FrancophonIA/ELRC3.0 huggingface dataset:
English: In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions.
Greek: Σε θηλυκά πειραµατόζωα η οξική οσατερόνη προκάλεσε σοβαρές παρενέργειες στις αναπαραγωγικές λειτουργίες.
English: The medicine is available as 1.875 mg, 3.75 mg, 7.5 mg or 15 mg tablets, which can be used for dogs of different weights (small, medium sized, large or very large dogs).
Greek: Το φάρµακο διατίθεται σε µορφή δισκίων των 1,875 mg, 3,75 mg, 7,5 mg ή 15 mg, τα οποία µπορούν να χορηγούνται σε σκύλους διαφορετικού βάρους (σκύλοι µικρού, µεσαίου, µεγάλου ή πολύ µεγάλου µεγέθους).
English: This veterinary medicine has been developed especially for dogs and is not for use in humans.
Greek: Το παρόν κτηνιατρικό φάρµακο παρασκευάστηκε ειδικά για σκύλους και δεν προορίζεται για χρήση από τον άνθρωπο.
English: Its effect can be seen within about 2 weeks, and lasts for 5 months.
Greek: Η επίδρασή του γίνεται εµφανής εντός 2 εβδοµάδων περίπου και διαρκεί 5 µήνες.
English: After this time, the dog should be re-examined by a veterinarian and treatment might be repeated.
Greek: Μετά την παρέλευση του χρονικού αυτού διαστήµατος, ο σκύλος πρέπει να εξετάζεται εκ νέου από κτηνίατρο και, ενδεχοµένως, να επαναλαµβάνεται η θεραπεία.
English: The most common side effects are a transient increase in appetite, and changes in the behaviour of the dog (changes in activity levels, more sociable behaviour).
Greek: Οι συχνότερες ανεπιθύµητες ενέργειες είναι παροδική αύξηση της όρεξης και αλλαγές στη συµπεριφορά του σκύλου (αλλαγές στην κινητική δραστηριότητα, πιο έντονη κοινωνική συµπεριφορά).
English: Data were provided on the pharmaceutical quality of the product, the tolerance of Ypozane in dogs and the safety of the tablets when handled by humans.
Greek: Παρασχέθηκαν στοιχεία σχετικά µε τη φαρµακευτική ποιότητα του προϊόντος, την ανοχή των σκύλων στο Ypozane και την ασφάλεια των δισκίων κατά τον χειρισµό τους από τον άνθρωπο.
English: Dogs with enlarged prostates from various breeds, age groups and weights, were either treated with Ypozane or with another product, which is already authorised in the EU for this indication.
Greek: Σκύλοι διαφόρων φυλών, ηλικιακών οµάδων και κατηγοριών βάρους, µε υπερτροφικό προστάτη, έλαβαν Ypozane ή ένα άλλο προϊόν ήδη εγκεκριµένο στην ΕΕ για τη συγκεκριµένη ένδειξη.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ypozane exceed its risks for the treatment of benign prostatic hypertrophy (BPH) in male dogs and recommended that Ypozane be given a marketing authorisation.
Greek: Η επιτροπή φαρµάκων για κτηνιατρική χρήση (CVMP) έκρινε ότι τα οφέλη του Ypozane υπερτερούν των κινδύνων στη θεραπεία της καλοήθους υπερτροφίας του προστάτη (ΚΥΠ) σε αρσενικούς σκύλους και εισηγήθηκε τη χορήγηση άδειας κυκλοφορίας για το Ypozane.
English: The effectiveness of osaterone acetate was investigated in a large study undertaken in a number of veterinary practices across Europe.
Greek: Η αποτελεσµατικότητα της οξικής οσατερόνης διερευνήθηκε σε µια εκτεταµένη µελέτη που πραγµατοποιήθηκε σε πλήθος κτηνιατρείων ανά την Ευρώπη.
English: Wash hands after administration.
Greek: Να πλένετε τα χέρια σας µετά τη χρήση του προϊόντος.
English: If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.
Greek: Σε περίπτωση που λάβετε κατά λάθος το φάρµακο, αναζητήστε αµέσως ιατρική βοήθεια και επιδείξτε στον ιατρό το φύλλο οδηγιών χρήσεως ή την ετικέτα του φαρµακευτικού προϊόντος.
English: What is Ypozane?
Greek: Τι είναι το Ypozane;
English: Ypozane has no adverse effects on semen quality.
Greek: Το Ypozane δεν έχει ανεπιθύµητες ενέργειες όσον αφορά στην ποιότητα του σπέρµατος.
English: The dogs received once a day for 7 days, one Ypozane tablet appropriate for their size to correspond to a daily dose of 0.250.5 mg osaterone acetate per kilogram bodyweight.
Greek: Στους σκύλους χορηγήθηκε µία φορά την ηµέρα επί 7 ηµέρες ένα δισκίο Ypozane µε περιεκτικότητα ανάλογη µε το µέγεθός τους ούτως ώστε να ισοδυναµεί µε ηµερήσια δόση 0,25 - 0,5 mg οξικής οσατερόνης ανά χιλιόγραµµο σωµατικού βάρους.
English: Therefore, women of child-bearing age should avoid contact with, or wear disposable gloves, when handling the tablets.
Greek: Εποµένως, οι γυναίκες σε ηλικία κυοφορίας πρέπει να αποφεύγουν την επαφή µε το προϊόν ή να φοράνε προστατευτικά γάντια όταν το χρησιµοποιούν.
English: What is the risk associated with Ypozane?
Greek: Ποιοι κίνδυνοι συνδέονται µε το Ypozane;
English: Ypozane are round, white tablets that contain osaterone acetate as the active substance.
Greek: Το Ypozane είναι στρογγυλά, λευκά δισκία που περιέχουν ως δραστική ουσία οξική οσατερόνη.
English: The prostate is a gland that produces a fluid that is part of the semen.
Greek: Ο προστάτης είναι ένας αδένας ο οποίος παράγει ένα υγρό που περιέχεται στο σπέρµα.
English: A clinical response to treatment (reduction of prostate volume) was seen within 14 days, which lasted for at least 5 months.
Greek: Κλινική ανταπόκριση στη θεραπεία (µείωση του µεγέθους του προστάτη) παρατηρήθηκε εντός 14 ηµερών και διήρκεσε τουλάχιστον 5 µήνες.
English: Ypozane is used in male dogs for the treatment of “benign prostatic hypertrophy”, which means an increase of the size of the prostate gland that is not related to cancer (benign).
Greek: Το Ypozane χρησιµοποιείται σε αρσενικούς σκύλους για τη θεραπεία της "καλοήθους υπερτροφίας του προστάτη", δηλαδή της αύξησης του µεγέθους του προστάτη η οποία δεν σχετίζεται µε καρκίνο (καλοήθης).
English: In male dogs, it blocks the transport of the male hormone testosterone into the prostate.
Greek: Στους αρσενικούς σκύλους αναστέλλει τη µεταφορά της ανδρικής ορµόνης τεστοστερόνης στον προστάτη.
English: Osaterone acetate is a hormone that is chemically related to progesterone, and as such it has anti-androgen and progestagen activity.
Greek: Η οξική οσατερόνη είναι µια ορµόνη µε χηµική συγγένεια µε την προγεστερόνη και για αυτόν το λόγο έχει αντι-ανδρογόνο και προγεσταγόνο δράση.
English: Ypozane is given daily for 7 days.
Greek: Το Ypozane χορηγείται καθηµερινά επί 7 ηµέρες.
English: The benefitrisk balance may be found in module 6 of this EPAR.
Greek: Η σχέση ωφέλειας/κινδύνου διατίθεται στην ενότητα 6 της παρούσας ευρωπαϊκής δηµόσιας έκθεσης αξιολόγησης.
English: By inhibiting testosterone, Ypozane helps the prostate to shrink back to its normal size.
Greek: Κατ΄ αυτόν τον τρόπο το Ypozane συµβάλλει στην επαναφορά του προστάτη στο φυσιολογικό του µέγεθος.
English: Why has Ypozane been approved?
Greek: Για ποιους λόγους εγκρίθηκε το Ypozane;
English: When it is enlarged, it can lead to abdominal pain, constipation and difficulties in urinating in the dogs affected.
Greek: Η αύξηση του µεγέθους του µπορεί να προκαλέσει στους προσβεβληµένους σκύλους πόνο στην κοιλιακή χώρα και δυσκολίες κατά την αφόδευση και την ούρηση.
English: Treatment with Ypozane was effective in the treatment of benign prostatic hypertrophy.
Greek: Η θεραπεία µε Ypozane ήταν αποτελεσµατική στη θεραπευτική αντιµετώπιση της καλοήθους υπερτροφίας του προστάτη.
English: Some dogs might also show vomiting, diarrhoea or increased thirst, or might develop a “feminisation syndrome”.
Greek: Ορισµένοι σκύλοι ενδέχεται να εµφανίσουν έµετο, διάρροια ή αυξηµένη δίψα ή ακόµη και σύνδροµο εκθήλυνσης, κατά το οποίο οι αρσενικοί σκύλοι ελκύουν ξαφνικά άλλους αρσενικούς σκύλους ή παρατηρείται αύξηση του µεγέθους των µαστικών τους αδένων.
English: Ypozane should be used with caution in dogs which have had liver problems.
Greek: Σε σκύλους µε ιστορικό ηπατικών προβληµάτων τo Ypozane πρέπει να χρησιµοποιείται µε προσοχή.
English: How has Ypozane been studied?
Greek: Ποιες µελέτες εκπονήθηκαν για το Ypozane;
English: What is Ypozane used for?
Greek: Σε ποιες περιπτώσεις χρησιµοποιείται το Ypozane;
English: PSURs FUM and SO
Greek: PSUR FUM και SO
English: The total in 2005 is expected to reach € 33,498,000
Greek: το 2005 στο ποσό των 33.498.000 €
English: Trend:
Greek: Τάση:
English: Status vaccines: Sections 4 and 5
Greek: Guideline on product information for vaccines: Sections 4 and 5
English: Technical Requirements for Blood and Blood Components (including those used for medicinal products derived from human blood and plasma)
Greek: Blood Components (including those used for medicinal products derived from human blood and plasma)
English: Honorary member of the Pharmaceutical Society of Great Britain since 2003 and honorary fellow of the Royal College of Physicians since 2004.
Greek: Society of Great Britain) από το 2003 και επίτιµος συνεργάτης του Royal College of Physicians από το 2004.
English: EudraVigilance - Definition of predefined queries for signal generation and usage of the data warehouse
Greek: EudraVigilance - Definition of predefined queries for signal generation and usage of the data warehouse του EudraVigilance
English: ICH quality system approach initiative EU Comments in preparation of ICH Guideline
Greek: ICH quality system approach initiative Παρατηρήσεις της ΕΕ για την την ICH
English: Need for revision of the current SPC guideline to give precise recommendation on prudent use and restrictions based on resistance data evolving from the SPC guideline
Greek: guideline to give precise recommendation on prudent use and restrictions based on resistance data evolving from the SPC guideline
English: ICH risk management
Greek: ICH risk management την ICH
English: CHMP Concept paper and guideline on quality requirements for manufacturing in and distribution from climatic zones 3 and 4
Greek: CHMP Concept paper and guideline on quality requirements for manufacturing in and distribution from climatic zones
English: Guideline on the use of medicinal products during pregnancy: need for post-marketing data
Greek: Guideline on the use of medicinal products during pregnancy: need for post-marketing data του 2005
English: Censor Jurado de Cuentas and Member of the Registro Oficial de Auditores de Cuentas in Spain.
Greek: του Registro Oficial de Auditores de Cuentas στην Ισπανία.
English: ICH E14 the clinical evaluation of QT/QTs interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs
Greek: ICH E14 the clinical evaluation of QT/QTs interval prolongation and proarrhythmic potential for non antiarrhythmic drugs
English: SOP and template for Community herbal monographs
Greek: SOP and template for Community herbal monographs του 2005
English: 4.3 Mutual recognition agreements
Greek: Mutual Recognition Procedure
English: EWP Reflection paper on clinical trials in small populations
Greek: EWP Reflection paper on clinical trials in small populations του 2005
English: The Paediatrics Working Party will be consulted at an early stage of the drafting of guidelines which are relevant to paediatric population developed by any CHMP working parties
Greek: The Paediatrics Working Party will be consulted at an early stage of the drafting of guidelines, which are relevant to paediatric population,
English: Concurrent administration of IVMPs in view of determining day X to be 14 days and consequent revision of the SPC guideline for immunologicals
Greek: Concurrent administration of IVMPs in view of determining day X to be 14
English: A*16 A*15 A*14 A*13 A*12 A*11 A*10 A*9 A*8 A*7 A*6 A*5 Total grade A B*11 B*10 B*9 B*8 B*7 B*6 B*5 B*4 B*3 Total grade B C*7 C*6 C*5 C*4 C*3 C*2 C*1 Total grade C D*5 D*4 D*3 D*2 Total grade D Total Staff
Greek: A*16 A*15 A*14 A*13 A*12 A*11 A*10 A*9 A*8 A*7 A*6 A*5
English: Further guidance on interpretation of the data from guideline CVMP-VICH GL27, guidance on pre-approval information for registration of new veterinary medicinal products for foodproducing animals with respect to antimicrobial resistance (CVMP/VICH/644/01)
Greek: Further guidance on interpretation of the data from guideline CVMP-VICH GL27, guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance
English: Note for guidance on the clinical investigation of recombinant Factor VIII and IX products (CPMP/BPWG/1561/99) and the Note for guidance on the clinical investigation of human plasma derived Factor VIII and IX products
Greek: VIII and IX products (CPMP/BPWG/1561/99) and the Note for guidance on the clinical investigation of human plasma derived Factor VIII and IX products
English: Discussion papers on other important organs to be considered when developing medicinal products in neonates complementary to the paper already published on renal maturation (e.g. hepatic, central nervous system)
Greek: Discussion papers on other important organs to be considered when developing a medicinal products in neonates complementary to the paper already published on renal maturation
English: Standard Operating Procedure on Urgent Safety Restrictions for Medicinal Products Authorised through Mutual Recognition Procedure
Greek: Standard Operating Procedure on Urgent Safety Restrictions for Medicinal Products Authorised through
English: SOP and template for List of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
Greek: SOP and template for List of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products του 2005
English: Concept paper on impact of analytical methods on Commission Decision 2002/657/EC compared with current analytical requirements for the establishment of MRLs
Greek: (2002/657/EC) compared with current analytical requirements for the establishment of MRLs
English: Guideline on the non-clinical documentation for mixed marketing authorisation applications
Greek: Guideline on the non-clinical documentation for mixed marketing authorisation applications του 2005
English: Discussion paper on the need for investigation of immune system
Greek: Discussion paper on the need for investigation of immune system του 2005
English: Guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolism in nonsurgical patients
Greek: Guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolism in non surgical patients
English: Note for Guidance on Quality, Preclinical and Clinical Aspects of Gene Transfer Medicines - Lentiviral Vectors
Greek: Note for Guidance on Quality, Pre clinical and Clinical Aspects of Gene Transfer Medicines - Lentiviral
English: Executive master of business administration from the Centre de Perfectionnement aux Affaires at HEC-CPA, in Jouy-en-Josas, France, in 2000.
Greek: aux Affaires, στο HEC-CPA, Jouy-en-Josas, Γαλλία.
English: Biostatistical/methodological issues arising from CHMP discussion on marketing authorisation applications: Choice of non-inferiority margin
Greek: Biostatistical/methodological issues arising from CHMP discussion on marketing authorisation applications:
English: Guideline on the use of data contained in EudraVigilance and EudraVigilance Veterinary (EVvet)
Greek: Simple guide to veterinary pharmacovigilance Guideline on the use of data contained in EudraVigilance and EudraVigilance Veterinary (EVvet)
English: Policy for the transmission of PhVWP Recommendations and Assessment Reports for mutually recognised and purely nationally authorised products to marketing authorisation holders
Greek: Reports for mutually recognised and purely nationally authorised products to marketing authorisation holders
English: Other documents on working practices and work-sharing as well as new document management and communication/information exchange/tracking tools, in particular
Greek: Other documents on working practices and work-sharing as well as new document management and communication/information exchange/tracking tools, in particular with view to implementing the EU Risk Management Strategy and the revised PhVWP Mandate of September 2003
English: Member of the UK Royal College of Veterinary Surgeons.
Greek: Royal College of Veterinary Surgeons, ΗΒ.
English: Position paper on the non-clinical safety studies to support clinical trials, with a single low dose of a compound
Greek: Position paper on the non-clinical safety studies to support clinical trials,
English: Evaluations
Greek: Recommendations and Assessment
English: Thomas Lönngren
Greek: Thomas Lönngren του 2006.
English: Operation, maintenance, support and further development of five EU telematics projects: EudraNet, EudraVigilance, EudraCT, EuroPharm and e-Submission
Greek: EudraVigilance, EudraCT, ΕuroPharm και ηλεκτρονική υποβολή του EudraNet, του EudraVigilance, του EudraCT, του EuroPharm και της ηλεκτρονικής του EudraVigilance
English: 2004 final
Greek: µε το 2004
English: Guideline on specification limits for residues of metal catalysts in medicinal products
Greek: Guideline on specification limits for residues of metal catalysts in medicinal products το 2005
English: Guideline on data monitoring committee
Greek: Guideline on data monitoring committee του 2005
English: Good Pharmacovigilance Practice (GVP)
Greek: Good Pharmacovigilance Practice
English: CPMP Note for Guidance on the rapid alert system and non-urgent information system in pharmacovigilance
Greek: Alert System and Non-Urgent Information System in Pharmacovigilance
English: CHMP Guideline for the requirements to the quality part of a request for authorisation of a clinical trial
Greek: CHMP Guideline for the requirements to the quality part of a request for authorisation of a clinical trial CHMP Guideline for formulations of choice for paediatric population
English: Core SPC for human plasma derived and recombinant coagulation Factor IX products
Greek: Core SPC for human plasma derived and recombinant coagulation Factor IX
English: p.m.
Greek: CVMP.
English: Note for Guidance on the conduct of pharmacovigilance for medicinal products authorised through mutual recognition
Greek: Pharmacovigilance for Medicinal Products Authorised through Mutual Recognition
English: Guideline on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling
Greek: Reproductive and Development Toxicities: From Data to Labelling
English: For product defect and other quality-related matters E-mail: qualitydefects@emea.eu.int Fax: (44-20) 74 18 85 90
Greek: barbara.freischem@emea.eu.int qualitydefects@emea.eu.int Φαξ: (44-20) 74 18 85 90
English: CVMP meetings in 2005
Greek: CVMP το 2005
English: Revised guideline on specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products
Greek: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products του 2005
English: Contents
Greek: ICH
English: Under development by the PhVWP-V
Greek: PhVWP-V
English: Infrastructure Services at the EMEA
Greek: EMEA Documentation service
English: Direct telephone: (44-20) 75 23 71 47 Fax: (44-20) 74 18 85 45
Greek: Απευθείας κλήση: (44-20) 75 23 71 47 Φαξ: (44-20) 74 18 85 45
English: Priorities for medicines for human use in 2005:
Greek: Communication for Medicinal Products for Human Use του 2005
English: Core SPC for human plasma derived and recombinant coagulation Factor VIII products
Greek: Core SPC for human plasma derived and recombinant coagulation Factor
English: Status studies in the safety evaluation of new medicinal products in animals
Greek: Pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals
English: Revised guideline on quality of herbal medicinal products
Greek: Revised guideline on quality of herbal medicinal products του 2005
English: Medicines for human use
Greek: Human Use
English: CHMP Guideline on the conduct of pharmacovigilance for medicines used by children
Greek: Pharmacovigilance Information CHMP Guideline on the Conduct of Pharmacovigilance for Medicines Used by Children του 2005
English: Points to consider on the development of live attenuated influenza vaccines
Greek: Points to consider on the development of live attenuated influenza vaccines Note for guidance on quality,
English: Review and possible revision of core SPC.
Greek: Need for revision of the current SPC
English: CHMP meetings in 2005
Greek: της CHMP το 2005
English: Guidance on the development of vaccines against emerging and reemerging diseases such as SARS, pathogens potentially used in bioterrorism, monovalent polio vaccines
Greek: Guidance on the development of vaccines against emerging and re emerging diseases such as SARS,
English: ICH-E2D: Post-Approval Safety Management: Definitions and Standards for Expedited Reporting and Good Case Management Practices
Greek: ICH-E2D: Post-Approval Safety
English: ICH-E2E: Pharmacovigilance Planning To be incorporated in revised Volume 9 (see above)
Greek: ICH-E2E: Pharmacovigilance Planning Προς ενσωµάτωση στον
English: E-mail: silvia.domingo@emea.eu.int
Greek: silvia.domingo@emea.eu.int
English: E-mail: ragini.shivji@emea.eu.int
Greek: : ragini.shivji@emea.eu.int
English: Questions and answers document on fixed combination of antihypertensive and lipid lowering agents
Greek: Guidance on clinical investigation of medicinal products for secondary prevention of cardiovascular events Questions and answers document on fixed combination of antihypertensive and lipid lowering agents
English: Total Title 2
Greek: (τύπος II).
English: 6-8 April
Greek: Σελίδα 8/94
English: • by writing to: EMEA Documentation service European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4HB UK
Greek: Canary Wharf London E14 4HB UK
English: The impact of maternally derived antibodies on vaccination
Greek: SPC guideline for immunologicals The impact of maternally derived antibodies on vaccination Preparation of new master seeds
English: E-mail: europeanexperts@emea.eu.int
Greek: europeanexperts@emea.eu.int
English: Review and possible revision of the guideline.
Greek: days and consequent revision of the
English: Qualified as a veterinary surgeon from the Royal Veterinary College, University of London.
Greek: και µέλος του Royal College of Veterinary Surgeons του Ηνωµένου Βασιλείου.
English: EWP contribution
Greek: EudraVigilance
English: CPMP/BWP/764/02
Greek: CHMP/BWP/764/02
English: 2-4 March
Greek: 3 and 4
English: CHMP Guideline for the preparation of assessment reports on periodic safety update reports
Greek: Assessment Reports on Periodic Safety
English: He was re-elected vice-chairman of the CVMP in 2004.
Greek: της CVMP το 2004.
English: Status of medicinal products for the treatment of hepatitis B
Greek: Guideline on the clinical investigation of medicinal products for the treatment of hepatitis B
English: Guideline on the limits for genotoxic impurities
Greek: Guideline on the limits for genotoxic impurities του 2005
English: Objectives and key initiatives:
Greek: Management: Definitions and
English: CPMP recommendations on transmissible agents and urinary derived medicinal products
Greek: Manufacture and control of recombinant allergens CHMP recommendations on transmissible agents and urinary derived medicinal products Guideline on similarity of orphan medicinal products
English: Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: press@emea.eu.int
Greek: Martin HARVEY ALLCHURCH Απευθείας κλήση: (44-20) 74 18 84 27
English: Concept paper on dossier requirements for bibliographic applications
Greek: Concept paper on dossier requirements for bibliographic applications VICH Target animal safety pharmaceuticals τη VICH
English: 1/2Q 2005
Greek: C*6 C*5
English: 14-17 March
Greek: Σελίδα 17/94
English: 19 - 20 September
Greek: Σελίδα 19/94
English: 22-23 March
Greek: Σελίδα 22/94
English: Guideline on product information for
Greek: Guideline on Handling Public
English: Standard statements for the SPC of certain classes / types of veterinary medicinal products
Greek: Standard statements for the SPC of certain classes / types of veterinary medicinal products Revision of guideline for fixed combination products Concept paper on dossier requirements for oncology products Target animal safety requirements for corticosteroids
English: 7-9 September
Greek: Σελίδα 9/94
English: CHMP Safety Working Party
Greek: developed by any CHMP working parties
English: 3.7 Regulatory activities
Greek: Good Case Management Practices