natgillin/translations-raw huggingface dataset:
Recombinant human acid sphingomyelinase
Recombinant human acid sphingomyelinase
Genzyme BV
• Genzyme BV
Treatment of Niemann- Pick disease, type B
Treatment of Niemann-Pick disease, type B
26. 02. 2001 11. 06. 2001 18. 07. 2001 38 days
• 26.02.2001 • 11.06.2001 • 18.07.2001 • 38 days
Repertaxin L- lysine salt
• Repertaxin L-lysine salt
Dompé s. p. a.
Dompé s.p.a.
Prevention of delayed graft function in organ transplant
Prevention of delayed graft function in organ transplant
05. 04. 2001 20. 04. 2001 18. 07. 2001 90 days
• 20.04.2001 • 18.07.2001 • 90 days
25. 07. 2001 19. 09. 2001
• 19.09.2001
Porcine lung surfactant
• Porcine lung surfactant
Treatment of Acute Lung Injury
Treatment of Acute Lung Injury
23. 05. 2001
• 23.05.2001
25. 07. 2001
• 25.07.2001
11. 06. 2001 18. 07. 2001 38 days
• 11.06.2001 • 18.07.2001 • 38 days
19. 09. 2001
• 19.09.2001
Dexrazoxane
• Dexrazoxane
TopoTarget A/ S
• TopoTarget A/S
Treatment of anthracycline extravasations
Treatment of anthracycline extravasations
24. 05. 2001 11. 06. 2001 18. 07. 2001 38 days
• 11.06.2001 • 18.07.2001 • 38 days
Pemetrexed disodium
• Pemetrexed disodium
25. 05. 2001 11. 06. 2001 18. 07. 2001 54 days
• 11.06.2001 • 18.07.2001 • 54 days
25. 07. 2001 17. 09. 2001
• 17.09.2001
Sponsor
•
Deoxyribose phosphorothioate (5 ’ - tct - ccc- agc- gtg- cgc- cat- 3 ’)
Deoxyribose phosphorothioate (5’- tct-ccc-agc-gtg-cgc-
Voisin Consulting SARL
• Voisin Consulting SARL
Treatment of chronic lymphocytic leukaemia
Treatment of chronic lymphocytic leukaemia
23. 05. 2001 30. 07. 2001 07. 09. 2001 40 days
• 07.09.2001 • 40 days
17. 09. 2001 20. 11. 2001
EMEA/COMP • Validation • Opinion • Active time • Clock stop
Idebenone
• Idebenone
Laboratoires Takeda
• Laboratoires Takeda
Treatment of Friedreich’ s ataxia
• Treatment of Friedreich’s ataxia
12. 07. 2001 30. 07. 2001 07. 09. 2001 40 days
• 12.07.2001 • 30.07.2001 • 07.09.2001 • 40 days
17. 09. 2001 20. 11. 2001
• 17.09.2001 • 20.11.2001
Imatinib mesilate
• Imatinib mesilate
Treatment of malignant gastrointestinal stromal tumours
Treatment of malignant gastrointestinal stromal tumours
13. 07. 2001 30. 07. 2001 07. 09. 2001 40 days
• 30.07.2001 • 07.09.2001 • 40 days
17. 09. 2001 20. 11. 2001
• 20.11.2001
Celecoxib
• Celecoxib
Pharmacia- Pfizer EEIG
• Pharmacia-Pfizer EEIG
Treatment of Familial Adenomatous Polyposis (FAP)
Treatment of Familial Adenomatous Polyposis (FAP)
04. 04. 2001 11. 06. 2001 07. 09. 2001 89 days
• 11.06.2001 • 07.09.2001 • 89 days
Phenylephrine hydrochloride
Phenylephrine hydrochloride
S. L. A Pharma (UK) Ltd
• S.L.A Pharma (UK) Ltd
Treatment of ileal pouch anal anastomosis (IPAA) related faecal incontinence
Treatment of ileal pouch anal anastomosis (IPAA) related faecal incontinence
29. 09. 2001 11. 06. 2001 07. 09. 2001 89 days
• 29.09.2001 • 11.06.2001 • 07.09.2001 • 89 days
Pharmion Ltd
• Pharmion Ltd
13. 07. 2001 30. 07. 2001 07. 09. 2001 40 days
• 13.07.2001 • 30.07.2001 • 07.09.2001 • 40 days
Pharmion Ltd
Pharmion Ltd
Treatment of erythema nodosum leprosum (ENL) or type II lepra reactions
Treatment of erythema nodosum leprosum (ENL) or type II lepra
Abetimus sodium
• Abetimus sodium
ICON Clinical Research UK Ltd
ICON Clinical Research UK Ltd
Treatment of lupus nephritis
Treatment of lupus nephritis
25. 05. 2001 11. 06. 2001 07. 09. 2001 89 days
• 11.06.2001 • 07.09.2001 • 89 days
Deoxyribose phosphorothioate (5 ’ - tct - ccc- agc- gtg- cgc- cat- 3 ’)
Deoxyribose phosphorothioate (5’-
17. 09. 2001 20. 11. 2001
•
Recombinant human monoclonal antibody to hsp90
Recombinant human monoclonal antibody to hsp90
NeuTec Pharma plc
• NeuTec Pharma plc
Treatment of invasive fungal infections
Treatment of invasive fungal infections
11. 04. 2001 11. 06. 2001 07. 09. 2001 89 days
• 11.04.2001 • 11.06.2001 • 07.09.2001 • 89 days
17. 09. 2001 05. 12. 2001
• 17.09.2001 • 05.12.2001
Apomorphine
• Apomorphine
Orion Corporation
• Orion Corporation
Treatment of off- periods in Parkinson’ s disease not responding
Treatment of off-periods in Parkinson’s disease not
25. 05. 2001
• 25.05.2001
17. 09. 2001
• 17.09.2001
to other oral treatment
responding to other oral
11. 06. 2001 07. 09. 2001 89 days
• 07.09.2001 • 89 days
Stiripentol
• Stiripentol
Laboratoires BIOCODEX
• Laboratoires BIOCODEX
Treatment of severe myoclonic epilepsy in infancy
Treatment of severe myoclonic epilepsy in infancy
04. 06. 2001 30. 07. 2001 07. 09. 2001 40 days
• 30.07.2001 • 07.09.2001 • 40 days
17. 09. 2001 05. 12. 2001
• 05.12.2001
Halofuginone hydrobromide
Halofuginone hydrobromide
PPD Global Ltd
• PPD Global Ltd
Treatment of systemic sclerosis
• Treatment of systemic sclerosis
12. 07. 2001
• 12.07.2001
05. 11. 2001
• 05.11.2001
30. 07. 2001 26. 10. 2001 89 days
• 30.07.2001 • 26.10.2001 • 89 days
11. 12. 2001
• 11.12.2001
Denileukin diftitox (Onzar)
• Denileukin diftitox (Onzar)
Ligand Pharmaceuticals
• Ligand Pharmaceuticals
Treatment of cutaneous T- cell Lymphoma
• Treatment of cutaneous T-cell Lymphoma
12. 07. 2001 30. 07. 2001 26. 10. 2001 89 days
• 12.07.2001 • 30.07.2001 • 26.10.2001 • 89 days
05. 11. 2001 11. 12. 2001
• 05.11.2001 • 11.12.2001
Octovalent Pseudomonas aeruginosa O - polysaccharide- toxin A conjugate vaccine
Octovalent Pseudomonas aeruginosa O- polysaccharide-toxin A conjugate vaccine
Prevention of Pseudomonas aeruginosa infections in patients with cystic fibrosis
Prevention of Pseudomonas aeruginosa infections in patients with cystic fibrosis
20. 07. 2001 24. 08. 2001 26. 10. 2001 64 days
• 20.07.2001 • 24.08.2001 • 26.10.2001 • 64 days
gly2- Recombinant human glucagon- like peptide
gly2-Recombinant human glucagon-like peptide
Pharm Research Associates (UK) Ltd
Pharm Research Associates (UK) Ltd
Treatment of short bowel syndrome
Treatment of short bowel syndrome
09. 08. 2001 24. 08. 2001 26. 10. 2001 64 days
• 09.08.2001 • 24.08.2001 • 26.10.2001 • 64 days
Iduronate- 2- sulfatase
• Iduronate-2-sulfatase
TKT UK Ltd
• TKT UK Ltd
Treatment of Mucopolysaccharidosis type II (Hunter Syndrome)
Treatment of Mucopolysaccharidosis type II
05. 09. 2001 20. 09. 2001 26. 10. 2001 37 days
• 20.09.2001 • 26.10.2001 • 37 days
05. 11. 2001 11. 12. 2001
• 11.12.2001
Kendle International Ltd
• Kendle International Ltd
23. 05. 2001
•
17. 09. 2001
Treatment of multiple myeloma
30. 07. 2001 07. 09. 2001 40 days
• 23.05.2001 • 30.07.2001 • 07.09.2001 • 40 days
19. 12. 2001
• 17.09.2001 • 19.12.2001
♣
•† •†
♣
•
Treatment of acute lung injury
Treatment of acute lung injury
27. 03. 2001 24. 08. 2001 21. 11. 2001 90 days
• 27.03.2001 • 24.08.2001 • 21.11.2001 • 90 days
Treatment of diarrhoea associated with intestinal microsporidial infection
Treatment of diarrhoea associated with intestinal
29. 05. 2001 20. 09. 2001 21. 11. 2001 63 days
• 20.09.2001 • 21.11.2001 • 63 days
♣
•†
Treatment of acute lymphoblastic leukaemia
Treatment of acute lymphoblastic leukaemia
09. 08. 2001 24. 08. 2001 21. 11. 2001 90 days
• 24.08.2001 • 21.11.2001 • 90 days
Treatment of systemic sclerosis
Treatment of systemic sclerosis
28. 08. 2001 20. 09. 2001 21. 11. 2001 62 days
• 28.08.2001 • 20.09.2001 • 21.11.2001 • 62 days
Treatment of high- grade glioma with subsequent use of ganciclovir sodium
Treatment of high-grade glioma with subsequent use of
04. 09. 2001 20. 09. 2001 21. 11. 2001 62 days
• 20.09.2001 • 21.11.2001 • 62 days
Sponsor
•†
Indikation
•† •†
EMEA/ COMP Godkendelse Udtalelse Nettotid Urstop
•
Europa - Kommissionen Udtalelse modtaget Dato for afgørelsen
Treatment of myelodysplastic syndromes
♣
• 05.09.2001
05. 09. 2001 20. 09. 2001 21. 11. 2001 62 days
• 20.09.2001 • 21.11.2001 • 62 days
Treatment of glioma
• Treatment of glioma
12. 10. 2001 26. 10. 2001 18. 12. 2001 54 days
• 12.10.2001 • 26.10.2001 • 18.12.2001 • 54 days
Treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic
• Treatment of Pseudomonas aeruginosa lung infection
06. 09. 2001 26. 10. 2001
• 26.10.2001
fibrosis
fibrosis
18. 12. 2001 54 days
• 18.12.2001 • 54 days
Treatment of Familial Adenomatous Polyposis (FAP).
Treatment of Familial Adenomatous Polyposis (FAP)
09. 08. 2001 26. 10. 2001 18. 12. 2001 54 days
• 26.10.2001 • 18.12.2001 • 54 days
Treatment of high- grade dysplasia in Barrett’ s Esophagus
Treatment of high-grade dysplasia in Barrett’s Esophagus
11. 10. 2001 26. 10. 2001 18. 12. 2001 54 days
• 26.10.2001 • 18.12.2001 • 54 days
♣ Afventer vedtagelse af Europa- Kommissionens afgørelse Bilag 10 Retningslinjer og arbejdsdokumenter i 2001
Annex 10 Guidelines and working documents in 2001
CPMP- arbejdsgruppe vedrørende bioteknologi
CPMP Biotechnology Working Party
Referencenummer CPMP/ BWP/ 269/ 95 Rev.
3
Titel på dokumentet Note for guidance on plasma- derived medicinal products
Note for guidance on plasma-derived medicinal products
Status Sendt til høring i januar 2001
Released for consultation January 2001
CPMP/ BWP/ 2490/ 99
CPMP/BWP/2490/00
Note for guidance on cell culture inactivated influenza vaccines – Annex to Note for guidance on harmonisation of requirements for influenza vaccines CPMP/ BWP/ 214/ 96
Note for guidance on cell culture inactivated influenza vaccines – Annex to Note for guidance on harmonisation of requirements for influenza vaccines CPMP/BWP/214/96
Sendt til høring i januar 2001
Released for consultation January 2001
CPMP/ BWP/ 3088/ 99
CPMP/BWP/3088/99
Note for guidance on the quality, pre- clinical and clinical aspects of gene transfer medicinal products
Note for guidance on the quality, pre-clinical and clinical Adopted April 2001 aspects of gene transfer medicinal products
EMEA/ 410/ 01 Rev.
EMEA/410/01 Rev.
Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products
Note for guidance on minimising the risk of transmitting Adopted by CPMP and CVMP May 2001 animal spongiform encephalopathy agents via human and veterinary medicinal products
CPMP/ BWP/ 3207/ 99
CPMP/BWP/3207/00
Note for guidance on comparability of medicinal products containing biotechnology- derived proteins as drug substance
Note for guidance on comparability of medicinal products containing biotechnology-derived proteins as drug substance
Vedtaget i september 2001
Adopted September 2001
CPMP- arbejdsgruppe vedrørende blodpræparater
CPMP Blood and Plasma Working Group
Referencenummer EMEA/ CPMP/ BPWG/ 283/ 99
Reference number
Titel på dokumentet Note for Guidance on the clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use
Document title
Status Sendt til høring i marts 2001
Status
EMEA/ CPMP/ BPWG/ 1089/ 99
EMEA/CPMP/BPWG/283/00
Note for guidance on the clinical investigation of plasma derived fibrin sealants
EMEA/CPMP/BPWG/1089/00 Note for guidance on the clinical investigation of plasma derived fibrin sealants
Sendt til høring i december 2001
Released for consultation December 2001
CPMP- arbejdsgruppe vedrørende virkninger
CPMP Efficacy Working Party
Referencenummer EMEA/ CPMP/ EWP/ 552/ 95 rev.
1
Titel på dokumentet Note for guidance on postmenopausal osteoporosis in women
Note for guidance on postmenopausal osteoporosis in women
Status Vedtaget i januar 2001
Adopted January 2001
EMEA/ CPMP/ EWP/ 49/ 99
EMEA/CPMP/EWP/49/01
Concept paper on the development of an Appendix to the CPMP Note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia, on methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia
Concept paper on the development of an Appendix to the CPMP Note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia, on methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia
Vedtaget i marts 2001
Adopted March 2001
EMEA/ CPMP/ EWP/ 18/ 99
EMEA/CPMP/EWP/18/01
Concept paper on the development of a CPMP Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence in women
Concept paper on the development of a CPMP Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence in women
CPMP/ EWP/ 567/ 98, rev.
1
Note for guidance on clinical investigation of medicinal products for the treatment and prevention of bipolar disorder
Note for guidance on clinical investigation of medicinal products for the treatment and prevention of bipolar disorder
Vedtaget i april 2001
Adopted April 2001
CPMP/ EWP/ 205/ 95, rev.
1
Note for guidance on evaluation of anticancer medicinal products in man
Note for guidance on evaluation of anticancer medicinal Adopted May 2001 products in man
EMEA/ CPMP/ EWP/ 1045/ 99
EMEA/CPMP/EWP/1045/01
Concept paper on the revision of the CPMP/ BWP Note for guidance (CPMP/ BWP/ 214/ 96) on harmonisation of requirements for influenza vaccines
Concept paper on the revision of the CPMP/BWP Adopted May 2001 Note for guidance (CPMP/BWP/214/96) on harmonisation of requirements for influenza vaccines
EMEA/ CPMP/ EWP/ 967/ 99
EMEA/CPMP/EWP/967/01
Concept paper on the development of a CPMP Note for guidance on the evaluation of medicinal products indicated for thrombolysis in acute myocardial infarction
Concept paper on the development of a CPMP Note for guidance on the evaluation of medicinal products indicated for thrombolysis in acute myocardial infarction
Vedtaget i maj 2001
Adopted May 2001
EMEA/ CPMP/ EWP/ 512/ 99
EMEA/CPMP/EWP/512/01
Concept paper on the development of a CPMP Note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia
Concept paper on the development of a CPMP Note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia
EMEA/ CPMP/ EWP/ 788/ 99
EMEA/CPMP/EWP/788/01
Concept paper on the development of a CPMP Note for Guidance on the evaluation of medicinal products for treatment of migraine
Concept paper on the development of a CPMP Note for Guidance on the evaluation of medicinal products for treatment of migraine
EMEA/ CPMP/ EWP/ 2330/ 99
EMEA/CPMP/EWP/2330/99
Points to consider on application with 1) meta - analyses and 2) one pivotal study
Points to consider on application with 1) meta-analyses and 2) one pivotal study
EMEA/ CPMP/ EWP/ 2284/ 99
EMEA/CPMP/EWP/2284/99
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
Vedtaget i juni 2001
Adopted June 2001
EMEA/ CPMP/ EWP/ 1417/ 98
EMEA/CPMP/EWP/PhVWP/ 1417/01
Joint PhVWP/ EWP Concept paper on the development of a CPMP Note for Guidance on the use of medicinal products during pregnancy: need for post- marketing data
Joint PhVWP/EWP Concept paper on the development of a CPMP Note for guidance on the use of medicinal products during pregnancy: need for post-marketing data
EMEA/ CPMP/ EWP/ 1343/ 99
EMEA/CPMP/EWP/1343/01
Concept paper on the development of a CPMP Points to consider document on the evaluation of new anti- fungal agents for invasive fungal infections
Concept paper on the development of a CPMP Points to consider document on the evaluation of new anti-fungal agents for invasive fungal infections
Vedtaget i juli 2001
Adopted July 2001
CPMP/ EWP/ 1401/ 98, rev.
1
Note for guidance on the investigation of bioavailability and bioequivalence
Note for guidance on the investigation of bioavailability and bioequivalence
EMEA/ CPMP/ EWP/ 561/ 98
EMEA/CPMP/EWP/561/98
Note for guidance on clinical investigation of medicinal products for the treatment of multiple sclerosis
Note for guidance on clinical investigation of medicinal products for the treatment of multiple sclerosis
EMEA/ CPMP/ EWP/ 1533/ 99
EMEA/CPMP/EWP/1533/01
Concept paper on the development of an addendum on acute cardiac failure to the CPMP Note for Guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure
Concept paper on the development of an addendum on acute cardiac failure to the CPMP Note for guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure
EMEA/ CPMP/ EWP/ 560/ 98
EMEA/CPMP/EWP/560/98
Points to consider on Clinical investigation of medicinal products for the treatment of acute stroke
Points to consider on Clinical investigation of medicinal products for the treatment of acute stroke
Note for Guidance on co- ordinating investigator signature of clinical study reports
Note for guidance on co-ordinating investigator signature of clinical study reports
Vedtaget i oktober 2001
Adopted October 2001
EMEA/ CPMP/ EWP/ 2991/ 2
EMEA/CPMP/EWP/2991/01 draft 2
Concept paper on the development of an addendum on the clinical requirements of modified release medicinal products submitted as a line- extension of an existing marketing authorisation to the CPMP Note for guidance on modified release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation) (CPMP/ EWP/ 280/ 96)
Concept paper on the development of an addendum on the clinical requirements of modified release medicinal products submitted as a line-extension of an existing marketing authorisation to the CPMP Note for guidance on modified release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation) (CPMP/EWP/280/96)
Vedtaget i november 2001
Adopted November 2001
EMEA/ CPMP/ EWP/ 1119/ 98
EMEA/CPMP/EWP/1119/98
Points to consider on the evaluation of diagnostic agents
Points to consider on the evaluation of diagnostic agents
EMEA/ CPMP/ EWP/ 1776/ 99 CPMP/ BPWG/ 602/ 95 rev.
Points to consider on missing data
Points to consider on missing data Points to consider on the assessment of anti- HIV medicinal products
Points to consider on the assessment of anti-HIV medicinal products
Vedtaget i november 2001 Vedtaget i december 2001
Adopted December 2001
CPMP/ EWP/ 1776/ 99 draft 5 CPMP/ EWP/ 908/ 99
CPMP/EWP/1776/99 draft 5
Points to consider on missing data Points to consider on multiplicity issues in clinical trials
Points to consider on missing data
Sendt til høring i januar 2001 Sendt til høring i juli 2001
Released for consultation January 2001
CPMP/ EWP/ 2863/ 99
CPMP/EWP/2863/99
Points to consider on adjustment for baseline covariates
Points to consider on adjustment for baseline covariates
CPMP/ 602/ 00/ rev. 1
1
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders
Note for guidance on clinical investigation of medicinal products in the treatment of depression
Sendt til høring i april 2001
Released for consultation April 2001
CPMP/ EWP/ 1080/ 98
CPMP/EWP/1080/00
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders
Note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus
Sendt til høring i juli 2001
Released for consultation July 2001
CPMP/ EWP/ 18/ 98
CPMP/EWP/18/01
Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence in women
Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence in women
Sendt til høring i november 2001
Released for consultation November 2001
CPMP/ EWP/ 612/ 00 draft 7
CPMP/EWP/612/00 draft 7
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders
Note for guidance on clinical investigation of medicinal products for treatment of pain
CPMP/ EWP/ 2922/ 00 draft 6
CPMP/EWP/2922/00 draft 6
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders
Note for guidance on the clinical investigation of medicinal products in the treatment of asthma
Sendt til høring i november 2001
Released for consultation November 2001 EMEA Annual Report 2001 63
Referencenummer CPMP/ PhVWP/ 1618/ 01
CPMP/PhVWP/1618/01
Titel på dokumentet Position paper on compliance with pharmacovigilance regulatory obligations
Position paper on compliance with pharmacovigilance regulatory obligations
Status Vedtaget i november 2001
Adopted November 2001
CPMP/ EWP/ PhVWP/ 1417/ 0 1
CPMP/EWP/PhVWP/1417/01
Concept paper on the development of a CPMP Note for guidance on the use of medicinal products during pregnancy:
Concept paper on the development of a CPMP Note for guidance on the use of medicinal products during pregnancy:
Need for post - marketing data
Need for post-marketing data
CPMP/ SWP/ 373/ 01
CPMP/SWP/373/01
Concept paper on the development of a CPMP Note for guidance on risk assessment of medicinal products on human reproductive and development toxicities:
Concept paper on the development of a CPMP Note for guidance on risk assessment of medicinal products on human reproductive and development toxicities:
From data to labelling
From data to labelling
CPMP/ PhVWP/ 175/ 95
CPMP/PhVWP/175/95
Note for guidance on the procedure for competent authorities on the undertaking of pharmacovigilance activities
Note for guidance on the procedure for competent authorities on the undertaking of pharmacovigilance activities
Offentliggjort af Europa - Kommissionen i december 2001 i bind 9 af 2001- udgaven af bestemmelserne om lægemidler i Den Europæiske Union
Published by the European Commission in December 2001 in volume 9 of the 2001 edition of the Rules governing medicinal products in the European Union
CPMP/ 183/ 97
CPMP/183/97
Note for guidance on the conduct of pharmacovigilance for centrally authorised products
Note for guidance on the conduct of pharmacovigilance for centrally authorised products
CPMP/ PhVWP/ 108/ 99
CPMP/PhVWP/108/99
Notice to marketing authorisation holders – pharmacovigilance guidlines
Notice to marketing authorisation holders - pharmacovigilance guidlines
CPMP- arbejdsgruppe vedrørende sikkerhed
CPMP Safety Working Party
Referencenummer CPMP/ SWP/ 2145/ 99
CPMP/SWP/2145/00
Titel på dokumentet Update of Note for guidance on non- clinical local tolerance testing of medicinal products
Update of Note for guidance on non-clinical local tolerance testing of medicinal products
Status Vedtaget i marts 2001
Adopted March 2001
CPMP/ SWP/ 372/ 99
CPMP/SWP/372/01
Points to consider document on the non- clinical assessment of the carcinogenic potential of insulin analogues
Points to consider document on the non-clinical assessment of the carcinogenic potential of insulin analogues
CPMP/ SWP/ 2877/ 99
CPMP/SWP/2877/00
opdatering af vejledningsnotat om kræftfremkaldende potentiale
Update of Note for guidance on carcinogenic potential
CPMP/ SWP/ 4447/ 99
CPMP/SWP/4447/00
diskussionsoplæg om vurdering af miljørisici i forbindelse med lægemidler
Discussion paper on environmental risk assessments for pharmaceuticals
CPMP/ SWP/ 446/ 99
CPMP/SWP/446/00
Note for guidance on specification limits for residues of heavy metal catalysts in medicinal products
Note for guidance on specification limits for residues of heavy metal catalysts in medicinal products
CPMP/ SWP/ 398/ 99 CPMP/ SWP/ 2600/ 99
Released for consultation March 2001
vejledningsnotat om afprøvning af fotosikkerhed dokument med "punkter, som bør tages i betragtning" vedrørende behovet for reproduktionsundersøgelser i forbindelse med udviklingen af humane insulinanaloge præparater
Points to consider document on the need for reproduction studies in the development of insulin analogues
Sendt til høring i marts 2001 Sendt til høring i september 2001
Released for consultation September 2001
EMEA' s arbejdsgruppe vedrørende urtemedicin
EMEA Herbal Medicinal Products Working Party
Referencenummer EMEA/ 18123/ 00- DA
Reference number
Titel på dokumentet Compilation of general quality questions answered by the Herbal Medicinal Products Working Party
Compilation of general quality questions answered by the Herbal Medicinal Products Working Party
Status Godkendt i marts 2001
Endorsed in March 2001
EMEA/ HMPWP/ 31/ 99 Rev 1
EMEA/HMPWP/31/99 Rev 1
Points to consider on good agricultural and collection practice for starting materials of herbal origin
Points to consider on good agricultural and collection practice for starting materials of herbal origin
CVMP- arbejdsgruppe vedrørende virkninger
CVMP Efficacy Working Party
Referencenummer EMEA/ CVMP/ 016/ 00
EMEA/CVMP/016/00