qanastek/EMEA-V3 huggingface dataset:
- UK
Annex 6:
mellitusus -
Chairman (España)
12 presentations -
Josep TORRENT i FARNELL
119 days -
Members
2
Belgique/België Danmark Deutschland Eλλ δα/Greece France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/Finland Sverige United Kingdom Patient organisation
- Myocet
André LHOIR Jan RENNEBERG Rembert ELBERS 1 George STRATHOPOULOS 2 François MEYER Brendan BUCKLEY Domenica TARUSCIO Henri METZ 3 Harrie SEEVERENS Hans Georg EICHLER José Manuel Gião TOSCANO RICO Kalle HOPPU Kerstin WESTERMARK Rashmi SHAH
- The Liposome
representatives
- L01DB
Moisés ABASCAL ALONSO 5 Yann LE CAM, 5 Vice-chairman Alastair KENT 6
- Myocet - The Liposome - L01DB - Powder and pre- -
EMEA representatives
- Myocet - The Liposome - L01DB - Powder and pre- - 30.07.1999 -
Jean-Michel ALEXANDRE 7 Gianmartino BENZI Mary TEELING 8
17.05.2000
Observers
- doxorubicin
Ísland Norge/Noreg
Company
1 2 3 4 5 6 7 8
- Treatment of metastatic admixtures for
Replaced Tilman OTT as of the September 2000 meeting.
- doxorubicin Company - Treatment of metastatic admixtures for -
Replaced Thrassyvoulos KEPHALAS as of the October 2000 meeting.
- doxorubicin Company - Treatment of metastatic admixtures for - 12.04.2000 -
Replaced Mariette BACKES LIES as of the November 2000 meeting.
- B - US breast cancer concentrate for, -
Replaced Alexander NICHOLSON as of the June 2000 meeting.
- B - US breast cancer concentrate for, - 167 days -
Representing the European Alliance of Genetic Support Groups (EAGS).
26.07.2000
Resigned as of the December 2000 meeting.
liposomal dispersion for infusion 50 mg 1 presentation
Resigned as of the September 2000 meeting.
-
68 EMEA General Report 2000
91 days -
Annex 7:
2
National competent authority partners
- Datscan - ioflupane - B
Further information on the national competent authorities is also available on the national authorities’ Internet sites: http://heads.medagencies.org and http://www.hevra.org
- -
(32-2) 227 55 67 Fax (32-2) 227 55 55/56 39 E-mail: andre.pauwels@afigp.fgov.be Internet: http://www.afigp.fogv.be
Nycomed Amersham UK
(45) 44 88 93 34 Fax (45) 44 88 91 09 E-mail: jyl@dkma.dk Internet: http://www.dkma.dk
- -
(49-22) 82 07 32 03 Fax (49-30) 87 07 55 14 E-mail: schweim@bfarm.de Internet: http://www.bfarm.de
V09AB03 Diagnosis of Parkinson disease
(49-30) 84 12 23 64 Fax (49-30) 84 12 29 65 E-mail: r.kroker@bgvv.de
- - -
(49-6103) 77 20 01 Fax (49-6103) 77 12 52 E-mail: loejo@pei.de Internet: http://www.pei.de
Solution for injection 74 MBq/ml 1 presentation
Internet: http://www.bgvv.de
18.12.1998 - 16.03.2000 - 178 days - 272 days -
69 EMEA General Report 2000
05.05.2000 27.07.2000 02.08.2000 OJ C 244, 25.08.2000, p.
Eλλ δα/GREECE Marios MARSELOS President National Organization for Medicines Mesogion 284 GR – 155 62 Holargos Athens Tel.
10
(30-1) 650 72 10 Fax (30-1) 654 95 86 E-mail: hmoutsop@eof.gr
73 EMEA Allgemeiner Tätigkeitsbericht 2000
(34-91) 596 16 27 Fax (34-91) 596 16 15 E-mail: sdaem@agamed.es Internet: http://www.agamed.es
Arzneimittel - Handelsname - INN - Teil A/B
19 F – 94701 Maisons Alfort CEDEX Tel.
Unternehmen - Name - Sitz
IRELAND
Anwendungsgebiet - ATC - Indikation
(353-1) 676 49 71 Fax (353-1) 676 78 36 E-mail: frank.hallinan@imb.ie Internet: http://www.imb.ie
Fertigarzneimittel - Darreichungsform - Dosierung - Anzahl der Packungsgrößen
(353-1) 607 24 34 Fax (353-1) 676 29 89 E-mail: seamus.healy@daff.irlgov.ie
EMEA/CPMP - Validierung - Gutachten - Bearbeitungszeit - Anhalten der Uhr
(39-6) 59 94 36 66 Fax (39-6) 59 94 34 56 E-mail: farmaci.sanita@interbusiness.it Internet: http://www.sanita.it/farmaci
Kommission - Gutachten erhalten am - Datum der Entscheidung - Benachrichtigung - Amtsblatt
(39-6) 59 94 39 45 Fax (39-6) 59 94 31 90 E-mail: danspv@izs.it
- Visudyne - verteporfin - B
70 EMEA General Report 2000
- Ciba Vision - CH
(352) 478 55 90 Fax (352) 26 20 01 47 E-mail: dpmlux@pt.lu
L01XX Treatment of age- related macular degeneration
(31-31) 747 54 91 Fax (31-31) 742 31 93 E-mail: brd@brd.agro.nl
- - -
(43-1) 711 00 47 17 Fax (43-1) 713 86 14 E-mail: gunter.liebeswar@bmsg.gv.at
Powder for solution for infusion 15 mg 1 presentation
(43-1) 711 00 46 73 Fax (43-1) 714 92 22 E-mail: alexander.jentzsch@bmsg.gv.at
- 27.08.1999 - - 12.04.2000 - - 138 days - - 63 days -
PORTUGAL Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P - 1749-004 Lisboa Tel.
10
(351) 213 23 95 66 Fax (351) 213 46 35 18 E-mail: rleitao@dgv.min-agricultura.pt
- NovoMix 30 - insulin aspart - A
71 EMEA General Report 2000
- Novo Nordisk - DK
Box 55 FIN - 00301 Helsinki Tel.
- A 10AD - Diabetes mellitus
UNITED KINGDOM
- - -
Observers:
Suspension for - injection - 100 IU/ml - 8 presentations -
ÍSLAND Rannveig GUNNARSDÓTTIR Chief Executive Director Icelandic Medicines Control Agency Eidistorg 13 - 15 IS - 170 Seltjarnarnes Tel.
24.09.1999 - 12.04.2000 - 144 days - 55 days -
NORGE/NOREG Gro Ramsten WESENBERG Director-General Statens legemiddelkontroll Sven Oftedals vei 6 N - 0950 Oslo Tel.
17.05.2000 01.08.2000 01.08.2000 OJ C 244, 25.08.2000, p.
LIECHTENSTEIN Brigitte BATLINER Amt für Lebensmittelkontrolle und Veterinärwesen Kontrollstelle für Arzneimittel Postplatz 2 FL – 9494 Schaan Tel.
10
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte.batliner@alk.llv.li
- Kogenate Bayer - octocog alfa - A
72 EMEA General Report 2000
- Bayer AG - D
Annex 8:
B02BD02 Treatment and prophylaxis of bleeding in haemophilia A
CPMP opinions in 2000 on medicinal products for human use
- - -
Product - Brandname - INN - Part A/B
Powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU 3 presentations
Company - Name - Origin
- - - -
Therapeutic area - ATC - Indication
26.02.1999 - 16.03.2000 - 182 days - 201 days -
Presentation - Form - Dosage - Number of presentations
10
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- Helixate NexGen - octocog alfa - A
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Bayer AG - D
- Orgalutran
- -
- N.V.
B02BD02 Treatment and prophylaxis of bleeding in haemophilia A
Organon - H01CC01
- - -
- Orgalutran - N.V.
Powder and solvent for solution for infusion 250 IU, 500 IU, 1000 IU 3 presentations
Organon - H01CC01 - Solution for injection -
- - - -
- Orgalutran - N.V.
26.02.1999 - 16.03.2000 - 182 days - 201 days -
Organon - H01CC01 - Solution for injection - 29.01.1999 -
10
22.02.2000
- - -
- ganirelix
Medeva Pharma Ltd UK
- Prevention of
J07BC Immunisation against hepatitis B virus in adults
- ganirelix - NL - Prevention of - 0.5 mg/ml -
Suspension for - injection - Monodose preparation - of 1 ml contains - Hepatitis B surface antigen S, pre-S1 and pre S 2 20 µg
- ganirelix - NL - Prevention of - 0.5 mg/ml - 19.01.2000 -
23.10.1998 - 16.03.2000 - 210 days - 293 days -
17.05.2000
10
-B
-
premature luteinising
2 presentations
-B premature luteinising - 2 presentations -
- Herceptin - trastuzumab - A
-B premature luteinising - 2 presentations - 162 days -
Roche Registration Ltd CH
22.05.2000
L01XC03 Treatment of patients with metastatic breast
hormone surges in conteolled ovarian hyperstimulation
305 days -
189 days -
OJ C 277, 29.09.2000, p.
OJ C 183, 30.06.2000, p.
14
3
26.02.1999 - 29.06.2000 - 187 days - 300 days -
Pegintron peginterferon alfa -2b
- Panretin - alitretinoin - B
- SP Europe - US
Ligand Pharmaceuticals Ltd US
L03AB10 Treatment of chronic hepatitis C
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi’s sarcoma
Powder and solvent for solution for injection 50 µg/0.5 ml, 80 µg/0.5 ml,
- Gel - - 0.1 %w/w - - 1 presentation - -
- 26.03.1999 - 17.02.2000 - 189 days
26.02.1999 - 29.06.2000 - 174 days - 313 days -
- 27.03.2000 - 25.05.2000 - 05.06.2000
2
-A
A10BG03 Combination treatment of Type II Diabetes mellitus
100 µg/0.5 ml 120 µg/0.5 ml, 150µg/0.5 ml 25 presentations
- Tablet - 15 mg, 30 mg - 6 presentations
- 139 days
31.07.2000 11.10.2000 17.10.2000 OJ C 337, 28.11.2000. p.
OJ C 183, 30.06.2000, p.
- Actos - pioglitazone - B
- Viraferon PEG - peginterferon alfa -2b -A
- Takeda Europe - JP
- SP Europe - US
A10BG03 Combination treatment of Type II Diabetes mellitus
L03AB10 Treatment of chronic hepatitis C
2
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
- Agenerase - amprenavir - B
- 03.01.2000 - 17.02.2000 - 43 days - 0 days
J05AE05 Treatment of HIV infected adults and children
3
Capsule, soft, Oral solution 50 mg, 150 mg, 15 mg/ml 4 presentations
Lantus insulin glargine
20.11.1998 - 29.06.2000 - 219 days - 324 days -
Aventis Pharma Deutschland
Arzneimittel - Handelsname - INN - Teil A/B
- A10AE - Diabetes mellitus
Unternehmen - Name - Sitz
- Solution for injection - 100 IU/ml - 7 presentations
Anwendungsgebiet - ATC - Indikation
- 23.04.1999 - 17.02.2000 - 215 days
Fertigarzneimittel - Darreichungsform - Dosierung - Anzahl der Packungsgrößen
- 23.03.2000 - 06.06.2000 - 14.06.2000
EMEA/CPMP - Validierung - Gutachten - Bearbeitungszeit - Anhalten der Uhr
-A
Kommission - Gutachten erhalten am - Datum der Entscheidung - Benachrichtigung - Amtsblatt
GmbH
- Infanrix hexa
- 8 3 days
- SmithKline
- OJ C 183,
- JO7CA - Powder and suspension for su
3
- Infanrix hexa - SmithKline - JO7CA -
- -
Powder and suspension for suspension -
Optisulin insulin glargine
- Infanrix hexa - SmithKline - JO7CA - Powder and suspension for suspension - 30.07.1999 -
-
09.08.2000
Aventis Pharma Deutschland
- Hep B-IPV HIB
- A10AE - Diabetes mellitus
- Immunisation against
- Solution for injection - 100 IU/ml - 7 presentations
- Hep B-IPV HIB Beecham - Immunisation against for injection -
- 24.09.1999 - 17.02.2000 - 116 days
- Hep B-IPV HIB Beecham - Immunisation against for injection - 29.06.2000 -
- 23.03.2000 - 27.06.2000 - 28.06.2000
23.10.2000
-A
vaccine
GmbH
Biologicals S.A.
- 28 days
Haemophilus influenza,
- OJ C 216,
-
-D
Diphtheria toxoid, adsorbed ≥ 30IU -
4
201 days -
- Nyracta - rosiglitazone -B
A
SmithKline Beecham Pharmaceuticals UK
B
A10BG02 Combination treatment of Type II diabetes mellitus
Diphtheria, Pertussis, Tetanus, HepB and Poliomyelitis
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
Tetanus toxoid, adsorbed ≥ 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 Conjugate of Haemophilus influenzae type b capsular polysaccharide (PRP) 10 µg and Tetanus toxoid (T), adsorbed (PRP-T) 20-40 µg
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
132 days -
- - - -
OJ C 337, 28.11.2000. p.
17.04.2000 11.07.2000 26.07.2000 OJ C 244, 25.08.2000, p.
16 presentations
SmithKline Beecham Pharmaceuticals UK
- Infanrix penta -
- -
SmithKline
A10BG02 Combination treatment of Type II diabetes mellitus
- JO7CA - Suspension for injection -
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
- Infanrix penta - SmithKline - JO7CA -
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
Suspension for injection -
- - - -
- Infanrix penta - SmithKline - JO7CA - Suspension for injection - 30.07.1999 -
4
- Hep B-IPV vaccine
- Venvia - rosiglitazone -B
- Primary and booster -
- -
- Hep B-IPV vaccine Beecham - Primary and booster - Diphtheria toxoid, -
SmithKline Beecham Pharmaceuticals UK
- A
- -
immunisation of infants
A10BG02 Combination treatment of Type II diabetes mellitusus
- A Biologicals S.A. immunisation of infants adsorbed ≥ 30IU -
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
- A Biologicals S.A. immunisation of infants adsorbed ≥ 30IU - 201 days -
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
- Pasteur Merieux - JO7CA
- Myocet - doxorubicin -B
- Comb vaccine
- -
- Purified diphtheria toxoid, -
The Liposome Company US
- F
- -
Diphtheria, pertussis,
L01DB Treatment of metastatic breast cancer
- A - F Diphtheria, pertussis, adsorbed ≥ 20 IU, -
- Powder and pre-admixtures for concentrate for, liposomal dispersion for infusion - 50 mg - 1 presentation
- A - F Diphtheria, pertussis, adsorbed ≥ 20 IU, - 180 days -
- 30.07.1999 - 12.04.2000 - 167 days - 91 days
OJ C 337, 28.11.2000. p.
17.05.2000 13.07.2000 26.07.2000 OJ C 244, 25.08.2000, p.
- 8 presentations
- Datscan - ioflupane -B
- Luveris
- -
- Ares Serono
- -
- G03G - Powder and solvent for -
- Solution for injection - 74 MBq/ml - 1 presentation
- Luveris - Ares Serono - G03G -
- 18.12.1998 - 16.03.2000 - 178 days - 272 days
Powder and solvent for -
- - - -
- Luveris - Ares Serono - G03G - Powder and solvent for - 25.06.1999 -
10
07.09.2000
73 EMEA General Report 2000
- lutropin alfa
Product - Brandname - INN - Part A/B
(Europe) Ltd
Company - Name - Origin
- Stimulation of follicular
Therapeutic area - ATC - Indication
solution for injection -
Presentation - Form - Dosage - Number of presentations
- lutropin alfa (Europe) Ltd - Stimulation of follicular solution for injection - 27.07.2000 -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
development in women -
Commission - Opinion received - Date of Decision - Notification - Official Journal
- A - CH development in women - 75 IU -
- Visudyne - verteporfin -B
- A - CH development in women - 75 IU - 192 days -
- Ciba Vision - CH
30.11.2000
- -
with servere Leng HEng and FSH deficiency
L01XX Treatment of age - related macular degeneration
6 presentations -
- 27.08.1999 - 12.04.2000 - 138 days - 63 days
200 days -
- - - -
OJ C 2, 05.01.2001, p.
15.05.2000 27.07.2000 31.07.2000 OJ C 244, 25.08.2000, p.
Arzneimittel - Handelsname - INN - Teil A/B
- NovoMix 30 - Novo Nordisk - insulin aspart - DK -A
Unternehmen - Name - Sitz
- A10AD - Diabetes mellitus
Anwendungsgebiet - ATC - Indikation
- Suspension for injection - 100 IU/ml - 8 presentations
EMEA/CPMP - Validierung - Gutachten - Bearbeitungszeit - Anhalten der Uhr
- 24.09.1999 - 12.04.2000 - 144 days - 55 days
Kommission - Gutachten erhalten am - Datum der Entscheidung - Benachrichtigung - Amtsblatt
- - - -
- NeoSpect - depreotide - B
10
Nycomed Imaging A/S NO
Kogenate Bayer octocog alfa
V09IA05 Scintigraphic imaging of suspected malignant tumours in the lung
B02BD02 Treatment and prophylaxis of bleeding
Kit for - radiopaharmaceutical - preparation - 47 µg - 2 presentations
Powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU
20.11.1998 - 27.07.2000 - 204 days - 404 days -
- 26.02.1999 - 16.0 3.2000 - 182 days
28.08.2000 29.11.2000 04.12.2000 OJ C 2, 05.01.2001, p.
- 05.06.2000 - 04.08.2000 - 07.08.2000
3
- 3 presentations
- Glaxo Group - UK
- 201 days
- 13.10.2000 - 08.12.2000 - -
10
Schwarz Pharma AG D
- Bayer AG -D
H01AC01 Treatment of growth failure
B02BD02 Treatment and prophylaxis of bleeding
21.10.1999 21.09.2000 174 days 186 days
Powder and solvent for solution for infusion 250 IU, 500 IU, 1000 IU
- 05.12.2000 - - -
- 26.02.1999 - 16.0 3.2000 - 182 days
- - -
- 05.06.2000 - 04.08.2000 - 07.08.2000
Elan Pharma International Ltd UK
in haemophilia A
- Solution for injection - - 5000 IU/ml - - 3 presentations - -
- 3 presentations
- 21.11.2000 - - -
- 201 days
- Tenecteplase
-
- Boehringer
10
- B01AD
- -
- Powder and solvent for -
Hepacare triple antigen hepatitis B vaccine
- 27.11.2000
- -
- tenecteplase - A
Medeva Pharma Ltd UK
Ingelheim International GmbH D
J07BC Immunisation against hepatitis B virus in adults
Treatment of suspected solution for injection - myocardial infarction - 6000 IU, 8000 IU, - 10000 IU - - 3 presentations
Suspension for injection Monodose preparation of 1 ml contains Hepatitis B surface antigen S, pre -S1 and
21.09.2000 176 days 215 days
- 23.10.1998 - 16.03.2000 - 210 days - 293 days
- Metalyse
- 16.05.2000 - 04.08.2000 - 07.08.2000 - OJ C 244,
- Boehringer
-A
- B01AD
-
- Powder and solvent for -
pre S2 20 µg 2 presentations
- 27.11.2000
25.08.2000, p.
- tenecteplase - A
- Herceptin - trastuzumab -A
Ingelheim International GmbH D
Roche Registration Ltd CH
Treatment of suspected solution for injection - myocardial infarction - 6000 IU, 8000 IU, - 10000 IU - - 3 presentations
L01XC03 Treatment of patients with metastatic breast cancer whose tumour overexpress HER2
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Powder for concentrate for solution for infusion 150 mg 1 presentation
- Film coated tablet - 5 mg - 13 presentations
- 26.02.1999 - 25.05.2000 - 147 days - 305 days
24.09.1999 21.09.2000 201 days 159 days
14
- Opulis - desloratadine - B
- Keppra - levetiracetam -B
- SP Europe - US
- UCB S.A. - US
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
N03A Adjunctive therapy in the partial onset seizures in epilepsy
24.09.1999 21.09.2000 201 days 159 days
- 26.02.1999 - 29.06.2000 - 187 days - 300 days
- 06.11.2000 - - -
- - - -
- Allex - desloratadine - B
12
- SP Europe - US
- Panretin - alitretinoin -B
- Film coated tablet - 5 mg - 13 presentations
Ligand Pharmaceuticals Ltd US
24.09.1999 21.09.2000 201 days 159 days
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi's sarcoma
- 06.11.2000 - - -
- Gel - 0.1 %w/w - 1 presentation
- Aerius - desloratadine - B
- 26.02.1999 - 29.06.2000 - 174 days - 313 days
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
2
- Film coated tablet - 5 mg - 13 presentations
- Glustin - pioglitazone -B
- SP Europe - US
Takeda Europe JP
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
A10BG03 Combination treatment of Type II Diabetes mellitus
- Film coated tablet - 5 mg - 13 presentations
- Tablet - 15 mg, 30 mg - 6 presentations
24.09.1999 21.09.2000 201 days 159 days
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
- Xeloda - capecitabine - B
- Actos - pioglitazone -B
Roche Registration Ltd CH
Takeda Europe JP
L01BC treatment of metastatic colorectal cancer
A10BG03 Combination treatment of Type II Diabetes mellitus
- Film coated tablet - 150 mg, 500 mg - 2 presentations
- Tablet - 15 mg, 30 mg - 6 presentations
21.10.1999 21.09.2000 201 days 159 days
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
- 20.11.2000 - - -
- - - -
- - -
2
Ovidrelle chorio - gonadotropin alfa A
- Agenerase - amprenavir -B
G03GA01 Assisted reproductive techniques sus as in vitro fertilisation (IVF)
J05AE05 Treatment of HIV infected adults and children
Powder and solvent for - solution for injection - 250 µg - 6 presentations -
- Capsule, soft, Oral solution - 50 mg, 150 mg, 15 mg/ml - 4 presentations
21.10.1999 21.09.2000 174 days 186 days
- 20.11.1998 - 29.06.2000 - 219 days - 324 days
- 23.11.2000 - - -
- - - -
76 EMEA Allgemeiner Tätigkeitsbericht 2000
74 EMEA General Report 2000
Arzneimittel - Handelsname - INN - Teil A/B
Product - Brandname - INN - Part A/B
Unternehmen - Name - Sitz
Company - Name - Origin
Anwendungsgebiet - ATC - Indikation
Therapeutic area - ATC - Indication
Fertigarzneimittel - Darreichungsform - Dosierung - Anzahl der Packungsgrößen
Presentation - Form - Dosage - Number of presentations
EMEA/CPMP - Validierung - Gutachten - Bearbeitungszeit - Anhalten der Uhr
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
Kommission - Gutachten erhalten am - Datum der Entscheidung - Benachrichtigung - Amtsblatt
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Prevenar
- -
- Wyeth-Lederle
Infanrix hexa Hep B-IPV HIB vaccine
- J07AL
-
- Prevenar - Wyeth-Lederle - J07AL - Suspension for injection -
SmithKline Beecham Biologicals
19.11.1999
- -
- 21.11.2000
JO7CA Immunisation against Haemophilus influenza,
- Prevenarp-
- -
Vaccines S.A.
30IU
- Active immunisation of -
- 30.07.1999 - 29.06.2000 - 201 days
- Prevenarp- Vaccines S.A. - Active immunisation of - A monodose preparation -
- 09.08.2000 - 23.10.2000 - 26.10.2000
-
S.A.
neumococcal conjugate vaccine A
Tetanus toxoid, adsorbed ≥
-
- OJ C 337,
US
-B
infants and children against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae
Tetanus, HepB and Poliomyelitis
of 0.5 ml contains Streptococcus pneumoniae: saccharide suspension of Serotype 4 2 µg Serotype 9V 2 µg Serotype 14 2 µg Serotype 18C 2 µg Serotype 19F 2 µg Serotype 23F 2 µg Serotype 6B 4 µg Conjugated to CRM197 carrier protein ~ 20 µg
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
205 days 125 days
28.11.2000. p.
2 presentations
2
Prandin replaglinide B
16 presentations
Novo Nordisk DK
Infanrix penta - Hep B-IPV vaccine
A10BX02 Treatment of Type II diabetes mellitus
SmithKline Beecham Biologicals
Tablet 0.5 mg, 1.0 mg, 2.0 mg, 18 presentations
JO7CA Primary and booster immunisation of infants
- - - -
- Suspension for injection - Diphtheria toxoid, adsorbed ≥ 30IU
30.06.2000 21.09.2000 91 days 0 days
- 30.07.1999 - 29.06.2000 - 201 days
- 26.10.2000 - - -
- 09.08.2000 - 23.10.2000 - 26.10.2000
- - -
-A
- -
S.A.
Wyeth Europe Ltd US
against Diphtheria,
Oral solution 1 mg/ml 5 presentations
Tetanus toxoid, adsorbed ≥
- - - -
- 132 days
- 08.01.2001 - - -
- OJ C 337,
- - -
-B
Targretin bexarotene B
Tetanus, Pertussis, Hepatitis B and Poliomyelitis
- -
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
Ligand Pharmaceuticals Ltd US
28.11.2000. p.
Capsule, soft 75 mg 1 presentation
8 presentations
- - - -
- Hexavac
- Sanofi - F
Pasteur
- - -
- JO7CA
Powder and solvent for - solution for infusion - 1.5 mg/ml - 1 presentation -
- Suspension for injection
- - - -
- 30.07.1999
- Trazec
- 10.08.2000
- Novartis
- Comb vaccine -A
- A10B03 - Film coated
Merieux MSD - -F
- Trazec - Novartis - A10B03 - Film coated tablet -
Immunisation Diphtheria, pertussis, Tetanus, HepB, Poliomyelitis, Haemophilus influenza
- nateglinide
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)
Europharm Ltd - Combination treatment -
- 26.06.2000 - 180 days - 153 days
- B - CH of diabetes mellitus 180 mg -
23.10.2000 26.10.2000 OJ C 337, 28.11.2000. p.
21 presentations - 0 days
8 presentations
- 21 presentations -
- Luveris - lutropin alfa -A
- Vaniqa - Bristol Myers - D11AX - Cream -
Ares Serono (Europe) Ltd CH
- eflornithine
G03G Stimulation of follicular development in women - 75 with servere Leng HEng and FSH deficiency
- Treatment of facial
- Powder and solvent for solution for injection IU - 6 presentations
- eflornithine Squibb Pharma - Treatment of facial - 11.5% -
- 25.06.1999 - 27.07.2000 - 192 days - 200 days
- B
07.09.2000 29.11.2000 30.11.2000 OJ C 2, 05.01.2001, p.
- B EEIG hirsutism - 3 presentations -
3
157 days
75 EMEA General Report 2000
- Starlix - nateglinide - B
Product - Brandname - INN - Part A/B
Novartis Europharm Ltd CH
Therapeutic area - ATC - Indication
A10BX03 Combination treatment of diabetes mellitus Type II
Presentation - Form - Dosage - Number of presentations
Film coated tablet - 60 mg, 120 mg, - 180 mg - 21 presentations -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
21.01.2000 14.12.2000 179 days 144 days
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Zometa - zoledronic acid
- NeoSpect - depreotide
Novartis Europharm Ltd
Nycomed Imaging A/S
M05BA08 Treatment of tumour
V09IA05 Scintigraphic imaging
Powder and solvent for - solution for infusion -
Kit for radiopaharmaceutical preparation
21.01.2000 14.12.2000
- 20.11.1998 - 27.07.2000
- B
-B
induced hypercalcaemia -
NO
- B - CH induced hypercalcaemia - 4 mg -
of suspected malignant tumours in the lung
3 presentations -
3
Capsule, soft, -
- Trizivir - lamivudine zidovudine abacavir -B
Laboratories
Glaxo Group UK
in combination of HIV -- 1 infected patients -
J05AF30 Treatment of HIV -1 infected patients
133.3/33.3 mg, - 80/20 mg/ml - 3 presentations
Film coated tablet 150/300/300 mg 3 presentations
145 days 0 days
- 21.01.2000 - 29.06.2000 - 158 days - 0 days
- Bracco S.P.A.
13.10.2000 08.12.2000
- SonoVue - Bracco S.P.A. - V08DA - Powder for injection -
- Nutropin AQ - - somatropin
27.08.1999
Schwarz Pharma AG
- sulphur
- H01AC01 - Treatment of growth
- Ultrasound agent to
- Solution for injection - 5 mg/ml
- sulphur - I - Ultrasound agent to - 8 µl/ml -
- 21.10.1999 - 21.09.2000
14.12.2000
- 05.1 2.2000 -
hexafluoride
- D
enhance the
failure
- 2 presentations -
- 2 presentations
194 days
- 174 days - 186 days
echogenicity of the blood
- Neurobloc - botulinum
276 days
Elan Pharma International
- Osteogenis
- Solution for injection - 5000 IU/ml
- Stryker-Biotech - M09AX
- 27.08.1999 - 21.09.2000
- Osteogenis - Stryker-Biotech - M09AX - Powder for suspension -
- 21.11.2000 -
30.07.1999
toxin type B
-
Ltd
Protein 1 Howmedia International Osteogenic Protein-1 BMP-7
- 3 presentations
- US
- 187 days
for implantation - 3.5 mg - 1 presentation -
- UK
14.12.2000 201 days 297 days
- 229 days
77 EMEA Allgemeiner Tätigkeitsbericht 2000
Boehringer Ingelheim International GmbH
Anhang 9:
- -
Arzneimittel - Handelsname - INN - Teil A/B
B01AD Treatment of suspected myocardial infarction
Unternehmen - Name - Sitz
- - -
Fertigarzneimittel - Darreichungsform - Dosierung - Anzahl der Packungsgrößen
Powder and solvent for solution for injection 6000 IU, 8000 IU, 10000 IU 3 presentations
EMEA/CPMP - Validierung - Gutachten - Bearbeitungszeit Benachrichtigung - Anhalten der Uhr
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
Kommission - Gutachten erhalten am - Datum der Entscheidung - Amtsblatt
- 27.11.2000 - - -
17.11.1998 - 10.11.1999 - 210 days - 176 days -
- Metalyse - tenecteplase -A
10.12.1999 09.03.
-
Boehringer Ingelheim D
Boehringer Ingelheim International GmbH
Dogs Initiation therapy for alleviation of pain and inflammation (QM01AC06)
- -
Solution for injection 5 mg/ml 1
B01AD Treatment of suspected myocardial infarction
12.01.1999 - 10.11.1999 - 210 days - 92 days -
Powder and solvent for solution for injection 6000 IU, 8000 IU, 10000 IU 3 presentations
10.12.1999 24.03.2000 27.03.2000 OJ C 120, 28.04.2000
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
Scored tablets
- 27.11.2000 - - -
14.07.1998 -
- Azomyr - desloratadine -B
International
- SP Europe - US
08. 12.1999 -
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
urinary incontinence (QG03CA04)
- Film coated tablet - 5 mg - 13 presentations
210 days - 302 days -
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
29.03.2000 OJ C 120, 28.04.2000
- 06.11.2000 - - -
Rabigen SAG2 Live vaccine Part A
- Opulis - desloratadine -B
Virbac F
- SP Europe - US
23.03.1998 - 08.12.1999 - 196 days - 428 days -
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
07.01.2000 06.04.2000 10.04.2000 OJ C 120, 28.04.2000
- Film coated tablet - 5 mg - 13 presentations
Eurifel FeLV Live vaccine Part A
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
Merial F
- 06.11.2000 - - -
Cats Vaccine against feline leukaemis (QJ57BA04)
- Allex - desloratadine -B
Pellet plus diluent 1 ml 3
- SP Europe - US
12.01.1999 - 08.12.1999 - 183 days - 120 days -
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
07.01.2000 13.04.2000 18.04.2000 OJ C 120, 28.04.2000
- Film coated tablet - 5 mg - 13 presentations
Porcilis Pesti Inactivated vaccine Part A
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
Intervet International NL
- 06.11.2000 - - -
Pigs Marker vaccine against CSF (QJ57EA)
- Aerius - desloratadine -B
Water in oil emulsion 120 Elisa Units/2ml 3
- SP Europe - US
14.07.1998 - 13.10.1999 - 210 days - 246 days -
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
12.11.1999 09.06.2000 14.06.2000 OJ C 183, 30.06.2000
- Film coated tablet - 5 mg - 13 presentations
Ibaflin Ibafloxacin Part B
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
Dogs Pyoderma (QG51AC)
- Neoclarityn - desloratadine -B
Tablet 150 & 300mg 1
- SP Europe - US
12.01.1999 - 09.02.2000 - 210 days - 184 days -
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
10.03.2000 13.06.2000 15.06.2000 OJ C 183, 30.06.2000
- Film coated tablet - 5 mg - 13 presentations
Metacam Meloxicam Part B (extension)
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
Boehringer Ingelheim D
- 06.11.2000 - - -
Dogs Post-operative pain (QM01AC06)
- Xeloda - capecitabine -B
Solution for injection 5mg/ml 1
- Roche Registration Ltd - CH
02.01.2000 - 19.04.2000 - 101 days - 7 days -
L01BC treatment of metastatic colorectal cancer
28.04.2000 15.09.2000 18.09.2000 OJ C 277, 29.09.2000
- Film coated tablet - 150 mg, 500 mg - 2 presentations
Econor Valnemulin Part B (extension)
- 21.10.1999 - 21.09.2000 - 201 days - 159 days
Novartis A
- 20.11.2000 - - -
Pigs Prevention & treatment of dysentery (QJ01XX94)
- -
0.5% premix various 2
Ovidrelle chorio- gonadotropin alfa
10.08.1999 - 19.04.2000 - 210 days - 43 days -
Ares Serono (Europe) Ltd CH
19.05.2000 15.09.2000 20.09.2000 OJ C 308, 27.10.2000
- -
Econor Valnemulin Part B extension
G03GA01 Assisted reproductive techniques sus as in vitro fertilisation (IVF)
Novartis A
- - -
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
Powder and solvent for solution for injection 250 µg 6 presentations
- - - -
- 21.10.1999 - 21.09.2000 - 174 days - 186 days
12.10.1999 - 08.03.2000 - 148 days - 0 -
- 23.11.2000 - - -
07.04.2000 15.09.2000 20.09.2000 OJ C 308, 27.10.2000
-A
78 EMEA Allgemeiner Tätigkeitsbericht 2000
76 EMEA General Report 2000
EMEA/CPMP - Validierung - Gutachten - Bearbeitungszeit Benachrichtigung - Anhalten der Uhr
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
Kommission - Gutachten erhalten am - Datum der Entscheidung - Amtsblatt
Commission - Opinion received - Date of Decision - Notification - Official Journal
Econor Valnemulin Part B (extension)
- Prevenar - Prevenarp- neumococcal conjugate vaccine -A
Novartis A
- Wyeth- Lederle Vaccines S.A. - US
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
- J07AL - Active immunisation of infants and children against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae
10%/50% premix various 2
- 19.11.1999 - 21.09.2000 - 205 days - 125 days
12.10.1999 - 08.03.2000 - 148 days - 0 -
- Prandin - replaglinide -B
07.04.2000 15.09.2000 22.09.2000 OJ C 308, 27.10.2000
- -
Dicural Difloxacin Part B (extension)
Novo Nordisk DK
Fort Dodge Animal Health NL
A10BX02 Treatment of Type II diabetes mellitus
Cattle & pigs Antibacterial for systemic use (QJ01MA)
- Tablet - 0.5 mg, 1.0 mg, 2.0 mg, - 18 presentations
Solution for injection 50 mg/ml 3
- 30.06.2000 - 21.09.2000 - 91 days - 0 days
16.12.1998 - 21.06.2000 - 203 days - 351 days -
- Rapamune - sirolimus -B
21.07.2000 24.10.2000 25.10.2000 OJ C 337, 28.11.2000
- -
Poulflox Difloxacin Part B
Wyeth Europe Ltd US
F
- -
Poultry Antibacterial for systemic use QJ01MA94)
L04AA10 rophylaxis of organ rejection in patient receiving renal transplants
Oral solution 100 mg/ml 3
- Oral solution - 1 mg/ml - 5 presentations
09.12.1999 21.06.2000 152 days 43 days
- Targretin - bexarotene -B
21.07.2000 16.11.2000 OJ C 2, 05.01.2001
Ligand Pharmaceuticals Ltd US
Bayovac CSF Marker Live vaccine Part A
- -
Bayer D
L01XX25 Treatment of skin manifestations of advanced stage of cutaneous T -cell Lymphoma
Pigs Marker vaccine against Classical Swine Fever (QJ57EA)
- Capsule, soft - 75 mg - 1 presentation
Emulsion for injection E2 glycoprotein of Classical Swine Fever virus 4
- 17.12.1999 - 16.11.2000 - 197 days - 159 days
- 07.08.2000
- Fasturtec
Porcilis AR-T-DF
-
Intervet
Sanofi
Pigs
-
Susp
V03AF07
-T-DF Intervet Pigs Suspension for injection -
- Powder and solvent for
1 2.01.1999
- 21.01.2000
- 18.08.2000
-
Inactivated vaccine Part A
- rasburicase -A
2 ml 2
-F
19.07.2000 204 days 336 days
Treatment of tumor induced hpreuricemia
Pruban Rescortol butyrate Part B
solution for infusion 1.5 mg/ml 1 presentation
Intervet International NL
- 16.11.2000 - 177 days - 118 days
Dogs Anti-inflammatory for cutaneous inflammatory disorders (QD07AC90)
- - -
Cream 1 mg/g 1
- Trazec - nateglinide -B
15.09.1998 19.07.2000 196 days 477 days
Novartis Europharm Ltd CH
18.08.2000 16.11.2000 OJ C 2, 05.01.2001
A10B03 Combination treatment of diabetes mellitus Type II
Dairy cattle Clinical & sub mastitis (QJ51FF90)
- Film coated tablet - 60 mg, 120 mg, 180 mg - 21 presentations
Sterile solution for intramammary use 5 mg/ml 4
- 31.10.2000 - 14.12.2000 - 58 days - 0 days
- 10.11.2000
- Vaniqa - eflornithine -B
-Plough
- -
Dogs Treatment of pain & inflammation
Bristol Myers Squibb Pharma EEIG US
18.05.1999 08.11.2000 210 days 330 days
D11AX Treatment of facial hirsutism
- 08.12.2000
- Cream - 11.5% - 3 presentations
Eurican herpes 205 Inactivated vaccine Part B
- 03.01.2000 - 14.12.2000 - 182 days - 157 days
Merial F
- - - -
Dogs Vaccine against canine herpes
- Starlix - nateglinide -B
13.07.1999 08.11.2000 209 days 274 days
Novartis Europharm Ltd CH
- 08.12.2000
- -
79 EMEA Allgemeiner Tätigkeitsbericht 2000
A10BX03 Combination treatment of diabetes mellitus Type II
Festsetzung von Rückstandshöchstmengen für neue Stoffe
- Film coated tablet - 60 mg, 120 mg, 180 mg - 21 presentations
Anwendungsgebiet - Zieltierarten
- 21.01.2000 - 14.12.2000 - 179 days - 144 days
EMEA/CVMP - Validierung - Gutachten - Bearbeitungszeit - Anhalten der Uhr
- - - -
Kommission - An die Kommission geschickt - Datum der Verordnung - Amtsblatt
- Zometa - zoledronic
Bismuth subnitrate (extension)
-
Bovine
Novartis Europharm
18.06.1999 13.10.1999 113 days 0
M05BA08 Treatment of tumour
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
- Powder and solvent for solution for infusion
Acetyl isovaleryl tylosin tartrate
- 21.01.2000 - 14.12.2000
18.10.1995 13.10.1999 195 days 1260 days
acid
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
Ltd
Methylprednisolone
induced hypercalcaemia - 4 mg
Bovine
- 177 days
13.07.1999 13.10.1999 92 days 0
- B
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
- CH
Deltamethrin (extension)
- 3 presentations
Fin fish
- 146 days
- 07.04.2000 - 15.09.2000 - OJ L 234, 16.09.2000
- Kaletra
Eggs
- Abbott
- - - -
- J05A
- 07.04.2000 - 15.09.2000 - OJ L 234, 16.09.2000
- Capsule, soft, Oral solution
Dicyclanil
- 18.07.2000
Ovine
-
25.02.1997 08.03.2000 281 days 825 days
lopinavir/ ritonavir
- 07.04.2000 - 15.09.2000 - OJ L 234, 16.09.2000
-
Tilmicosin (extension)
Laboratories US
- 12.11.1999 - 20.10.2000 - OJ L 269, 21.10.2000
Combination treatment - 133.3/33.3 mg, 80/20 mg/ml in combination of HIV- - 3 presentations
Flumequine (extension)
- 14.12.2 000 - 145 days
27.07.1999 10.11.1999 89 days 0
-B
Tiamulin (extension)
1 infected patients
Rabbit
- 0 days
- 11.02.2000 - 20.10.2000 - OJ L 269, 21.10.2000
- SonoVue - sulphur hexafluoride -B
Dicyclanil (modification)
- Bracco S.P.A. -I - V08DA
23.02.2000 17.05.2000 84 days 0
Ultrasound agent to enhance the echogenicity of the blood
- 16.06.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- Powder for injection - 8 µl/ml - 2 presentations
Butafosfan (extension)
- 27.08.1999 - 14.12.2000 - 194 days - 276 days
19.01.2000 19.04.2000 90 days 0
- -
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
Osteogenis Protein 1 Howmedia International Osteogenic Protein-1 BMP-7
Tilmicosin (extension)
- -
Bovine milk
Stryker - Biotech US
22.02.1999 19.04.2000 203 days 210 days
M09AX Treatment of non-union of tibia of at least 9 month duration
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- Powder for suspension for implantation - 3.5 mg - 1 presentation
Phoxim (extension)
- 30.07.1999 - 14.12.2000 - 201 days - 297 days
19.01.2000 19.04.2000 90 0
77 EMEA General Report 2000
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
Product - Brandname - INN - Part A/B
80 EMEA Allgemeiner Tätigkeitsbericht 2000
Company - Name - Origin
Substanz - INN
Therapeutic area - Target species - Indication
Anwendungsgebiet - Zieltierarten
Presentation - Form - Dosage - Number of presentations
EMEA/CVMP - Validierung - Gutachten - Bearbeitungszeit - Anhalten der Uhr
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
Kommission - An die Kommission geschickt - Datum der Verordnung - Amtsblatt
Commission - Opinion received - Date of Decision - Notification - Official Journal
Flumethrin (extension)
Ibraxion Inactivated vaccine Part A
Ovine
Merial F
- - - -
Cattle Vaccine against IBR (QJ57DA)
19.01.2000 19.04.2000 90 days 0
Emulsion for injection 2 ml 1
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- 17.11.1998 - 10.11.1999 - 210 days - 176 days
23.03.2000 21.06.2000 90 days 0
00 OJ C 95, 04.04.2000
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
Metacam Meloxicam Part B extension
Toltrazuril (extension)
Boehringer Ingelheim D
Porcine
Solution for injection 5 mg/ml 1
16.02.1999 21.06.2000 206 days 284 days
10.12.1999 24.03.2000 27.03.2000 OJ C 120, 28.04.2000
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
Dogs Hormone-dependent urinary incontinence (QG03CA04)
Thiamphenicol (extension)
Scored tablets 1 mg 1
Porcine, Ovine, Turkey, Fish
- 14.07.1998 - 08.12.1999 - 210 days - 302 days
15.05.1998 21.06.2000 206 days 562 days
07.01.2000 24.03.2000 29.03.2000 OJ C 120, 28.04.2000
- 08.11.2000
Rabigen SAG2 Virbac Live vaccine F Part A
Difloxacin (extension)
Foxes Vaccine against rabies (QJ57HA)
Bovine, Porcine
- 23.03.1998 - 08.12.1999 - 196 days - 428 days
14.07.1998 21.06.2000 205 days 503 days
07.01.2000 06.04.2000 10.04.2000 OJ C 120, 28.04.2000
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
Eurifel FeLV Live vaccine Part A
Halofuginone
Merial F
Bovine
Pellet plus diluent 1 ml 3
10.12.1996 21.06.2000 281 days 1008 days
12.11.1999 09.06.2000 14.06.2000 OJ C 183, 30.06.2000
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
Ibaflin Ibafloxacin Part B
Linear dodecyl benzene sulfonic acid
Intervet International NL
Bovine
Tablet 150 & 300mg 1
22.01.1999 19.07.2000 195 days 321 days
Metacam Meloxicam Part B (extension)
- 18.08.2000
Boehringer Ingelheim D
Phoxim (extension)
Solution for injection 5mg/ml 1
Ovine
- 02.01.2000 - 19.04.2000 - 101 days - 7 days
19.01.2000 19.07.2000 120 days 0
Econor Valnemulin Part B (extension)
- 18.08.2000
Novartis A
Acetyl isovaleryl tylosin tartrate
Pigs Prevention & treatment of dysentery (QJ01XX94)
Porcine
0.5% premix various 2
18.01.1995 13.09.2000 274 days 1790 days
Econor Valnemulin Part B extension
- 18.02.2000
Novartis A
Florfenicol (extension)
10%/50% premix various 2
Fish
- 12.10.1999 - 08.03.2000 - 148 days -0
29.01.1996 11.11.2000 212 days 1504 days
07.04.2000 15.09.2000 20.09.2000 OJ No.
- 08.11.2000
308, 27.10.2000
Meloxicam (extension)
Econor Valnemulin Part B (extension)
Porcine
Novartis A
- - - -
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
07.09.2000 06.12.2000 90 days 0 days
10%/50% premix various 2
- 04.01.2001
- 12.10.1999 - 08.03.2000 - 148 days -0
07.09.2000 06.12.2000 90 days 0 days
07.04.2000 15.09.2000 22.09.2000 OJ C 308, 27.10.2000
81 EMEA Allgemeiner Tätigkeitsbericht 2000
78 EMEA General Report 2000
Gutachten des COMP zu Arzneimitteln für seltene Leiden 2000
Product - Brandname - INN - Part A/B
Arzneimittel
Company - Name - Origin
Investor
Therapeutic area - Target species - Indication
Indikation
Presentation - Form - Dosage - Number of presentations
EMEA/COMP - Vorlage - Validierung - Gutachten - Bearbeitungszeit
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
Kommission - Gutachten erhalten - Datum der Ausweisung
Commission - Opinion received - Date of Decision - Notification - Official Journal
Somatropin
Dicural Difloxacin Part B (extension)
Ares-Serono
Fort Dodge Animal Health NL
AIDS -wasting - 28.04.2000
Cattle & pigs Antibacterial for systemic use (QJ01MA)
-Serono AIDS-wasting -
Solution for injection 50 mg/ml 3
- 17.07.2000
- 16.12.1998 - 21.06.2000 - 203 days - 351 days
15.06.2000 11.07.2000 27 days
21.07.2000 24.10.2000 25.10.2000 OJ C 337, 28.11.2000
- 08.08.2000
Poulflox Difloxacin Part B
Alpha -
Virbac S.A.
TKT Europe-
Poultry Antibacterial for systemic use (QJ01MA94)
Treatment of Fabry disease
Oral solution 100 mg/ml 3
- TKT Europe - Treatment of Fabry disease -
- 09.12.1999 - 21.06.2000 - 152 days - 43 days
- 17.07.2000
- 21.07.2000 - 16.11.2000 - OJ C 2, 05.01.2001
Galactosidase A
Bayovac CSF Marker Live vaccine Part A
5S AB
Bayer D
- - -
Pigs Marker vaccine against Classical Swine Fever (QJ57EA)
15.06.2000 11.07.2000 27 days
Emulsion for injection E2 glycoprotein of Classical Swine Fever virus 4
- 08.08.2000
- 16.12.1998 - 19.07.2000 - 210 days - 309 days
Alpha -
- 07.08.2000
- Genzyme BV Treatment of Fabry disease -
Porcilis AR -T- DF Inactivated vaccine Part A
12.05.2000
Intervet International NL
- 17.07.2000
Pigs Vaccine against atrophic rhinitis (QJ57EA)
Galactosidase A
Suspension for injection 2 ml 2
15.06.2000 11.07.2000 27 days
- 12.01.1999 - 19.07.2000 - 204 days - 336 days
- 08.08.2000
- 18.08.2000 - 16.11.2000 - OJ C 2, 05.01.2001
Fluorouracil
Pruban Rescortol butyrate Part B
Ethypharm S.A.
Intervet International NL
Treatment of glioblastoma
Dogs Anti-inflammatory for cutaneous inflammatory disorders (QD07AC90)
- - - -
Cream 1 mg/g 1
26.05.2000 31.07.2000 13.09.2000 45 days
- 15.09.1998 - 19.07.2000 - 196 days - 477 days
- 18.09.2000 - 18.10.2000
- 18.08.2000 - 16.11.2000 - OJ C 2, 05.01.2001
Gemtuzumab
Pirsue Pirlimycin Part B
Wyeth-Ayerst
Pharmacia Upjohn B
Treament of acute myeloid leukaemia - 07.06.2000
Dairy cattle Clinical & sub-clinical mastitis (QJ51FF90)
-Ayerst Treament of acute myeloid leukaemia -
Sterile solution for intramammary use 5 mg/ml 4
07.06.2000
- 12.01.1999 - 11.10.2000 - 210 days - 428 days
- 18.09.2000
- 10.11.2000
ozogamicin
Zubrin Tepoxalin Part B
Research
Schering - Plough UK
- - -
Oral lyophilisate 30,50,100 & 200 mg/ml 39
31.07.2000 13.09.2000 45 days
- 18.05.1999 - 08.11.2000 - 210 days - 330 days
- 18.10.2000
- 08.12.2000
1,5 -(Butylimino)-
Eurican herpes 205 Inactivated vaccine Part B
Oxford
Merial F
Treatment of Gaucher disease
Dogs Vaccine against canine herpes
-(Butylimino)- Oxford Treatment of Gaucher disease -
Powder plus solvent for emulsion for injection 1 ml 2
07.06.2000
- 13.07.1999 - 08.11.2000 - 209 days - 274 days
- 18.09.2000
- 08.12.2000
1,5-dideoxy, D-
79 EMEA General Report 2000
GlycoSciences - 31.07.2000
Establishment of maximum residue limits for new substances
-dideoxy, D - GlycoSciences -
Substance - INN
31.07.2000
Therapeutic area - Target species
- 18.10.2000
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
glucitol
Commission - Sent to Commission - Date of Regulation - Official Journal
Ltd
Bismuth subnitrate (extension)
- -
Bovine
13.09.2000 45 days
- 18.06.1999 - 13.10.1999 - 113 days -0
N -carbamyl-L-
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
Orphan Europe
Acetyl isovaleryl tylosin tartrate
Treatment of N-acetylglutamate
Porcine
-carbamyl-L- Orphan Europe Treatment of N-acetylglutamate -
- 18.10.1995 - 13.10.1999 - 195 days - 1260 days
- 18.09.2000
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
glutamic acid
Methylprednisolone
Sarl
Bovine
synthetase (NAGS) deficiency
- 13.07.1999 - 13.10.1999 - 92 days -0
- - -
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
31.07.2000 13.09.2000 45 days
Deltamethrin (extension)
- 18.10.2000
Fin fish
Arsenic trioxide
- 09.12.1999 - 08.03.2000 - 90 days -0
Voisin Consulting Sarl
- 07.04.2000 - 15.09.2000 - OJ L 234, 16.09.2000
Treatment of acute promyelocytic leukaemia
Tylosin (extension)
- - - -
Eggs
08.05.2000 15.06.2000 13.09.2000 90 days
- 09.11.1999 - 08.03.2000 - 90 days -0
- 18.09.2000 - 18.10.2000
- 07.04.2000 - 15.09.2000 - OJ L 234, 16.09.2000
Thalidomide
Dicyclanil
- - - -
Ovine
01.06.2000 25.08.2000 27.10.2000 64 days
25.02.1997 - 08.03.2000 - 281 days - 825 days
- 6.11.2000 - 29.12.2000
- 07.04.2000 - 15.09.2000 - OJ L 234, 16.09.2000
Anagrelide hydrochloride
Tilmicosin (extension)
- - - -
Rabbit
31.05.2000 31.07.2000 27.10.2000 89 days
- 16.07.1999 - 13.10.1999 - 86 days -0
- 6.11.2000 - 29.12.2000
- 12.11.1999 - 20.10.2000 - OJ L 269, 21.10.2000
Busulfan (intravenous use)
Flumequine (extension)
Pierre Fabre Médicament
Bovine milk & turkey
09.06.2000 31.07.2000 27.10.2000 89 days
- 27.07.1999 - 10.11.1999 - 89 days -0
- 6.11.2000 - 29.12.2000
- 09.12.1999 - 20.10.2000 - OJ L 269, 21.10.2000
Swedish Orphan AB
Tiamulin (extension)
05.06.2000 25.08.2000 27.10.2000 64 days
- 14.10.1999 - 12.01.2000 - 90 days -0
- 6.11.2000 - 29.12.2000
- 11.02.2000 - 20.10.2000 - OJ L 269, 21.10.2000
82 EMEA Allgemeiner Tätigkeitsbericht 2000
Dicyclanil (modification)
Investor
Sheep fat
EMEA/COMP - Vorlage - Validierung - Gutachten - Bearbeitungszeit
- 23.02.2000 - 17.05.2000 - 84 days -0
Kommission - Gutachten erhalten - Datum der Ausweisung
- 16.06.2000 - 27.10.2000 - OJ L 276, 28.10.2000
Ethyl eicosopentaenoate
Butafosfan (extension)
Laxdale Ltd
Dairy cattle
05.06.2000 31.07.2000 27.10.2000 89 days
- 19.01.2000 - 19.04.2000 - 90 days -0
- 6.11.2000 - 29.12.2000
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
Iloprost
Tilmicosin (extension)
Schering AG
Bovine milk
- - - -
- 22.02.1999 - 19.04.2000 - 203 days - 210 days
10.05.2000 31.07.2000 27.10.2000 89 days
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- 6.11.2000 - 29.12.2000
Phoxim (extension)
...
Ovine
- - - -
- 19.01.2000 - 19.04.2000 - 90 -0
07.08.2000 25.08.2000 21.11.2000 89 days
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
Treatment of acute promyelocytic
80 EMEA General Report 2000
- - -
Substance - INN
22.09.2000 21.11.2000 61 days
Therapeutic area - Target species
......
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
Treatment of acute respiratory distress syndrome
Commission - Sent to Commission - Date of Regulation - Official Journal
01.09.2000 22.09.2000 21.11.2000 61 days
Flumethrin (extension)
......
Ovine
Treatment of cystic fibrosis
- 19.01.2000 - 19.04.2000 - 90 days -0
-
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
09.08.2000
Flunixin (extension)
- - -
Equine
22.09.2000 19.12.2000 89 days
- 23.03.2000 - 21.06.2000 - 90 days -0
......
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
Treatment of patent ductus arteriosus
Toltrazuril (extension)
- - - -
Porcine
02.05.2000 19.10.2000 19.12.2000 62 days
- 16.02.1999 - 21.06.2000 - 206 days - 284 days
Treatment of glycogen storage disease
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
10.08.2000
Thiamphenicol (extension)
-
Porcine, Ovine, Turkey, Fish
type II (Pompe’s disease)
- 15.05.1998 - 21.06.2000 - 206 days - 562 days
- - -
- 08.11.2000
19.10.2000 19.12.2000 62 days
Difloxacin (extension)
Treatment of acromegaly
Bovine, Porcine
- - - -
- 14.07.1998 - 21.06.2000 - 205 days - 503 days
11.08.2000 19.10.2000 19.12.2000 62 days
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
-
Halofuginone
......
Bovine
Treatment of pulmonary arterial
- 10.12.1996 - 21.06.2000 - 281 days - 1008 days
-
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
21.08.2000
Linear dodecyl benzene sulfonic acid
-
Bovine
hypertension and chronic thromboembolic pulmonary hypertension
- 22.01.1999 - 19.07.2000 - 195 days - 321 days
- - -
- 18.08.2000
19.10.2000 19.12.2000 62 days
Phoxim (extension)
Treatment of haemorrhagic fever with renal syndrome
- 19.01.2000 - 19.07.2000 - 120 days -0
- - - -
- 18.08.2000
06.09.2000 19.10.2000 19.12.2000 62 days
Acetyl isovaleryl tylosin tartrate
......
Porcine
Treatment of mucopolysaccharidosis
- 18.01.1995 - 13.09.2000 - 274 days - 1790 days
- - -
- 18.02.2000
19.10.2000 19.12.2000 62 days
Florfenicol (extension)
......
Fish
Treatment of chronic myeloid leukaemia
- 29.01.1996 - 11.11.2000 - 212 days - 1504 days
- - - -
- 08.11.2000
03.10.2000 19.10.2000 19.12.2000 62 days
Meloxicam (extension)
Mucopolysaccharidosis type VI
- 07.09.2000 - 06.12.2000 - 90 days - 0 days
-
- 04.01.2001
04.10.2000
Tilmicosin z(extension)
(Maroteaux
Turkey
-Lamy Syndrome)
- 07.09.2000 - 06.12.2000 - 90 days - 0 days
- - -
- 04.01.2001
83 EMEA Allgemeiner Tätigkeitsbericht 2000
81 EMEA General Report 2000
Anhang 11:
Annex 10:
EMEA-Leitlinien 2000 CPMP-Arbeitsgruppe Biotechnologie
COMP opinions in 2000 on orphan medicinal products
Dokumentennummer
Product
Leitlinien/Stand
Sponsor
EMEA/CPMP/BWP/840/00
Indication