ENEA'S CASE - Ligneous Conjunctivitis - HUMAN PLASMINOGEN: EMEA

Document Date: 22 December, 2009
European Medicines Agency Meetings & Events - Scientific Committee Meetings Year 2010

Meetings & Events - Scientific Committee Meetings Year 2010
- COMP Committee for Orphan Medicinal Products
- - - Link: http://www.ema.europa.eu/meetings/committee.htm

EMEA: HUMAN PLASMINOGEN : Treatment of ligneous conjunctivitis
POSITIVE OPINION FOR ORPHAN DESIGNATION

Document Date: London, 16 January 2008
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use
Document Date: London, 16 January 2008 Doc.Ref.: EMEA/COMP/285792/2007
COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS
PUBLIC SUMMARY OF POSITIVE OPINION FOR ORPHAN DESIGNATION
OF human plasminogen for the treatment of ligneous conjunctivitis
On 3 August 2007, orphan designation (EU/3/07/461) was granted by the European Commission
to Kedrion S.p.A., Italy, for human plasminogen for the treatment of ligneous conjunctivitis.
- - - Link: http://www.emea.europa.eu/pdfs/human/comp/opinion/28579207en.pdf

Translations of the active ingredient and indication in all EU languages and Norwegian and Icelandic

Language	Active Ingredient	Indication
English	Human plasminogen	Treatment of ligneous conjunctivitis
Bulgarian
Czech	Lidský plazminogen	Lécba konjuktivitidy lignea
Danish	Humant plasminogen	Behandling af conjunctivitis lignosa
Dutch	Humaan plasminogen	Behandeling van conjunctivitis lignosa
Estonian	Inimese plasminogeen	Ligneoosse sidekestapõletiku ravi
Finnish	Ihmisen plasminogeeni	Conjunctivitis lignosan hoitoon
French	Plasminogène humain	Traitement de la conjonctivite ligneuse
German	Humanes Plasminogen	Behandlung der Konjunktivitis lignosa
Greek
Hungarian	Humán plazminogén	Conjunctivitis lignosa kezelése
Italian	Plasminogeno umano	Trattamento delle congiuntivite lignea
Latvian	Cilveka plazminogens	Fibroza konjunktivita arstešana
Lithuanian	Žmogaus plazminogenas	Medžiu žiedadulkiu sukelto konjunktyvito gydymas
Maltese	Plasminogen uman	Kura tal-konguntivite linjuza
Polish	Plazminogen ludzki	Leczenie zapalenia spojówek z tworzeniem pseudoblony
Portuguese	Plasminogénio humano	Tratamento da conjuntivite lenhosa
Romanian	Plasminogen uman	Tratamentul conjunctivitei lemnoase
Slovak	Ludský plazminogén	Liecba ligneóznej konjunktivit?dy
Slovenian	Cloveški plazminogen	Tretma lesastega vnetja ocesnih veznic
Spanish	Plasminógeno humano	Tratamiento de la conjuntivitis leñosa
Swedish	Human plasminogen	Behandling av träartad konjunktivit
Norwegian	Human plasminogen	Behandling av conjunctivitis lignosa
Icelandic	Forplasmín úr mönnum	Meðferð við trjákenndri tárubólgu (iigneous conjunctivitis)

EMEA: Human Plasminogen,
Orphan Medicinal Product Designations received since the July 2007 COMP Meeting

Document Date: 12 September 2007
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use
Document Date: 12 September 2007 Doc.Ref.: EMEA/COMP/420207/2007
COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS
PRESS RELEASE
Committee for Orphan Medicinal Products
September 2007 Meeting

The eighty-second meeting of the Committee for Orphan Medicinal Products (COMP) took place on
11-12 September 2007.
The Committee adopted its 500th opinion on orphan designation at this meeting. This is a clear sign of
the successful implementation of the orphan regulation. It is also a strong indication of the continuous
effort of all stakeholders and the commitment and dedication of the COMP and the EMEA.

ANNEX 1 to COMP September 2007
Press Release
Orphan Medicinal Product Designations received since the July 2007 COMP Meeting

Active substance	Human plasminogen
Sponsor	Kedrion S.p.A.
Orphan Indication	Treatment of ligneous conjunctivitis
Opinion receipt	date 9 July 2007
Date of Commission Decision	3 August 2007

- - - Link: http://www.ema.europa.eu/pdfs/human/comp/42020707en.pdf

EMEA: HUMAN PLASMINOGEN: POSITIVE OPINION

Document Date: 27 June 2007
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use
Document Date: 27 June 2007 Doc.Ref.: EMEA/COMP/276840/2007 Corr.
COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS
PRESS RELEASE
Committee for Orphan Medicinal Products
June 2007 Meeting

The eightieth meeting of the Committee for Orphan Medicinal Products (COMP) took place on 26-27 June 2007.
COMP Opinions for Orphan Medicinal Product Designation

The Committee adopted 10 positive opinions on orphan medicinal product designation during this meeting:

• Arsenic trioxide, Cephalon Europe, for treatment of acute myeloid leukaemia (review time: day 62)

• Ciprofloxacin (inhalation use), from Bayer Healthcare AG, for treatment of cystic fibrosis (review time: day 90)

• Dihydroartemisinin, piperaquine, from Sigma Tau Industrie Farmaceutiche Riunite S.p.A, for treatment of malaria (review time: day 90)

• Human plasminogen, from Kedrion S.p.A, for treatment of ligneous conjunctivitis (review time: day 62)

• Eltrombopag olamine, GlaxoSmithKline Research & Development Limited, for treatment of idiopathic thrombocytopenic purpura (review time: day 62)

• L-threo-3,4-dihydroxyphenylserine, The Weinberg Group LLC, for treatment of orthostatic hypotension in patients with multiple system atrophy (review time: day 62)

• L-threo-3,4-dihydroxyphenylserine, The Weinberg Group LLC, for treatment of orthostatic hypotension in patients with pure autonomic failure (review time: day 62)

• Panobinostat lactate, from Novartis Europharm Limited, for treatment of cutaneous T-Cell Lymphoma (review time: day 62)

• Pyridoxalated hemoglobin polyoxyethylene, Curacyte AG, for treatment of cardiogenic shock (review time: day 62)

• Recombinant human soluble Fc-gamma receptor II b, SuppreMol GmbH, for treatment of idiopathic thrombocytopenic purpura (review time: day 62)

- - - Link: http://www.ema.europa.eu/pdfs/human/comp/27684007en.pdf

FDA: Documents
EVALUATION AND RESEARCH AND PLASMA PROTEIN THERAPEUTICS ASSOCIATION
COMPARABILITY STUDIES FOR HUMAN PLASMA-DERIVED THERAPEUTICS

Document Date: Rockville, Maryland, May 30, 2002

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH AND PLASMA PROTEIN THERAPEUTICS ASSOCIATION
COMPARABILITY STUDIES FOR HUMAN PLASMA-DERIVED THERAPEUTICS
Thursday, May 30, 2002 - 8:00 a.m.
Doubletree Hotel - Rockville, Maryland
MILLER REPORTING CO., INC. 735 - 8TH STREET, S.E. WASHINGTON, D.C. 20003 (202) 546-6666
- - - Link: http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/UCM054605.pdf