qanastek/EMEA-V3 huggingface dataset:
(as at 20.12.2000)
(43- 1) 711 00 46 73 Fax (43- 1) 714 92 22 E- mail: alexander. jentzsch@ bmsg. gv. at
Expenditure Staff
PORTUGAL
salaries interim and other support persons other staff-related expenditure total title 1
Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P – 1749- 004 Lisboa Tel.
15 074 905 955 456 1 191 570 17 221 931
(351) 213 23 95 66 Fax (351) 213 46 35 18 E- mail: rleitao@ dgv. min- agricultura. pt
36.61% 2.32% 2.89% 41.82%
SUOMI/ FINLAND
18 493 000 1 058 000 1 350 000 20 901 000
Box 55 FIN – 00301 Helsinki Puh.
33.45% 1.91% 2.44% 37.80%
SVERIGE
21 772 000 35.15% 1 379 000 2.23% 1 501 000 2.42% 24 652 000 39.80%
(46- 18) 17 46 00 Fax (46- 18) 54 85 66 E- post: gunnar. alvan@ mpa. se Internet: http: // www. mpa. se
Building/ equipment
Michael RUTTER
rent/ charges expenditure on data processing other capital expenditure postage and communications other administrative expenditure
Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey, KT15 3NB United Kingdom Tel.
2 136 038 1 034 357 1 824 960 370 754 1 194 962
Observadores:
5.19% 2.51% 4.43% 0.90% 2.90%
ÍSLAND
5 212 220 2 423 500 2 353 000 480 000 1 593 000
(354) 520 21 00 Fax (354) 561 21 70 E- mail: rannveig. gunnarsdottir@ lyfjanefnd. is Internet: http: // www. lyfjanefnd. is
9.43% 4.38% 4.26% 0.87% 2.88%
LIECHTENSTEIN
5 685 000 9.18% 1 400 000 2.26% 824 500 1.33% 537 000 0.87% 1 784 500 2.88%
(423) 236 73 25 Fax (423) 236 73 10 E- mail: brigitte. batliner@ alk. llv. li
total title 2
NORGE/ NOREG
6 561 071
Page
15.93%
71/ 88
12 061 720 21.82%
Apresentação - Forma
10 231 000 16.52%
EMEA/ CPMP - Validação
Operational expenditure
Comissão - Parecer recebido em
meetings
- DCI - Origem - Indicação
3 274 441
- Dosagem
7.95%
- Parecer
3 487 000 6.31%
- Data da decisão
6 565 000 10.60%
- Parte A/ B
evaluations translation studies and consultants publications
Número de apresentações
13 894 457 93 650 137 130
- Orgalutran - ganirelix - B
33.74% 0.00% 0.23% 0.33%
Organon NL
5 000 150 000
- - -
33.79% 0.00% 0.01% 0.27%
Solution for injection 0. 5 mg/ ml 2 presentations
19 658 000 31.74% 428 000 0.69% 180 000 0.29% 220 000 0.36%
- 29. 01. 1999 - 19. 01. 2000 - 162 days - 189 days
TOTAL EXPENDITURE
- 26. 03. 1999 - 17. 02. 2000
41 182 680 100.00%
- 27. 03. 2000 - 25. 05. 2000
55 287 220 100.00%
alfa- 2b - A
fees general EU contribution special EU orphan medicinal
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
217 000 0.39% 1 471 000 2.66%
- 03. 01. 2000 - 17. 02. 2000
2 440 000 3.94% 1 334 000 2.15%
- 27. 03. 2000 - 25. 05. 2000
TOTAL REVENUE
- peginterferon alfa- 2b - A
(3) 2001 budget: draft appropriations.
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
Dietrich HENSCHLER, Jean-Pierre REYNIER
- 23. 04. 1999 - 17. 02. 2000 - 215 days - 83 days
André PAUWELS, Frans GOSSELINCKX Ib VALSBORG, Jytte LYNGVIG 5 Hermann Josef PABEL, Gerhard Josef KOTHMANN, (Vice-chairman)
- D -
Eλλ δα / Greece España
Optisulin
Marios MARSELOS 6, Elias MOSSIALOS 7 María Victoria de la CUESTA GARCIA 8, Ramón PALOP BAIXAULI 9
- Aventis - A10AE - Solution for injection - 24. 09. 19
Observers
- Optisulin - Aventis -
Ísland
A10AE - Solution for injection
Rannveig GUNNARSDÓTTIR, Ingolf PETERSEN
- Optisulin - Aventis - A10AE -
Liechtenstein Norge/ Noreg
- Optisulin - Aventis - A10AE - Solution for injection -
Brigitte BATLINER, Peter MALIN Andreas DISEN, Gro Ramsten WESENBERG
- Optisulin - Aventis - A10AE - Solution for injection - 24. 09. 1999 -
1 Resigned at the 20 December 2000 meeting.
23. 03. 2000
2 Replaced Dietrich HENSCHLER as of the 22 February 2000 meeting.
Pharma - Diabetes mellitus - 100 IU/ ml - 17. 02.
3 Replaced Jörn KECK as of the 22 February 2000 meeting.
- insulin Pharma -
4 Replaced Joachim HEINE as of the 22 February 2000 meeting.
Diabetes mellitus - 100 IU/ ml
7 Replaced John PSOMAS as of the 20 December 2000 meeting.
- insulin Pharma - Diabetes mellitus -
10 Replaced Jacques BOISSEAU as of the 22 February 2000 meeting.
- insulin Pharma - Diabetes mellitus - 100 IU/ ml -
11 Replaced John COSTELLOE as of the 22 February 2000 meeting.
- insulin Pharma - Diabetes mellitus - 100 IU/ ml - 17. 02. 2000 -
65 EMEA General Report 2000
27. 06. 2000
•
- D -
· Jean-Michel ALEXANDRE (France), Chairman
Nyracta - - A10BG02 - Film coated tablet - 18. 12. 1998 - 17. 04.
The country of the nominating Member State is given for information purposes only.
- Nyracta - - A10BG02 - Film coated tablet - 18. 12. 1998 -
Replaced Gorm JENSEN as of the January 2000 meeting.
17. 04. 2000
Replaced Alfred HILDEBRANDT as of the September 2000 meeting.
- rosiglitazone SmithKli - Combination - 1 mg, 2 mg, 4 mg, 8 mg -
Replaced Mary TEELING as Vice-chairman as of the September 2000 meeting.
- rosiglitazone SmithKli - Combination - 1 mg, 2 mg, 4 mg, 8 mg - 21. 10. 1999 -
Replaced Eva ALHAVA as of the March 2000 meeting.
11. 07. 2000
Replaced Rogério GASPAR as of the January 2000 meeting.
treatment of Type - 12 presentations
Replaced David JEFFERYS as of the March 2000 meeting.
- B ne treatment of Type - 12 presentations -
Replaced Mary TEELING as of the September 2000 meeting.
- B ne treatment of Type - 12 presentations - 186 days -
66 EMEA General Report 2000
26. 07. 2000
Members of the Committee for Veterinary Medicinal Products1
Beecham Pharmac euticals
Reinhard KROKER (Deutschland), Chairman
II diabetes mellitus
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
-
Replaced Annika WENNBERG as of the October 2000 meeting.
Avandia rosiglitazone B
Replaced Carlos SINOGAS as of the July 2000 meeting.
- SmithKli - ne Beecham Phramac euticals
Replaced Christos HIMONAS as of the April 2000 meeting.
A10BG02 Combination treatment of Type II diabetes mellitus
67 EMEA General Report 2000
Film coated tablet 1 mg, 2 mg, 4 mg, 8 mg 12 presentations
Annex 6:
- - - -
Chairman (España)
18. 12. 1998 - 21. 10. 1999 - 186 days - 119 days -
Josep TORRENT i FARNELL
4
Members
-
Belgique/België Danmark Deutschland Eλλ δα/Greece France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/Finland Sverige United Kingdom Patient organisation
UK
representatives
Venvia rosiglitazone B
Moisés ABASCAL ALONSO 5 Yann LE CAM, 5 Vice-chairman Alastair KENT 6
-
EMEA representatives
- SmithKli - ne Beecham Pharmac euticals
Jean-Michel ALEXANDRE 7 Gianmartino BENZI Mary TEELING 8
A10BG02 Combination treatment of Type II diabetes mellitusus
Observers
- - -
Ísland Norge/Noreg
Film coated tablet 1 mg, 2 mg, 4 mg, 8 mg 12 presentations
Sigurdur THORSTEINSSON Randi NORDAL
18. 12. 1998 - 21. 10. 1999 - 186 days - 119 days -
Replaced Tilman OTT as of the September 2000 meeting.
-
68 EMEA General Report 2000
UK
(49-30) 84 12 23 64 Fax (49-30) 84 12 29 65 E-mail: r.kroker@bgvv.de
Myocet doxorubicin B
Internet: http://www.bgvv.de
The - Liposom - e Empresa US
69 EMEA General Report 2000
L01DB Treatment of metastatic breast cancer
Eλλ δα/GREECE Marios MARSELOS President National Organization for Medicines Mesogion 284 GR – 155 62 Holargos Athens Tel.
- - -
(34-91) 596 16 27 Fax (34-91) 596 16 15 E-mail: sdaem@agamed.es Internet: http://www.agamed.es
Powder and pre - admixtures for concentrate for, liposomal dispersion for infusion 50 mg 1 presentation
FRANCE
- - - -
(33-1) 55 87 30 14 Fax (33-1) 55 87 30 12 E-mail: philippe.duneton@afssaps.sante.fr Internet: http://agmed.sante.gouv.fr
30. 07. 1999 - 12. 04. 2000 - 167 days - 91 days -
19 F – 94701 Maisons Alfort CEDEX Tel.
17. 05. 2000 13. 07. 2000 26. 07. 2000 OJ C 244, 25. 08. 2000, p.
Nello MARTINI Direttore Generale del Dipartimento per Valutazione dei medicinale e la farmacovigilanza Ministero della Sanità Viale Civilità Romana 7 I -00144 Roma Tel.
Datscan ioflupane B
Romano MARABELLI Direttore Generale del Dipartimento degli alimenti e nutrizione e della sanità pubblica veterinaria Ministero della Sanità Piazzale Marconi 25 I -00144 Roma Tel.
-
70 EMEA General Report 2000
- Nycome - d Amersha
(352) 478 55 90 Fax (352) 26 20 01 47 E-mail: dpmlux@pt.lu
V09AB03 Diagnosis of Parkinson disease
(31-31) 747 54 91 Fax (31-31) 742 31 93 E-mail: brd@brd.agro.nl
Solution for injection 74 MBq/ ml 1 presentation
(43-1) 711 00 46 73 Fax (43-1) 714 92 22 E-mail: alexander.jentzsch@bmsg.gv.at
18. 12. 1998 - 16. 03. 2000 - 178 days - 272 days -
(351) 213 23 95 66 Fax (351) 213 46 35 18 E-mail: rleitao@dgv.min-agricultura.pt
05. 05. 2000 27. 07. 2000 02. 08. 2000 OJ C 244,
71 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Relatório Anual 2000
Box 55 FIN - 00301 Helsinki Tel.
Page 72/ 88
SVERIGE Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8, Box 26 S - 751 03 Uppsala Tel.
Medicamento - Denom. comercial
UNITED KINGDOM
Empresa - Nome
Observers:
Área terapêutica - ATC
NORGE/NOREG Gro Ramsten WESENBERG Director-General Statens legemiddelkontroll Sven Oftedals vei 6 N - 0950 Oslo Tel.
Apresentação - Forma
72 EMEA General Report 2000
EMEA/ CPMP - Validação
CPMP opinions in 2000 on medicinal products for human use
Comissão - Parecer recebido em
Product - Brandname - INN - Part A/B
- DCI - Parte A/ B
Company - Name - Origin
- Origem
Therapeutic area - ATC - Indication
- Indicação
Presentation - Form - Dosage - Number of presentations
- Dosagem - Número de apresentações
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- Parecer - Tempo activo - Tempo inactivo
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Data da decisão - Data da notificação - Jornal Oficial
- Orgalutran
m - UK
Organon - H01CC01
10
Organon - H01CC01 - Solution for injection -
- Visudyne - verteporfin - B
- Orgalutran - N.V.
- Ciba Vision - CH
- ganirelix
- L01XX - Treatment of age - related macular degeneration
- Prevention of
- Powder for solution for infusion - 15 mg - 1 presentation
- ganirelix - NL - Prevention of - 0.5 mg/ml -
- 27. 08. 1999 - 12. 04. 2000 - 138 days - 63 days
- ganirelix - NL - Prevention of - 0.5 mg/ml - 19.01.2000 -
- 15. 05. 2000 - 27. 07. 2000 - 31. 07. 2000 - OJ C 244, 25. 08. 2000, p.
premature luteinising
- NovoMix 30 - insulin aspart - A
-B premature luteinising - 2 presentations -
- Novo Nordisk - DK
-B premature luteinising - 2 presentations - 162 days -
- A10AD - Diabetes mellitus
hormone surges in conteolled ovarian hyperstimulation
- Suspension for injection - 100 IU/ ml - 8 presentations
189 days -
- 24. 09. 1999 - 12. 04. 2000 - 144 days - 55 days
3
- 17. 05. 2000 - 01. 08. 2000 - 01. 08. 2000 - OJ C 244, 25. 08. 2000, p.
Pegintron peginterferon alfa -2b
- Kogenate Bayer - octocog alfa - A
L03AB10 Treatment of chronic hepatitis C
- B02BD02 - Treatment and prophylaxis of bleeding in haemophilia A
Powder and solvent for solution for injection 50 µg/0.5 ml, 80 µg/0.5 ml,
- Powder and solvent for solution for injection - 250 IU, 500 IU, 1000 IU - 3 presentations
- 26.03.1999 - 17.02.2000 - 189 days
- 26. 02. 1999 - 16. 03. 2000 - 182 days - 201 days
- 27.03.2000 - 25.05.2000 - 05.06.2000
- 05. 06. 2000 - 04. 08. 2000 - 07. 08. 2000 - OJ C 244, 25. 08. 2000, p.
- Viraferon PEG - peginterferon alfa -2b -A
- Helixate NexGen - octocog alfa - A
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
- Powder and solvent for solution for infusion - 250 IU, 500 IU, 1000 IU - 3 presentations
- 03.01.2000 - 17.02.2000 - 43 days - 0 days
- 26. 02. 1999 - 16. 03. 2000 - 182 days - 201 days
3
- 05. 06. 2000 - 04. 08. 2000 - 07. 08. 2000 - OJ C 244, 25. 08. 2000, p.
Lantus insulin glargine
- Hepacare - triple antigen hepatitis B vaccine - A
Aventis Pharma Deutschland
- Medeva Pharma Ltd - UK
- A10AE - Diabetes mellitus
- J07BC - Immunisation against hepatitis B virus in adults
- Solution for injection - 100 IU/ml - 7 presentations
- Suspension for injection - Monodose preparation of 1 ml contains Hepatitis B surface antigen S, pre- S1 and pre S2 20 µg - 2 presentations
- 23.04.1999 - 17.02.2000 - 215 days
- 23. 10. 1998 - 16. 03. 2000 - 210 days - 293 days
- 23.03.2000 - 06.06.2000 - 14.06.2000
- 16. 05. 2000 - 04. 08. 2000 - 07. 08. 2000 - OJ C 244, 25. 08. 2000, p.
- OJ C 183,
- Herceptin - trastuzumab - A
- A10AE - Diabetes mellitus
- Roche Registrat ion Ltd - CH
- Solution for injection - 100 IU/ml - 7 presentations
- L01XC03 - Treatment of patients with metastatic breast cancer whose tumour overexpress HER2
- 24.09.1999 - 17.02.2000 - 116 days
- Powder for concentrate for solution for infusion - 150 mg - 1 presentation
- 23.03.2000 - 27.06.2000 - 28.06.2000
- 26. 02. 1999 - 25. 05. 2000 - 147 days - 305 days
- OJ C 216,
- 03. 07. 2000 - 28. 08. 2000 - 04. 09. 2000 - OJ C 277, 29. 09. 2000, p.
-D
14
- Nyracta - rosiglitazone -B
- Keppra - levetiracetam - B
- -
- UCB S. A. - US
SmithKline Beecham Pharmaceuticals UK
- N03A - Adjunctive therapy in the partial onset seizures in epilepsy
- -
- Film coated tablet - 250 mg, 500 mg, 750 mg, 1000 mg - 26 presentations
A10BG02 Combination treatment of Type II diabetes mellitus
- 26. 02. 1999 - 29. 06. 2000 - 187 days - 300 days
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
12
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
- Panretin - alitretinoin - B
- - - -
- Gel - 0. 1% w/ w - 1 presentation
17.04.2000 11.07.2000 26.07.2000 OJ C 244, 25.08.2000, p.
- 31. 07. 2000 - 11. 10. 2000 - 18. 10. 2000 - OJ C 337, 28. 11. 2000. p.
- Avandia - rosiglitazone -B
- Glustin - pioglitazone - B
A10BG02 Combination treatment of Type II diabetes mellitus
- A10BG03 - Combination treatment of Type II Diabetes mellitus
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
- Tablet - 15 mg, 30 mg - 6 presentations
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
- 23. 04. 1999 - 29. 06. 2000 - 178 days - 251 days
17.04.2000 11.07.2000 28.06.2000 OJ C 216, 28.07.2000, p.
- 31. 07. 2000 - 11. 10. 2000 - 17. 10. 2000 - OJ C 337, 28. 11. 2000. p.
- Venvia - rosiglitazone -B
- Actos - pioglitazone - B
A10BG02 Combination treatment of Type II diabetes mellitusus
- A10BG03 - Combination treatment of Type II Diabetes mellitus
17.04.2000 11.07.2000 26.07.2000 OJ C 244, 25.08.2000, p.
- 31. 07. 2000 - 13. 10. 2000 - 19. 10. 2000 - OJ C 337, 28. 11/ 00. p.
- Myocet - doxorubicin -B
- Agenerase - amprenavir - B
L01DB Treatment of metastatic breast cancer
- J05AE05 - Treatment of HIV infected adults and children
- Powder and pre-admixtures for concentrate for, liposomal dispersion for infusion - 50 mg - 1 presentation
- Capsule, soft, Oral solution - 50 mg, 150 mg, 15 mg/ ml - 4 presentations
- 30.07.1999 - 12.04.2000 - 167 days - 91 days
- 20. 11. 1998 - 29. 06. 2000 - 219 days - 324 days
17.05.2000 13.07.2000 26.07.2000 OJ C 244, 25.08.2000, p.
- 09. 08. 2000 - 20. 10. 2000 - 25. 10. 2000 - OJ C 337, 28. 11. 2000. p.
- Datscan - ioflupane -B
EMEA/ MB/ 050/ 00 Relatório Anual 2000
Nycomed Amersham UK
Page 73/ 88
V09AB03 Diagnosis of Parkinson disease
Infanrix hexa - - OJ7CA - Powder and suspension for - 30. 07. 1999 - 09. 08.
- Solution for injection - 74 MBq/ml - 1 presentation
- Infanrix hexa - -
- 18.12.1998 - 16.03.2000 - 178 days - 272 days
OJ7CA - Powder and suspension for
- - - -
- Infanrix hexa - - OJ7CA -
10
- Infanrix hexa - - OJ7CA - Powder and suspension for - 30. 07. 1999 -
73 EMEA General Report 2000
09. 08. 2000
Company - Name - Origin
Hep B- IPV
Therapeutic area - ATC - Indication
SmithKli - Immunisation suspension for injection - 29. 06.
Presentation - Form - Dosage - Number of presentations
- Hep B- IPV SmithKli -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
Immunisation
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Hep B- IPV SmithKli - Immunisation suspension for injection -
- Visudyne - verteporfin -B
- Hep B- IPV SmithKli - Immunisation suspension for injection - 29. 06. 2000 -
- Ciba Vision - CH
23. 10. 2000
- -
HIB vacci
- - -
ne ne
Powder for solution for infusion 15 mg 1 presentation
against
- NovoMix 30 - Novo Nordisk - insulin aspart - DK -A
- Diphtheria toxoid, -
- A10AD - Diabetes mellitus
- Diphtheria toxoid, - 201 days -
- Suspension for injection - 100 IU/ml - 8 presentations
- A Beecham Haemophilus -
- 24.09.1999 - 12.04.2000 - 144 days - 55 days
- A Beecham Haemophilus - 132 days -
- - - -
- B
17.05.2000 01.08.2000 01.08.2000 OJ C 244, 25.08.2000, p.
Pertussis, Tetanus, HepB and Poliomyelitis
Kogenate Bayer octocog alfa
Infanrix penta
- Bayer AG -D
- SmithKli
B02BD02 Treatment and prophylaxis of bleeding
OJ7CA Primary and
Powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU
Suspension for injection Diphtheria toxoid, adsorbed ≥ 30IU
- 26.02.1999 - 16.0 3.2000 - 182 days
30. 07. 1999 - 29. 06. 2000 -
- 05.06.2000 - 04.08.2000 - 07.08.2000
09. 08. 2000 23. 10. 2000
- 3 presentations
Tetanus toxoid, adsorbed ≥
- 201 days
201 days -
OJ C 244, 25.08.2000, p.
2
Helixate NexGen octocog alfa
Hexavac Comb
- Bayer AG -D
- Pasteur Merieux
B02BD02 Treatment and prophylaxis of bleeding
OJ7CA Immunisation
Powder and solvent for solution for infusion 250 IU, 500 IU, 1000 IU
Suspension for injection Purified diphtheria toxoid, adsorbed ≥ 20 IU,
- 26.02.1999 - 16.0 3.2000 - 182 days
30. 07. 1999 - 26. 06. 2000 -
- 05.06.2000 - 04.08.2000 - 07.08.2000
10. 08. 2000 23. 10. 2000
-A
vaccine
in haemophilia A
MSD
- 3 presentations
Diphtheria,
-
180 days -
10
26. 10. 2000
Hepacare triple antigen hepatitis B vaccine
A
Medeva Pharma Ltd UK
pertussis,
J07BC Immunisation against hepatitis B virus in adults
Purified tetanus toxoid, adsorbed ≥ 40 IU
- 23.10.1998 - 16.03.2000 - 210 days - 293 days
153 days -
-A
Tetanus, HepB, Poliomyelitis, Haemophilus influenza
-
Purified pertussis toxoid, adsorbed 25 µg Purified pertussis filamentous haemagglutinin adsorbed 25 µg Recombinant hepatitis B surface antigen 5. 0 µg Inactivated poliomyelitis virus: type 1 40 D units type 2 8 D units type 3 32 D units Haemophilus influenzae polysaccharide type b 12 µg conjugated to tetanus toxoid (24 µg)
- Herceptin - trastuzumab -A
8 presentations
- -
EMEA/ MB/ 050/ 00 Relatório Anual 2000
Roche Registration Ltd CH
Page 74/ 88
L01XC03 Treatment of patients with metastatic breast cancer whose tumour overexpress HER2
Luveris - Ares - G03G - Powder and solvent for - 25. 06. 1999 - 07. 09.
- - -
- Luveris -
Powder for concentrate for solution for infusion 150 mg 1 presentation
Ares - G03G - Powder and solvent for - 25. 0
- 26.02.1999 - 25.05.2000 - 147 days - 305 days
- Luveris - Ares -
14
- Luveris - Ares - G03G - Powder and solvent for -
- Keppra - levetiracetam -B
- Luveris - Ares - G03G - Powder and solvent for - 25. 06. 1999 -
- UCB S.A. - US
07. 09. 2000
N03A Adjunctive therapy in the partial onset seizures in epilepsy
Serono - Stimulation of solution for injection - 27. 07
- - -
- lutropin alfa Serono -
Film coated tablet 250 mg, 500 mg, 750 mg, 1000 mg 26 presentations
- lutropin alfa Serono - Stimulation of solution for injection -
- 26.02.1999 - 29.06.2000 - 187 days - 300 days
- lutropin alfa Serono - Stimulation of solution for injection - 27. 07. 2000 -
12
A
- Panretin - alitretinoin -B
(Europe)
Ligand Pharmaceuticals Ltd US
follicular
- Gel - 0.1 %w/w - 1 presentation
- A (Europe) follicular - 75 IU -
- 26.02.1999 - 29.06.2000 - 174 days - 313 days
- A (Europe) follicular - 75 IU - 192 days -
2
Ltd CH
- Glustin - pioglitazone -B
development in women with servere Leng HEng and FSH deficiency
Takeda Europe JP
6 presentations
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
200 days
Takeda Europe JP
NeoSpect depreotide B
- Tablet - 15 mg, 30 mg - 6 presentations
- Nycome - d Imaging A/ S NO
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
V09IA05 Scintigraphic imaging of suspected malignant tumours in the lung
- 20.11.1998 - 29.06.2000 - 219 days - 324 days
20. 11. 1998 27. 07. 2000 204 days 404 days
74 EMEA General Report 2000
- - -
Product - Brandname - INN - Part A/B
Trizivir lamivudine zidovudine abacavir B
Therapeutic area - ATC - Indication
Glaxo - Group - UK
Presentation - Form - Dosage - Number of presentations
J05AF30 Treatment of HIV- 1 infected patients
Infanrix hexa Hep B-IPV HIB vaccine
Film coated tablet 150/ 300/ 300 mg 3 presentations
SmithKline Beecham Biologicals
21. 01. 2000 29. 06. 2000 158 days 0 days
JO7CA Immunisation against Haemophilus influenza,
13. 10. 2000 08. 12. 2000
- 30.07.1999 - 29.06.2000 - 201 days
Nutropin AQ somatropin A
Diphtheria, Pertussis,
Schwarz - Pharma - AG
Tetanus toxoid, adsorbed ≥
H01AC01 Treatment of growth failure
- OJ C 337,
- - -
16 presentations
21. 10. 1999 21. 09. 2000 174 days
SmithKline Beecham Biologicals
05. 12. 2000
- 132 days
186 days
- OJ C 337,
-
Tetanus, Pertussis, Hepatitis B and Poliomyelitis
Neurobloc botulinum toxin type B B
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
- Elan - Pharma - Internati onal Ltd - UK
2
M03AX01 Treatment of cervical dystonia
8 presentations
Solution for injection - 5000 IU/ ml - 3 presentations - -
- Hexavac
27. 08. 1999 21. 09. 2000 187 days 229 days
Pasteur
21. 11. 2000
- Suspension for injection
Tenecteplase - - B01AD - Powder and solvent for - 24. 09. 1999 - 27. 11.
- 30.07.1999
- Tenecteplase - -
- 10.08.2000
B01AD - Powder and solvent
- Comb vaccine -A
- Tenecteplase - - B01AD -
Merieux MSD - -F
- Tenecteplase - - B01AD - Powder and solvent for -
Immunisation Diphtheria, pertussis, Tetanus, HepB, Poliomyelitis, Haemophilus influenza
- Tenecteplase - - B01AD - Powder and solvent for - 24. 09. 1999 -
Purified diphtheria toxoid, adsorbed ≥ 20 IU, Purified tetanus toxoid, adsorbed ≥ 40 IU Purified pertussis toxoid, adsorbed 25 µg Purified pertussis filamentous haemagglutinin adsorbed 25 µg Recombinant hepatitis B surface antigen 5.0 µg Inactivated poliomyelitis virus: type 1 40 D units type 2 8 D units type 3 32 D units Haemophilus influenzae polysaccharide type b 12 µg conjugated to tetanus toxoid (24 µg)
Boehring - Treatment of solution for injection
- 26.06.2000 - 180 days - 153 days
- tenecteplase Boehring -
- - -
Treatment of
23.10.2000 26.10.2000 OJ C 337, 28.11.2000. p.
- tenecteplase Boehring - Treatment of solution for injection -
8 presentations
suspected
- Luveris - lutropin alfa -A
- A er suspected - 6000 IU, 8000 IU, 10000 -
- -
176 days
- Powder and solvent for solution for injection IU - 6 presentations
Ingelhei m Internati onal GmbH
- 25.06.1999 - 27.07.2000 - 192 days - 200 days
myocardial infarction
75 EMEA General Report 2000
215 days
Product - Brandname - INN - Part A/B
Metalyse - - B01AD - Powder and solvent for - 24. 09. 1999 - 27. 11.
Company - Name - Origin
- Metalyse - -
Therapeutic area - ATC - Indication
B01AD - Powder and solvent
Presentation - Form - Dosage - Number of presentations
- Metalyse - - B01AD -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- Metalyse - - B01AD - Powder and solvent for -
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Metalyse - - B01AD - Powder and solvent for - 24. 09. 1999 -
- NeoSpect - depreotide
27. 11. 2000
Nycomed Imaging A/S
tenecteplase
- -
Boehring - Treatment of solution for injection
V09IA05 Scintigraphic imaging
- tenecteplase Boehring -
-
Treatment of
Kit for radiopaharmaceutical preparation
- tenecteplase Boehring - Treatment of solution for injection -
- 20.11.1998 - 27.07.2000
21. 09. 2000
-
A
- 27.08.1999 - 21.09.2000
R06AX27 - Relief of -
toxin type B
24. 09. 1999 21. 09. 2000
cancer
06. 11. 2000
- 3 presentations
13 presentations
- 187 days
201 days 159 days
- 229 days
SP - Europe -
- Tenecteplase - tenecteplase -A
24. 09. 1999 21. 09. 2000
Boehringer Ingelheim International GmbH
06. 11. 2000
Powder and solvent for solution for injection 6000 IU, 8000 IU, 10000 IU 3 presentations
US
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
symptoms - associated with seasonal allergic rhinitis
- 27.11.2000 - - -
13 presentations
- Metalyse - tenecteplase -A
201 days 159 days
B01AD Treatment of suspected myocardial infarction
Aerius desloratadine
- 27.11.2000 - - -
Film coated tablet 5 mg
- Azomyr - desloratadine -B
24. 09. 1999 21. 09. 2000
- Opulis - desloratadine -B
EMEA/ MB/ 050/ 00 Relatório Anual 2000
- SP Europe - US
Page 75/ 88
- Film coated tablet - 5 mg - 13 presentations
- Neoclarityn - SP -
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
R06AX27 - Film coated tablet
- 06.11.2000 - - -
- Neoclarityn - SP - R06AX27 -
- Allex - desloratadine -B
- Neoclarityn - SP - R06AX27 - Film coated tablet -
- SP Europe - US
- Neoclarityn - SP - R06AX27 - Film coated tablet - 24. 09. 1999 -
- 29.01.1999 - 16.11.2000 - 214 days - 393 days
08. 01. 2001
- 08.01.2001 - - -
- - -
- Capsule, soft - 75 mg - 1 presentation
- - -
- 17.12.1999 - 16.11.2000 - 197 days - 159 days
Capsule, soft 75 mg 1 presentation
- 18.07.2000
-
lopinavir/ ritonavir
Combination
77 EMEA General Report 2000
Pedidos centralizados
Annex 9:
Empresa
CVMP opinions in 2000 on medicinal products for veterinary use Centralised applications
- Parecer recebido em
Therapeutic area - Target species - Indication
- Indicação
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
- Parecer - Tempo activo
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Data da decisão - Notificação
Ibraxion Inactivated vaccine Part A
Ibraxion Inactivated vaccine Parte A
Metacam Meloxicam Part B extension
Metacam Meloxicam Parte B extension
Incurin Oestriol Part B
Incurin Oestriol Parte B
Rabigen SAG2 Virbac Live vaccine F Part A
Rabigen SAG2 Live vaccine Parte A
Eurifel FeLV Live vaccine Part A
Eurifel FeLV Live vaccine Parte A
Ibaflin Ibafloxacin Part B
Ibaflin Ibafloxacin Parte B
Metacam Meloxicam Part B (extension)
Metacam Meloxicam Parte B (extension)
Econor Valnemulin Part B (extension)
Econor Valnemulin Parte B (extension)
Econor Valnemulin Part B extension
Econor Valnemulin Parte B extension EMEA/ MB/ 050/ 00
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
Pigs Prevention / treatment of dysentery and treatment/ control of enzootic pneumonia
10%/50% premix various 2
Relatório Anual
78 EMEA General Report 2000
2000
Company - Name - Origin
- Parecer - Tempo activo
Dicural Difloxacin Part B (extension)
Dicural Difloxacin Parte B (extension)
Poulflox Difloxacin Part B
Poulflox Difloxacin Parte B
Bayovac CSF Marker Live vaccine Part A
Bayovac CSF Marker Live vaccine Parte A
Porcilis AR -T- DF Inactivated vaccine Part A
Porcilis AR- T - DF Inactivated vaccine Parte A
Intervet International NL
Intervet Internati onal NL
Pruban Rescortol butyrate Part B
Pruban Rescortol butyrate Parte B
Pirsue Pirlimycin Part B
Pirsue Pirlimycin Parte B
Pharmacia Upjohn B
Pharmaci a UpOJhn B
Zubrin Tepoxalin Part B
Zubrin Tepoxalin Parte B
Eurican herpes 205 Inactivated vaccine Part B
Eurican herpes 205 Inactivated vaccine Parte B
Establishment of maximum residue limits for new substances
EMEA/ MB/ 050/ 00 Relatório Anual 2000 Estabelecimento dos limites máximos de resíduos para substâncias
Substance - INN
novas
Therapeutic area - Target species
Page 80/ 88
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
Substância Área terapêutica EMEA/ CVMP - DCI - Espécie - Validação - Parecer - Tempo activo - Tempo inactivo
Commission - Sent to Commission - Date of Regulation - Official Journal
Comissão - Enviado à Comissão - Data do regulamento - Jornal Oficial
- 27.07.1999 - 10.11.1999 - 89 days -0
Flumequine Bovine milk & turkey - 27. 07. 1999 (extension) - 10. 11. 1999 - 89 days - 0
Ovine
- 19. 05. 2000 - 27. 10. 2000 - OJ L 276, 28. 10. 2000
- 19.01.2000 - 19.04.2000 - 90 -0
Flumethrin Ovine - 19. 01. 2000 (extension) - 19. 04. 2000 - 90 days - 0
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
Flunixin Equine - 23. 03. 2000 (extension) - 21. 06. 2000 - 90 days - 0
Commission - Sent to Commission - Date of Regulation - Official Journal
- 21. 07. 2000 - 29. 12. 2000 - OJ L 336, 30. 12. 2000
Flumethrin (extension)
EMEA/ MB/ 050/ 00 Relatório Anual 2000
Ovine
Page 81/ 88
- 19.01.2000 - 19.04.2000 - 90 days -0
Substância - DCI
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
Área terapêutica - Espécie
Flunixin (extension)
EMEA/ CVMP - Validação
Equine
Comissão - Enviado à Comissão
- 23.03.2000 - 21.06.2000 - 90 days -0
- Parecer - Tempo activo - Tempo inactivo
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
- Data do regulamento - Jornal Oficial
81 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Relatório Anual 2000 Anexo 10 Pareceres do COMP sobre medicamentos órfãos emitidos em 2000
Annex 10:
Page 82/ 88
Product
Medicamento
Sponsor
Patrocinador
EMEA/COMP - Submission - Validation - Opinion - Active time
EMEA/ CPMP - Apresentação - Validação - Parecer - Tempo activo
Commission - Opinion received - Date of Designation
Comissão - Parecer recebido em - Data da designação
AIDS-wasting
AIDS- wasting Treatment of Fabry disease
Ethypharm S.A.
Treatment of glioblastoma
Treatment of glioblastoma
Ethypharm S. A.
Voisin Consulting Treatment of acute promyelocytic leukaemia Sarl
Voisin Consulting Sarl
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
Treatment of tyrosinaemia type 1
Treatment of tyrosinaemia type 1 Treatment of Huntington” s disease
Treatment of acute promyelocytic leukaemia
EMEA/ MB/ 050/ 00 Relatório Anual 2000
- 08.08.2000
Page 83/ 88
-
Medicamento
- 22.09.2000
Patrocinador
- 21.11.2000
Indicação
- 61 days
EMEA/ CPMP
- -
Comissão
Treatment of acute respiratory distress syndrome
- Apresentação - Validação - Parecer - Tempo activo
- 01.09.2000
- Parecer recebido - Data de designação
- 21.11.2000
Treatment of acute promyelocytic leukaemia
- 61 days
- 08. 08. 2000 - 22. 09. 2000 - 21. 11. 2000 - 61 days
Treatment of cystic fibrosis
Treatment of acute respiratory distress syndrome
- 09.08.2000
- 01. 09. 2000 - 22. 09. 2000 - 21. 11. 2000 - 61 days
- 19.12.2000
Treatment of cystic fibrosis
- 89 days
- 09. 08. 2000 - 22. 09. 2000 - 19. 12. 2000 - 89 days
Treatment of glycogen storage disease type II
Treatment of glycogen storage disease type II (Pompe” s disease)
(Pompe's disease)
...
- 19.10.2000 - 19.12.2000 - 62 days
- 21. 08. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 19.10.2000
- 08. 09. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 19.12.2000
-
Mucopolysaccharidosis type VI (Maroteaux -Lamy
Grupo de Trabalho “ Biotecnologia ” do CPMP
- 04.10.2000
Número de referência
-
Linhas de orientação Final EU recommendations for the
Syndrome)
Situação
- 19.10.2000 - 19.12.2000 - 62 days
EMEA/ CPMP/ BWP/ 840/ 00
EMEA guidelines in 2000
Aprovada em Abril de 2000
Reference number
human TSEs and plasma- derived medicinal products, 15- 16 Maio de 2000 Concept paper on the Development of a
Guidelines/Status
Aprovada em Julho de 2000
Final EU recommendations for the Influenza vaccine composition for the season 2000/2001 Adopted April 2000
Aprovada em Novembro de 2000
EMEA/ CPMP/ BWP/3326/99
Publicado para consulta em Janeiro
Concept paper on the Development of a Points to consider on xenogeneic cell therapy Adopted November 2000
de 2000
Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Released for consultation January 2000
2000
EMEA/CPMP/BWP/1143/00
Publicado para consulta em Julho de
Revision of section 3.2.5 of CPMP Note for guidance on Plasma-derived medicinal products Released for consultation July 2000
2000 Publicado para consulta em
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines Released for consultation November 2000
Novembro de 2000
CPMP Blood and Plasma Working Group
Grupo de Trabalho “ Produtos Sanguíneos ” do CPMP
Reference number
Número de referência
Guidelines/Status
Situação
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Aprovada em Junho de 2000
1
investigation of human normal
Note for guidance on the Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
Aprovada em Junho de 2000
Core SPC for Human and anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Aprovada em Junho de 2000
Core SPC for Human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
Aprovada em Junho de 2000
Core SPC for Human plasma derived and recombinant coagulation factor VIII products Adopted June 2000
Aprovada em Junho de 2000
Core SPC for Human plasma derived and recombinant coagulation factor IX products Adopted June 2000
Aprovada em Junho de 2000
Note for Guidance on the Clinical investigation of human plasma derived factor VIII and IX products Adopted October 2000
Aprovada em Outubro de 2000
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adopted October 2000
Aprovada em Outubro de 2000
1
Core SPC for Human albumin
Core SPC for Human albumin Adopted October 2000 Note for guidance on the Clinical investigation of human plasma derived factor VIII and IX products Released for consultation June 2000
Publicado para consulta em Junho de
EMEA/ CPMP/ BPWG/1561/99
EMEA/ CPMP/ BPWG/ 2220/ 99
Note for guidance on the Clinical investigation of recombinant factor VIII and IX products Released for consultation June 2000
Dezembro de 2000
EMEA/ CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
EMEA/ CPMP/ BPWG/ 3226/ 99
EMEA/ CPMP/BPWG/3226/99
Publicado para consulta em
Core SPC for Human plasma derived antithrombin Released for consultation December 2000
Dezembro de 2000
CPMP Efficacy Working Party Reference number
Número de referência
Note for Guidance on clinical investigation of steroid contraceptives in woman Adopted February 2000
Aprovada em Fevereiro de 2000
Points to consider concerning Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells Adopted February 2000
factors for mobilisation of autologous stem cells Points to consider on the clinical investigation of new medicinal products for
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
Aprovada em Fevereiro de 2000
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
Aprovada em Fevereiro de 2000
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
Aprovada em Fevereiro de 2000
Points to consider on Clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk Adopted June 2000
Aprovada em Fevereiro de 2000
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adopted June 2000
Aprovada em Junho de 2000
Points to consider on pharmaco-kinetics and pharmacodynamics in the development of anti-bacterial medicinal products Adopted July 2000
Aprovada em Junho de 2000
Points to consider on switching between superiority and non-inferiority Adopted July 2000
Aprovada em Julho de 2000
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
Aprovada em Julho de 2000
Points to consider on Clinical investigation of medicinal products for treatment of Amyotrophic Lateral Sclerosis (ALS) Adopted October 2000
Aprovada em Julho de 2000
EMEA/CPMP/EWP/785/97
EMEA/ CPMP/ EWP/ 565/ 98
Concept paper on the Evaluation of drugs for the treatment of the irritable bowel syndrome Adopted November 2000
Aprovada em Outubro de 2000
EMEA/CPMP/EWP/566/98 rev.
EMEA/ CPMP/ EWP/ 785/ 97
1
for the treatment of the irritable bowel syndrome Note for Guidance on Clinical investigation
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders Adopted in November 2000
Aprovada em Novembro de 2000
EMEA/CPMP/EWP/2284/99
1
Points to consider on Clinical investigation of medicinal products for the management of Crohn's disease Released for consultation July 2000
Aprovada em Novembro de 2000 Publicado para consulta em Julho de
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
2000 e prorrogado em Setembro de 2000 por mais 2 meses Publicado para consulta em Outubro
Points to consider on Clinical investigation of medicinal products in the treatment of acute stroke Released for consultation October 2000
de 2000 Publicado para consulta em Outubro
Points to consider on Validity and interpretation of meta-analyses, and one pivotal study Released for consultation October 2000
de 2000
Points to consider on the Evaluation of diagnostic agents Released for consultation November 2000
Novembro de 2000 Publicado para consulta em
Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Released for consultation November 2000
Novembro de 2000
Note for Guidance on the investigation of bioavailability and bioequivalence Released for consultation December 2000
Publicado para consulta em Dezembro de 2000 Publicado para consulta em
Note for Guidance on co-ordinating investigator signature of clinical study reports Released for consultation December 2000
Dezembro de 2000
CPMP Pharmacovigilance Working Party
Grupo de Trabalho “ Farmacovigilância ” do CPMP
Guidelines/Status
Situação Publicado para consulta em Maio de
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
2000
CPMP Safety Working Party
Grupo de Trabalho “ Segurança ” do CPMP
CPMP Position paper on Selective Serotonin Uptake Inhibitors (SSRIs) and dependency/withdrawal reactions Adopted April 2000
Aprovada em Abril de 2000
Note for Guidance on Repeated dose toxicity Adopted July 2000
Aprovada em Julho de 2000
Discussion paper on Possible pre-clinical studies to investigate addiction and dependence/withdrawal related to use of SSRIs Adopted December 2000
Aprovada em Dezembro de 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
Aprovada em Dezembro de 2000
Note for Guidance on Non-clinical local tolerance testing of medicinal products Released for consultation September 2000
Publicado para consulta em Setembro de 2000
EMEA Herbal Medicinal Products Working Party
Grupo de Trabalho “ Medicamentos à Base de Plantas ” da EMEA
Guidelines/Status
Situação Aprovada pelo Grupo de Trabalho
Position paper on the Risks associated with the use of Herbal Products containing Aristolochia Species Adopted by the Working Party in October 2000
em Outubro de 2000
Note for guidance on quality of herbal medicinal products Released for consultation November 2000
Novembro de 2000 Publicado para consulta em
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
Novembro de 2000
86 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Relatório Anual 2000 Grupo de Trabalho “ Eficácia ” CVMP
Guidelines/Status Conduct of pharmacokinetic studies in animals Adopted March 2000
Aprovada em Março de 2000
Conduct of efficacy studies for intramammary products for use in cattle Adopted March 2000
Aprovada em Março de 2000
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
Aprovada em Novembro de 2000
The conduct of bioequivalence studies for veterinary medicinal products Released for consultation January 2000
de 2000 Publicado para consulta em Julho de
CVMP/VICH/546/00
Specific CVMP/ VICH/ 545/ 00
Specific recommendations for poultry Released for consultation July 2000
2000 Publicado para consulta em Julho de
CVMP Immunologicals Working Party Reference number CVMP/IWP/52/97
Grupo de Trabalho “ Imunologia ” do CVMP
Guidelines/Status Requirements for combined veterinary vaccines Adopted March 2000
Aprovada em Março de 2000
DNA vaccines non-amplifiable in eukaryotic cells for veterinary use Adopted March 2000
Aprovada em Março de 2000
Duration of protection achieved by veterinary vaccines Adopted October 2000
Aprovada em Outubro de 2000 Publicado para consulta em Março
Field trials with veterinary vaccines Released for consultation March 2000
de 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
de 2000
CVMP Pharmacovigilance Working Party
Grupo de Trabalho “ Farmacovigilância ” do CVMP
Reference number EMEA/ CVMP/044/99
Número de referência
Guidelines/Status Conduct of post-marketing surveillance studies of veterinary medicinal products Adopted April 2000
Aprovada em Abril de 2000
CVMP Safety Working Party
Grupo de Trabalho “ Segurança ” do CVMP
Reference
Número de referência
Assessment of the effect of antimicrobial substances on dairy starter cultures Adopted March 2000
Aprovada em Março de 2000
Determination of withdrawal periods for milk Adopted March 2000
Aprovada em Março de 2000
Environmental impact assessment (EIAS) for veterinary medicinal products - Phase 1 Adopted July 2000
Aprovada em Julho de 2000 Publicado para consulta em Maio de
Risk analysis approach for residues of veterinary medicinal products in food of animal origin Released for consultation May 2000
2000
Genotoxicity studies Released for consultation July 2000
Publicado para consulta em Julho de
Reproduction studies Released for consultation July 2000
2000 Publicado para consulta em Julho de
Joint CPMP/CVMP Quality Working Party
EMEA/ MB/ 050/ 00 Relatório Anual 2000 Grupo de Trabalho Conjunto “ Qualidade ” dos CPMP/ CVMP
Reference number
Número de referência Linhas de orientação
Concept Paper on the Development of a CPMP/CVMP Note for Guidance on Quality of Water for Pharmaceutical Use Adopted July 2000
Aprovada em Julho de 2000
Note for Guidance on Parametric Release Released for consultation March 2000
Publicado para consulta em Março de 2000
Note for Guidance on Medicinal Gases – Pharmaceutical Information Released for consultation July 2000
Publicado para consulta em Julho de 2000
Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products Released for consultation November 2000
Publicado para consulta em Novembro de 2000
Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products Released for consultation November 2000
Publicado para consulta em Novembro de 2000
CPMP/QWP/2819/00 (CVMP/814/00) EMEA/ CVMP/065/99
Development pharmaceutics for veterinary medicinal
Note for Guidance on Quality of Herbal Medicinal Products Released for consultation November 2000 Annex to Guideline:
Publicado para consulta em Novembro de 2000
Decision trees for the selection of sterilisation methods Adopted February 2000
Aprovada em Fevereiro de 2000
Declaration of storage conditions for veterinary medicinal products in the product particulars Adopted February 2000
Aprovada em Fevereiro de 2000
Stability testing of biotechnological/biological veterinary medicinal products Adopted June 2000
Aprovada em Junho de 2000
Impurities: residual solvents Adopted June 2000
Aprovada em Junho de 2000
Maximum shelf-life for sterile medicinal products after first opening or following reconstitution Adopted July 2000
Aprovada em Julho de 2000
Good clinical practices Adopted July 2000
Aprovada em Julho de 2000
Stability testing of existing active substances and related finished products Adopted November 2000
Aprovada em Novembro de 2000
Statistical principles for veterinary clinical trials Released for consultation November 2000
Novembro de 2000
Ad hoc GMP Inspectors Working Group
Grupo de Trabalho ad hoc “ Inspectores de GMP ”
ENTR/6266/00
ENTR/ 6109/ 00
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Finalised in April 2000
de 2000 Publicado para consulta em Abril de
ENTR/6109/00
ENTR/ 6270/ 00
Draft Annex 17 to EU Guide to Good Manufacturing Practice on Parametric Release Released for consultation April 2000
EMEA/ MB/ 050/ 00 Relatório Anual 2000
88
Page 89/ 88
The European Agency for the Evaluation of Medicinal Products
Agência Europeia de Avaliação de Medicamentos
Seventh Annual Report 2001
Relatório Geral 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.
Aprovado pelo Conselho de Administração em 18 de Dezembro de 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
Aprovado pelo Conselho de Administração em 18 de Dezembro de 2001
7 8
5 6 7 8 8 9 9 9
Chapter 4 Inspections
1. 5 1. 6 1. 7 1. 8 1. 9
European Department for the Quality of Medicines Financial control
Análise do sistema europeu de autorização de introdução no mercado Gestão da qualidade Parceiros internacionais Departamento Europeu para a Qualidade dos Medicamentos Controlo financeiro
10 11 12
10 10 11 12 12
5.3 5.4
CAPÍTULO 2 MEDICAMENTOS DE USO HUMANO 2. 1 Avaliação inicial 2. 2 Actividades pós- autorização 2. 3 Actividades de farmacovigilância e de manutenção 2. 4 Aconselhamento Científico 2. 5 Arbitragens e procedimentos comunitários de recurso 2. 6 Serviços especiais 2. 7 Actividades internacionais 2. 8 Medicamentos órfãos 2. 9 Grupos de trabalho e grupos ad hoc 2. 10 Grupo de Facilitação do Reconhecimento Mútuo CAPÍTULO 3 MEDICAMENTOS VETERINÁRIOS 3. 1 Avaliação inicial 3. 2 Estabelecimento de limites máximos de resíduos para substâncias antigas 3. 3 Actividades pós- autorização 3. 4 Actividades de farmacovigilância e de manutenção 3. 5 Aconselhamento Científico 3. 6 Arbitragens e procedimentos comunitários de recurso 3. 7 Partes interessadas 3. 8 Actividades internacionais 3. 9 Grupos de trabalho e grupos ad hoc 3. 10 Grupo de Facilitação do Reconhecimento Mútuo de Medicamentos Veterinários CAPÍTULO 4 INSPECÇÕES CAPÍTULO 5 ADMINISTRAÇÃO E ACTIVIDADES DE APOIO 5. 1 Administração 5. 2 Gestão de documentos e publicações 5. 3 Serviços de gestão de reuniões e conferências 5. 4 Tecnologias de informação ANEXOS Anexo 1 Composição do Conselho de Administração Anexo 3 Composição do Comité dos Medicamentos Veterinários Anexo 4 Membros do Comité dos Medicamentos Órfãos Anexo 5 Autoridades nacionais competentes Anexo 6 Resumo geral dos orçamentos da EMEA 2000 – 2002 Anexo 7 Pareceres do CPMP sobre medicamentos de uso humano emitidos em 2001 Anexo 8 Pareceres do CVMP sobre medicamentos veterinários emitidos em 2001 Anexo 9 Pareceres do COMP sobre medicamentos órfãos emitidos em 2001 Anexo 10 Normas orientadoras e documentos de trabalho em 2001 Anexo 11 Pontos de contacto da EMEA O relatório anual de 2001 é apresentado ao Conselho de Administração pelo Director
Meeting management and conferences Information technology
14 16 18 19 20 22 24 24 25 27 32 35 37 39 39 40 40 40 41 41 42 44 45 48 48 51 52 53 55 56 58 59 60 64 65 69 72 79 84 Executivo, em
34 35
Encontra- se disponível em todas as línguas oficiais da UE e será fornecido mediante pedido.
Pharmacovigilance and maintenance activities Scientific advice Arbitration and Community referrals
Os relatórios anuais de anos anteriores, bem como outros documentos de referência, podem ser obtidos no website da EMEA, no seguinte endereço: http: // www. emea. eu. int.
13 14 15
O presente relatório abrange as actividades levadas a cabo pela EMEA em 2001.
Annexes 1 Members of the Management Board 2 Members of the Committee for Proprietary
O capítulo 1 descreve as actividades desenvolvidas pelo Conselho de Administração.