natgillin/translations-raw huggingface dataset:
- 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
Bovine milk & turkey
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
80 EMEA General Report 2000
Flumethrin Ovine - 19. 01. 2000 (extension) - 19. 04. 2000 - 90 days - 0
Substance - INN
- 19. 05. 2000 - 27. 10. 2000 - OJ L 276, 28. 10. 2000
Therapeutic area - Target species
Flunixin Equine - 23. 03. 2000 (extension) - 21. 06. 2000 - 90 days - 0
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
- 21. 07. 2000 - 29. 12. 2000 - OJ L 336, 30. 12. 2000
Commission - Sent to Commission - Date of Regulation - Official Journal
EMEA/ MB/ 050 Vuosikertomus 2000
Flumethrin (extension)
sivu 77/ 85
Ovine
Aine
- 19.01.2000 - 19.04.2000 - 90 days -0
Hoitoalue
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
EMEA/ CVMP
Flunixin (extension)
Komissio
Equine
- INN
- 23.03.2000 - 21.06.2000 - 90 days -0
- Validointi - Lausunto - Aktiivinen aika - Kellon pysäytys
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
- Toimitettu komissiolle - Asetuksen päivämäärä - EYVL
- 16.02.1999 - 21.06.2000 - 206 days - 284 days
- 16. 02. 1999 - 21. 06. 2000 - 206 days - 284 days
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
- 21. 07. 2000 - 29. 12. 2000 - OJ L 336, 30. 12. 2000
- 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 Vuosikertomus 2000 Liite 10 COMP: n lausunnot harvinaislääkkeistä vuonna 2000
Annex 10:
sivu 78/ 85
Sponsor
Rahoittaja
EMEA/COMP - Submission - Validation - Opinion - Active time
EMEA/ COMP - Hakemus jätetty - Validointi - Lausunto - Aktiivinen aika
Commission - Opinion received - Date of Designation
Komissio - Lausunto saatu - Päätöksen päivämäärä
Ares-Serono (Europe) Ltd
AIDS- wasting
AIDS-wasting
Ares- Serono (Europe) Ltd
- 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
- 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
Ethypharm S.A.
Ethypharm S. A.
- 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
Wyeth-Ayerst Research
Wyeth- Ayerst Research
- 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
Orphan Europe Sarl
Orphan Europe
Treatment of N-acetylglutamate synthetase (NAGS) deficiency
Treatment of N- acetylglutamate synthetase (NAGS) deficiency
- 02.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
- 31. 07. 2000 - 13. 09. 2000 - 45 days
- 18.09.2000 - 18.10.2000
- 18. 10. 2000
Voisin Consulting Treatment of acute promyelocytic leukaemia Sarl
Treatment of acute promyelocytic leukaemia
- 08.05.2000 - 15.06.2000 - 13.09.2000 - 90 days
- 08. 05. 2000 - 15. 06. 2000 - 13. 09. 2000 - 90 days
Treatment of erythema nodosum leprosum or type II reactions in Hansen's disease
Treatment of erythema nodosum leprosum or type II reactions in Hansen’ s disease Treatment of essential thrombocythaemia
- 01.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
- 01. 06. 2000 - 25. 08. 2000 - 27. 10. 2000 - 64 days
- 6.11.2000 - 29.12.2000
- 6. 11. 2000 - 29. 12. 2000
- 31.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
- 31. 05. 2000 - 31. 07. 2000 - 27. 10. 2000 - 89 days
- 09.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
- 09. 06. 2000 - 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
Treatment of Huntington's disease
Treatment of Huntington’ s disease
- 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
- -
sivu 79/ 85
Treatment of acute promyelocytic leukaemia
Tuote
- 08.08.2000
Rahoittaja
-
Indikaatio
- 22.09.2000
EMEA/ COMP - Hakemus jätetty - Validointi - Lausunto - Aktiivinen aika
- 21.11.2000
Komissio - Lausunto saatu - Päätöksen päivämäärä
- 61 days
...
- -
...
Treatment of acute respiratory distress syndrome
Treatment of acute promyelocytic leukaemia
- 01.09.2000
- 08. 08. 2000 - 22. 09. 2000 - 21. 11. 2000 - 61 days
- 22.09.2000
...
- 21.11.2000
...
- 61 days
- 01. 09. 2000 - 22. 09. 2000 - 21. 11. 2000 - 61 days
- 09.08.2000
- 09. 08. 2000 - 22. 09. 2000 - 19. 12. 2000 - 89 days
- 89 days
...
- 02.05.2000
- 02. 05. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 62 days
...
Treatment of glycogen storage disease type II
Treatment of glycogen storage disease type II (Pompe’ s disease)
- 10.08.2000
- 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
Treatment of pulmonary arterial hypertension and
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
- 21.08.2000
- 21. 08. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
chronic thromboembolic pulmonary hypertension
...
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
- 06. 09. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 08.09.2000
- 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
- 19.10.2000
...
- 19.12.2000
Mucopolysaccharidosis type VI (Maroteaux - Lamy Syndrome)
- 62 days
- 04. 10. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
Mucopolysaccharidosis type VI (Maroteaux -Lamy
EMEA/ MB/ 050 Vuosikertomus 2000 Liite 11 EMEAn ohjeet vuonna 2000
- 04.10.2000
sivu 80/ 85
-
CPMP: n bioteknologian työryhmä
Syndrome)
Viitenumero
- 19.10.2000 - 19.12.2000 - 62 days
Ohje Final EU recommendations for the
83 EMEA General Report 2000
Influenza vaccine composition for the season 2000/ 2001 Report of the EMEA Expert Workshop on
EMEA guidelines in 2000
Hyväksytty huhtikuussa 2000
CPMP Biotechnology Working Party
EMEA/ CPMP/ BWP/ 1244/ 00
Reference number
human TSEs and plasma- derived medicinal products, 15- 16 May 2000 Concept paper on the Development of a
Guidelines/Status
Hyväksytty heinäkuussa 2000
EMEA/ CPMP/ BWP/840/00
EMEA/ CPMP/ BWP/ 3326/ 99
Final EU recommendations for the Influenza vaccine composition for the season 2000/2001 Adopted April 2000
Hyväksytty marraskuussa 2000
EMEA/ CPMP/ BWP/1244/00
EMEA/ CPMP/ BWP/ 3354/ 99
Report of the EMEA Expert Workshop on human TSEs and plasma-derived medicinal products, 15-16 May 2000 Adopted July 2000
quality control of animal immunoglobulins
EMEA/ CPMP/ BWP/3326/99
Toimitettu lausuntoa varten
Concept paper on the Development of a Points to consider on xenogeneic cell therapy Adopted November 2000
tammikuussa 2000
EMEA/ CPMP/ BWP/3354/99 Draft
EMEA/ CPMP/ BWP/ 3207/ 00
Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Released for consultation January 2000
toukokuussa 2000
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
tumorigenic cells of human origin for the
EMEA/CPMP/BWP/1143/00
Toimitettu lausuntoa varten
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
heinäkuussa 2000
EMEA/CPMP/BWP/269/95rev.
Toimitettu lausuntoa varten
Revision of section 3.2.5 of CPMP Note for guidance on Plasma-derived medicinal products Released for consultation July 2000
heinäkuussa 2000 Toimitettu lausuntoa varten
EMEA/CPMP/BWP/2571/00
EMEA/ CPMP/ BWP/ 2571/ 00
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines Released for consultation November 2000
marraskuussa 2000
CPMP Blood and Plasma Working Group
CPMP: n veri - ja plasmatyöryhmä
Guidelines/Status
Tilanne
EMEA/CPMP/BPWG/575/99
EMEA/ CPMP/ BPWG/ 575/ 99
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Hyväksytty kesäkuussa 2000
EMEA/CPMP/BPWG/388/95 rev.
Hyväksytty kesäkuussa 2000
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
EMEA/CPMP/BPWG/574/99
EMEA/ CPMP/ BPWG/ 574/ 99 EMEA/ CPMP/ BPWG/ 859/ 95
Core SPC for Human and anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Hyväksytty kesäkuussa 2000
EMEA/CPMP/BPWG/859/95 rev.
rev.
Core SPC for Human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
Hyväksytty kesäkuussa 2000
EMEA/ CPMP/ BPWG/1619/99
EMEA/ CPMP/ BPWG/ 1619/ 99
Core SPC for Human plasma derived and recombinant coagulation factor VIII products Adopted June 2000
Hyväksytty kesäkuussa 2000
EMEA/ CPMP/ BPWG/1625/99
EMEA/ CPMP/ BPWG/ 1625/ 99
Core SPC for Human plasma derived and recombinant coagulation factor IX products Adopted June 2000
Hyväksytty kesäkuussa 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
Hyväksytty lokakuussa 2000
EMEA/CPMP/BPWG/ 1561/99
EMEA/ CPMP/ BPWG/ 1561/ 99 EMEA/ CPMP/ PhvWP/ BPWG /
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adopted October 2000
Hyväksytty lokakuussa 2000
84 EMEA General Report 2000
Hyväksytty lokakuussa 2000
EMEA/CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/198/95 rev.
investigation of human plasma derived
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
factor VIII and IX products Note for guidance on the Clinical
EMEA/ CPMP/ BPWG/1561/99
EMEA/ CPMP/ BPWG/ 1561/ 99
Note for guidance on the Clinical investigation of recombinant factor VIII and IX products Released for consultation June 2000
kesäkuussa 2000
EMEA/ CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
EMEA/ CPMP/ BPWG/ 2220/ 99
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
investigation of plasma derived antithrombin products
EMEA/ CPMP/BPWG/3226/99
EMEA/ CPMP/ BPWG/ 3226/ 99
Core SPC for Human plasma derived antithrombin Released for consultation December 2000
joulukuussa 2000
CPMP Efficacy Working Party Reference number
CPMP: n tehokkuustyöryhmä
Guidelines/Status
Viitenumero
EMEA/ CPMP/ EWP/519/98
EMEA/ CPMP/ EWP/ 519/ 98
Note for Guidance on clinical investigation of steroid contraceptives in woman Adopted February 2000
Hyväksytty helmikuussa 2000
EMEA/ CPMP/ EWP/197/99
EMEA/ CPMP/ EWP/ 197/ 99
Points to consider concerning Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells Adopted February 2000
Hyväksytty helmikuussa 2000
EMEA/ CPMP/ EWP/570/98
EMEA/ CPMP/ EWP/ 570/ 98
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
Hyväksytty helmikuussa 2000
EMEA/ CPMP/ EWP/2922/99
EMEA/ CPMP/ EWP/ 2922/ 99
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
Hyväksytty helmikuussa 2000
EMEA/ CPMP/ EWP/2863/99
EMEA/ CPMP/ EWP/ 2863/ 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
Hyväksytty helmikuussa 2000
EMEA/ CPMP/ EWP/707/98
EMEA/ CPMP/ EWP/ 707/ 98
Points to consider on Clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk Adopted June 2000
Hyväksytty kesäkuussa 2000
EMEA/ CPMP/ EWP/612/00
EMEA/ CPMP/ EWP/ 612/ 00
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adopted June 2000
Hyväksytty kesäkuussa 2000
EMEA/ CPMP/ EWP/2655/99
EMEA/ CPMP/ EWP/ 2655/ 99
Points to consider on pharmaco-kinetics and pharmacodynamics in the development of anti-bacterial medicinal products Adopted July 2000
Hyväksytty heinäkuussa 2000
EMEA/ CPMP/ EWP/482/99
EMEA/ CPMP/ EWP/ 482/ 99
Points to consider on switching between superiority and non-inferiority Adopted July 2000
Hyväksytty heinäkuussa 2000
EMEA/ CPMP/ EWP/1080/00
EMEA/ CPMP/ EWP/ 1080/ 00
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
Hyväksytty heinäkuussa 2000
EMEA/ CPMP/ EWP/565/98
EMEA/ CPMP/ EWP/ 565/ 98
Points to consider on Clinical investigation of medicinal products for treatment of Amyotrophic Lateral Sclerosis (ALS) Adopted October 2000
Hyväksytty lokakuussa 2000
EMEA/CPMP/EWP/785/97
EMEA/ CPMP/ EWP/ 785/ 97
Concept paper on the Evaluation of drugs for the treatment of the irritable bowel syndrome Adopted November 2000
Hyväksytty marraskuussa 2000
EMEA/CPMP/EWP/566/98 rev.
EMEA/ CPMP/ EWP/ 566/ 98 rev.
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders Adopted in November 2000
heinäkuussa 2000
EMEA/CPMP/EWP/2284/99
EMEA/ MB/ 050
Points to consider on Clinical investigation of medicinal products for the management of Crohn's disease Released for consultation July 2000
Vuosikertomus 2000
85 EMEA General Report 2000
sivu 82/ 85
EMEA/CPMP/EPW/205/95 rev.
EMEA/ CPMP/ EPW/ 205/ 95 rev.
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
Note for Guidance on Evaluation of
EMEA/ CPMP/ EWP/560/98
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
lokakuussa 2000 Toimitettu lausuntoa varten
EMEA/ CPMP/ EWP/2330/99
EMEA/ CPMP/ EWP/ 2330/ 99
Points to consider on Validity and interpretation of meta-analyses, and one pivotal study Released for consultation October 2000
lokakuussa 2000
EMEA/ CPMP/ EWP/1119/98
EMEA/ CPMP/ EWP/ 1119/ 98
Points to consider on the Evaluation of diagnostic agents Released for consultation November 2000
marraskuussa 2000 Toimitettu lausuntoa varten
EMEA/ CPMP/ EWP/714/98
EMEA/ CPMP/ EWP/ 714/ 98
Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Released for consultation November 2000
marraskuussa 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
Toimitettu lausuntoa varten joulukuussa 2000 Toimitettu lausuntoa varten
EMEA/CPMP/EWP/2747/00
EMEA/ CPMP/ EWP/ 2747/ 00
Note for Guidance on co-ordinating investigator signature of clinical study reports Released for consultation December 2000
joulukuussa 2000
CPMP Pharmacovigilance Working Party
CPMP: n lääketurvatoiminnan työryhmä
Guidelines/Status
Tilanne Toimitettu lausuntoa varten
EMEA/CPMP/PhVWP/2058/99
EMEA/ CPMP/ PhVWP/ 2058/ 99
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
toukokuussa 2000
CPMP Safety Working Party
CPMP: n turvallisuustyöryhmä
Guidelines/Status
Ohje CPMP Position paper on Selective
EMEA/ CPMP/ SWP/2775/99
EMEA/ CPMP/ SWP/ 2775/ 99
CPMP Position paper on Selective Serotonin Uptake Inhibitors (SSRIs) and dependency/withdrawal reactions Adopted April 2000
Hyväksytty huhtikuussa 2000
EMEA/ CPMP/ SWP/1042/99
EMEA/ CPMP/ SWP/ 1042/ 99
Note for Guidance on Repeated dose toxicity Adopted July 2000
Hyväksytty heinäkuussa 2000
EMEA/ CPMP/ SWP/2278/00
EMEA/ CPMP/ SWP/ 2278/ 00
Discussion paper on Possible pre-clinical studies to investigate addiction and dependence/withdrawal related to use of SSRIs Adopted December 2000
Hyväksytty joulukuussa 2000
EMEA /CPMP/SWP/4163/00
EMEA/ CPMP/ SWP/ 4163/ 00
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
Hyväksytty joulukuussa 2000
EMEA/CPMP/SWP/2145/00 Draft 4
EMEA/ CPMP/ SWP/ 2145/ 00 Draft 4
Note for Guidance on Non-clinical local tolerance testing of medicinal products Released for consultation September 2000
Toimitettu lausuntoa varten syyskuussa 2000
EMEA Herbal Medicinal Products Working Party
EMEA: n luonnonlääkevalmisteiden työryhmä
Guidelines/Status
Tilanne Työryhmä hyväksynyt lokakuussa
EMEA/HMPWP/23/00
EMEA/ HMPWP/ 23/ 00
Position paper on the Risks associated with the use of Herbal Products containing Aristolochia Species Adopted by the Working Party in October 2000
2000
CPMP/QWP/2819/00
CPMP/ QWP/ 2819/ 00
Note for guidance on quality of herbal medicinal products Released for consultation November 2000
marraskuussa 2000
CPMP/QWP/2820/00
CPMP/ QWP/ 2820/ 00
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
marraskuussa 2000
86 EMEA General Report 2000
EMEA/ MB/ 050 Vuosikertomus 2000 CVMP: n tehokkuustyöryhmä
CVMP Efficacy Working Party Reference number EMEA/ CVMP/133/99
EMEA/ CVMP/ 133/ 99 animals Conduct of efficacy studies for
Guidelines/Status Conduct of pharmacokinetic studies in animals Adopted March 2000
Hyväksytty maaliskuussa 2000
EMEA/ CVMP/344/99
EMEA/ CVMP/ 344/ 99 intramammary products for use in cattle Testing and evaluation of the efficacy of antiparasitic substances for the treatment
Conduct of efficacy studies for intramammary products for use in cattle Adopted March 2000
Hyväksytty maaliskuussa 2000
EMEA/ CVMP/005/00
EMEA/ CVMP/ 005/ 00 and prevention of tick and flea infestation in cats and dogs
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
Hyväksytty marraskuussa 2000
EMEA/CVMP/016/00
Specific CVMP/ VICH/ 546/ 00
The conduct of bioequivalence studies for veterinary medicinal products Released for consultation January 2000
tammikuussa 2000 Toimitettu lausuntoa varten
Efficacy of anthelmintics:
recommendations for poultry Efficacy of anthelmintics:
Specific recommendations for poultry Released for consultation July 2000
heinäkuussa 2000 Toimitettu lausuntoa varten
CVMP/VICH/545/00
recommendations for feline
Specific recommendations for feline Released for consultation July 2000
heinäkuussa 2000
CVMP Immunologicals Working Party Reference number CVMP/IWP/52/97
CVMP: n immunologisten valmisteiden työryhmä
Guidelines/Status Requirements for combined veterinary vaccines Adopted March 2000
Hyväksytty maaliskuussa 2000
CVMP/IWP/07/98
CVMP/ IWP/ 07/ 98
DNA vaccines non-amplifiable in eukaryotic cells for veterinary use Adopted March 2000
Hyväksytty maaliskuussa 2000
EMEA/ CVMP/682/99
EMEA/ CVMP/ 682/ 99
Duration of protection achieved by veterinary vaccines Adopted October 2000
Hyväksytty lokakuussa 2000 Toimitettu lausuntoa varten
EMEA/ CVMP/852/99
EMEA/ CVMP/ 852/ 99
Field trials with veterinary vaccines Released for consultation March 2000
maaliskuussa 2000
EMEA/CVMP/743/00
EMEA/ CVMP/ 743/ 00
Requirements and controls applied to bovine serum (foetal or calf) used in the protection of immunological veterinary medicinal products Released for consultation October 2000
lokakuussa 2000
CVMP Pharmacovigilance Working Party
CVMP: n lääketurvatoiminnan työryhmä
Reference number EMEA/ CVMP/044/99
EMEA/ CVMP/ 044/ 99
Guidelines/Status Conduct of post-marketing surveillance studies of veterinary medicinal products Adopted April 2000
Hyväksytty huhtikuussa 2000
CVMP/VICH/547/00
CVMP/ VICH/ 547/ 00
Management of adverse event reports (AERs) Released for consultation July 2000
heinäkuussa 2000
CVMP Safety Working Party
CVMP: n turvallisuustyöryhmä
linesStatus number
Viitenumero
Reference
Ohje Assessment of the effect of antimicrobial
EMEA/ CVMP/276/99
EMEA/ CVMP/ 276/ 99
Assessment of the effect of antimicrobial substances on dairy starter cultures Adopted March 2000
Hyväksytty maaliskuussa 2000
EMEA/ CVMP/473/98
EMEA/ CVMP/ 473/ 98
Determination of withdrawal periods for milk Adopted March 2000
Hyväksytty maaliskuussa 2000
CVMP/ VICH/592/98
CVMP/ VICH/ 592/ 98
Environmental impact assessment (EIAS) for veterinary medicinal products - Phase 1 Adopted July 2000
for veterinary medicinal products - Phase 1 Risk analysis approach for residues of
EMEA/CVMP/187/00
EMEA/ CVMP/ 187/ 00
Risk analysis approach for residues of veterinary medicinal products in food of animal origin Released for consultation May 2000
toukokuussa 2000
CVMP/VICH/526/00
CVMP/ VICH/ 526/ 00