natgillin/translations-raw huggingface dataset:
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.
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.
(39- 6) 59 94 39 45 Fax (39- 6) 59 94 31 90 E- mail: danspv@ izs. it
(39-6) 59 94 39 45 Fax (39-6) 59 94 31 90 E-mail: danspv@izs.it
LUXEMBOURG
70 EMEA General Report 2000
Mariette BACKES- LIES Pharmacien- Inspecteur Chef de Division Directeur de la Santé Division de la pharmacie et des médicaments Villa Louvigny – 1er étage L – 2120 Luxembourg Tél.
LUXEMBOURG Mariette BACKES-LIES Pharmacien-Inspecteur Chef de Division Directeur de la Santé Division de la pharmacie et des médicaments Villa Louvigny – 1er étage L – 2120 Luxembourg Tel.
(352) 478 55 90 Fax (352) 26 20 01 47 E- mail: dpmlux@ pt. lu
(352) 478 55 90 Fax (352) 26 20 01 47 E-mail: dpmlux@pt.lu
College ter Beoordeling van Geneesmiddelen Ministerie van V. W. S.
NEDERLAND André BROEKMANS Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V.W.S.
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Tel.
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Tel.
(31- 70) 356 74 50 Fax (31- 70) 356 75 15 E- mail: aw. broekmans@ cbg. meb. nl Internet: http: // www. cbg- meb. nl
(31-70) 356 74 50 Fax (31-70) 356 75 15 E-mail: aw.broekmans@cbg.meb.nl Internet: http://www.cbg-meb.nl
de registratie van diergeneesmiddelen Bureau Registratie Diergeneesmiddelen Postbus 289 6700 AG Wageningen Nederland Tel.
Kees KUIPER Hoofd van het Agentschap voor de registratie van diergeneesmiddelen Bureau Registratie Diergeneesmiddelen Postbus 289 6700 AG Wageningen Nederland Tel.
(31- 31) 747 54 91 Fax (31- 31) 742 31 93 E- mail: brd@ brd. agro. nl
(31-31) 747 54 91 Fax (31-31) 742 31 93 E-mail: brd@brd.agro.nl
Günter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für Soziale, Sicherheit und Generationen Radetzkystraße 2 A – 1030 Wien Tel.
ÖSTERREICH Gunter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für Soziale, Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
(43- 1) 711 00 47 17 Fax (43- 1) 713 86 14 E- mail: gunter. liebeswar@ bmsg. gv. at Fax (43- 1) 714 92 22 E- Mail: alexander. jentzsch@ bmsg. gv. at
(43-1) 711 00 47 17 Fax (43-1) 713 86 14 E-mail: gunter.liebeswar@bmsg.gv.at
Alexander JENTZSCH Ministerialrat Leiter der Gruppe für Pharmazeutische Angelegenheiten Bundesministerium für Soziales, Sicherheit und Generationen Radetzkystraße 2 A – 1030 Wien Tel.
Alexander JENTZSCH Ministerialrat Leiter der Gruppe für Pharmazeutische Angelegenheiten Bundesministerium für Soziales, Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
(43- 1) 711 00 46 73
(43-1) 711 00 46 73 Fax (43-1) 714 92 22 E-mail: alexander.jentzsch@bmsg.gv.at
Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P – 1749- 004 Lisboa Tel.
PORTUGAL Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P - 1749-004 Lisboa Tel.
(351) 217 98 71 16 Fax (351) 217 98 71 20/ 24 E- mail: miguel. andrade@ infarmed. pt Internet: http: // www. infarmed. pt
(351) 217 98 71 16 Fax (351) 217 98 71 20/24 E-mail: miguel.andrade@infarmed.pt Internet: http://www.infarmed.pt
Rui MARQUES LEITÃO Director Geral Direcçao Geral de Veterinária Lg Academia Nacional de Belas Artes 2 P – 1294 Lisboa Tel.
Rui MARQUES LEITÃO Director Geral Direcçao Geral de Veterinária Lg Academia Nacional de Belas Artes 2 P - 1294 Lisboa Tel.
(351) 213 23 95 66 Fax (351) 213 46 35 18 E- mail: rleitao@ dgv. min- agricultura. pt
(351) 213 23 95 66 Fax (351) 213 46 35 18 E-mail: rleitao@dgv.min-agricultura.pt
SUOMI/ FINLAND
71 EMEA General Report 2000
Hannes WAHLROOS Ylijohtaja Lääkelaitos Läkemedelsverket Mannerheimintie 166 P. O.
SUOMI/FINLAND Hannes WAHLROOS Ylijohtaja Lääkelaitos Läkemedelsverket Mannerheimintie 166 P.O.
Box 55 FIN – 00301 Helsinki Puh.
Box 55 FIN - 00301 Helsinki Tel.
(358- 9) 47 33 42 00 Fax (358- 9) 47 33 43 45 Sähköposti: hannes. wahlroos@ nam. fi Internet: http: // www. nam. fi
(358-9) 47 33 42 00 Fax (358-9) 47 33 43 45 E-mail: hannes.wahlroos@nam.fi Internet: http://www.nam.fi
Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8 Box 26 S – 751 03 Uppsala Tfn.
SVERIGE Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8, Box 26 S - 751 03 Uppsala Tel.
(46- 18) 17 46 00 Fax (46- 18) 54 85 66 E- post: gunnar. alvan@ mpa. se Internet: http: // www. mpa. se
(46-18) 17 46 00 Fax (46-18) 54 85 66 E-mail: gunnar.alvan@mpa.se Internet: http://www.mpa.se
EMEA/ MB/ 050/ 00 2000 ησεθκέ αισήτΕ UNITED KINGDOM Keith JONES
UNITED KINGDOM
Director and Chief Executive Officer Medicines Control Agency Market Towers, Room 1629 1, Nine Elms Lane London, SW8 5NQ United Kingdom Tel.
Keith JONES Director and Chief Executive Officer Medicines Control Agency Market Towers, Room 1629 1, Nine Elms Lane London, SW8 5NQ United Kingdom Tel.
(44- 20) 72 73 01 00 Fax (44- 20) 72 73 05 48 E- mail: keith. jones@ mca. gov. uk Internet: http: // www. open. gov. uk/ mca
(44-20) 72 73 01 00 Fax (44-20) 72 73 05 48 E-mail: keith.jones@mca.gov.uk Internet: http://www.open.gov.uk/mca
Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey, KT15 3NB United Kingdom Tel.
Michael RUTTER Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey, KT15 3NB United Kingdom Tel.
(44- 1932) 33 69 11 Fax (44- 1932) 33 66 18 E- mail: m. rutter@ vmd. maff. gov. uk Internet: http: // www. open. gov. uk/ vmd
(44-1932) 33 69 11 Fax (44-1932) 33 66 18 E-mail: m.rutter@vmd.maff.gov.uk Internet: http://www.open.gov.uk/vmd
ÍSLAND
Observers:
Rannveig GUNNARSDÓTTIR Chief Executive Director Icelandic Medicines Control Agency Eidistorg 13 - 15 IS – 170 Seltjarnarnes Tel.
ÍSLAND Rannveig GUNNARSDÓTTIR Chief Executive Director Icelandic Medicines Control Agency Eidistorg 13 - 15 IS - 170 Seltjarnarnes Tel.
(354) 520 21 00 Fax (354) 561 21 70 E- mail: rannveig. gunnarsdottir@ lyfjanefnd. is Internet: http: // www. lyfjanefnd. is
(354) 520 21 00 Fax (354) 561 21 70 E-mail: rannveig.gunnarsdottir@ lyfjanefnd.is Internet: http://www.lyfjanefnd.is
Gro Ramsten WESENBERG Director- General Statens legemiddelkontroll Sven Oftedals vei 6 N – 0950 Oslo Tel.
NORGE/NOREG Gro Ramsten WESENBERG Director-General Statens legemiddelkontroll Sven Oftedals vei 6 N - 0950 Oslo Tel.
(47- 22) 89 77 00 Fax (47- 22) 89 77 99 E- mail: gro. wesenberg@ slk. no Internet: http: // www. slk. no
(47-22) 89 77 00 Fax (47-22) 89 77 99 E-mail: gro.wesenberg@slk.no Internet: http://www.slk.no
ησήρχ ηνιπώρθνα αιγ ατνόϊορπ άκιτυεκα ραφ -
LIECHTENSTEIN Brigitte BATLINER Amt für Lebensmittelkontrolle und Veterinärwesen Kontrollstelle für Arzneimittel Postplatz 2 FL – 9494 Schaan Tel.
ηξιεδνέ ήκιτυεπαρεΘ
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte.batliner@alk.llv.li
ήκινχετοκα ραΦ
72 EMEA General Report 2000
α ονΌ
Annex 8:
ςη ώνγ ςητ ηψήΛ
CPMP opinions in 2000 on medicinal products for human use
- ηξιεδνΈ -
Product - Brandname - INN - Part A/B
ησό∆ -
Company - Name - Origin
ςησαφόπα αίνη ορε Η υελέορπ - ςησ -
Therapeutic area - ATC - Indication
A/ B - νωεσάισυοραπ ςό θιρΑ - ςονόρΧ -
Presentation - Form - Dosage - Number of presentations
- ςορέΜ A/ B - νωεσάισυοραπ ςό θιρΑ -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- ςορέΜ A/ B - νωεσάισυοραπ ςό θιρΑ - ςονόρΧ -
Commission - Opinion received - Date of Decision - Notification - Official Journal
- ςονόρΧ -
- Orgalutran
- N. V. - H01CC01 - Solution for injection - 29. 01. 1999
Organon - H01CC01
- Orgalutran - N. V. -
- Orgalutran - N.V.
H01CC01 - Solution for injection
Organon - H01CC01 - Solution for injection -
- Orgalutran - N. V. - H01CC01 -
- Orgalutran - N.V.
- Orgalutran - N. V. - H01CC01 - Solution for injection -
Organon - H01CC01 - Solution for injection - 29.01.1999 -
22. 02. 2000
22.02.2000
ganirelix
- ganirelix
- ganirelix Organon -
- NL
Prevention of - 0. 5 mg/ ml
- Prevention of
- ganirelix Organon - Prevention of -
- ganirelix - NL - Prevention of - 0.5 mg/ml -
- ganirelix Organon - Prevention of - 0. 5 mg/ ml - 19. 01. 2000 -
- ganirelix - NL - Prevention of - 0.5 mg/ml - 19.01.2000 -
17. 05. 2000
17.05.2000
- B - NL premature luteinising -
premature luteinising
- B - NL premature luteinising - 2 presentations -
-B premature luteinising - 2 presentations -
- B - NL premature luteinising - 2 presentations - 162 days -
-B premature luteinising - 2 presentations - 162 days -
22. 05. 2000
22.05.2000
hormone surges in conteolled ovarian hyperstimulation
hormone surges in conteolled ovarian hyperstimulation
189 days -
189 days -
OJ C 183, 30. 06. 2000, p.
OJ C 183, 30.06.2000, p.
Pegintron
Pegintron peginterferon alfa -2b
- Pegintron - SP -
- SP Europe - US
- Powd
- -
- Pegintron - SP - L03AB10 - Powder and solvent for -
L03AB10 Treatment of chronic hepatitis C
Europe - Treatment of chronic solution for injection - 17. 02. 20
Powder and solvent for solution for injection 50 µg/0.5 ml, 80 µg/0.5 ml,
- peginterferon Europe -
- 26.03.1999 - 17.02.2000 - 189 days
- peginterferon Europe - Treatment of chronic solution for injection -
- 27.03.2000 - 25.05.2000 - 05.06.2000
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
100 µg/0.5 ml 120 µg/0.5 ml, 150µg/0.5 ml 25 presentations
189 days - 139 days -
- 139 days
3
OJ C 183, 30.06.2000, p.
-
3
Viraferon
- Viraferon PEG - peginterferon alfa -2b -A
- SP - L03AB10 - Powder and solvent for - 03. 01. 2000
- SP Europe - US
- Viraferon - SP -
- -
L03AB10
L03AB10 Treatment of chronic hepatitis C
- Powd
- - -
- Viraferon - SP - L03AB10 - Powder and solvent for -
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
- Viraferon - SP - L03AB10 - Powder and solvent for - 03. 01. 2000 -
- 03.01.2000 - 17.02.2000 - 43 days - 0 days
27. 03. 2000
- - - -
PEG
3
solution for injection
Lantus insulin glargine
17. 02. 2000 -
Aventis Pharma Deutschland
25. 05. 2000
- A10AE - Diabetes mellitus
- -
- Solution for injection - 100 IU/ml - 7 presentations
peginterferon alfa- 2b A
- 23.04.1999 - 17.02.2000 - 215 days
-
- 23.03.2000 - 06.06.2000 - 14.06.2000
US
-A
hepatitis C
GmbH
- -
- 8 3 days
43 days - 0 days -
-D
05. 06. 2000 OJ C 183, 30. 06. 2000, p.
30.06.2000, p.
Lantus insulin glargine A
Optisulin insulin glargine
Aventis Pharma Deutschl and GmbH D
Aventis Pharma Deutschland
A10AE Diabetes mellitus
- A10AE - Diabetes mellitus
Solution for injection 100 IU/ ml 7 presentations
- Solution for injection - 100 IU/ml - 7 presentations
23. 04. 1999 - 17. 02. 2000 - 215 days - 83 days -
- 24.09.1999 - 17.02.2000 - 116 days
3
- 23.03.2000 - 27.06.2000 - 28.06.2000
Aventis Pharma Deutschl and GmbH D
GmbH
- - -
- OJ C 216,
- - - -
-D
24. 09. 1999 - 17. 02. 2000 - 116 days - 28 days -
28.07.2000, p.
Nyracta rosiglitazone B
- Nyracta - rosiglitazone -B
SmithKli ne Beecham Pharmac euticals
SmithKline Beecham Pharmaceuticals UK
A10BG02 Combination treatment of Type II diabetes mellitus
A10BG02 Combination treatment of Type II diabetes mellitus
Film coated tablet 1 mg, 2 mg, 4 mg, 8 mg 12 presentations
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
18. 12. 1998 - 21. 10. 1999 - 186 days - 119 days -
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
UK
2
Avandia rosiglitazone B
- Avandia - rosiglitazone -B
SmithKli ne Beecham Phramac euticals
SmithKline Beecham Pharmaceuticals UK
- - - -
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
18. 12. 1998 - 21. 10. 1999 - 186 days - 119 days -
- - - -
17. 04. 2000 11. 07. 2000 28. 06. 2000 OJ C 216, 28. 07. 2000, p.
17.04.2000 11.07.2000 28.06.2000 OJ C 216, 28.07.2000, p.
Venvia rosiglitazone B
- Venvia - rosiglitazone -B
A10BG02 Combination treatment of Type II diabetes mellitusus
A10BG02 Combination treatment of Type II diabetes mellitusus
Myocet doxorubicin B
- Myocet - doxorubicin -B
The Liposom e Compan y US
The Liposome Company US
L01DB Treatment of metastatic breast cancer
L01DB Treatment of metastatic breast cancer
Powder and pre - admixtures for concentrate for, liposomal dispersion for infusion 50 mg 1 presentation
- Powder and pre-admixtures for concentrate for, liposomal dispersion for infusion - 50 mg - 1 presentation
- - - -
- 30.07.1999 - 12.04.2000 - 167 days - 91 days
30. 07. 1999 - 12. 04. 2000 - 167 days - 91 days -
- - - -
17. 05. 2000 13. 07. 2000 26. 07. 2000 OJ C 244, 25. 08. 2000, p.
17.05.2000 13.07.2000 26.07.2000 OJ C 244, 25.08.2000, p.
Datscan ioflupane B
- Datscan - ioflupane -B
Nycome d Amersha
Nycomed Amersham UK
V09AB03 Diagnosis of Parkinson disease
V09AB03 Diagnosis of Parkinson disease
Solution for injection 74 MBq/ ml 1 presentation
- Solution for injection - 74 MBq/ml - 1 presentation
18. 12. 1998 - 16. 03. 2000 - 178 days - 272 days -
- 18.12.1998 - 16.03.2000 - 178 days - 272 days
m UK
05.05.2000 27.07.2000 02.08.2000 OJ C 244, 25.08.2000, p.
- Ciba - L01XX - Powder for solution for - 27. 08.
73 EMEA General Report 2000
- Visudyne - Ciba -
Product - Brandname - INN - Part A/B
- Visudyne - Ciba - L01XX -
Company - Name - Origin
- Visudyne - Ciba - L01XX - Powder for solution for -
Therapeutic area - ATC - Indication
- Visudyne - Ciba - L01XX - Powder for solution for - 27. 08. 1999 -
Presentation - Form - Dosage - Number of presentations
- verteporfin Vision -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- verteporfin Vision - Treatment of age - infusion -
Commission - Opinion received - Date of Decision - Notification - Official Journal
- verteporfin Vision - Treatment of age - infusion - 12. 04. 2000 -
- Visudyne - verteporfin -B
27. 07. 2000
- Ciba Vision - CH
related macular
L01XX Treatment of age - related macular degeneration
- 15 m
- - -
- B - CH related macular - 15 mg -
Powder for solution for infusion 15 mg 1 presentation
- B - CH related macular - 15 mg - 138 days -
- 27.08.1999 - 12.04.2000 - 138 days - 63 days
OJ C 244, 25. 08. 2000, p.
15.05.2000 27.07.2000 31.07.2000 OJ C 244, 25.08.2000, p.
NovoMix 30 insulin aspart A
- NovoMix 30 - Novo Nordisk - insulin aspart - DK -A
A10AD Diabetes mellitus
- A10AD - Diabetes mellitus
Suspension for injection 100 IU/ ml 8 presentations
- Suspension for injection - 100 IU/ml - 8 presentations
- - - -
- 24.09.1999 - 12.04.2000 - 144 days - 55 days
24. 09. 1999 - 12. 04. 2000 - 144 days - 55 days -
- - - -
17. 05. 2000 01. 08. 2000 01. 08. 2000 OJ C 244, 25. 08. 2000, p.
17.05.2000 01.08.2000 01.08.2000 OJ C 244, 25.08.2000, p.
Kogenate
Kogenate Bayer octocog alfa
- Bayer - B02BD02 - Powder and solvent for - 26. 02.
- Bayer AG -D
- Kogenate - Bayer -
- -
- Kogenate - Bayer - B02BD02 - Powder and solvent for -
B02BD02 Treatment and prophylaxis of bleeding
solution for injection
Powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU
16. 03. 2000 -
- 26.02.1999 - 16.0 3.2000 - 182 days
04. 08. 2000
- 05.06.2000 - 04.08.2000 - 07.08.2000
Helixate NexGen
Helixate NexGen octocog alfa
Bayer AG
- Bayer AG -D
B02BD02 Treatment and
B02BD02 Treatment and prophylaxis of bleeding
Powder and solvent for solution for infusion
Powder and solvent for solution for infusion 250 IU, 500 IU, 1000 IU
26. 02. 1999 - 16. 03. 2000 -
- 26.02.1999 - 16.0 3.2000 - 182 days
05. 06. 2000 04. 08. 2000
- 05.06.2000 - 04.08.2000 - 07.08.2000
Hepacare triple antigen hepatitis B
Hepacare triple antigen hepatitis B vaccine
Medeva Pharma Ltd
Medeva Pharma Ltd UK
J07BC Immunisation against hepatitis
J07BC Immunisation against hepatitis B virus in adults
Suspension for injection Monodose preparation of 1 ml contains Hepatitis B
Suspension for injection Monodose preparation of 1 ml contains Hepatitis B surface antigen S, pre -S1 and
23. 10. 1998 - 16. 03. 2000 - 210 days -
- 23.10.1998 - 16.03.2000 - 210 days - 293 days
16. 05. 2000 04. 08. 2000 07. 08. 2000
- 16.05.2000 - 04.08.2000 - 07.08.2000 - OJ C 244,
UK
-A
surface antigen S, pre- S1 and pre S2 20 µg 2 presentations
pre S2 20 µg 2 presentations
OJ C 244, 25. 08. 2000, p.
25.08.2000, p.
Herceptin trastuzumab A
- Herceptin - trastuzumab -A
Roche Registrat ion Ltd CH
Roche Registration Ltd CH
L01XC03 Treatment of patients with metastatic breast cancer whose tumour overexpress HER2
L01XC03 Treatment of patients with metastatic breast cancer whose tumour overexpress HER2
Powder for concentrate for solution for infusion 150 mg 1 presentation
Powder for concentrate for solution for infusion 150 mg 1 presentation
- - - -
- 26.02.1999 - 25.05.2000 - 147 days - 305 days
26. 02. 1999 - 25. 05. 2000 - 147 days - 305 days -
- - - -
03. 07. 2000 28. 08. 2000 04. 09. 2000 OJ C 277, 29. 09. 2000, p.
03.07.2000 28.08.2000 04.09.2000 OJ C 277, 29.09.2000, p.
Keppra levetiracetam B
- Keppra - levetiracetam -B
N03A Adjunctive therapy in the partial onset seizures in epilepsy
N03A Adjunctive therapy in the partial onset seizures in epilepsy
Film coated tablet 250 mg, 500 mg, 750 mg, 1000 mg 26 presentations
Film coated tablet 250 mg, 500 mg, 750 mg, 1000 mg 26 presentations
26. 02. 1999 - 29. 06. 2000 - 187 days - 300 days -
- - - -
31. 07. 2000 29. 09. 2000 11. 10. 2000 OJ C 308, 27. 10. 2000, p.
31.07.2000 29.09.2000 11.10.2000 OJ C 308, 27.10.2000, p.
Panretin alitretinoin B
- Panretin - alitretinoin -B
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi' s sarcoma
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi's sarcoma
Gel 0. 1% w/ w 1 presentation
- 26.02.1999 - 29.06.2000 - 174 days - 313 days
31. 07. 2000 11. 10. 2000 18. 10. 2000 OJ C 337, 28. 11. 2000. p.
31.07.2000 11.10.2000 18.10.2000 OJ C 337, 28.11.2000. p.
Glustin pioglitazone B
- Glustin - pioglitazone -B
31. 07. 2000 11. 10. 2000 17. 10. 2000 OJ C 337, 28. 11. 2000. p.
31.07.2000 11.10.2000 17.10.2000 OJ C 337, 28.11.2000. p.
Actos pioglitazone B
- Actos - pioglitazone -B
31. 07. 2000 13. 10. 2000 19. 10. 2000 OJ C 337, 28. 11/ 00. p.
31.07.2000 13.10.2000 19.10.2000 OJ C 337, 28.11/00. p.
Agenerase amprenavir
- Agenerase - amprenavir -B
Glaxo Group
- Glaxo Group - UK
HIV infected adults and children
J05AE05 Treatment of HIV infected adults and children
50 mg, 150 mg, 15 mg/ ml 4 presentations
- Capsule, soft, Oral solution - 50 mg, 150 mg, 15 mg/ml - 4 presentations
219 days - 324 days -
- 20.11.1998 - 29.06.2000 - 219 days - 324 days
2
- - - -
EMEA/ MB/ 050/ 00 2000 ησεθκέ αισήτΕ
2
αδίλεΣ
74 EMEA General Report 2000
Infanrix hexa - - JO7CA - Powder and suspension for - 30. 07. 1999 - 09. 08.
Product - Brandname - INN - Part A/B
- Infanrix hexa - -
Company - Name - Origin
JO7CA - Powder and suspension fo
Therapeutic area - ATC - Indication
- Infanrix hexa - - JO7CA -
Presentation - Form - Dosage - Number of presentations
- Infanrix hexa - - JO7CA - Powder and suspension for -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- Infanrix hexa - - JO7CA - Powder and suspension for - 30. 07. 1999 -
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Hep B- IPV SmithKli -
Infanrix hexa Hep B-IPV HIB vaccine
s
-
- Hep B- IPV SmithKli - Immunisation suspension for injection -
SmithKline Beecham Biologicals
against
JO7CA Immunisation against Haemophilus influenza,
Diphtheria toxoid, - 201 days - 26. 10
Powder and suspension for suspension for injection Diphtheria toxoid, adsorbed ≥.
- Diphtheria toxoid, -
30IU
- Diphtheria toxoid, - 201 days -
- 30.07.1999 - 29.06.2000 - 201 days
- A Beecham Haemophilus adsorbed ≥ 30IU -
Tetanus toxoid, adsorbed ≥
- A Beecham Haemophilus adsorbed ≥ 30IU - 132 days -
- 132 days
Pertussis, Tetanus, HepB and Poliomyelitis
Tetanus, HepB and Poliomyelitis
Pertussis toxoid, adsorbed 25 µg Filamentous haemagglutinin, adsorbed 25 µg Pertactin, adsorbed 8 µ g Recombinant Hepatitis B surface Antigen (S protein), adsorbed 10 µg Inactivated type 1 Poliovirus 40 DU Inactivated type 2 Poliovirus 8 DU Inactivated type 3 Poliovirus 32 DU Conjugate of Haemophilus influenzae type b capsular polysaccharide (PRP) 10 µg and Tetanus toxoid (T), adsorbed (PRP- T) 20- 40 µg
40IUPertussis toxoid, adsorbed 25 µg Filamentous haemagglutinin, adsorbed 25 µg Pertactin, adsorbed 8 µg Recombinant Hepatitis B surface Antigen (S protein), adsorbed 10 µg Inactivated type 1 Poliovirus 40 DU Inactivated type 2 Poliovirus 8 DU Inactivated type 3 Poliovirus 32 DU Conjugate of Haemophilus influenzae type b capsular polysaccharide (PRP) 10 µg and Tetanus toxoid (T), adsorbed (PRP-T) 20-40 µg
Infanrix penta Hep B- IPV vaccine A
Infanrix penta - Hep B-IPV vaccine
SmithKli ne Beecham Biologic als S. A.
SmithKline Beecham Biologicals
JO7CA Primary and booster immunisation of infants against Diphtheria,
JO7CA Primary and booster immunisation of infants
Suspension for injection Diphtheria toxoid, adsorbed ≥ 30IU Tetanus toxoid, adsorbed ≥ 40IU Pertussis toxoid, adsorbed
- Suspension for injection - Diphtheria toxoid, adsorbed ≥ 30IU
30. 07. 1999 - 29. 06. 2000 - 201 days - 132 days -
- 30.07.1999 - 29.06.2000 - 201 days
2
- 09.08.2000 - 23.10.2000 - 26.10.2000
Tetanus, Pertussis, Hepatitis B and Poliomyelitis
Tetanus, Pertussis, Hepatitis B and Poliomyelitis
25 µg Filamentous haemagglutinin, adsorbed 25 µg, Pertactin, adsorbed 8 µ g Recombinant Hepatitis B surface antigen (S protein), adsorbed 10 µg Inactivated type 1 Poliovirus 40 DU Inactivated type 2 Poliovirus 8 DU Inactivated type 3 Poliovirus 32 DU
40IU 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
Hexavac Comb vaccine
- Hexavac
Pasteur Merieux MSD
Pasteur
JO7CA Immunisation Diphtheria,
- JO7CA
Suspension for injection Purified diphtheria toxoid, adsorbed ≥ 20 IU,
- Suspension for injection
- - -
- 30.07.1999
30. 07. 1999 - 26. 06. 2000 - 180 days -
- 10.08.2000
10. 08. 2000 23. 10. 2000 26. 10. 2000
- Comb vaccine -A
-
Merieux MSD - -F
A
Immunisation Diphtheria, pertussis, Tetanus, HepB, Poliomyelitis, Haemophilus influenza
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)
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)
153 days -
- 26.06.2000 - 180 days - 153 days
OJ C 337, 28. 11. 2000. p.
23.10.2000 26.10.2000 OJ C 337, 28.11.2000. p.
- lutropin alfa Serono -
Ares Serono (Europe) Ltd CH
follicular - 75 IU
G03G Stimulation of follicular development in women - 75 with servere Leng HEng and FSH deficiency
6 presentations -
- Powder and solvent for solution for injection IU - 6 presentations
200 days -
- 25.06.1999 - 27.07.2000 - 192 days - 200 days
OJ C 2, 05. 01. 2001, p.
07.09.2000 29.11.2000 30.11.2000 OJ C 2, 05.01.2001, p.
depreotide
Nycomed Imaging A/S
- depreotide Nycome -
- -
- depreotide Nycome - Scintigraphic radiopaharmaceutical -
-
- depreotide Nycome - Scintigraphic radiopaharmaceutical - 27. 07. 2000 -
Kit for radiopaharmaceutical preparation
- B d imaging of preparation -
28.08.2000 29.11.2000
04. 12. 2000
-B
Imaging A/ S NO
NO
- - -
- Nutropin AQ - - somatropin
Nutropin AQ somatropin A
Schwarz Pharma AG
- -
- H01AC01 - Treatment of growth
Schwarz - Pharma - AG D
- Solution for injection - 5 mg/ml
H01AC01 Treatment of growth failure
- 21.10.1999 - 21.09.2000
- - -
- 05.1 2.2000 -
Solution for injection 5 mg/ ml 2 presentations
-A
Elan - Pharma - Internati onal Ltd UK
Elan Pharma International
27. 08. 1999 21. 09. 2000 187 days 229 days
- 27.08.1999 - 21.09.2000