qanastek/EMEA-V3 huggingface dataset:
premature luteinising
related macular
-B premature luteinising - 2 presentations -
- B - CH related macular - 15 mg -
-B premature luteinising - 2 presentations - 162 days -
- B - CH related macular - 15 mg - 138 days -
22.05.2000
31.07.2000
hormone surges in conteolled ovarian hyperstimulation
presentation
189 days -
63 days -
OJ C 183, 30.06.2000, p.
OJ C 244, 25.08.2000, p.
Pegintron peginterferon alfa -2b
NovoMix 30 insulin aspart A
- -
Novo - Nordisk - DK
L03AB10 Treatment of chronic hepatitis C
A10AD Diabetes mellitus
Powder and solvent for solution for injection 50 µg/0.5 ml, 80 µg/0.5 ml,
Suspension for injection 100 IU/ ml 8 presentations
- 26.03.1999 - 17.02.2000 - 189 days
- - - -
- 27.03.2000 - 25.05.2000 - 05.06.2000
24.09.1999 - 12.04.2000 - 144 days - 55 days -
100 µg/0.5 ml 120 µg/0.5 ml, 150µg/0.5 ml 25 presentations
-Bayer - B02BD02 - Powder and solvent for - 26.02.1
- 139 days
- Kogenate -Bayer -
3
solution for injection - 16
- Viraferon PEG - peginterferon alfa -2b -A
- Treatment and solution for injection -
- SP Europe - US
- Treatment and solution for injection - 16.03.2000 -
L03AB10 Treatment of chronic hepatitis C
prophylaxis of
- - -
- 250 I
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
- octocog alfa -D prophylaxis of - 250 IU, 500 IU, 1000 IU -
- 03.01.2000 - 17.02.2000 - 43 days - 0 days
- octocog alfa -D prophylaxis of - 250 IU, 500 IU, 1000 IU - 182 days -
3
- 3 pr
Lantus insulin glargine
Helixate
-
-Bayer -
Aventis Pharma Deutschland
Powder and solvent for -
- A10AE - Diabetes mellitus
26.02.1999 -
- Solution for injection - 100 IU/ml - 7 presentations
solution for infusion - 16
- 23.04.1999 - 17.02.2000 - 215 days
- Treatment and solution for infusion -
- 23.03.2000 - 06.06.2000 - 14.06.2000
- Treatment and solution for infusion - 16.03.2000 -
GmbH
-D
- 8 3 days
- 250 I
- OJ C 183,
-
-D
A
30.06.2000, p.
bleeding in
Optisulin insulin glargine
Hepacare triple antigen
Aventis Pharma Deutschland
Medeva - Pharma -
- A10AE - Diabetes mellitus
J07BC - Immunisation -
- Solution for injection - 100 IU/ml - 7 presentations
Suspension for injection - Monodose preparation of 1 -
- 24.09.1999 - 17.02.2000 - 116 days
23.10.1998 - 16.03.2000 -
- 23.03.2000 - 27.06.2000 - 28.06.2000
16.05.2000 04.08.2000
-A
hepatitis B
GmbH
Ltd
- 28 days
against hepatitis
- OJ C 216,
ml contains Hepatitis B
4
210 days -
- Nyracta - rosiglitazone -B
07.08.2000
SmithKline Beecham Pharmaceuticals UK
vaccine A
A10BG02 Combination treatment of Type II diabetes mellitus
UK
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
B virus in adults
2
surface antigen S, pre-S1 and pre S2 20 µg 2 presentations
- Avandia - rosiglitazone -B
-
- -
293 days -
SmithKline Beecham Pharmaceuticals UK
10
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
Herceptin trastuzumab
4
Roche - Registrat -
- Venvia - rosiglitazone -B
L01XC03 Treatment of
SmithKline Beecham Pharmaceuticals UK
Powder for concentrate for solution for infusion
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
26.02.1999 - 25.05.2000 -
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
03.07.2000 28.08.2000
- Myocet - doxorubicin -B
ion Ltd CH
The Liposome Company US
150 mg 1 presentation
L01DB Treatment of metastatic breast cancer
147 days - 305 days -
- 30.07.1999 - 12.04.2000 - 167 days - 91 days
14
2
Keppra
- Datscan - ioflupane -B
- UCB - N03A - Film coated tablet - 26.02.1
- -
- Keppra - UCB -
Nycomed Amersham UK
N03A
- -
- Film
- Solution for injection - 74 MBq/ml - 1 presentation
- Keppra - UCB - N03A - Film coated tablet -
- 18.12.1998 - 16.03.2000 - 178 days - 272 days
- Keppra - UCB - N03A - Film coated tablet - 26.02.1999 -
- - - -
31.07.2000
73 EMEA General Report 2000
levetiracetam
Product - Brandname - INN - Part A/B
S. A. - Adjunctive - 250 mg, 500 mg, 750 mg, - 29.06
Company - Name - Origin
- levetiracetam S. A. -
Therapeutic area - ATC - Indication
Adjunctive
Presentation - Form - Dosage - Number of presentations
- 250 m
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- levetiracetam S. A. - Adjunctive - 250 mg, 500 mg, 750 mg, -
- Visudyne - verteporfin -B
- levetiracetam S. A. - Adjunctive - 250 mg, 500 mg, 750 mg, - 29.06.2000 -
- Ciba Vision - CH
29.09.2000
L01XX Treatment of age - related macular degeneration
B
- 27.08.1999 - 12.04.2000 - 138 days - 63 days
therapy in the
- - - -
100
10
- B - US therapy in the 1000 mg -
- NovoMix 30 - Novo Nordisk - insulin aspart - DK -A
- B - US therapy in the 1000 mg - 187 days -
- A10AD - Diabetes mellitus
11.10.2000
- Suspension for injection - 100 IU/ml - 8 presentations
partial onset seizures in epilepsy
- 24.09.1999 - 12.04.2000 - 144 days - 55 days
- 26 presentations -
- - - -
300 days -
17.05.2000 01.08.2000 01.08.2000 OJ C 244, 25.08.2000, p.
OJ C 308, 27.10.2000, p.
- Bayer AG -D
Panretin -
- -
Ligand -
B02BD02 Treatment and prophylaxis of bleeding
L01XX22
- -
- Gel -
- 26.02.1999 - 16.0 3.2000 - 182 days
26.02.1999 -
- 05.06.2000 - 04.08.2000 - 07.08.2000
31.07.2000
- 3 presentations
Pharmac - Ttopical - 0.1 %w/ w - 29.06
- 201 days
- alitretinoin Pharmac -
-
Ttopical - 0.1 %w/ w
10
- alitretinoin Pharmac - Ttopical -
- -
- alitretinoin Pharmac - Ttopical - 0.1 %w/ w -
Helixate NexGen octocog alfa
- alitretinoin Pharmac - Ttopical - 0.1 %w/ w - 29.06.2000 -
- Bayer AG -D
11.10.2000
B02BD02 Treatment and prophylaxis of bleeding
treatment of - 1 presentation
- -
- B euticals treatment of -
Powder and solvent for solution for infusion 250 IU, 500 IU, 1000 IU
- B euticals treatment of - 1 presentation -
- 26.02.1999 - 16.0 3.2000 - 182 days
- B euticals treatment of - 1 presentation - 174 days -
- 05.06.2000 - 04.08.2000 - 07.08.2000
18.10.2000
in haemophilia A
Ltd US
- 3 presentations
cutaneous lesions in AIDS related Kaposi's sarcoma
- 201 days
-
-
313 days -
OJ C 244, 25.08.2000, p.
OJ C 337, 28.11.2000. p.
Hepacare triple antigen hepatitis B vaccine
Glustin pioglitazone
Medeva Pharma Ltd UK
Tablet 15 mg, 30 mg
J07BC Immunisation against hepatitis B virus in adults
23.04.1999 - 29.06.2000 -
- 23.10.1998 - 16.03.2000 - 210 days - 293 days
JP
- 16.05.2000 - 04.08.2000 - 07.08.2000 - OJ C 244,
treatment of Type - II Diabetes mellitus
-A
6 presentations
Roche Registration Ltd CH
Actos pioglitazone
- - -
Takeda - Europe -
Powder for concentrate for solution for infusion 150 mg 1 presentation
A10BG03 - Combination -
- 26.02.1999 - 25.05.2000 - 147 days - 305 days
Tablet 15 mg, 30 mg
- Keppra - levetiracetam -B
23.04.1999 - 29.06.2000 -
- UCB S.A. - US
31.07.2000 13.10.2000
N03A Adjunctive therapy in the partial onset seizures in epilepsy
B
Film coated tablet 250 mg, 500 mg, 750 mg, 1000 mg 26 presentations
JP
- 26.02.1999 - 29.06.2000 - 187 days - 300 days
treatment of Type - II Diabetes mellitus
31.07.2000 29.09.2000 11.10.2000 OJ C 308, 27.10.2000, p.
19.10.2000 OJ C 337, 28.11/ 00. p.
Ligand Pharmaceuticals Ltd US
Agenerase
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi's sarcoma
- Glaxo - J05AE05 - Capsule, soft, Oral - 20.11.1
- Gel - 0.1 %w/w - 1 presentation
- Agenerase - Glaxo -
- 26.02.1999 - 29.06.2000 - 174 days - 313 days
J05AE05 - Capsule, soft, Oral
2
C
- Glustin - pioglitazone -B
- Agenerase - Glaxo - J05AE05 - Capsule, soft, Oral -
Takeda Europe JP
amprenavir
- -
- amprenavir Group -
A10BG03 Combination treatment of Type II Diabetes mellitus
Treatment of
- Tablet - 15 mg, 30 mg - 6 presentations
- amprenavir Group - Treatment of solution -
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
- amprenavir Group - Treatment of solution - 29.06.2000 -
Takeda Europe JP
HIV infected
- -
- 50 mg
A10BG03 Combination treatment of Type II Diabetes mellitus
- B - UK HIV infected - 50 mg, 150 mg, 15 mg/ ml -
- Tablet - 15 mg, 30 mg - 6 presentations
- B - UK HIV infected - 50 mg, 150 mg, 15 mg/ ml - 219 days -
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
- 4 presentations -
- - - -
324 days -
31.07.2000 13.10.2000 19.10.2000 OJ C 337, 28.11/00. p.
OJ C 337, 28.11.2000. p.
- Agenerase - amprenavir -B
EMEA/ MB/ 050/ 00 Relazione annuale 2000
- Glaxo Group - UK
Pagina 75/ 91
J05AE05 Treatment of HIV infected adults and children
Infanrix hexa - - JO7CA - Powder and suspension for - 30.07.1999 - 09.08.
- Capsule, soft, Oral solution - 50 mg, 150 mg, 15 mg/ml - 4 presentations
- Infanrix hexa - -
- 20.11.1998 - 29.06.2000 - 219 days - 324 days
JO7CA - Powder and suspension for
- - - -
- Infanrix hexa - - JO7CA -
09.08.2000 20.10.2000 25.10.2000 OJ C 337, 28.11.2000. p.
09.08.2000
74 EMEA General Report 2000
Hep B-IPV
Product - Brandname - INN - Part A/B
SmithKli - Immunisation suspension for injection - 29.06.
Company - Name - Origin
- Hep B-IPV SmithKli -
Therapeutic area - ATC - Indication
Immunisation
Presentation - Form - Dosage - Number of presentations
su
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- Hep B-IPV SmithKli - Immunisation suspension for injection -
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Hep B-IPV SmithKli - Immunisation suspension for injection - 29.06.2000 -
Infanrix hexa Hep B-IPV HIB vaccine
HIB vacci
-
ne ne
SmithKline Beecham Biologicals
against
JO7CA Immunisation against Haemophilus influenza,
Diphtheria toxoid, - 201 days - 26.10
- 30.07.1999 - 29.06.2000 - 201 days
- Diphtheria toxoid, - 201 days -
- 09.08.2000 - 23.10.2000 - 26.10.2000
26.10.2000
-B
Biologic
Tetanus, HepB and Poliomyelitis
influenza,
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
Tetanus toxoid, adsorbed ≥
28.11.2000. p.
28.11.2000. p.
SmithKline Beecham Biologicals
- SmithKli
JO7CA Primary and booster immunisation of infants
JO7CA Primary and
- Suspension for injection - Diphtheria toxoid, adsorbed ≥ 30IU
Suspension for injection Diphtheria toxoid, adsorbed ≥ 30IU
- 30.07.1999 - 29.06.2000 - 201 days
30.07.1999 - 29.06.2000 -
- 09.08.2000 - 23.10.2000 - 26.10.2000
09.08.2000 23.10.2000
S.A.
ne Beecham
against Diphtheria,
booster immunisation of
Tetanus toxoid, adsorbed ≥
Tetanus toxoid, adsorbed ≥
- 132 days
201 days - 132 days -
- OJ C 337,
26.10.2000 OJ C 337,
Tetanus, Pertussis, Hepatitis B and Poliomyelitis
infants against
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
40IU
Pasteur
JO7CA Immunisation
- JO7CA
- -
- 30.07.1999
30.07.1999 - 26.06.2000 -
- 10.08.2000
10.08.2000 23.10.2000
Immunisation Diphtheria, pertussis, Tetanus, HepB, Poliomyelitis, Haemophilus influenza
Diphtheria,
- 26.06.2000 - 180 days - 153 days
180 days -
23.10.2000 26.10.2000 OJ C 337, 28.11.2000. p.
28.11.2000. p.
- Luveris - lutropin alfa -A
EMEA/ MB/ 050/ 00 Relazione annuale 2000
Ares Serono (Europe) Ltd CH
Luveris - Ares - G03G - Powder and solvent for - 25.06.1999 - 07.09.
G03G Stimulation of follicular development in women - 75 with servere Leng HEng and FSH deficiency
Ares - G03G - Powder and solvent for - 25.0
3
- Luveris - Ares - G03G - Powder and solvent for - 25.06.1999 -
75 EMEA General Report 2000
07.09.2000
Company - Name - Origin
Serono - Stimulation of solution for injection - 27.07
Commission - Opinion received - Date of Decision - Notification - Official Journal
- lutropin alfa Serono - Stimulation of solution for injection - 27.07.2000 -
- NeoSpect - depreotide
29.11.2000
- 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, p.
J05AF30 Treatment of HIV -1 infected patients
J05AF30 Treatment of HIV-1 infected patients
- 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
- 21.10.1999 - 21.09.2000
21.10.1999 21.09.2000 174 days
failure
- - -
- Neurobloc - botulinum
Solution for injection - 5000 IU/ ml - 3 presentations - -
Elan Pharma International
B01AD - Powder and solvent
M03AX01 Treatment of cervical
Treatment of
- Solution for injection - 5000 IU/ml
- tenecteplase Boehring - Treatment of solution for injection -
- 27.08.1999 - 21.09.2000
21.09.2000
- 21.11.2000 -
- A er suspected - 6000 IU, 8000 IU, 10000 -
toxin type B
176 days
cancer
myocardial infarction
- 3 presentations
IU 3 presentations
- 187 days
215 days
-B
-D -
- UK
- Metalyse - -
- 229 days
- Metalyse - - B01AD -
- Tenecteplase - tenecteplase -A
- tenecteplase Boehring -
- 27.11.2000 - - -
- SP - R06AX27 - Film coated tablet - 24.09.1
-D
- Azomyr - SP -
- Metalyse - tenecteplase -A
- Azomyr - SP - R06AX27 -
-
- Azomyr - SP - R06AX27 - Film coated tablet -
Boehringer Ingelheim International GmbH
- Azomyr - SP - R06AX27 - Film coated tablet - 24.09.1999 -
B01AD Treatment of suspected myocardial infarction
Europe - Relief of - 5 mg
- - -
- desloratadine Europe -
Powder and solvent for solution for injection 6000 IU, 8000 IU, 10000 IU 3 presentations
Relief of - 5 mg
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
- desloratadine Europe - Relief of -
- 27.11.2000 - - -
- desloratadine Europe - Relief of - 5 mg -
-D
- US
- Azomyr - desloratadine -B
- B - US symptoms -
- Neoclarityn - desloratadine -B
EMEA/ MB/ 050/ 00 Relazione annuale 2000
- SP Europe - US
- Neoclarityn - SP - - desloratadine Europe - - B - US
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
R06AX27 - Relief of - symptoms - associated with seasonal allergic rhinitis
- Film coated tablet - 5 mg - 13 presentations
Film coated tablet 5 mg 13 presentations
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
24.09.1999 21.09.2000 201 days 159 days
- Xeloda - capecitabine -B
06.11.2000
- Roche Registration Ltd - CH
- Xeloda - Roche - - capecitabine Registrat - - B ion Ltd - CH
L01BC treatment of metastatic colorectal cancer
L01BC - treatment of - metastatic - colorectal cancer
- Film coated tablet - 150 mg, 500 mg - 2 presentations
Film coated tablet 150 mg, 500 mg 2 presentations
- 21.10.1999 - 21.09.2000 - 201 days - 159 days
21.10.1999 21.09.2000 201 days 159 days
Ovidrelle chorio- gonadotropin alfa
Ovidrelle
Ares Serono (Europe) Ltd CH
- chorio- Serono -
76 EMEA General Report 2000
Prevenar Prevenarpneu mococcal conjugate
Product - Brandname - INN - Part A/B
Wyeth- Lederle Vaccines S. A.
Therapeutic area - ATC - Indication
J07AL Active immunisation of infants and
Presentation - Form - Dosage - Number of presentations
Suspension for injection A monodose preparation of 0.5 ml contains Streptococcus pneumoniae:
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
vaccine
- Wyeth- Lederle Vaccines S.A. - US
saccharide suspension of Serotype 4 2 µg
- J07AL - Active immunisation of infants and children against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae
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
Serotype 9V 2 µg Serotype 14 2 µg Serotype 18C 2 µg Serotype 19F 2 µg Serotype 23F 2 µg Serotype 6B 4 µg Conjugated to CRM197 carrier protein ∼ 20 µg
- 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
- 29.01.1999 - 16.11.2000 - 214 days - 393 days
29.01.1999 16.11.2000 214 days 393 days
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
- 17.12.1999 - 16.11.2000 - 197 days - 159 days
17.12.1999 16.11.2000 197 days 159 days
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
- 31.10.2000 - 14.12.2000 - 58 days - 0 days
31.10.2000 14.12.2000 58 days 0 days
- 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
- 21.01.2000 - 14.12.2000 - 179 days - 144 days
21.01.2000 14.12.2000 179 days 144 days
- 177 days
21.01.2000 14.12.2000 177 days
- 18.07.2000
18.07.2000
lopinavir/ ritonavir
lopinavir/
- SonoVue - sulphur hexafluoride -B
- SonoVue -Bracco -
- Bracco S.P.A. -I - V08DA
- SonoVue -Bracco - V08DA -
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 -
77 EMEA General Report 2000
Prodotto - Nome commerciale
Annex 9:
Ditta - Nome
CVMP opinions in 2000 on medicinal products for veterinary use Centralised applications
EMEA/ CVMP - Convalida
Product - Brandname - INN - Part A/B
Commissione - Parere ricevuto il
Company - Name - Origin
- Indicazione
Therapeutic area - Target species - Indication
- Data della decisione
Presentation - Form - Dosage - Number of presentations
- Numero di presentazioni
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
- Tempo attivo - Tempo inattivo
Commission - Opinion received - Date of Decision - Notification - Official Journal
G. U.
- 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 - 10.03.
00 OJ C 95, 04.04.2000
00 - OJ C 95, 04.04.2000
- 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
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
- 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)
- 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
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.
308, 27.10.2000
308, 27.10.2000
Econor Valnemulin Part B (extension)
Prodotto - Nome commerciale
Novartis A
Ditta - Nome
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
Area terapeutica - Specie bersaglio
10%/50% premix various 2
EMEA/ CVMP - Convalida
- 12.10.1999 - 08.03.2000 - 148 days -0
Commissione - Parere ricevuto il
- - - -
- DCI
07.04.2000 15.09.2000 22.09.2000 OJ C 308, 27.10.2000
- Data della decisione
78 EMEA General Report 2000
- Numero di presentazioni
Product - Brandname - INN - Part A/B
- Tempo attivo - Tempo inattivo
Company - Name - Origin
- Data delle notifica - Rif.
Therapeutic area - Target species - Indication
Econor Valnemulin Part B (extension)
Presentation - Form - Dosage - Number of presentations
Pigs Prevention / treatment of dysentery and treatment/ control of enzootic pneumonia (QJ01XX94)
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
- 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
- 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)
- 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)
- 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
Schering - Plough UK
Schering- Plough UK
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
Establishment of maximum residue limits for new substances
EMEA/ MB/ 050/ 00 Relazione annuale 2000 Determinazione dei limiti massimi di residui per le nuove sostanze
Substance - INN
Pagina 81/ 91
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
Sostanza Area terapeutica EMEA/ CVMP - DCI - Specie bersaglio - Convalida - Parere - Tempo attivo - Tempo inattivo
Commission - Sent to Commission - Date of Regulation - Official Journal
Commissione - Invio alla Commissione - Data del regolamento - Rif.
Bovine
GUCE
- 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
- 18.10.1995 - 13.10.1999 - 195 days - 1260 days
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
- 16.07.1999 - 13.10.1999 - 86 days -0
Tilmicosin Rabbit - 16.07.1999 (extension) - 13.10.1999 - 86 days -0
- 12.11.1999 - 20.10.2000 - OJ L 269, 21.10.2000
- 12.11.1999 - 20.10.2000 - OJ L 269, 21.10.2000
- 27.07.1999 - 10.11.1999 - 89 days -0
Flumequine Bovine milk & turkey - 27.07.1999 (extension) - 10.11.1999 - 89 days -0
- 09.12.1999 - 20.10.2000 - OJ L 269, 21.10.2000
- 09.12.1999 - 20.10.2000 - OJ L 269, 21.10.2000
- 14.10.1999 - 12.01.2000 - 90 days -0
Tiamulin Rabbit - 14.10.1999 (extension) - 12.01.2000 - 90 days -0
- 11.02.2000 - 20.10.2000 - OJ L 269, 21.10.2000
- 11.02.2000 - 20.10.2000 - OJ L 269, 21.10.2000
- 23.02.2000 - 17.05.2000 - 84 days -0
Dicyclanil Sheep fat - 23.02.2000 (modification) - 17.05.2000 - 84 days -0
- 16.06.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- 16.06.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- 19.01.2000 - 19.04.2000 - 90 days -0
Butafosfan Dairy cattle - 19.01.2000 (extension) - 19.04.2000 - 90 days -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
- 22.02.1999 - 19.04.2000 - 203 days - 210 days
Tilmicosin Bovine milk - 22.02.1999 (extension) - 19.04.2000 - 203 days - 210 days
- 19.01.2000 - 19.04.2000 - 90 -0
Phoxim Ovine - 19.01.2000 (extension) - 19.04.2000 - 90 -0
- 19.01.2000 - 19.04.2000 - 90 days -0
Flumethrin Ovine - 19.01.2000 (extension) - 19.04.2000 - 90 days -0
- 23.03.2000 - 21.06.2000 - 90 days -0
Flunixin Equine - 23.03.2000 (extension) - 21.06.2000 - 90 days -0
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
- 16.02.1999 - 21.06.2000 - 206 days - 284 days
- 16.02.1999 - 21.06.2000 - 206 days - 284 days
- 15.05.1998 - 21.06.2000 - 206 days - 562 days
- 15.05.1998 - 21.06.2000 - 206 days - 562 days
- 08.11.2000
- 08.11.2000
- 14.07.1998 - 21.06.2000 - 205 days - 503 days
- 14.07.1998 - 21.06.2000 - 205 days - 503 days
- 10.12.1996 - 21.06.2000 - 281 days - 1008 days
- 10.12.1996 - 21.06.2000 - 281 days - 1008 days
- 22.01.1999 - 19.07.2000 - 195 days - 321 days
- 22.01.1999 - 19.07.2000 - 195 days - 321 days
- 18.08.2000
- 18.08.2000
- 19.01.2000 - 19.07.2000 - 120 days -0
- 19.01.2000 - 19.07.2000 - 120 days -o
- 18.01.1995 - 13.09.2000 - 274 days - 1790 days
- 18.01.1995 - 13.09.2000 - 274 days - 1790 days
- 18.02.2000
- 18.02.2000
- 29.01.1996 - 11.11.2000 - 212 days - 1504 days
- 29.01.1996 - 11.11.2000 - 212 days - 1504 days
- 07.09.2000 - 06.12.2000 - 90 days - 0 days
- 07.09.2000 - 06.12.2000 - 90 days - 0 days
- 04.01.2001
- 04.01.2001
Tilmicosin z(extension)
Tilmicosin z(extension)
81 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Relazione annuale 2000 Allegato 10 Pareri del COMP sui medicinali orfani nel 2000
Annex 10:
Pagina 83/ 91
Product
Prodotto
EMEA/COMP - Submission - Validation - Opinion - Active time
- Convalida - Parere - Tempo attivo
Commission - Opinion received - Date of Designation
- Data di assegnazione della qualifica
Ares-Serono (Europe) Ltd
Ares-Serono (Europe) Ltd
AIDS-wasting
AIDS-wasting
- 28.04.2000 - 15.06.2000 - 11.07.2000 - 27 days
- 28.04.2000 - 15.06.2000 - 11.07.2000 - 27 days
- 17.07.2000 - 08.08.2000
- 17.07.2000 - 08.08.2000
Alpha - Galactosidase A
Alpha- Galactosidase A
TKT Europe- 5S AB
TKT Europe-5S AB
- 03.05.2000 - 15.06.2000 - 11.07.2000 - 27 days
- 03.05.2000 - 15.06.2000 - 11.07.2000 - 27 days
- 12.05.2000 - 15.06.2000 - 11.07.2000 - 27 days
- 12.05.2000 - 15.06.2000 - 11.07.2000 - 27 days
Treatment of glioblastoma
Treatment of glioblastoma Treament of acute myeloid leukaemia
- 26.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
- 26.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
- 18.09.2000 - 18.10.2000
- 18.09.2000 - 18.10.2000
Treament of acute myeloid leukaemia
Treatment of Gaucher disease
- 07.06.2000 - 31.07.2000 - 13.09.2000 - 45 days
- 07.06.2000 - 31.07.2000 - 13.09.2000 - 45 days
1,5 -(Butylimino)- 1,5-dideoxy, D-glucitol
1,5-(Butylimino)- 1,5-dideoxy, D- glucitol
N -carbamyl-L- glutamic acid
N-carbamyl-L- glutamic acid
- 02.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
- 02.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
- 08.05.2000 - 15.06.2000 - 13.09.2000 - 90 days
- 08.05.2000 - 15.06.2000 - 13.09.2000 - 90 days
- 01.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
- 01.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
- 31.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
- 31.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
Pierre Fabre Médicament
Pierre Fabre
- 09.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
- 31.07.2000 - 27.10.2000 - 89 days
- 05.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
- 05.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
- 05.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
- 05.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
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
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
- 10.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
- 10.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
- -
EMEA/ MB/ 050/ 00
Treatment of acute promyelocytic leukaemia
Relazione annuale 2000
- 08.08.2000
- Presentazione domanda
-
- Parere ricevuto il
- 22.09.2000
- Convalida - Parere - Tempo attivo
- 21.11.2000
- Data di assegnazione della qualifica
- 61 days
- 08.08.2000 - 22.09.2000 - 21.11.2000 - 61 days
- 61 days
- 01.09.2000 - 22.09.2000 - 21.11.2000 - 61 days
- 89 days
- 09.08.2000 - 22.09.2000 - 19.12.2000 - 89 days
- 62 days
- 02.05.2000 - 19.10.2000 - 19.12.2000 - 62 days
- 10.08.2000
...
(Pompe's disease)
Treatment of glycogen storage disease type II (Pompe’ s disease)
- 19.10.2000 - 19.12.2000 - 62 days
- 10.08.2000 - 19.10.2000 - 19.12.2000 - 62 days
- 11.08.2000 - 19.10.2000 - 19.12.2000 - 62 days
- 11.08.2000 - 19.10.2000 - 19.12.2000 - 62 days
chronic thromboembolic pulmonary hypertension
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
- 19.10.2000 - 19.12.2000 - 62 days
- 21.08.2000 - 19.10.2000 - 19.12.2000 - 62 days
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
- 06.09.2000 - 19.10.2000 - 19.12.2000 - 62 days
- 62 days
- 08.09.2000 - 19.10.2000 - 19.12.2000 - 62 days
- 03.10.2000
- 03.10.2000 - 19.10.2000 - 19.12.2000 - 62 days
- 19.12.2000
...
- 62 days
- 04.10.2000 - 19.10.2000 - 19.12.2000 - 62 days
Mucopolysaccharidosis type VI (Maroteaux -Lamy
EMEA/ MB/ 050/ 00 Relazione annuale 2000 Allegato 11 Linee guida dell’ EMEA nel 2000
- 04.10.2000
Pagina 85/ 91
-
Gruppo di lavoro del CPMP sulla biotecnologia
Syndrome)
Numero di riferimento
- 19.10.2000 - 19.12.2000 - 62 days
Linee guida Final EU recommendations for the
83 EMEA General Report 2000
Situazione normativa
Annex 11:
EMEA/ CPMP/ BWP/ 840/ 00
EMEA guidelines in 2000
Adottate nell’ aprile 2000
EMEA/ CPMP/ BWP/840/00
EMEA/ CPMP/ BWP/ 1244/ 00
Final EU recommendations for the Influenza vaccine composition for the season 2000/2001 Adopted April 2000
Adottate nel luglio 2000
EMEA/ CPMP/ BWP/1244/00
EMEA/ CPMP/ BWP/ 3326/ 99
Report of the EMEA Expert Workshop on human TSEs and plasma-derived medicinal products, 15-16 May 2000 Adopted July 2000
Points to consider on xenogeneic cell therapy Note for Guidance on the production and
Concept paper on the Development of a Points to consider on xenogeneic cell therapy Adopted November 2000
Adottate nel novembre 2000
EMEA/ CPMP/ BWP/3354/99 Draft
EMEA/ CPMP/ BWP/ 3354/ 99
Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Released for consultation January 2000
gennaio 2000
EMEA/ CPMP/ BWP/3207/00
EMEA/ CPMP/ BWP/ 3207/ 00 EMEA/ CPMP/ BWP/ 1143/ 00
Note for Guidance on Comparability of medicinal products containing biotechnology-derived proteins as active substances Released for consultation May 2000
medicinal products containing biotechnology-derived proteins as active substances Position statement on the Use of tumorigenic cells of human origin for the
EMEA/CPMP/BWP/1143/00
Pubblicate per consultazione nel maggio 2000 Pubblicate per consultazione nel
Position statement on the Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products Released for consultation July 2000
luglio 2000
EMEA/CPMP/BWP/269/95rev.
EMEA/ CPMP/ BWP/ 269/ 95
Revision of section 3.2.5 of CPMP Note for guidance on Plasma-derived medicinal products Released for consultation July 2000
luglio 2000 Pubblicate per consultazione nel
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines Released for consultation November 2000
novembre 2000
CPMP Blood and Plasma Working Group
Gruppo di lavoro del CPMP sugli emoderivati
Reference number
Numero di riferimento
Guidelines/Status
Situazione normativa
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Adottate nel giugno 2000
EMEA/CPMP/BPWG/388/95 rev.
investigation of human normal
Note for guidance on the Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
immunoglobulin for intravenous administration (IVIg) Core SPC for Human and anti-D
Core SPC for Human and anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Adottate nel giugno 2000
Core SPC for Human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
Adottate nel giugno 2000
Core SPC for Human plasma derived and recombinant coagulation factor VIII products Adopted June 2000
Adottate nel giugno 2000
Core SPC for Human plasma derived and recombinant coagulation factor IX products Adopted June 2000
Adottate nel giugno 2000
EMEA/CPMP/BPWG/198/95 rev.1
EMEA/ CPMP/ BPWG/ 198/ 95 rev.1
Note for Guidance on the Clinical investigation of human plasma derived factor VIII and IX products Adopted October 2000
Adottate nell’ ottobre 2000
EMEA/CPMP/BPWG/ 1561/99
Core SPC for Human albumin
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adopted October 2000
Adottate nell’ ottobre 2000
84 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Relazione annuale 2000
Note for guidance on the Clinical investigation of recombinant factor VIII and IX products Released for consultation June 2000
giugno 2000
EMEA/ CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
EMEA/ CPMP/ PhvWP/ BPWG/
Core SPC for Human albumin Released for consultation June 2000 Note for Guidance on the Clinical investigation of plasma derived antithrombin products Released for consultation December 2000
Note for Guidance on the Clinical
EMEA/ CPMP/BPWG/3226/99
EMEA/ CPMP/ BPWG/ 2220/ 99
Core SPC for Human plasma derived antithrombin Released for consultation December 2000
dicembre 2000
CPMP Efficacy Working Party Reference number
Core SPC for Human plasma derived
Guidelines/Status
Pubblicate per consultazione nel
EMEA/ CPMP/ EWP/519/98
antithrombin
Note for Guidance on clinical investigation of steroid contraceptives in woman Adopted February 2000
dicembre 2000
EMEA/ CPMP/ EWP/197/99
EMEA/ CPMP/ EWP/ 519/ 98
Points to consider concerning Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells Adopted February 2000
Adottate nel febbraio 2000
EMEA/ CPMP/ EWP/570/98
EMEA/ CPMP/ EWP/ 197/ 99
Points to consider on the clinical investigation of new medicinal products for treatment of acute coronary syndrome (ACS) without persistent ST-segment elevation Adopted February 2000
Adottate nel febbraio 2000
EMEA/ CPMP/ EWP/2922/99
EMEA/ CPMP/ EWP/ 570/ 98
Concept paper on the development of a CPMP Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma Adopted February 2000
Adottate nel febbraio 2000
EMEA/ CPMP/ EWP/2863/99
EMEA/ CPMP/ EWP/ 2922/ 99
Concept paper on the development of a CPMP Points to Consider on biostatistical/methodological issues arising from CPMP discussions on licensing applications: adjustment for baseline covariates Adopted February 2000
Adottate nel febbraio 2000
EMEA/ CPMP/ EWP/707/98
EMEA/ CPMP/ EWP/ 2863/ 99
Points to consider on Clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk Adopted June 2000
Adottate nel febbraio 2000
EMEA/ CPMP/ EWP/612/00
EMEA/ CPMP/ EWP/ 707/ 98
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adopted June 2000
Adottate nel giugno 2000
EMEA/ CPMP/ EWP/2655/99
EMEA/ CPMP/ EWP/ 612/ 00
Points to consider on pharmaco-kinetics and pharmacodynamics in the development of anti-bacterial medicinal products Adopted July 2000
Adottate nel giugno 2000
EMEA/ CPMP/ EWP/482/99
EMEA/ CPMP/ EWP/ 2655/ 99
Points to consider on switching between superiority and non-inferiority Adopted July 2000
Adottate nel luglio 2000
EMEA/ CPMP/ EWP/1080/00
EMEA/ CPMP/ EWP/ 482/ 99
Concept paper on the Development of a CPMP Note for Guidance on Clinical investigation of medicinal products in the treatment of diabetes mellitus Adopted July 2000
Adottate nel luglio 2000
EMEA/ CPMP/ EWP/565/98
EMEA/ CPMP/ EWP/ 1080/ 00
Points to consider on Clinical investigation of medicinal products for treatment of Amyotrophic Lateral Sclerosis (ALS) Adopted October 2000
Adottate nel luglio 2000
Concept paper on the Evaluation of drugs for the treatment of the irritable bowel syndrome Adopted November 2000
Adottate nel novembre 2000
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders Adopted in November 2000
Adottate nel novembre 2000
Points to consider on Clinical investigation of medicinal products for the management of Crohn's disease Released for consultation July 2000
Relazione annuale 2000
85 EMEA General Report 2000
Pubblicate per consultazione
Note for Guidance on Evaluation of anticancer medicinal products in man Released for consultation July 2000 and extended in September 2000 for a further 2 months
anticancer medicinal products in man
EMEA/ CPMP/ EWP/560/98
settembre 2000 per due mesi ulteriori Points to consider on Clinical investigation Pubblicate per consultazione EMEA/ CPMP/ EWP/ 560/ 98
Points to consider on Clinical investigation of medicinal products in the treatment of acute stroke Released for consultation October 2000
nell’ ottobre 2000 Pubblicate per consultazione
Points to consider on Validity and interpretation of meta-analyses, and one pivotal study Released for consultation October 2000
nell’ ottobre 2000
Points to consider on the Evaluation of diagnostic agents Released for consultation November 2000
novembre 2000 Pubblicate per consultazione nel
Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Released for consultation November 2000
novembre 2000
EMEA/ CPMP/EWP/QWP/ 1401/98
EMEA/ CPMP/ EWP/ QWP/ 1401/ 98
Note for Guidance on the investigation of bioavailability and bioequivalence Released for consultation December 2000
Pubblicate per consultazione nel dicembre 2000 Pubblicate per consultazione nel
Note for Guidance on co-ordinating investigator signature of clinical study reports Released for consultation December 2000
dicembre 2000
CPMP Pharmacovigilance Working Party
Gruppo di lavoro del CPMP sulla farmacovigilanza
Guidelines/Status
Situazione normativa Pubblicate per consultazione nel
Joint Pilot Plan for the implementation of the electronic transmission of individual case safety reports between the EMEA, national competent authorities, and the Pharmaceutical Industry Released for consultation May 2000
maggio 2000
CPMP Safety Working Party
Gruppo di lavoro del CPMP sulla sicurezza
CPMP Position paper on Selective Serotonin Uptake Inhibitors (SSRIs) and dependency/withdrawal reactions Adopted April 2000
Adottate nell’ aprile 2000
Note for Guidance on Repeated dose toxicity Adopted July 2000
Adottate nel luglio 2000
Discussion paper on Possible pre-clinical studies to investigate addiction and dependence/withdrawal related to use of SSRIs Adopted December 2000
Adottate nel dicembre 2000
Concept paper on the Development of a CPMP Points to consider on the need for reproduction toxicity studies in the development of human insulin analogues Adopted December 2000
Adottate nel dicembre 2000
Note for Guidance on Non-clinical local tolerance testing of medicinal products Released for consultation September 2000
Pubblicate per consultazione nel settembre 2000
EMEA Herbal Medicinal Products Working Party
Gruppo di lavoro dell’ EMEA sui
Reference number
rimedi vegetali
Guidelines/Status
Numero di riferimento
Position paper on the Risks associated with the use of Herbal Products containing Aristolochia Species Adopted by the Working Party in October 2000
nell’ ottobre 2000
CPMP/QWP/2819/00
CPMP/ QWP/ 2820/ 00
Note for guidance on quality of herbal medicinal products Released for consultation November 2000
novembre 2000 Pubblicate per consultazione nel
CPMP/QWP/2820/00
herbal drugs, herbal drug preparations and herbal medicinal products
Note for guidance on specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products Released for consultation November 2000
novembre 2000
86 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Relazione annuale 2000 Gruppo di lavoro del CVMP
CVMP Efficacy Working Party Reference number EMEA/ CVMP/133/99
EMEA/ CVMP/ 133/ 99
Guidelines/Status Conduct of pharmacokinetic studies in animals Adopted March 2000
Adottate nel marzo 2000
EMEA/ CVMP/344/99
EMEA/ CVMP/ 344/ 99
Conduct of efficacy studies for intramammary products for use in cattle Adopted March 2000
Adottate nel marzo 2000
EMEA/ CVMP/005/00
EMEA/ CVMP/ 005/ 00
Testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in cats and dogs Adopted November 2000
Adottate nel novembre 2000
EMEA/CVMP/016/00
EMEA/ CVMP/ 016/ 00
The conduct of bioequivalence studies for veterinary medicinal products Released for consultation January 2000
The conduct of bioequivalence studies for
Efficacy of anthelmintics:
Specific
Specific recommendations for poultry Released for consultation July 2000
gennaio 2000 Pubblicate per consultazione nel
Specific recommendations for feline Released for consultation July 2000
luglio 2000
CVMP Immunologicals Working Party Reference number CVMP/IWP/52/97
Gruppo di lavoro del CVMP sui medicinali ad azione immunologica
Guidelines/Status Requirements for combined veterinary vaccines Adopted March 2000
Adottate nel marzo 2000
DNA vaccines non-amplifiable in eukaryotic cells for veterinary use Adopted March 2000
Adottate nel marzo 2000
Duration of protection achieved by veterinary vaccines Adopted October 2000
Adottate nell’ ottobre 2000 Pubblicate per consultazione nel
Field trials with veterinary vaccines Released for consultation March 2000
marzo 2000
Requirements and controls applied to bovine serum (foetal or calf) used in the protection of immunological veterinary medicinal products Released for consultation October 2000
nell’ ottobre 2000
CVMP Pharmacovigilance Working Party
Gruppo di lavoro del CVMP
Guidelines/Status Conduct of post-marketing surveillance studies of veterinary medicinal products Adopted April 2000
Adottate nell’ aprile 2000
Management of adverse event reports (AERs) Released for consultation July 2000
luglio 2000
CVMP Safety Working Party
Gruppo di lavoro del CVMP
linesStatus number
sulla sicurezza
Reference
Numero di riferimento
Assessment of the effect of antimicrobial substances on dairy starter cultures Adopted March 2000
Adottate nel marzo 2000
Determination of withdrawal periods for milk Adopted March 2000
Adottate nel marzo 2000
Risk analysis approach for residues of veterinary medicinal products in food of animal origin Released for consultation May 2000
maggio 2000
Genotoxicity studies Released for consultation July 2000
luglio 2000 Pubblicate per consultazione nel
Reproduction studies Released for consultation July 2000
luglio 2000
87 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Relazione annuale 2000 Gruppo di lavoro congiunto CPMP/ CVMP sulla qualità
Reference number
Pagina 89/ 91
CPMP/ QWP/1676/00
Numero di riferimento Linee guida CPMP/ QWP/ 1676/ 00 Concept Paper on the Development of a CPMP/ CVMP Note for Guidance on Quality of Water for Pharmaceutical Use
Concept Paper on the Development of a CPMP/CVMP Note for Guidance on Quality of Water for Pharmaceutical Use Adopted July 2000
Situazione normativa Adottate nel luglio 2000
Note for Guidance on Parametric Release Released for consultation March 2000
Pubblicate per consultazione nel marzo 2000
Note for Guidance on Medicinal Gases – Pharmaceutical Information Released for consultation July 2000
Pubblicate per consultazione nel luglio 2000
Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products Released for consultation November 2000
Pubblicate per consultazione nel novembre 2000
Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products Released for consultation November 2000
Pubblicate per consultazione nel novembre 2000
Note for Guidance on Quality of Herbal Medicinal Products Released for consultation November 2000 Annex to Guideline:
Note for Guidance on Quality of Herbal Medicinal Products Annex to Guideline:
Development pharmaceutics for veterinary medicinal products:
Development pharmaceutics for veterinary medicinal
Decision trees for the selection of sterilisation methods Adopted February 2000
Adottate nel febbraio 2000
Declaration of storage conditions for veterinary medicinal products in the product particulars Adopted February 2000
Adottate nel febbraio 2000
Stability testing of biotechnological/biological veterinary medicinal products Adopted June 2000
Adottate nel giugno 2000
Impurities: residual solvents Adopted June 2000
Adottate nel giugno 2000
Maximum shelf-life for sterile medicinal products after first opening or following reconstitution Adopted July 2000
Adottate nel luglio 2000
Good clinical practices Adopted July 2000
Adottate nel luglio 2000
Stability testing of existing active substances and related finished products Adopted November 2000
Adottate nel novembre 2000
Statistical principles for veterinary clinical trials Released for consultation November 2000
novembre 2000
Ad hoc GMP Inspectors Working Group
Gruppo di lavoro ad hoc degli ispettori GMP
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Finalised in April 2000
Ultimate nell’ aprile 2000 Pubblicate per consultazione nel
88
Pagina 90/ 91
The European Agency for the Evaluation of Medicinal Products
Dell’ Agenzia Europea di Valutazione dei Medicinali
Seventh Annual Report 2001
Settima Relazione Annuale 2001
Adopted by the Management Board on 18 December 2001 The annual report for 2001 is presented to the Management Board by the Executive Director in accordance with Article 55(3) of Council Regulation (EEC) No 2309/ 93.
Adottato dal consiglio di amministrazione il 18 dicembre 2001 The annual report for 2001 is presented to the Management Board by the Executive Director in accordance with Article 55(3) of Council Regulation (EEC) No 2309/ 93.
Foreword by the Chairman of the Management Board
adottata dal consiglio di amministrazione il 18 dicembre 2001
3.2 Establishment of maximum residue limits for old substances
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int Indice PREFAZIONE DEL PRESIDENTE DEL CONSIGLIO DI AMMINISTRAZIONE INTRODUZIONE DEL DIRETTORE ESECUTIVO STRUTTURA DELL’ EMEA
3.3 Post-authorisation activities 3.4 Pharmacovigilance and maintenance activities
CAPITOLO 1 L’ EMEA NEL SISTEMA EUROPEO 1.1 Consiglio di amministrazione 1.2 Autorità nazionali competenti 1.3 Dialogo sulla trasparenza e sulla regolamentazione 1.4 Revisione dei diritti da corrispondere all’ EMEA