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May 2013

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Date Content
17/05/2013News and press releases: European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics
17/05/2013News and press releases: International Clinical Trials Day: 20 May 2013
17/05/2013Human medicines European Public Assessment Report (EPAR): Lyrica,

pregabalin

Revision: 22, Authorised
17/05/2013Human medicines European Public Assessment Report (EPAR): Neulasta,

pegfilgrastim

Revision: 19, Authorised
17/05/2013Referral: Article 20 procedures, Tredaptive, Pelzont and Trevaclyn,

laropiprant / nicotinic acid

(updated)
17/05/2013News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 2013
17/05/2013Pending EC decision: AFTOVAXPUR DOE,

1-3 inactivated, purified FMD virus(es) out of a set of 7 (multistrain)

Opinion date: 16-May-2013
17/05/2013Pending EC decision: ProZinc,

insulin human

Opinion date: 16-May-2013
17/05/2013News and press releases: European Medicines Agency recommends first vaccine for foot-and-mouth disease for authorisation at EU level
17/05/2013Referral: Article 20 procedures, Protelos and Osseor,

strontium ranelate

17/05/2013Referral: Article 31 referrals, Almitrine-containing medicines,

almitrine

(updated)
17/05/2013News and press releases: Benefits of Diane 35 and generics outweigh risks in specific patient group
17/05/2013News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2013
17/05/2013Referral: Article 31 referrals, Renin-angiotensin system (RAS)-acting agents,

angiotensin receptor blockers (ARBs),
angiotensin converting enzyme inhibitors (ACEis),
direct renin inhibitors (aliskiren)

17/05/2013Referral: Article 107i procedures, Cyproterone- and ethinylestradiol-containing medicines,

cyproterone / ethinylestradiol

(updated)
17/05/2013CVMP monthly report of application procedures, guidelines and related documents: April 2013
17/05/2013Human medicines European Public Assessment Report (EPAR): Rivastigmine Sandoz,

rivastigmine

Revision: 5, Authorised
17/05/2013Opinion template (annex I and II) (updated)
17/05/2013Withdrawn application: Fanaptum,

iloperidone

Initial authorisation (updated)
17/05/2013Human medicines European Public Assessment Report (EPAR): Qutenza,

capsaicin

Revision: 7, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Epivir,

lamivudine

Revision: 27, Authorised
16/05/2013Extended EudraVigilance product report message (XEVMPD) substances (updated)
16/05/2013Extended EudraVigilance product report message (XEVMPD) organisations (updated)
16/05/2013Human medicines European Public Assessment Report (EPAR): Glustin,

pioglitazone

Revision: 20, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Glubrava,

pioglitazone / metformin

Revision: 10, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Actos,

pioglitazone

Revision: 20, Authorised
16/05/2013European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) (updated)
16/05/2013Veterinary medicine European Public Assessment Report (EPAR): RevitaCAM,

meloxicam

Revision: 2, Authorised
16/05/2013Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 3, draft: consultation open (updated)
16/05/2013Human medicines European Public Assessment Report (EPAR): Grepid,

clopidogrel

Revision: 8, Authorised
16/05/2013Regulatory and procedural guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q4B annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests – General chapter - Step 4, adopted (updated)
16/05/2013Human medicines European Public Assessment Report (EPAR): Kivexa,

abacavir / lamivudine

Revision: 16, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Trizivir,

abacavir (as sulfate) / lamivudine / zidovudine

Revision: 20, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Rivastigmine Hexal,

rivastigmine

Revision: 5, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Exelon,

rivastigmine

Revision: 27, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Pelzont,

laropiprant / nicotinic acid

Revision: 11, Withdrawn
16/05/2013Human medicines European Public Assessment Report (EPAR): Combivir,

lamivudine / zidovudine

Revision: 17, Authorised
16/05/2013Masivet : EPAR - All Authorised presentations (updated)
16/05/2013Human medicines European Public Assessment Report (EPAR): TachoSil,

human fibrinogen / human thrombin

Revision: 14, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Tredaptive,

laropiprant / nicotinic acid

Revision: 11, Withdrawn
16/05/2013Human medicines European Public Assessment Report (EPAR): Amyvid,

florbetapir (18F)

Revision: 1, Authorised
16/05/2013News and press releases: European Medicines Agency closed 20 May 2013
16/05/2013Human medicines European Public Assessment Report (EPAR): Trevaclyn,

laropiprant / nicotinic acid

Revision: 11, Withdrawn
16/05/2013News and press releases: World Hypertension Day: 17 May 2013
16/05/2013Veterinary medicine European Public Assessment Report (EPAR): Ecoporc Shiga,

genetically modified Shiga-toxin-2e antigen

Revision: 0, Authorised
15/05/2013Draft inventory of paediatric medicines - Infectious diseases
15/05/2013Regulatory and procedural guideline: EMA/PDCO Standard Paediatric Investigation Plan for Allergen Products for Specific Immunotherapy, adopted (updated)
15/05/2013Human medicines European Public Assessment Report (EPAR): Menveo,

meningococcal group A, C, W-135 and Y conjugate vaccine

Revision: 7, Authorised
15/05/2013Human medicines European Public Assessment Report (EPAR): Intelence,

etravirine

Revision: 12, Authorised
15/05/2013Human medicines European Public Assessment Report (EPAR): Vpriv,

velaglucerase alfa

Revision: 4, Authorised
15/05/2013Agenda: Agenda - PDCO agenda of the 15-17 May 2013 meeting
15/05/2013Report: Applications for new human medicines under evaluation by the CHMP: May 2013
14/05/2013Human medicines European Public Assessment Report (EPAR): Ziagen,

abacavir

Revision: 24, Authorised
14/05/2013Agenda: Agenda - PRAC draft agenda of meeting 13-16 May 2013
14/05/2013Human medicines European Public Assessment Report (EPAR): Ecansya (previously Capecitabine Krka),

capecitabine

Revision: 2, Authorised
14/05/2013Orphan designation:

(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one

for the: Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
14/05/2013Orphan designation:

Nintedanib

for the: Treatment of idiopathic pulmonary fibrosis
14/05/2013Orphan designation:

2-Hydroxypropyl-β-cyclodextrin

for the: Treatment of Niemann-Pick disease type C
14/05/2013Orphan designation:

4-[2-(6-Methylpyridin-2-yl)-5,6-dihydro-4H-pyrrolo[1,2-b]pyrazol-3-yl]-quinoline-6-carboxamide monohydrate

for the: Treatment of glioma
14/05/2013Orphan designation:

Lenvatinib

for the: Treatment of follicular thyroid cancer
14/05/2013Orphan designation:

R,S-O-(3-piperidino-2-hydroxy-1-propyl)-nicotinic acid amidoxime dihydrochloride

for the: Treatment of Duchenne muscular dystrophy
14/05/2013Orphan designation:

Lenvatinib

for the: Treatment of papillary thyroid cancer
14/05/2013Withdrawn application: Hyalograft C autograft,

characterised viable autologous chondrocytes expanded in vitro, seeded and cultured on a hyaluronan-based scaffold

Initial authorisation (updated)
14/05/2013Herbal Medicinal Products: Phaseolus, Phaseoli fructus (sine semine), Phaseolus vulgaris L. (updated)
13/05/2013Notices of calls for tender - 2012 (updated)
13/05/2013PRAC rapporteur risk management plan update assessment report - report template
13/05/2013PRAC rapporteur risk management plan assessment report - report template
13/05/2013PRAC rapporteur generic risk management plan assessment report - report template
13/05/2013Veterinary medicine European Public Assessment Report (EPAR): Meloxidolor,

meloxicam

Revision: 0, Authorised
13/05/2013Public statement: Public statement on Bondenza: Withdrawal of the marketing authorisation in the European Union
13/05/2013Human medicines European Public Assessment Report (EPAR): Aprovel,

irbesartan

Revision: 28, Authorised
13/05/2013Human medicines European Public Assessment Report (EPAR): Karvea,

irbesartan

Revision: 28, Authorised
13/05/2013Veterinary medicine European Public Assessment Report (EPAR): BTVPUR AlSap 1,

bluetongue-virus serotype-1 antigen

Revision: 2, Authorised
13/05/2013Veterinary medicine European Public Assessment Report (EPAR): BTVPUR AlSap 1-8,

bluetongue-virus serotype-1 antigen / bluetongue-virus serotype-8 antigen

Revision: 2, Authorised
13/05/2013Regulatory and procedural guideline: Initial notices for parallel distribution – April 2013
13/05/2013Referral: Article 31 referrals, Diacerein-containing medicines for oral administration,

diacerein

(updated)
13/05/2013Referral: Article 31 referrals, Nicotinic acid,

nicotinic acid, acipimox, xantinol nicotinate

(updated)
13/05/2013Referral: Article 31 referrals, Domperidone-containing medicines,

domperidone

(updated)
13/05/2013Medication-errors workshop - List of participants
13/05/2013Regulatory and procedural guideline: Guideline on the use of the Common Technical Document format in the preparation of a registration application for traditional herbal medicinal products, adopted
13/05/2013European Union regulatory workshop on medication errors, European Medicines Agency, London, UK, From: 28-Feb-2013, To: 01-Mar-2013 (updated)
13/05/2013Report: Medication-errors workshop report
13/05/2013Overview of comments received on 'Guideline on the use of the Common Technical Document format in the preparation of a registration application for traditional herbal medicinal products'
13/05/2013Work instructions for review of previously granted paediatric product-specific or class waivers, adopted
08/05/2013Healthcare professionals' organisations involved in the Agency's activities (updated)
08/05/2013Regulatory and procedural guideline: Procedural advice on appeal procedure for orphan-medicinal-product designation or review of orphan-designation criteria at the time of marketing authorisation (updated)
08/05/2013Referral: Article 107i procedures, Tetrazepam-containing medicines,

tetrazepam

(updated)
08/05/2013News and press releases: European Medicines Agency simplifies processing of fee reductions for orphan medicines
08/05/2013Regulatory and procedural guideline: Procedure for orphan-medicinal-product designation: Guidance for sponsors (updated)
08/05/2013Plasma-master-file certifications (updated)
08/05/2013News and press releases: Comments invited on draft revised guideline on biosimilars
08/05/2013Human medicines European Public Assessment Report (EPAR): Prialt,

ziconotide

Revision: 15, Authorised
08/05/2013Report: Uptake of the traditional-use registration scheme and implementation of the provisions of Directive 2004/24/EC in European Union Member States (updated)
08/05/2013Human medicines European Public Assessment Report (EPAR): Temozolomide Hospira,

temozolomide

Revision: 7, Authorised
08/05/2013News and press releases: New recommendations on the use of phthalates and parabens as excipients in human medicines released for public consultation
08/05/2013Scientific guideline: Draft guideline on the use of phthalates as excipients in human medicinal products, draft: consultation open
08/05/2013Scientific guideline: Draft reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use, draft: consultation open
08/05/2013European Medicines Agency policy on changes in scope of paediatric-investigation-plan decisions (updated)
07/05/2013Human medicines European Public Assessment Report (EPAR): Trisenox,

arsenic trioxide

Revision: 16, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Incivo,

telaprevir

Revision: 7, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Reyataz,

atazanavir sulphate

Revision: 33, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Norvir,

ritonavir

Revision: 43, Authorised
07/05/2013Report: Summary of Product Characteristics Advisory Group two-year activity report (April 2011-November 2012)
07/05/2013News and press releases: European Medicines Agency closed 9-10 May 2013
07/05/2013Human medicines European Public Assessment Report (EPAR): Olanzapine Teva,

olanzapine

Revision: 11, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Olanzapine Neopharma,

olanzapine

Revision: 8, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Olanzapine Mylan,

olanzapine

Revision: 7, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Zalasta,

olanzapine

Revision: 10, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop),

irbesartan

Revision: 12, Authorised
07/05/2013Newsletter: Human medicines highlights - April 2013
07/05/2013Agenda: Agenda - COMP agenda of the 14-15 May 2013 meeting
06/05/2013Regulatory and procedural guideline: Procedural advice on publication of information on negative opinions and refusals of marketing authorisation applications for human medicinal products, adopted (updated)
06/05/2013Regulatory and procedural guideline: Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products, adopted (updated)
06/05/2013Regulatory and procedural guideline: Deadlines for submission of applications for orphan-medicinal-product designation to the European Medicines Agency 2013/2014 (updated)
06/05/2013Workshop for micro, small and medium-sized enterprises (SMEs) - European Medicines Agency regulatory support pre- and post-authorisation, European Medicines Agency, London, UK, From: 26-Apr-2013, To: 26-Apr-2013 (updated)
06/05/2013Human medicines European Public Assessment Report (EPAR): Privigen,

human normal immunoglobulin (IVIg)

Revision: 13, Authorised
06/05/2013Minutes of the COMP meeting 12-13 March 2013
06/05/2013Human medicines European Public Assessment Report (EPAR): Capecitabine Teva,

capecitabine

Revision: 1, Authorised
06/05/2013Human medicines European Public Assessment Report (EPAR): Tyverb,

lapatinib

Revision: 17, Authorised
06/05/2013Human medicines European Public Assessment Report (EPAR): Cervarix,

human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)

Revision: 12, Authorised
06/05/2013Human medicines European Public Assessment Report (EPAR): Opgenra,

eptotermin alfa

Revision: 6, Authorised
06/05/2013Human medicines European Public Assessment Report (EPAR): Imatinib Actavis,

imatinib

Revision: 0, Authorised
06/05/2013Human medicines European Public Assessment Report (EPAR): Ribavirin BioPartners,

ribavirin

Revision: 2, Withdrawn
03/05/2013Human medicines European Public Assessment Report (EPAR): Capecitabine Medac,

capecitabine

Revision: 1, Authorised
03/05/2013Human medicines European Public Assessment Report (EPAR): Rivastigmine 1 A Pharma,

rivastigmine

Revision: 5, Authorised
03/05/2013Human medicines European Public Assessment Report (EPAR): Mepact,

mifamurtide

Revision: 8, Authorised
03/05/2013Human medicines European Public Assessment Report (EPAR): Rotarix,

rotavirus vaccine, live, attenuated

Revision: 10, Authorised
03/05/2013Report: Scientific recommendation on classification of advanced-therapy medicinal products: Adult autologous regenerative cells in autologous cell-enriched matrix for subcutaneous administration
03/05/2013Report: Scientific recommendation on classification of advanced-therapy medicinal products: Adult autologous regenerative cells for subcutaneous administration
03/05/2013Human medicines European Public Assessment Report (EPAR): Pantoloc Control,

pantoprazole

Revision: 5, Authorised
03/05/2013Workshop on paediatric investigation plans in type-2 diabetes mellitus, European Medicines Agency, London, UK, From: 25-Feb-2013, To: 25-Feb-2013 (updated)
03/05/2013Human medicines European Public Assessment Report (EPAR): Pantecta Control,

pantoprazole

Revision: 3, Authorised
03/05/2013Human medicines European Public Assessment Report (EPAR): Ruconest,

conestat alfa

Revision: 2, Authorised
03/05/2013Work instructions for scientific-advice / protocol-assistance peer review, adopted (updated)
03/05/2013Frequently asked questions about parallel distribution
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

1-(2R,5R)-5-ethynyl-5-(hydroxymethyl)-2,5-dihydro-2-furanyl)-5-methyl-2,4(1H,3H)-pyrimidinedione (BMS-986001)

Therapeutic area: Infectious diseases
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

sialic acid

Therapeutic area: Other
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

bisoprolol / amlodipine

Therapeutic area: Cardiovascular diseases
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

lutetium [177 Lu]

Therapeutic area: Other
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

alendronic acid / colecalciferol

Therapeutic area: Immunology-Rheumatology-Transplantation
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

clonidine (hydrochloride)

Therapeutic area: Anaesthesiology
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

gabapentin

Therapeutic area: Pain
03/05/2013Human medicines European Public Assessment Report (EPAR): Victrelis,

boceprevir

Revision: 7, Authorised
03/05/2013Human medicines European Public Assessment Report (EPAR): IntronA,

interferon alfa-2b

Revision: 21, Authorised
03/05/2013Human medicines European Public Assessment Report (EPAR): Xiapex,

collagenase Clostridium histolyticum

Revision: 2, Authorised
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

pegylated human recombinant factor VIII (BAX 855)

Therapeutic area: Haematology-Hemostaseology
03/05/2013Veterinary medicine European Public Assessment Report (EPAR): Prac-tic,

pyriprole

Revision: 6, Authorised
03/05/2013News and press releases: European Medicines Agency website unavailable Saturday 4 May
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

autologous CD34+ cells transduced ex-vivo with retroviral vector (GIADAl) containing human adenosine deaminase gene from cDNA

Therapeutic area: Immunology-Rheumatology-Transplantation
03/05/2013Human medicines European Public Assessment Report (EPAR): Vedrop,

d-alpha-tocopherol

Revision: 4, Authorised
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Hexvix,

hexaminolevulinate

Therapeutic area: Diagnostic/Endocrinology, -gynacology-fertility-metabolism/Oncology
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Cilengitide

Therapeutic area: Oncology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Dalbavancin

Therapeutic area: Infectious diseases (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Benlysta,

Belimumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Votubia,

Everolimus

Therapeutic area: Uro-nephrology/Neurology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Lumigan, Latisse,

Bimatoprost

Therapeutic area: Ophthalmology/Dermatology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Victrelis,

Boceprevir

Therapeutic area: Infectious diseases (updated)
03/05/2013News and press releases: European Medicines Agency reorganisation
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Palexia and associated names, Yantil and associated names, Tapentadol and associated names,

Tapentadol (hydrochloride)

Therapeutic area: Pain (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Vedolizumab

Therapeutic area: Gastroentology-Hepatology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Certican, Afinitor and associated names,

Everolimus

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Onglyza,

Saxagliptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Elvitegravir

Therapeutic area: Infectious diseases (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Palexia and associated names, Yantil and associated names, Tapentadol and associated names,

Tapentadol (hydrochloride)

Therapeutic area: Pain (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Volibris,

Ambrisentan

Therapeutic area: Cardiovascular diseases (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Brivaracetam

Therapeutic area: Neurology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Trobalt,

Retigabine

Therapeutic area: Neurology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Guanfacine (hydrochloride)

Therapeutic area: Psychiatry (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Palexia and associated names, Yantil and associated names, Tapentadol and associated names,

Tapentadol (hydrochloride)

Therapeutic area: Pain (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Mepolizumab

Therapeutic area: Pneumology-allergology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Emend,

Aprepitant

Therapeutic area: Oncology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

baricitinib

Therapeutic area: Immunology-Rheumatology-Transplantation
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

anacetrapib

Therapeutic area: Cardiovascular diseases
03/05/2013Herbal Medicinal Products: Rubus, Rubi idaei folium, Rubus idaeus L. (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

sarilumab

Therapeutic area: Immunology-Rheumatology-Transplantation
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

oritavancin (diphosphate)

Therapeutic area: Dermatology/Infectious diseases
03/05/2013Human medicines European Public Assessment Report (EPAR): Avamys,

fluticasone furoate

Revision: 9, Authorised
02/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

etoxybamide

Therapeutic area: Neurology/Anaesthesiology
02/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

asfotase alfa

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
02/05/2013Guidelines and concept papers adopted during the CHMP meeting 22-25 April 2013
02/05/2013Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted during the CHMP meeting 22-25 April 2013
02/05/2013Opinions on safety variations adopted at the CHMP meeting of 22-25 April 2013
02/05/2013Organisational matters - CHMP meeting 22-25 April 2013
02/05/2013Human medicines European Public Assessment Report (EPAR): Controloc Control,

pantoprazole

Revision: 3, Authorised
02/05/2013Human medicines European Public Assessment Report (EPAR): Somac Control,

pantoprazole

Revision: 4, Authorised
02/05/2013Human medicines European Public Assessment Report (EPAR): Pantozol Control,

pantoprazole

Revision: 3, Authorised
02/05/2013Scientific guideline: Draft guideline on similar biological medicinal products, draft: consultation open
02/05/2013Scientific guideline: Guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure, adopted (updated)
02/05/2013Referral: Article 13 referrals, Kantos Master,

beclomethasone dipropionate / formoterol fumarate

(updated)
02/05/2013Regulatory and procedural guideline: HMPC rules of procedure (updated)
02/05/2013Mandate, objectives and rules of procedure for the HMPC Working Party on Community Monographs and Community List (MLWP) (updated)