What's New Archive - March 2008

CHMP revised EPARs on:

Advagraf INN: tacrolimus Rev. 2
Kepivance INN: palifermin Rev. 5
Kivexa INN: abacavir/lamivudine Rev. 7
Levemir INN: insulin detemir Rev. 8
Quadramet INN: samarium [153Sm] lexidronam pentasodium Rev. 10
Trizivir INN: abacavir/lamivudine/zidovudine Rev. 11
Yondelis INN: trabectedin Rev. 1
Ziagen INN: abacavir Rev. 14
Tasmar INN: tolcapone Rev. 10

CVMP revised EPAR on: Pirsue 5 mg/ml intramammary solution Rev. 8

Standard Operating Procedures and Work Instructions

Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) Appendix 1

Community herbal monograph on Echinaceae purpureae herba Echinacea purpurea (L.) Moench (purple coneflower herb)

CHMP revised EPARs on: Paxene INN: paclitaxel Rev. 12

CHMP revised EPARs on:

Levitra INN: vardenafil Rev. 7
Vivanza INN: vardenafil Rev. 7
Mircera INN: methoxy polyethylene glycol-epoetin beta Rev. 1

New and updated EMEA Standard Operating Procedures:

Book loans
Book orders

Standard Operating Procedures and Work Instructions

Standard Operating Procedures and Work Instructions

EMEA implementation of electronic-only submissions and eCTD submissions in the centralised procedure: Statement of Intent - Questions and Answers relating to strategic and general aspects of the implementation

New CHMP post-authorisation Summaries of Positive Opinion for:

Viread INN:tenofovir disoproxil fumarate
Zevalin INN:ibritumomab tiuxetan

New CHMP Summaries of Positive Opinion for:

Extavia INN: interferon beta-1b

Q&A on recommendation for the refusal of the Marketing Authorisation for:
Ceplene INN: histamine dihydrochloride
Cimzia INN: certolizumab pegol
Rhucin INN: recombinant human C1 inhibitor

CHMP Revised EPAR on: Lumigan INN: bimatoprost Rev. 13

Guideline on The procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with Bovine Viral Diarrhoea (BVD) Virus
Overview of comments received on draft Guideline on The procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with Bovine Viral Diarrhoea (BVD) Virus

Substances considered as not falling within the scope of Council regulation (EEC) No 2377/90 (Rev. 12)

New templates:

- Request for modification of an agreed paediatric investigation plan
- Request of confirmation on the applicability of the EMEA decision on class waivers

EMEA decision on the application for product-specific waiver for:

- Caspofungin acetate (Cancidas)
- Latanoprost (Xalatan)
- Losartan potassium (Cozaar and associated names)
- Montelukast sodium (Singulair and associated names)

Witdrawal assessment reports for:

Insulin Human 30/70 Mix Marvel
Insulin Human Long Marvel
Insulin Human Rapid Marvel

CHMP revised opinions on medicines for use outside the European Union:

Lamivudine GSK Common name: Lamivudine GSK Rev. 4
Lamivudine/Zidovudine GSK Common name: Lamivudine/zidovudine GSK Rev. 3

Opinions on medicines for use outside the European Union

CHMP revised EPARs on:

Sebivo INN: telbivudine Rev. 2
Truvada INN: emtricitabine/tenofovir disoproxil Rev. 12
Viread INN: tenofovir disoproxil Rev. 17
Aldara INN: imiquimod Rev. 10
Ketek INN:telithromycin Rev. 11

CHMP revised EPARs on:

Prevenar Common Name: pneumococcal saccharide conjugated vaccine, absorbed
Champix INN: varenicline tartrate
Replagal INN: agalsidase alfa

Public consultation in preparation of a legal proposal to combat counterfeit medicines for human use - key ideas for better protection of patients against the risk of counterfeit medicines
Counterfeiting of medicinal products has become an increasing threat for patients and industry and a concern for EU and national policy-makers. The Directorate-General Enterprise and Industry is consulting all stakeholders and interested parties on key ideas for amending the regulatory framework for medicinal products in an effort to combat the counterfeiting of medicinal products.
For the purpose of this public consultation, which concentrates on sectoral pharmaceutical EU-legislation, the Commission has identified three areas of regulation of medicinal products where improvements to the regulatory framework could make a real contribution to protecting against counterfeit medicinal products.
These measures relate to:
1) Manufacture, placing on the market of medicinal products and related inspections
2) Import, export, transit (transhipment) of medicinal products
3) Manufacture, placing on the market of active substances and related inspections

New CVMP post-authorisation Summaries of Positive Opinion for:

Aivlosin INN: Tylvalosin (previously: acetylisovaleryltylosin
RABIGEN SAG2

New EMEA Standard Operating Procedures on:

Processing requests for fee reduction falling under paragraph 1 of Article 9 of Council Regulation (EC) No 297/95
Processing of requests for reclassification of applications in fee categories under the terms of Article 11(3) of Council Regulation (EC) No 297/95

EMEA Standard Operating Procedures (SOP) and Work Instructions (WIN)

CVMP revised EPARs on:

Ingelvac CircoFLEX Rev. 1
Purevax RC Vaccine against feline viral rhinotracheitis and feline calicivirosis Rev. 4
Purevax RCCh Vaccine against feline viral rhinotracheitis, feline calicivirosis and chlamydiosis Rev. 4
Purevax RCP Vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia Rev. 4
Purevax RCP FeLV Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia Rev. 4
Purevax RCPCh Vaccine against rhinotracheitis, calcivirosis, chlamydiosis and panelucopenia in cats Rev. 3
Purevax RCPCh FeLV Vaccine against feline viral rhinotracheitis, feline calicivirosis, chlamydiosis, feline panleucopenia and feline leukaemia Rev. 4

Parallel Distribution

CHMP revised EPARs on:

Lyrica INN: pregabalin Rev. 6
Byetta INN: exenatide Rev. 2
Aldurazyme INN: laronidase Rev. 6
MabCampath INN: alemtuzumab Rev. 8

Updated EMEA Pre-Submission Procedural Advice:

Q2 - How and when should the eligibility request be sent to the EMEA?
Q3 - What will be the legal basis for my application?
Q4 - How will I know if the proposed invented name of my medicinal product is acceptable from a public health point of view?
Q4a - Dates for submission of Invented Names requests
Q7 - What is the procedure for appointment of CHMP Rapporteur/Co-Rapporteur and their assessment teams?
Q7a - Submission dates for Rapporteur appointment requests
Q8 - Is my medicinal product eligible for an accelerated Assessment?
Q9 - If I intend to submit multiple applications for the same medicinal product?
Q25 - When to submit the Marketing Authorisation Application?
Q48 - Do I need to address any paediatric requirements in my application?
Q49 - Can I submit an application for a Paediatric Use Marketing Authorisation (PUMA)?

Updated EMEA Post-Authorisation Procedural Advice:

Type II Variations
Q5 - How shall my Type II application be handled (timetable)?
Extension applications
Q5 - How shall my Extension application be handled (timetable)?
Annual Re-assessment
Q5 - How shall my Annual Re-assessment be handled (timetable)?
Follow-Up Measures (FUMs) / Specific Obligations (SOs)
Q3 - When shall I submit my FUM/SO data?
Q5 - How shall my submission of FUM / SO data be handled (timetable), and what could be the outcome of the evaluation?
Renewal
Q6 - How shall my renewal be handled (timetable)?
Transfer of Marketing Authorisation
Q2 - How shall I present my application for the Transfer of my Marketing Authorisation?
Q12 - Can I include changes to the Detailed Description of Pharmacovigilance System in my Transfer of Marketing Authorisation application?
Other
Q4 - How do I notify EMEA of changes to my Contact Persons specified in the application form?

CHMP revised EPARs on:

NeuroBloc INN: botulinum Toxin Type B Rev. 11
CellCept INN: mycophenolate mofetil Rev. 15
Fasturtec INN: rasburicase Rev. 10
Dynepo INN: epoetin delta Rev. 9
Atryn INN: antithrombin alfa Rev. 4
Nespo INN: darbepoetin alfa Rev. 15
Aranesp INN: darbepoetin alfa Rev. 17
Ytracis INN: yttrium (⁹⁰Y) chloride Rev. 5
NeoRecormon INN: epoetin beta Rev. 13
Epoetin alfa Hexal INN: recombinant human erythropoietin alfa Rev. 1
Binocrit INN: recombinant human erythropoietin alfa Rev. 1
Angiox INN: bivalirudin Rev. 8
Abseamed INN: recombinant human erythropoietin alfa Rev. 1

CHMP revised EPARs on:

Tandemact INN: pioglitazone/glimepiride Rev. 2
Galvus INN: vildagliptin Rev. 1
Regranex INN: becaplermin Rev. 13
Macugen INN: pegaptanib sodium Rev. 3
Circadin INN: melatonin Rev. 3

EMEA Standard Operating Procedures (SOP) and Work Instructions (WIN)

New CHMP EPARs on:

Mycophenolate mofetil Teva INN: mycophenolate mofetil
Myfenax INN: mycophenolate mofetil

EMEA Standard Operating Procedures (SOP) and Work Instructions (WIN)

CHMP revised EPARs on:

Avastin INN: bevacizumab Rev. 9
Caelyx INN: doxorubicin hydrochloride Rev. 17
Myocet INN: doxorubicin Rev. 6
Zavesca INN: miglustat Rev. 10
Zevalin INN: ibritumomab tiuxetan Rev. 9

CHMP revised EPARs on:

Arava INN: leflunomide Rev. 14
Telzir INN: fosamprenavir Rev. 13
Abilify INN: aripiprazole Rev. 11
Ganfort INN: bimatoprost/timolol Rev. 2
Orencia INN: abatacept Rev. 1
Aloxi INN: palonosetron Rev. 5

Guideline on Clinical Investigation of Medicinal Products for Prophylaxis of High Intra- and Post-operative Venous Thromboembolic Risk Rev. 1 Corr

Guideline on the development of new medicinal products for the treatment of ulcerative colitis
   See also: Overview of Comments received on the draft guideline

Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications

Concept paper on the need for revision of the Note for Guidance on photosafety testing (CPMP/SWP/398/01)

CVMP revised EPAR on: Dexdomitor INN: dexmedetomidine Rev. 08

CHMP revised EPARs on:

ViraferonPeg INN: interferon alfa-2b Rev. 13
Eucreas INN: vildagliptin/metformin hydrochloride Rev. 1
Olanzapine Teva INN: olanzapine Rev. 1
Twinrix Paediatric Common name: combined hepatitis A and hepatitis B vaccine Rev. 9
Combivir INN: lamivudine/zidovudine Rev. 10

CVMP revised EPAR on: Oxyglobin Rev. 08

CHMP revised EPARs on:

BeneFIX INN: nonacog alfa Rev. 14
Thelin INN: sitaxentan sodium Rev. 5

New EMEA Standard Operating Procedure on Preparation of a withdrawal European Public Assessment (EPAR)

EMEA Standard Operating Procedures (SOP) and Work Instructions (WIN)