season 2000/2001 Adoptada en abril de 2000
EMEA/ CPMP/ BWP/1244/00
EMEA/ CPMP/ BWP/1244/00
Report of the EMEA Expert Workshop on human TSEs and plasma-derived medicinal products, 15-16 May 2000 Adopted July 2000
Report of the EMEA Expert Workshop on human TSEs and plasma- derived medicinal products, 15-16 May 2000 Adoptada en julio de 2000
EMEA/ CPMP/ BWP/3326/99
EMEA/ CPMP/ BWP/3326/99
Concept paper on the Development of a Points to consider on xenogeneic cell therapy Adopted November 2000
Concept paper on the Development of a Points to consider on xenogeneic cell therapy Adoptada en noviembre de 2000
EMEA/ CPMP/ BWP/3354/99 Draft
EMEA/ CPMP/ BWP/3354/99 Draft
Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Released for consultation January 2000
Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Publicada para consulta en enero de 2000