What's New - February 2010

Call for expression of interest for National Experts on Secondment

- Expert on Secondment for Safety of Veterinary Medicines Sector

Updated referral for:

Extraneal INN: icodextrin

CHMP revised EPARs on:

MabCampath INN: alemtuzumab Rev. 12
Torisel INN: temsirolimus Rev. 5
Kinzalmono INN: telmisartan Rev. 16
Kepivance INN: palifermin Rev. 12
Gardasil Common name: human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed) Rev. 14
Micardis INN: telmisartan Rev. 15
Pritor INN: telmisartan Rev. 16
Telzir INN: fosamprenavir Rev. 22
Tevagrastim INN: filgrastim Rev. 4
Thalidomide Celgene INN: thalidomide Rev. 5

Updated Pre-Submission Procedural Advice
-Q1 - Is my medicinal product eligible for evaluation under the Centralised Procedure?
- Q2 - How and when should the eligibility request be sent to the EMA?
- Q7 - What is the procedure for appointment of CHMP Rapporteur/Co-Rapporteur and their assessment teams?
- Q8 - Is my medicinal product eligible for an accelerated Assessment?
Q25-1 - When to submit the Marketing Authorisation Application?

- Explanatory note on the Pre-submission request form

CHMP revised EPARs on:

Lysodren INN: mitotane Rev. 6
Fasturtec INN: rasburicase Rev. 12
Effentora INN: fentanyl citrate Rev. 4

New Standard operating procedure:

Organisation of Heads of Unit meetings

European Medicines Agency Standard Operating Procedures (SOP) and Work Instructions (WIN)

Curcuma longa L, rhizoma

- Assessment report
- List of references supporting the assessment report
- Community herbal monograph
- Opinion on community herbal monograph
- Overview of comments received during the public consultation

CHMP revised EPARs on:

Cystadane INN: betaine anhydrous Rev. 3
Crixivan INN: indinavir Rev. 25
Docetaxel Winthrop INN: docetaxel Rev. 3
Fuzeon INN: enfuvirtide Rev. 8
Abseamed INN: recombinant human erythropoietin alfa Rev. 8

CHMP revised EPARs on:

Betaferon INN: interferon beta-1b Rev. 8
Binocrit INN: recombinant human erythropoietin alfa Rev. 8
Epoetin alfa Hexal INN: recombinant human erythropoietin alfa Rev. 8
Topotecan Actavis INN: topotecan Rev. 1

CVMP revised EPARs on:

Purevax RCP Common name: Vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia Rev. 7
Convenia INN: cefovecin Rev. 3

CHMP revised EPARs on:

Taxotere INN: docetaxel Rev. 20
Silapo INN: epoetin zeta Rev. 4
NeoRecormon INN: epoetin beta Rev. 15

Guideline on Clinical Investigation of Medicinal Products used in the Treatment of Osteoarthritis

CHMP revised EPARs on:

BeneFIX INN: nonacog alfa Rev. 19
Panretin INN: alitretinoin Rev. 8
Removab INN: catumaxomab Rev. 1
Revlimid INN: lenalidomide Rev. 9
Xagrid INN: anagrelide Rev. 13
Iressa INN: gefitinib Rev. 1
Exjade INN: deferasirox Rev. 11