natgillin/translations-raw huggingface dataset:
er Ingelhei m Internati onal GmbH
Boehringer Ingelheim International GmbH
- Neoclarityn - SP - R06AX27 -
- 06.11.2000 - - -
- desloratadine Europe -
- Neoclarityn - desloratadine -B
- B - US symptoms -
- SP Europe - US
associated with seasonal allergic rhinitis
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Film coated tablet
- Film coated tablet - 5 mg - 13 presentations
- capecitabine Registrat - treatment of -
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
- capecitabine Registrat - treatment of - 150 mg, 500 mg -
- 06.11.2000 - - -
- B ion Ltd metastatic -
- Xeloda - capecitabine -B
- B ion Ltd metastatic - 2 presentations -
- Roche Registration Ltd - CH
colorectal cancer
L01BC treatment of metastatic colorectal cancer
Serono - Assisted solution for injection
- Film coated tablet - 150 mg, 500 mg - 2 presentations
- chorio - Serono -
- 21.10.1999 - 21.09.2000 - 201 days - 159 days
- chorio - Serono - Assisted solution for injection -
- 20.11.2000 - - -
gonadotropin alfa A
Ovidrelle chorio- gonadotropin alfa
(Europe) Ltd CH
Ares Serono (Europe) Ltd CH
reproductive techniques sus as in vitro fertilisation (IVF)
G03GA01 Assisted reproductive techniques sus as in vitro fertilisation (IVF)
250 µg 6 presentations
Powder and solvent for solution for injection 250 µg 6 presentations
174 days 186 days
- 21.10.1999 - 21.09.2000 - 174 days - 186 days
- -
- 23.11.2000 - - -
Prevenar Prevenarpneu mococcal conjugate vaccine A
Product - Brandname - INN - Part A/B
- -
Company - Name - Origin
Wyeth - Lederle Vaccines S. A.
Therapeutic area - ATC - Indication
US
- Prevenar - Prevenarp- neumococcal conjugate vaccine -A
- -
- Wyeth- Lederle Vaccines S.A. - US
- - -
- Capsule, soft - 75 mg - 1 presentation
Capsule, soft 75 mg 1 presentation
- 17.12.1999 - 16.11.2000 - 197 days - 159 days
J05A -
- J05A
Capsule, soft, Oral -
- Capsule, soft, Oral solution
treatment in
Laboratories US
133. 3/ 33. 3 mg, -
Combination treatment - 133.3/33.3 mg, 80/20 mg/ml in combination of HIV- - 3 presentations
Powder for injection - 8 µl/ ml - 2 presentations - -
- Powder for injection - 8 µl/ml - 2 presentations
non- union of tibia of at least 9 month duration
M09AX Treatment of non-union of tibia of at least 9 month duration
3. 5 mg - 1 presentation -
- Powder for suspension for implantation - 3.5 mg - 1 presentation
9
-A
αδίλεΣ
77 EMEA General Report 2000
82/ 97
Annex 9:
η εσωδέξε υοπ ςε ώνΓ ατνόϊορπ άκιτυεκα ραφ
CVMP opinions in 2000 on medicinal products for veterinary use Centralised applications
- ηξιεδνΈ
Product - Brandname - INN - Part A/B
- ησό∆
Company - Name - Origin
- ςορέΜ
Therapeutic area - Target species - Indication
- νωεσάισυοραπ ςό θιρΑ
Presentation - Form - Dosage - Number of presentations
- ςονόρΧ ησηίοπονιοΚ
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
- ςονόρΧ
Commission - Opinion received - Date of Decision - Notification - Official Journal
αδίρε ηφΕ ςησηίοπογρενεπα Ibraxion Inactivated vaccine Part A
Ibraxion Inactivated vaccine Part A
10. 12. 1999 09. 03.
10.12.1999 09.03.
00 OJ C 95, 04. 04. 2000
00 OJ C 95, 04.04.2000
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
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
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. 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
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
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
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
Econor Valnemulin Part B EMEA/ MB/ 050/ 00 2000
Econor Valnemulin Part B extension
Pigs Prevention / treatment of
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
- 12. 10. 1999 - 08. 03. 2000 - 148 days
- 12.10.1999 - 08.03.2000 - 148 days -0
07. 04. 2000 15. 09. 2000 20. 09. 2000
07.04.2000 15.09.2000 20.09.2000 OJ No.
27. 10. 2000
308, 27.10.2000
extension
Econor Valnemulin Part B (extension)
ςορέΜ
Novartis A
η ώνΓ - ησό∆ - ηξιεδνΈ - αρώΧ -
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
ησό∆ - ηξιεδν
10%/50% premix various 2
- η ώνΓ - ησό∆ -
- 12.10.1999 - 08.03.2000 - 148 days -0
ςοδίε όκιωΖ - ηξιεδνέ
07.04.2000 15.09.2000 22.09.2000 OJ C 308, 27.10.2000
ήκιτυεπαρεΘ
78 EMEA General Report 2000
- ςορέΜ
Company - Name - Origin
- νωεσάισυοραπ ςό θιρΑ
Therapeutic area - Target species - Indication
- ςονόρΧ ησηίοπονιοΚ
Presentation - Form - Dosage - Number of presentations
- ςονόρΧ
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
07. 04. 2000 15. 09. 2000 22. 09. 2000 OJ C 308, 27. 10. 2000
Commission - Opinion received - Date of Decision - Notification - Official Journal
Dicural Difloxacin Part B (extension)
Dicural Difloxacin Part B (extension)
Fort Dodge Animal Health NL
Fort Dodge Animal Health NL
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
Poulflox Difloxacin Part B
Poulflox Difloxacin Part B
Virbac S. A.
Virbac S.A.
21. 07. 2000 16. 11. 2000 OJ C 2, 05. 01. 2001
- 21.07.2000 - 16.11.2000 - OJ C 2, 05.01.2001
Bayovac CSF Marker Live vaccine Part A
Bayovac CSF Marker Live vaccine Part A
Bayer D
Bayer D
07. 08. 2000
- 07.08.2000
Porcilis AR - T- DF Inactivated vaccine Part A
Porcilis AR -T- DF Inactivated vaccine Part A
18. 08. 2000 16. 11. 2000 OJ C 2, 05. 01. 2001
- 18.08.2000 - 16.11.2000 - OJ C 2, 05.01.2001
Pruban Rescortol butyrate Part B
Pruban Rescortol butyrate Part B
Pirsue Pirlimycin Part B
Pirsue Pirlimycin Part B
Pharmacia Upjohn B
Pharmacia Upjohn B
10. 11. 2000
- 10.11.2000
Zubrin Tepoxalin Part B
Zubrin Tepoxalin Part B
Schering - Plough UK
Schering - Plough UK
08. 12. 2000
- 08.12.2000
Eurican herpes 205 Inactivated vaccine Part B
Eurican herpes 205 Inactivated vaccine Part B
-
- 08.12.2000
08. 12. 2000
79 EMEA General Report 2000
EMEA/ MB/ 050/ 00 2000 ησεθκέ αισήτΕ ςείσυο ςεέν αιγ νωπίολατακ νωίρο νωτάτωνα ησωρέιθαΚ
Establishment of maximum residue limits for new substances
αδίλεΣ
Substance - INN
85/ 97
Therapeutic area - Target species
αίσυΟ ηξιεδνέ ήκιτυεπαρεΘ EMEA/ CVMP - INN - ςοδίε όκιωΖ - ησωρύκιπΕ - η ώνΓ - ςονόρΧ ςησηίοπογρενε ςαίσακιδαιδ - ςονόρΧ ςησηίοπογρενεπα
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
ήπορτιπΕ - ήπορτιπΕ νητσ ςησαβίβαιδ αίνη ορε Η - ύο σινονακ ςησοδκέ αίνη ορε Η - αδίρε ηφΕ η ησίπΕ
Commission - Sent to Commission - Date of Regulation - Official Journal
Bismuth subnitrate Bovine - 18. 06. 1999 (extension) - 13. 10. 1999 - 113 days - 0
Bismuth subnitrate (extension)
Deltamethrin Fin fish - 09. 12. 1999 (extension) - 08. 03. 2000 - 90 days - 0
Deltamethrin (extension)
Tiamulin Rabbit - 14. 10. 1999 (extension) - 12. 01. 2000 - 90 days - 0
Tiamulin (extension)
Tilmicosin Bovine milk - 22. 02. 1999 (extension) - 19. 04. 2000 - 203 days - 210 days
Tilmicosin (extension)
- 19. 05. 2000 - 27. 10. 2000 - OJ L 276, 28. 10. 2000
Bovine milk
Phoxim Ovine - 19. 01. 2000 (extension) - 19. 04. 2000 - 90 - 0
- 22.02.1999 - 19.04.2000 - 203 days - 210 days
Flumethrin Ovine - 19. 01. 2000 (extension) - 19. 04. 2000 - 90 days - 0
Phoxim (extension)
Flunixin Equine - 23. 03. 2000 (extension) - 21. 06. 2000 - 90 days - 0
- 19.01.2000 - 19.04.2000 - 90 -0
- 21. 07. 2000 - 29. 12. 2000 - OJ L 336, 30. 12. 2000
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
EMEA/ MB/ 050/ 00 2000
80 EMEA General Report 2000
- INN -
Substance - INN
ςοδίε όκιωΖ - ησωρύκιπΕ - ήπορτιπ
Therapeutic area - Target species
- INN - ςοδίε όκιωΖ -
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
- INN - ςοδίε όκιωΖ - ησωρύκιπΕ -
Commission - Sent to Commission - Date of Regulation - Official Journal
ήπορτιπΕ νητσ ςησαβίβαιδ αίνη ορε Η
Flumethrin (extension)
-
Ovine
η ώνΓ - ύο σινονακ ςησοδκέ α
- 19.01.2000 - 19.04.2000 - 90 days -0
- η ώνΓ -
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
ύο σινονακ ςησοδκέ αίνη ορε Η
Flunixin (extension)
-
Equine
ςονόρΧ - αδίρε ηφΕ
- 23.03.2000 - 21.06.2000 - 90 days -0
- ςονόρΧ -
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
ςησηίοπογρενεπα Toltrazuril (extension)
Toltrazuril (extension)
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
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
19. 01. 2000 19. 07. 2000 120 days o
- 19.01.2000 - 19.07.2000 - 120 days -0
18. 01. 1995 13. 09. 2000 274 days 1790 days
- 18.01.1995 - 13.09.2000 - 274 days - 1790 days
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
αδίλεΣ
81 EMEA General Report 2000
87/ 97
Annex 10:
η εσωδέξε υοπ ςε ώνΓ ακα ράφ
COMP opinions in 2000 on orphan medicinal products
ηξιεδνΈ
Product
EMEA/ COMP - ήλοβοπΥ
Sponsor
ήπορτιπΕ - ςη ώνγ ςητ ηψήΛ
Indication
- ησωρύκιπΕ - η ώνΓ - ςονόρΧ ςησηίοπογρενε ςαίσακιδαιδ
EMEA/COMP - Submission - Validation - Opinion - Active time
- αίνη ορε Η ύο σιροιδσορπ
Commission - Opinion received - Date of Designation
Alpha - Galactosidase A
Alpha - Galactosidase A
Voisin Consulting Sarl
Voisin Consulting Treatment of acute promyelocytic leukaemia Sarl
ησεθκέ αισήτΕ
- -
αδίλεΣ 88/ 97
Treatment of acute promyelocytic leukaemia
νόϊορΠ
- 08.08.2000
ςόγηροΧ
-
EMEA/ COMP - ήλοβοπΥ
- 22.09.2000
- αίνη ορε Η ύο σιροιδσορπ
- 21.11.2000
- 08. 08. 2000 - 22. 09. 2000 - 21. 11. 2000 - 61 days
- 61 days
Treatment of acute respiratory distress syndrome
- 21.11.2000
Treatment of cystic fibrosis
- 19.12.2000
- 09. 08. 2000 - 22. 09. 2000 - 19. 12. 2000 - 89 days
- 89 days
...
- 19.10.2000
Treatment of patent ductus arteriosus
- 19.12.2000
- 02. 05. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 62 days
...
- 10.08.2000
Treatment of glycogen storage disease type II (Pompe’ s disease)
(Pompe's disease)
- 10. 08. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 19.10.2000 - 19.12.2000 - 62 days
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
chronic thromboembolic pulmonary hypertension
- 21. 08. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 19.10.2000 - 19.12.2000 - 62 days
Treatment of chronic myeloid leukaemia
- 19.12.2000
- 03. 10. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 62 days
Mucopolysaccharidosis type VI (Maroteaux - Lamy Syndrome)
- 19.12.2000
- 04. 10. 2000 - 19. 10. 2000 - 19. 12. 2000 - 62 days
- 62 days
EMEA/ MB/ 050/ 00 2000 ησεθκέ αισήτΕ
Mucopolysaccharidosis type VI (Maroteaux -Lamy
α ητράραΠ
- 04.10.2000
αδίλεΣ
-
89/ 97
Syndrome)
ο εσωδέξε υοπ ςέ αργ ςειρήτνυθυεταΚ
- 19.10.2000 - 19.12.2000 - 62 days
EMEA
83 EMEA General Report 2000
οτ άτακ
Annex 11:
ςητ ςαίσαγρε αδά Ο CPMP αίγολονχετοιβ ητ αιγ.
CPMP Biotechnology Working Party
ςάροφανα θιρΑ
Reference number
ςώτσεθαΚ
Guidelines/Status
EMEA/ CPMP/ BWP/ 840/ 00
EMEA/ CPMP/ BWP/840/00
Influenza vaccine composition for the season 2000/ 2001 Report of the EMEA Expert Workshop on
Final EU recommendations for the Influenza vaccine composition for the season 2000/2001 Adopted April 2000
EMEA/ CPMP/ BWP/ 1244/ 00
EMEA/ CPMP/ BWP/1244/00
human TSEs and plasma- derived medicinal products, 15- 16 May 2000 Concept paper on the Development of a
Report of the EMEA Expert Workshop on human TSEs and plasma-derived medicinal products, 15-16 May 2000 Adopted July 2000
EMEA/ CPMP/ BWP/ 3326/ 99
EMEA/ CPMP/ BWP/3326/99
Points to consider on xenogeneic cell therapy
Concept paper on the Development of a Points to consider on xenogeneic cell therapy Adopted November 2000
αν υονέ ιεκορπ εκηθόδκΕ Note for Guidance on the production and EMEA/ CPMP/ BWP/ 3354/ 99
EMEA/ CPMP/ BWP/3354/99 Draft
and immunosera for human use Note for Guidance on Comparability of medicinal products containing
Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Released for consultation January 2000
biotechnology- derived proteins as active substances Position statement on the Use of tumorigenic cells of human origin for the
Note for Guidance on Comparability of medicinal products containing biotechnology-derived proteins as active substances Released for consultation May 2000
production of biological and biotechnological medicinal products
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
EMEA/ CPMP/ BWP/ 269/ 95
EMEA/CPMP/BWP/269/95rev.
for guidance on Plasma- derived medicinal
Revision of section 3.2.5 of CPMP Note for guidance on Plasma-derived medicinal products Released for consultation July 2000
elimination or substitution of thiomersal in vaccines
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines Released for consultation November 2000
ςητ ςαίσαγρε αδά Ο α σάλπ.
CPMP Blood and Plasma Working Group
EMEA/ CPMP/ BPWG/ 575/ 99
EMEA/CPMP/BPWG/575/99
immunoglobulin for intravenous and/ or intramuscular use Note for guidance on the Clinical
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
investigation of human normal
EMEA/CPMP/BPWG/388/95 rev.
immunoglobulin for intravenous administration (IVIg) Core SPC for Human and anti- D
Note for guidance on the Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
EMEA/ CPMP/ BPWG/ 574/ 99 EMEA/ CPMP/ BPWG/ 859/ 95
EMEA/CPMP/BPWG/574/99
immunoglobulin for intravenous and/ or intramuscular use Core SPC for Human normal
Core SPC for Human and anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
υοτ οινύοΙ νοτ εκηθίρκγΕ 2000
EMEA/CPMP/BPWG/859/95 rev.
immunoglobulin for intravenous administration (IVIg) Core SPC for Human plasma derived and
Core SPC for Human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
recombinant coagulation factor VIII products Core SPC for Human plasma derived and
Core SPC for Human plasma derived and recombinant coagulation factor VIII products Adopted June 2000
υοτ οινύοΙ νοτ εκηθίρκγΕ 2000
Core SPC for Human plasma derived and recombinant coagulation factor IX products Adopted June 2000
investigation of human plasma derived factor VIII and IX products Note for Guidance on the Clinical
Note for Guidance on the Clinical investigation of human plasma derived factor VIII and IX products Adopted October 2000
EMEA/ CPMP/ BPWG/ 1561/ 99 EMEA/ CPMP/ PhvWP/ BPWG /
EMEA/CPMP/BPWG/ 1561/99
investigation of recombinant factor VIII and IX products
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adopted October 2000
Core SPC for Human albumin
84 EMEA General Report 2000
αδίλεΣ αν υονέ ιεκορπ εκηθόδκΕ
EMEA/CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/198/95 rev.
factor VIII and IX products Note for guidance on the Clinical
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
investigation of recombinant factor VIII
Note for guidance on the Clinical investigation of recombinant factor VIII and IX products Released for consultation June 2000
EMEA/ CPMP/ PhvWP/ BPWG /
EMEA/ CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
Note for Guidance on the Clinical
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
Core SPC for Human plasma derived
Core SPC for Human plasma derived antithrombin Released for consultation December 2000
ςάροφανα θιρΑ
CPMP Efficacy Working Party Reference number
EMEA/ CPMP/ EWP/ 519/ 98
EMEA/ CPMP/ EWP/519/98
υοτ οιράυορβεΦ νοτ εκηθίρκγΕ
Note for Guidance on clinical investigation of steroid contraceptives in woman 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 concerning Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells Adopted February 2000
treatment of acute coronary syndrome (ACS) without persistent ST- segment elevation Concept paper on the development of a CPMP Note for Guidance on the clinical
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
investigation of medicinal products in the treatment of asthma Concept paper on the development of a CPMP Points to Consider on biostatistical/ methodological issues arising
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
from CPMP discussions on licensing applications: adjustment for baseline covariates Points to consider on Clinical investigation of medicinal products for prophylaxis of
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
υοτ οινύοΙ νοτ εκηθίρκγΕ 2000
Points to consider on Clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk Adopted June 2000
υοτ οινύοΙ νοτ εκηθίρκγΕ 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
and pharmacodynamics in the development of anti- bacterial medicinal products Points to consider on switching between
Points to consider on pharmaco-kinetics and pharmacodynamics in the development of anti-bacterial medicinal products Adopted July 2000
υοτ οιλύοΙ νοτ εκηθίρκγΕ 2000
Points to consider on switching between superiority and non-inferiority Adopted July 2000
investigation of medicinal products in the treatment of diabetes mellitus Points to consider on Clinical investigation
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
υοτ οιρβώτκΟ νοτ εκηθίρκγΕ
Points to consider on Clinical investigation of medicinal products for treatment of Amyotrophic Lateral Sclerosis (ALS) Adopted October 2000
for the treatment of the irritable bowel syndrome Note for Guidance on Clinical investigation
Concept paper on the Evaluation of drugs for the treatment of the irritable bowel syndrome Adopted November 2000
of medicinal products in the treatment of epileptic disorders
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders Adopted in November 2000
Points to consider on Clinical investigation of medicinal products for the management of Crohn’ s disease
Points to consider on Clinical investigation of medicinal products for the management of Crohn's disease Released for consultation July 2000
αν
85 EMEA General Report 2000
υονέ ιεκορπ εκηθόδκΕ ονε ίεκιτνα ιεσέλετοπα 2000
EMEA/CPMP/EPW/205/95 rev.
υοτ οιλύοΙ νοτ νωεσύελυοβαιδ anticancer medicinal products in man 2 ςενή η όκα αιγ εκηθάταραπ ιακ 2000. υοτ οιρβ έτπεΣ νοτ αν υονέ ιεκορπ εκηθόδκΕ Points to consider on Clinical investigation ονε ίεκιτνα ιεσέλετοπα EMEA/ CPMP/ EWP/ 560/ 98
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
of medicinal products in the treatment of acute stroke
EMEA/ CPMP/ EWP/560/98
υοτ οιρβώτκΟ νοτ νωεσύελυοβαιδ
Points to consider on Clinical investigation of medicinal products in the treatment of acute stroke Released for consultation October 2000
2000 αν υονέ ιεκορπ εκηθόδκΕ Points to consider on Validity and ονε ίεκιτνα ιεσέλετοπα EMEA/ CPMP/ EWP/ 2330/ 99
EMEA/ CPMP/ EWP/2330/99
interpretation of meta- analyses, and one pivotal study
Points to consider on Validity and interpretation of meta-analyses, and one pivotal study Released for consultation October 2000
Points to consider on the Evaluation of
Points to consider on the Evaluation of diagnostic agents Released for consultation November 2000
of medicinal products for the treatment of peripheral arterial occlusive disease
Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Released for consultation November 2000
Note for Guidance on the investigation of bioavailability and bioequivalence Note for Guidance on co- ordinating
Note for Guidance on the investigation of bioavailability and bioequivalence Released for consultation December 2000
investigator signature of clinical study reports
Note for Guidance on co-ordinating investigator signature of clinical study reports Released for consultation December 2000
ςητ ςαίσαγρε αδά Ο.
CPMP Pharmacovigilance Working Party
EMEA/ CPMP/ PhVWP/ 2058/ 99
EMEA/CPMP/PhVWP/2058/99
case safety reports between the EMEA, national competent authorities, and the Pharmaceutical Industry
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
ςητ ςαίσαγρε αδά Ο CPMP.
CPMP Safety Working Party
EMEA/ CPMP/ SWP/ 2775/ 99
EMEA/ CPMP/ SWP/2775/99
Serotonin Uptake Inhibitors (SSRIs) and dependency/ withdrawal reactions Note for Guidance on Repeated dose
CPMP Position paper on Selective Serotonin Uptake Inhibitors (SSRIs) and dependency/withdrawal reactions Adopted April 2000
υοτ οιλύοΙ νοτ εκηθίρκγΕ
Note for Guidance on Repeated dose toxicity Adopted July 2000
dependence/ withdrawal related to use of SSRIs Concept paper on the Development of a CPMP Points to consider on the need for
Discussion paper on Possible pre-clinical studies to investigate addiction and dependence/withdrawal related to use of SSRIs Adopted December 2000
reproduction toxicity studies in the development of human insulin analogues
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
Draft 4
EMEA/CPMP/SWP/2145/00 Draft 4
tolerance testing of medicinal products
Note for Guidance on Non-clinical local tolerance testing of medicinal products Released for consultation September 2000
υοτ οιρβ έτπεΣ νοτ νωεσύελυοβαιδ 2000
EMEA Herbal Medicinal Products Working Party
αδίλεΣ
Reference number
ςαίσαγρε αδά ο νητ όπα εκηθίρκγΕ EMEA/ HMPWP/ 23/ 00
EMEA/HMPWP/23/00
the use of Herbal Products containing
Position paper on the Risks associated with the use of Herbal Products containing Aristolochia Species Adopted by the Working Party in October 2000
medicinal products
CPMP/QWP/2819/00
υοτ οιρβ έοΝ νοτ νωεσύελυοβαιδ 2000
Note for guidance on quality of herbal medicinal products Released for consultation November 2000
CPMP/ QWP/ 2820/ 00
CPMP/QWP/2820/00
Note for guidance on specifications: test procedures and acceptance criteria for
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
αδίλεΣ
86 EMEA General Report 2000
ςάροφανα θιρΑ
CVMP Efficacy Working Party Reference number EMEA/ CVMP/133/99
ςέ αργ ςειρήτνυθυεταΚ Conduct of pharmacokinetic studies in
Guidelines/Status Conduct of pharmacokinetic studies in animals Adopted March 2000
EMEA/ CVMP/ 133/ 99
EMEA/ CVMP/344/99