ΕΠΙΣΗΜΗ ΕΦΗΜΕΡΙΔΑ ΤΗΣ ΚΥΠΡΙΑΚΗΣ ΔΗΜΟΚΡΑΤΙΑΣ ΚΥΡΙΟ ΜΕΡΟΣ ΤΜΗΜΑ B. Αριθμός 5018 Τετάρτη, 7 Ιουνίου

ΕΠΙΣΗΜΗ ΕΦΗΜΕΡΙΔΑ ΤΗΣ ΚΥΠΡΙΑΚΗΣ ΔΗΜΟΚΡΑΤΙΑΣ ΚΥΡΙΟ ΜΕΡΟΣ ΤΜΗΜΑ B Αριθμός 5018 Τετάρτη, 7 Ιουνίου 2017 3407 Aριθμός 4576 ΑΔΕΙΕΣ ΠΑΡΑΛΛΗΛΗΣ ΕΙΣΑΓΩΓΗΣ ΠΟΥ ΕΧΟΥΝ ΕΚΔΟΘΕΙ ΑΠΟ ΤΟ ΣΥΜΒΟΥΛΙΟ ΦΑΡΜΑΚΩΝ Το Συμβούλιο Φαρμάκων, σύμφωνα με τις πρόνοιες του άρθρου 25 των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων, και σύμφωνα με τα στοιχεία που υπέβαλαν οι αιτητές, εκδίδει Άδεια Παράλληλης Εισαγωγής Φαρμακευτικών Προϊόντων με τα πιο κάτω στοιχεία: Αρ. Άδειας Παράλληλης Εισαγωγής Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας Παράλληλης Εισαγωγής Ημερομηνία Έκδοσης Άδειας Παράλληλης Εισαγωγής PI0053 MOVATEC TABLET 15MG MELOXICAM KRINERA HEALTH LTD 03/03/2017 PI0051 TRIATEC TABLET 2.5MG RAMIPRIL KRINERA HEALTH LTD 03/03/2017 PI0052 TRIATEC TABLET 5MG RAMIPRIL KRINERA HEALTH LTD 03/03/2017

Αριθμός 4577 ΑΝΑΝΕΩΣΕΙΣ ΕΙΔΙΚΩΝ ΑΔΕΙΩΝ ΚΥΚΛΟΦΟΡΙΑΣ ΠΟΥ ΕΧΟΥΝ ΕΓΚΡΙΘΕΙ ΑΠΟ ΤΟ ΣΥΜΒΟΥΛΙΟ ΦΑΡΜΑΚΩΝ Το Συμβούλιο Φαρμάκων, 3408 - σύμφωνα με τις πρόνοιες του άρθρου 13A των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων του, και - σύμφωνα με τα στοιχεία που υπέβαλαν οι αιτητές με τις αρχικές τους αιτήσεις, ανανεώνει την ισχύ των Ειδικών Αδειών Φαρμακευτικών Προϊόντων με τα πιο κάτω στοιχεία: Αρ. Ειδικής άδειας κυκλοφορίας S00870 S00857 S00330 S00900 S00896 Όνομα φαρμακευτικού SALOFALK GRANU-STIX GASTRO- RESISTANT PROLONGED RELEASE GRANULES FOR ORAL SUSPENSION 1000MG/SACHET ISOKET RETARD TABLET, PROLONGED- RELEASE 40MG FLUTINASAL NASAL SPRAY 0.5MG/G ZAOLIN SOLUTION FOR INFUSION 50MG/5ML THILOCOF EYE DROPS, SOLUTION 10MG/ML Κάτοχος ειδικής άδειας κυκλοφορίας Ισχύς άδειας DR. FALK PHARMA GMBH 19/12/2018 MERUS LABS LUXCO II S.A.R.L. IASIS PHARMACEUTICALS HELLAS SA 18/12/2018 19/12/2018 PHARMAZAC S.A. 21/12/2018 PHARMEX SA 21/12/2018 S00888 SAOCIN-D EYE OINTMENT PHARMEX SA 21/12/2018 S00902 S00890 S01030 LEUPROL POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 11.25MG/VIAL PHARMEXIN EYE DROPS, SOLUTION 2MG/ML TRIMETAZIDINA LPH TABLET, FILM COATED 20MG PHARMAZAC S.A. 21/12/2018 PHARMEX SA 21/12/2018 LABORMED-PHARMA SA 11/09/2018 S00846 CYPROTERONE ACETATE TABLET 50MG WOCKHARDT UK LTD 12/11/2018 S00582 MAGNESIUM SULPHATE SOLUTION FOR INJECTION 50% W/V AURUM PHARMACEUTICALS LTD 03/11/2018 S00291 S00290 CLOPIXOL TABLET, FILM COATED 25MG CLOPIXOL TABLET, FILM COATED 10MG LUNDBECK HELLAS A.E.,CYPRUS LUNDBECK HELLAS A.E.,CYPRUS 14/11/2018 14/11/2018 S00292 CLOPIXOL ORAL DROPS SOLUTION 20MG/ML LUNDBECK HELLAS A.E.,CYPRUS 14/11/2018 S00848 S01034 S00586 S00297 S00878 CROMODAL EYE DROPS, SOLUTION 40MG/ML T4 TABLET 12MCG APOTEL PLUS SOLUTION FOR INJECTION ETOPOSIDE MYLAN SOLUTION FOR INFUSION, CONCENTRATE FOR 20MG/ML CLOMETHIAZOLE CAPSULE, SOFT 192MG ZWITTER PHARMACEUTICALS LTD UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES SA UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES SA 04/11/2018 09/12/2018 04/12/2018 MYLAN SAS 07/12/2018 CHEPLAPHARM ARZNEIMITTEL GMBH 18/12/2018 S00319 MITOMYCIN-C KYOWA POWDER FOR SOLUTION FOR INJECTION 2MG/VIAL MEDILINK PHARMACEUTICALS LTD 19/12/2018 S00320 MITOMYCIN-C KYOWA POWDER FOR SOLUTION FOR INJECTION 10MG/VIAL MEDILINK PHARMACEUTICALS LTD 19/12/2018

3409 Αρ. Ειδικής άδειας κυκλοφορίας Όνομα φαρμακευτικού Κάτοχος ειδικής άδειας κυκλοφορίας Ισχύς άδειας S00851 LIDOCAINE HYDROCHLORIDE SOLUTION FOR INJECTION 2% W/V HAMELN PHARMACEUTICALS LTD 18/12/2018 S00302 DOPAMINE MYLAN SOLUTION FOR INFUSION 40MG/ML MYLAN SAS 07/12/2018 S00849 URPEM EYE DROPS, SOLUTION 0.25MG/ML ZWITTER PHARMACEUTICALS LTD 04/11/2018 S00296 S00860 S00304 S00873 NALOXONE MYLAN SOLUTION FOR INJECTION 0.4MG/ML GLYCERYL TRINITRATE SOLUTION FOR INFUSION 1MG/ML NORADRENALINE MYLAN (SULPHITE FREE) SOLUTION FOR INJECTION, CONCENTRATE FOR 2MG/ML HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED 200MG MYLAN SAS 07/12/2018 HAMELN PHARMACEUTICALS LTD 18/12/2018 MYLAN SAS 07/12/2018 BRISTOL LABORATORIES LTD 18/12/2018 S00847 EUCALYTUX SYRUP TILMAN S.A. 07/11/2018 S00568 ZINDACLIN GEL 1% W/W MEDILINK PHARMACEUTICALS LTD 14/10/2018 S00865 MEDIJEL ORAL GEL DDD LIMITED, UK 18/12/2018 S00288 S00578 S00577 S00863 S00864 S00850 S00903 S00883 S00882 S00885 LOMEXIN SOLUTION, CUTANEOUS SPRAY 20MG/ML FRAGMIN SOLUTION FOR INJECTION 5000 ANTI-XA IU/0.2ML FRAGMIN SOLUTION FOR INJECTION 2500 ANTI-XA IU/0.2ML FYSIOFER ORAL SOLUTION 800(40Fe)MG/15ML FYSIOFOL POWDER AND SOLVENT FOR ORAL SOLUTION CISPLATIN SOLUTION FOR INFUSION, CONCENTRATE FOR 1MG/ML TERAZOSIN TABLET 5MG DIAZEPAM RECTUBES RECTAL SOLUTION 4MG/ML DIAZEPAM RECTUBES RECTAL SOLUTION 2MG/ML CYTAMEN SOLUTION FOR INJECTION 1000MCG/ML C G PAPALOISOU LTD 14/11/2018 PFIZER HELLAS AE 15/10/2018 PFIZER HELLAS AE 15/10/2018 ITF HELLAS A.E. 20/12/2018 ITF HELLAS A.E. 20/12/2018 ACCORD HEALTHCARE LIMITED ACCORD HEALTHCARE LIMITED 21/12/2018 21/12/2018 WOCKHARDT UK LTD 18/12/2018 WOCKHARDT UK LTD 18/12/2018 RPH PHARMACEUTICALS AB 18/12/2018 S00877 ATROPINE SULPHATE SOLUTION FOR INJECTION 600MCG/ML HAMELN PHARMACEUTICALS LTD 18/12/2018 S00855 ATROPINE EYE DROPS 1% W/V MARTINDALE PHARMACEUTICALS LTD 18/12/2018 S00283 S00299 S00295 ENDOXAN POWDER FOR SOLUTION FOR INFUSION 500MG/VIAL DOBUTAMINE MYLAN SOLUTION FOR INFUSION, CONCENTRATE FOR 250MG/20ML ACICLOVIR MYLAN POWDER FOR SOLUTION FOR INJECTION 250MG/VIAL BAXTER (HELLAS) EPE 25/10/2018 MYLAN SAS 07/12/2018 MYLAN SAS 07/12/2018

Αριθμός 4578 3410 ΕΙΔΙΚΕΣ ΑΔΕΙΕΣ ΚΥΚΛΟΦΟΡΙΑΣ ΠΟΥ ΕΧΟΥΝ ΕΚΔΟΘΕΙ ΑΠΟ ΤΟ ΣΥΜΒΟΥΛΙΟ ΦΑΡΜΑΚΩΝ Το Συμβούλιο Φαρμάκων, σύμφωνα με τις πρόνοιες του άρθρου 13Α των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων, και σύμφωνα με τα στοιχεία που υπέβαλαν οι αιτητές, εκδίδει Ειδικές Άδειες Φαρμακευτικών Προϊόντων με τα πιο κάτω στοιχεία: Αρ. Ειδικής Άδειας S01099 S01100 S01101 S01102 S01103 S01104 S01105 S01106 S01107 S01108 Όνομα Φαρμακευτικού Προϊόντος TAROMENTIN POWDER FOR SOLUTION FOR INJECTION/INFUSION SUXAMETHONIUM CHLORID VUAB POWDER FOR SOLUTION FOR INJECTION/INFUSION 100MG/VIAL PROBENECID BIOKANOL TABLET 500MG ERRKES ORAL SOLUTION 20MG/5ML ZITHROTEL POWDER FOR SOLUTION FOR INFUSION 500MG/VIAL TEKTROTYDE LYOPHILISATE FOR SOLUTION FOR INJECTION 16MCG/VIAL UNIMAZOLE TABLET 10MG FOSCAVIR SOLUTION FOR INFUSION 24MG/ML UNIMAZOLE TABLET 20MG UNIMAZOLE TABLET 5MG Δραστικά Συστατικά AMOXICILLIN 1000. mg CLAVULANIC ACID 200. mg SUXAMETHONIUM CHLORIDE DIHYDRATE 110. mg PROBENECID 500. mg KETOROLAC TROMETAMOL 4. mg AZITHROMYCIN DIHYDRATE 524.1 mg HYNIC-[D-PHEL1,TYR3- OCTREOTIDE]-TFA 16. µg THIAMAZOLE 10. mg FOSCARNET SODIUM HEXAHYDRATE 24. mg THIAMAZOLE 20. mg THIAMAZOLE 5. mg Κάτοχος Ειδικής Άδειας TARCHOMINSKIE ZAKLADY FARMACEUTYCZNE POLFA SPOLKA AKCYJNA Ημερομηνία Έκδοσης Ειδικής Άδειας 22/02/2017 VUAB PHARMA A.S. 22/02/2017 BIOKANOL PHARMA GMBH 22/02/2017 VERISFIELD (UK) LTD 24/02/2017 ANFARM HELLAS SA 02/03/2017 MEDIRAY GPC 22/03/2017 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES SA CLINIGEN HEALTHCARE LTD UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES SA UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES SA 23/02/2017 14/03/2017 23/02/2017 23/02/2017

Αριθμός 4579 3411 ΑΔΕΙΕΣ ΧΟΝΔΡΙΚΗΣ ΠΩΛΗΣΗΣ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ Το Συμβούλιο Φαρμάκων σύμφωνα με τις πρόνοιες του άρθρου 82 των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων του 2001 έως 2014, και σύμφωνα με τα στοιχεία που υπέβαλαν οι αιτητές, έχει εκδώσει Άδειες Χονδρικής Πώλησης Φαρμακευτικών Προϊόντων με τα πιο κάτω στοιχεία: 1. Αριθμός Άδειας: 127 Ημερομηνία Έκδοσης Άδειας: 20/02/2017 Ισχύει μέχρι: 19/02/2022 Κάτοχος Άδειας: LASERTA LTD LTD Διεύθυνση Αλληλογραφίας: Άδρια 9, Γραφείο 203, 1070, Λευκωσία Κύπρος 2 Αριθμός Άδειας: 128 Ημερομηνία Έκδοσης Άδειας: 20/02/2017 Ισχύει μέχρι: 19/02/2022 Κάτοχος Άδειας: OMEGA ALPHARM (CYPRUS) LTD Διεύθυνση Αλληλογραφίας: Κολοκοτρώνη 6, 1101, Λευκωσία, Κύπρος 1

3412 Αριθμός 4580 Το Συμβούλιο Φαρμάκων, ΑΝΑΝΕΩΣΕΙΣ ΑΔΕΙΩΝ ΚΥΚΛΟΦΟΡΙΑΣ ΠΟΥ ΕΧΟΥΝ ΕΓΚΡΙΘΕΙ ΑΠΟ ΤΟ ΣΥΜΒΟΥΛΙΟ ΦΑΡΜΑΚΩΝ - σύμφωνα με τις πρόνοιες του άρθρου 34 των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων του 2001 έως 2007, - σύμφωνα με τα στοιχεία που υπέβαλαν οι αιτητές με τις αρχικές τους αιτήσεις, και - σύμφωνα με τις τροποποιήσεις που υποβλήθηκαν στο μεταξύ διάστημα και έγιναν αποδεκτές, ανανεώνει την ισχύ των Αδειών Φαρμακευτικών Προϊόντων με τα πιο κάτω στοιχεία: Αρ. Άδειας Όνομα Φαρμακευτικού Προϊόντος Κάτοχος Άδειας Ισχύς Άδειας 020731 SUCRYL TABLET 1MG COSTAKIS TSISIOS & CO LTD Επ αόριστον 020733 SUCRYL TABLET 3MG COSTAKIS TSISIOS & CO LTD Επ αόριστον 020901 RAFAZIL TABLET, FILM COATED 5MG COSTAKIS TSISIOS & CO LTD Επ αόριστον 020734 SUCRYL TABLET 4MG COSTAKIS TSISIOS & CO LTD Επ αόριστον 020900 RAFAZIL TABLET, FILM COATED 10MG COSTAKIS TSISIOS & CO LTD Επ αόριστον 020732 SUCRYL TABLET 2MG COSTAKIS TSISIOS & CO LTD Επ αόριστον 020323 MOXICLAV POWDER FOR SOLUTION FOR INJECTION/INFUSION 1000MG/200MG MEDOCHEMIE LTD Επ αόριστον 021244 COTOVETOL TABLET, FILM COATED 50/12.5MG DELORBIS PHARMACEUTICALS LTD Επ αόριστον 021245 COTOVETOL TABLET, FILM COATED 100/25MG DELORBIS PHARMACEUTICALS LTD Επ αόριστον 021149 ZOBRAL TABLET, FILM COATED 5MG DELORBIS PHARMACEUTICALS LTD Επ αόριστον 021143 TOVETOL TABLET, FILM COATED 100MG DELORBIS PHARMACEUTICALS LTD Επ αόριστον 021142 TOVETOL TABLET, FILM COATED 50MG DELORBIS PHARMACEUTICALS LTD Επ αόριστον 021153 LIPIDIL NT TABLET, FILM COATED 145MG VARNAVAS HADJIPANAYIS LTD Επ αόριστον 019981 MEDODERMONE OINTMENT 0.05% W/W MEDOCHEMIE LTD Επ αόριστον 021398 ATALINE SYRUP 1.5MG/5ML MEDOCHEMIE LTD Επ αόριστον 021026 MONOCLOX POWDER FOR SOLUTION FOR INJECTION/INFUSION 1G MEDOCHEMIE LTD Επ αόριστον 021025 MONOCLOX POWDER FOR SOLUTION FOR INJECTION/INFUSION 500MG 021024 MONOCLOX POWDER FOR SOLUTION FOR INJECTION/INFUSION 250MG MEDOCHEMIE LTD Επ αόριστον MEDOCHEMIE LTD Επ αόριστον

3413 Αριθμός 4581 ΑΝΑΝΕΩΣΕΙΣ ΑΔΕΙΩΝ ΠΑΡΑΣΚΕΥΗΣ/ΕΙΣΑΓΩΓΗΣ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ ΑΠΟ ΤΡΙΤΕΣ ΧΩΡΕΣ Το Συμβούλιο Φαρμάκων, σύμφωνα με τις πρόνοιες του άρθρου 39 των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων του 2001 έως 2014, και σύμφωνα με τα στοιχεία που υπέβαλαν οι αιτητές, έχει ανανεώσει την ισχύ των πιο κάτω Άδειών Παρασκευής /Εισαγωγής Φαρμακευτικών Προϊόντων από τρίτες χώρες με τα πιο κάτω στοιχεία: 1. Αριθμός Άδειας: 001/2002 Ημερομηνία Έκδοσης Άδειας: 02/05/2002 Προηγούμενη λήξη: 30/04/2017 Ισχύει μέχρι: 30/04/2022 Κάτοχος Άδειας: MUNDIPHARMA PHARMACEUTICALS LTD Διεύθυνση Αλληλογραφίας: P. O. Box 23661, 1685, Λευκωσία, Κύπρος To πεδίο εφαρμογής της πιο πάνω Άδειας είναι: Παρασκευή φαρμακευτικών προϊόντων 2. Αριθμός Άδειας: 039 Ημερομηνία Έκδοσης Άδειας: 21/10/2011 Προηγούμενη λήξη: 20/10/2016 Ισχύει μέχρι: 20/10/2021 Κάτοχος Άδειας: MARATHON DISTRIBUTORS LTD Διεύθυνση Αλληλογραφίας: P.O. Box 21464, 1509, Λευκωσία, Κύπρος To πεδίο εφαρμογής της πιο πάνω Άδειας είναι: Εργασίες Μερικής Παρασκευής φαρμακευτικών προϊόντων (Δευτερογενής Συσκευασία) Αριθμός 4582 ΑΝΑΝΕΩΣΕΙΣ ΑΔΕΙΩΝ ΧΟΝΔΡΙΚΗΣ ΠΩΛΗΣΗΣ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ Το Συμβούλιο Φαρμάκων, σύμφωνα με τις πρόνοιες του άρθρου 82 των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων του 2001 έως 2014, και σύμφωνα με τα στοιχεία που υπέβαλαν οι αιτητές, έχει ανανεώσει την ισχύ των πιο κάτω Άδειών Χονδρικής Πώλησης Φαρμακευτικών Προϊόντων με τα πιο κάτω στοιχεία: 1. Αριθμός Άδειας: 063 Ημερομηνία Έκδοσης Άδειας: 02/02/2007 Προηγούμενη λήξη: 01/02/2017 Ισχύει μέχρι: 01/02/2022 Κάτοχος Άδειας: KYPROPHARM LTD Διεύθυνση Αλληλογραφίας: P.O. Box 22085, 1517, Nicosia, Cyprus Αριθμός 4583 ΕΓΓΡΑΦΕΣ ΣΤΟ ΜΗΤΡΩΟ ΕΙΔΙΚΕΥΜΕΝΩΝ ΠΡΟΣΩΠΩΝ Το Συμβούλιο Φαρμάκων, σύμφωνα με τις πρόνοιες του άρθρου 42(5) των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων του 2001 έως 2014, και σύμφωνα με τα στοιχεία που υπέβαλε ο αιτητής, ενέκρινε την εγγραφή στο Μητρώο Ειδικευμένων Προσώπων των πιο κάτω: 1. Όνομα Χαρά Ξυψιτή Αριθμός Μητρώου: 052 Ημερομηνία Εγγραφής: 20/2/2017 2. Όνομα: Νόρα Αντωνίου Αριθμός Μητρώου: 053 Ημερομηνία Εγγραφής: 20/2/2017

Το Συμβούλιο Φαρμάκων, σύμφωνα με τις πρόνοιες του άρθρου 9 των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων του 2001 (70(I)/2001) όπως εκάστοτε τροποποιείται, και σύμφωνα με τα στοιχεία που υπέβαλαν οι αιτητές, εκδίδει Άδειες Φαρμακευτικών Προϊόντων με τα πιο κάτω στοιχεία: Ημερομηνία Έκδοσης Άδειας 3414 Αριθμός 4584 ΑΔΕΙΕΣ ΚΥΚΛΟΦΟΡΙΑΣ ΠΟΥ ΕΧΟΥΝ ΕΚΔΟΘΕΙ ΑΠΟ ΤΟ ΣΥΜΒΟΥΛΙΟ ΦΑΡΜΑΚΩΝ Αρ. Άδειας Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας 019806 HUMULIN REGULAR SOLUTION FOR INJECTION 100IU/ML INSULIN HUMAN PHADISCO LTD 01/03/2017 HUMULIN NPH SUSPENSION FOR 019807 INJECTION 100IU/ML INSULIN HUMAN PHADISCO LTD 01/03/2017 HUMULIN M3 SUSPENSION FOR 019808 INJECTION 100IU/ML INSULIN HUMAN PHADISCO LTD 01/03/2017 022436 SAGILIA TABLET 1MG RASAGILINE TARTRATE MEDOCHEMIE LTD 17/01/2017 MERIOFERT POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 022437 75IU/VIAL MENOTROPHIN LABORATOIRES GENEVRIER SA 12/01/2017 MERIOFERT POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 022438 150IU/VIAL MENOTROPHIN LABORATOIRES GENEVRIER SA 12/01/2017 VALSIMIA TABLET, FILM COATED 022439 5MG/80MG AMLODIPINE BESYLATE ELPEN PHARMACEUTICAL CO INC 16/01/2017 VALSIMIA TABLET, FILM COATED 022439 5MG/80MG VALSARTAN ELPEN PHARMACEUTICAL CO INC 16/01/2017

022442 REXTOL CAPSULE, SOFT 1MCG PARICALCITOL RAFARM S.A. 17/01/2017 022443 REXTOL CAPSULE, SOFT 2MCG PARICALCITOL RAFARM S.A. 17/01/2017 022444 REXTOL CAPSULE, SOFT 4MCG PARICALCITOL RAFARM S.A. 17/01/2017 3415 Αρ. Άδειας 022440 022440 022441 022441 Ημερομηνία Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας Έκδοσης Άδειας VALSIMIA TABLET, FILM COATED 5MG/160MG VALSARTAN ELPEN PHARMACEUTICAL CO INC 16/01/2017 VALSIMIA TABLET, FILM COATED 5MG/160MG AMLODIPINE BESYLATE ELPEN PHARMACEUTICAL CO INC 16/01/2017 VALSIMIA TABLET, FILM COATED 10MG/160MG VALSARTAN ELPEN PHARMACEUTICAL CO INC 16/01/2017 VALSIMIA TABLET, FILM COATED 10MG/160MG AMLODIPINE BESYLATE ELPEN PHARMACEUTICAL CO INC 16/01/2017 022445 022445 022445 022446 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 100MG/25MG/200MG LEVODOPA ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 100MG/25MG/200MG ENTACAPONE ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 100MG/25MG/200MG CARBIDOPA ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 150MG/37.5MG/200MG LEVODOPA ACCORD HEALTHCARE LIMITED 19/01/2017

3416 Αρ. Άδειας Ημερομηνία Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας Έκδοσης Άδειας 022446 022446 022447 022447 022447 022448 022448 022448 022449 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 150MG/37.5MG/200MG ENTACAPONE ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 150MG/37.5MG/200MG CARBIDOPA ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 125MG/31.25MG/200MG LEVODOPA ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 125MG/31.25MG/200MG CARBIDOPA ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 125MG/31.25MG/200MG ENTACAPONE ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 200MG/50MG/200MG LEVODOPA ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 200MG/50MG/200MG ENTACAPONE ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 200MG/50MG/200MG CARBIDOPA ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 50MG/12.5MG/200MG CARBIDOPA ACCORD HEALTHCARE LIMITED 19/01/2017

022454 VIANIB CAPSULE, HARD 100MG IMATINIB MESYLATE VIANEX S.A 01/02/2017 3417 Αρ. Άδειας 022449 022449 022450 022450 022450 022451 022452 022453 Ημερομηνία Όνομα Φαρμακευτικού Προϊόντος Έκδοσης Άδειας Δραστικά Συστατικά Κάτοχος Άδειας LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 50MG/12.5MG/200MG ENTACAPONE ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 50MG/12.5MG/200MG LEVODOPA ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 75MG/18.75MG/200MG ENTACAPONE ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 75MG/18.75MG/200MG LEVODOPA ACCORD HEALTHCARE LIMITED 19/01/2017 LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD TABLET, FILM COATED 75MG/18.75MG/200MG CARBIDOPA ACCORD HEALTHCARE LIMITED 19/01/2017 QUETIAPINE ACCORD TABLET, PROLONGED-RELEASE 150MG QUETIAPINE FUMARATE ACCORD HEALTHCARE LIMITED 19/01/2017 VALGANCICLOVIR ACCORD TABLET, VALGANCICLOVIR FILM COATED 450MG HYDROCHLORIDE ACCORD HEALTHCARE LIMITED 19/01/2017 IRINOTECAN ACCORD SOLUTION FOR IRINOTECAN INFUSION, CONCENTRATE FOR HYDROCHLORIDE 20MG/ML TRIHYDRATE ACCORD HEALTHCARE LIMITED 19/01/2017

Ημερομηνία Έκδοσης Άδειας 3418 Αρ. Άδειας Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας 022455 VIANIB CAPSULE, HARD 400MG IMATINIB MESYLATE VIANEX S.A 01/02/2017 022456 OLMESARTAN+HCT/ZENTIVA TABLET, FILM COATED 20MG/12.5MG HYDROCHLOROTHIAZIDE SANOFI-AVENTIS CYPRUS LTD 18/01/2017 022456 OLMESARTAN+HCT/ZENTIVA TABLET, FILM COATED 20MG/12.5MG OLMESARTAN MEDOXOMIL SANOFI-AVENTIS CYPRUS LTD 18/01/2017 022457 OLMESARTAN+HCT/ZENTIVA TABLET, FILM COATED 20MG/25MG HYDROCHLOROTHIAZIDE SANOFI-AVENTIS CYPRUS LTD 18/01/2017 022457 OLMESARTAN+HCT/ZENTIVA TABLET, FILM COATED 20MG/25MG OLMESARTAN MEDOXOMIL SANOFI-AVENTIS CYPRUS LTD 18/01/2017 022458 OLMESARTAN+HCT/ZENTIVA TABLET, FILM COATED 40MG/12.5MG OLMESARTAN MEDOXOMIL SANOFI-AVENTIS CYPRUS LTD 18/01/2017 022458 OLMESARTAN+HCT/ZENTIVA TABLET, FILM COATED 40MG/12.5MG HYDROCHLOROTHIAZIDE SANOFI-AVENTIS CYPRUS LTD 18/01/2017 022459 OLMESARTAN+HCT/ZENTIVA TABLET, FILM COATED 40MG/25MG OLMESARTAN MEDOXOMIL SANOFI-AVENTIS CYPRUS LTD 18/01/2017 022459 OLMESARTAN+HCT/ZENTIVA TABLET, FILM COATED 40MG/25MG HYDROCHLOROTHIAZIDE SANOFI-AVENTIS CYPRUS LTD 18/01/2017 VORICONAZOLE FRESENIUS KABI POWDER FOR SOLUTION FOR 022460 INFUSION 200MG/VIAL VORICONAZOLE FRESENIUS KABI HELLAS AE 06/02/2017 BUDESONIDE BILLEV PHARMA BILLEV PHARMA APS (TORSLEV), 022461 NEBULISER SUSPENSION 0.25MG/2ML BUDESONIDE DENMARK 07/02/2017

Ημερομηνία Έκδοσης 022465 PRELYNCA CAPSULE, HARD 25MG PREGABALIN PHARMATHEN S.A. 22/02/2017 022466 PRELYNCA CAPSULE, HARD 50MG PREGABALIN PHARMATHEN S.A. 22/02/2017 022467 PRELYNCA CAPSULE, HARD 75MG PREGABALIN PHARMATHEN S.A. 22/02/2017 022468 PRELYNCA CAPSULE, HARD 100MG PREGABALIN PHARMATHEN S.A. 22/02/2017 022469 PRELYNCA CAPSULE, HARD 150MG PREGABALIN PHARMATHEN S.A. 22/02/2017 022470 PRELYNCA CAPSULE, HARD 200MG PREGABALIN PHARMATHEN S.A. 22/02/2017 022471 PRELYNCA CAPSULE, HARD 225MG PREGABALIN PHARMATHEN S.A. 22/02/2017 022472 PRELYNCA CAPSULE, HARD 300MG PREGABALIN PHARMATHEN S.A. 22/02/2017 Άδειας 3419 Αρ. Άδειας Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας 022462 022463 022464 022464 BUDESONIDE BILLEV PHARMA NEBULISER SUSPENSION 0.5MG/2ML BUDESONIDE BUDESONIDE BILLEV PHARMA NEBULISER SUSPENSION 1MG/2ML BUDESONIDE SKUDEXA TABLET, FILM COATED DEXKETOPROFEN 75MG/25MG TROMETAMOL SKUDEXA TABLET, FILM COATED TRAMADOL 75MG/25MG HYDROCHLORIDE BILLEV MENARINI INTERNATIONAL OPERATIONS MENARINI INTERNATIONAL OPERATIONS PHARMA APS (TORSLEV), DENMARK 07/02/2017 BILLEV PHARMA APS (TORSLEV), DENMARK 07/02/2017 LUXEMBOURG SA 10/02/2017 LUXEMBOURG SA 10/02/2017 022473 RASAGILINE KRKA TABLET 1MG RASAGILINE HEMITARTRATE KRKA D.D. NOVO MESTO 22/02/2017 OLMESARTAN MEDOXOMIL JUBILANT 022474 TABLET, FILM COATED 10MG OLMESARTAN MEDOXOMIL JUBILANT PHARMACEUTICALS NV 22/02/2017

022482 CODALIS TABLET, FILM COATED 5MG TADALAFIL CODAL SYNTO LTD 01/03/2017 022483 CODALIS TABLET, FILM COATED 10MG TADALAFIL CODAL SYNTO LTD 01/03/2017 3420 Αρ. Άδειας 022475 022476 022477 022478 022479 Ημερομηνία Όνομα Φαρμακευτικού Προϊόντος Άδειας Δραστικά Συστατικά Κάτοχος Άδειας Έκδοσης OLMESARTAN MEDOXOMIL JUBILANT TABLET, FILM COATED 20MG OLMESARTAN MEDOXOMIL JUBILANT PHARMACEUTICALS NV 22/02/2017 OLMESARTAN MEDOXOMIL JUBILANT TABLET, FILM COATED 40MG OLMESARTAN MEDOXOMIL JUBILANT PHARMACEUTICALS NV 22/02/2017 MICALCET TABLET, FILM COATED CINACALCET (AS 30MG HYDROCHLORIDE) SANOFI-AVENTIS CYPRUS LTD 10/02/2017 MICALCET TABLET, FILM COATED CINACALCET (AS 60MG HYDROCHLORIDE) SANOFI-AVENTIS CYPRUS LTD 10/02/2017 MICALCET TABLET, FILM COATED CINACALCET (AS 90MG HYDROCHLORIDE) SANOFI-AVENTIS CYPRUS LTD 10/02/2017 022480 FUROSEMIDE BRISTOL TABLET 40MG FUROSEMIDE BRISTOL LABORATORIES LTD 14/02/2017 CYMEVENE POWDER FOR 022481 CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/VIAL GANCICLOVIR G A STAMATIS & CO LTD 21/02/2017 022484 CODALIS TABLET, FILM COATED 20MG TADALAFIL CODAL SYNTO LTD 01/03/2017 VARLOTA TABLET, FILM COATED ERLOTINIB PHAROS-PHARMACEUTICAL ORIENTED 022485 25MG HYDROCHLORIDE SERVICES LTD 01/03/2017 VARLOTA TABLET, FILM COATED ERLOTINIB PHAROS-PHARMACEUTICAL ORIENTED 022486 50MG HYDROCHLORIDE SERVICES LTD 01/03/2017

Ημερομηνία Έκδοσης Άδειας 3421 Αρ. Άδειας Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας 022487 VARLOTA TABLET, FILM COATED 100MG ERLOTINIB HYDROCHLORIDE PHAROS-PHARMACEUTICAL ORIENTED SERVICES LTD 01/03/2017 022488 VARLOTA TABLET, FILM COATED 150MG ERLOTINIB HYDROCHLORIDE PHAROS-PHARMACEUTICAL ORIENTED SERVICES LTD 01/03/2017 022489 022490 PIMAXEF POWDER FOR SOLUTION FOR INJECTION/INFUSION 500MG/VIAL PIMAXEF POWDER FOR SOLUTION FOR INJECTION/INFUSION 1G/VIAL CEFEPIME HYDROCHLORIDE MONOHYDRATE CODAL SYNTO LTD 06/03/2017 CEFEPIME HYDROCHLORIDE MONOHYDRATE CODAL SYNTO LTD 06/03/2017 022491 022492 022493 022494 022495 022496 PIMAXEF POWDER FOR SOLUTION FOR INJECTION/INFUSION 2G/VIAL ERLOTINIB REMEDICA TABLET, FILM COATED 25MG ERLOTINIB REMEDICA TABLET, FILM COATED 50MG ERLOTINIB REMEDICA TABLET, FILM COATED 100MG ERLOTINIB REMEDICA TABLET, FILM COATED 150MG NUROFEN FOR CHILDREN CHEWABLE CEFEPIME HYDROCHLORIDE MONOHYDRATE CODAL SYNTO LTD 06/03/2017 ERLOTINIB HYDROCHLORIDE REMEDICA LTD 06/03/2017 ERLOTINIB HYDROCHLORIDE REMEDICA LTD 06/03/2017 ERLOTINIB HYDROCHLORIDE REMEDICA LTD 06/03/2017 ERLOTINIB CAPSULE, SOFT 100MG IBUPROFEN HYDROCHLORIDE REMEDICA LTD 06/03/2017 RECKITT BENCKISER HELLAS CHEMICAL ABEE 06/03/2017 022497 PALEXIA ORAL SOLUTION 4MG/ML TAPENTADOL HYDROCHLORIDE GRUNENTHAL GMBH 20/03/2017 022498 VALSARTAN JUBILANT TABLET, FILM COATED 320MG VALSARTAN JUBILANT PHARMACEUTICALS NV 20/03/2017

Ημερομηνία Έκδοσης 022501 RAPYDAN MEDICATED PLASTER TETRACAINE EUROCEPT INTERNATIONAL B.V 28/03/2017 Άδειας 3422 Αρ. Άδειας Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας 022499 022500 DUCILTIA GASTRO-RESISTANT CAPSULE, HARD 30MG DUCILTIA GASTRO-RESISTANT CAPSULE, HARD 60MG DULOXETINE HYDROCHLORIDE PHARMATHEN S.A. 20/03/2017 DULOXETINE HYDROCHLORIDE PHARMATHEN S.A. 20/03/2017 022501 RAPYDAN MEDICATED PLASTER LIDOCAINE EUROCEPT INTERNATIONAL B.V 28/03/2017 BORTEZOMIB LEDPHARM POWDER FOR SOLUTION FOR INJECTION 022502 3.5MG/VIAL BORTEZOMIB O.S.K. LEDPHARM LTD 10/04/2017 022503 MENOPUR POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 600IU MENOTROPHIN FERRING HELLAS MEPE 04/04/2017 MENOPUR POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 022504 1200IU MENOTROPHIN FERRING HELLAS MEPE 04/04/2017 022505 MEDOQUIP TABLET, FILM COATED 0.25MG ROPINIROLE HYDROCHLORIDE MEDOCHEMIE LTD 05/04/2017 022506 MEDOQUIP TABLET, FILM COATED 0.5MG ROPINIROLE HYDROCHLORIDE MEDOCHEMIE LTD 05/04/2017 022507 MEDOQUIP TABLET, FILM COATED 1MG ROPINIROLE HYDROCHLORIDE MEDOCHEMIE LTD 05/04/2017 022508 MEDOQUIP TABLET, FILM COATED 2MG ROPINIROLE HYDROCHLORIDE MEDOCHEMIE LTD 05/04/2017

Ημερομηνία Έκδοσης Άδειας 3423 Αρ. Άδειας Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας 022509 MEDOQUIP TABLET, FILM COATED 5MG ROPINIROLE HYDROCHLORIDE MEDOCHEMIE LTD 05/04/2017 022510 TROVAL TABLET, FILM COATED 40MG VALSARTAN DELORBIS PHARMACEUTICALS LTD 03/03/2017 FORMALINAVD\DAT TETRAXIM SUSPENSION FOR POLIOVIRUS TYP 3 (STAM 022511 INJECTION IN PRE-FILLED SYRINGE SAUKETT) SANOFI PASTEUR SA 13/04/2017 TETRAXIM SUSPENSION FOR BORDETELLA PERTUSSIS 022511 INJECTION IN PRE-FILLED SYRINGE ANTIGENS TOXOID SANOFI PASTEUR SA 13/04/2017 BORDETELLA PERTUSSIS TETRAXIM SUSPENSION FOR ANTIGENS FILAMENTOUS 022511 INJECTION IN PRE-FILLED SYRINGE HAEMAGGLUTININ SANOFI PASTEUR SA 13/04/2017 TETRAXIM SUSPENSION FOR 022511 INJECTION IN PRE-FILLED SYRINGE TETANUS TOXOID SANOFI PASTEUR SA 13/04/2017 022511 TETRAXIM SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE FORMALINAVD\DAT POLIOVIRUS TYP 1 (STAM BRUNENDERS) SANOFI PASTEUR SA 13/04/2017 022511 022511 022512 TETRAXIM SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE TETRAXIM SUSPENSION FOR FORMALINAVD\DAT POLIOVIRUS TYP 2 (STAM MEF1) SANOFI PASTEUR SA 13/04/2017 INJECTION IN PRE-FILLED SYRINGE DIPHTHERIA TOXOID SANOFI PASTEUR SA 13/04/2017 VAXIGRIPTETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 15MCG/DOSE B/BRISBANE/60/2008 SANOFI PASTEUR SA 13/04/2017

3424 Αρ. Άδειας Ημερομηνία Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας Έκδοσης Άδειας 022512 022512 022512 022513 022513 022514 022514 022515 022516 022518 VAXIGRIPTETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 15MCG/DOSE B/MASSACHUSETTS/02/2012 SANOFI PASTEUR SA 13/04/2017 VAXIGRIPTETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 15MCG/DOSE A/CALIFORNIA/7/2009 (H1N1) SANOFI PASTEUR SA 13/04/2017 VAXIGRIPTETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 15MCG/DOSE A/TEXAS/50/2012 (H3N2) SANOFI PASTEUR SA 13/04/2017 SEPTANEST SOLUTION FOR INJECTION SEPTANEST SOLUTION FOR ARTICAINE HYDROCHLORIDE SEPTODONT 14/02/2017 INJECTION EPINEPHRINE BITARTRATE SEPTODONT 14/02/2017 SEPTANEST FORTE SOLUTION FOR INJECTION SEPTANEST FORTE SOLUTION FOR ARTICAINE HYDROCHLORIDE SEPTODONT 14/02/2017 INJECTION EPINEPHRINE BITARTRATE SEPTODONT 14/02/2017 BUPIVACAINE ACCORD SOLUTION FOR INJECTION 5MG/ML LATANOPROST DEMO EYE DROPS, BUPIVACAINE HYDROCHLORIDE ACCORD HEALTHCARE LIMITED 26/04/2017 SOLUTION 50MCG/ML LATANOPROST DEMO S.A. 20/04/2017 CASPOFUNGIN DEMO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 50MG/VIAL CASPOFUNGIN ACETATE DEMO S.A. 26/04/2017

Ημερομηνία Έκδοσης Άδειας 3425 Αρ. Άδειας Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας 022519 CASPOFUNGIN DEMO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 70MG/VIAL CASPOFUNGIN ACETATE DEMO S.A. 26/04/2017 ARITAVI GASTRO-RESISTANT DULOXETINE 022520 CAPSULE, HARD 30MG HYDROCHLORIDE ACTAVIS GROUP PTC EHF 26/04/2017 ARITAVI GASTRO-RESISTANT DULOXETINE 022521 CAPSULE, HARD 60MG HYDROCHLORIDE ACTAVIS GROUP PTC EHF 26/04/2017 022522 INJEXATE SOLUTION FOR INJECTION IN PREFILLED SYRINGES 50MG/ML METHOTREXATE ACCORD HEALTHCARE LIMITED 26/04/2017 022523 MYDRANE SOLUTION FOR INJECTION LIDOCAINE HYDROCHLORIDE LABORATOIRES THEA 26/04/2017 022523 MYDRANE SOLUTION FOR INJECTION PHENYLEPHRINE HYDROCHLORIDE LABORATOIRES THEA 26/04/2017 022523 MYDRANE SOLUTION FOR INJECTION TROPICAMIDE LABORATOIRES THEA 26/04/2017 022524 PALEXIA ORAL SOLUTION 20MG/ML TAPENTADOL HYDROCHLORIDE GRUNENTHAL GMBH 26/04/2017

Το Συμβούλιο Φαρμάκων, σύμφωνα με τις πρόνοιες του άρθρου 31 των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων του 2001 (70(I)/2001) όπως εκάστοτε τροποποιείται, ενέκρινε τις πιο κάτω τροποποιήσεις: 3426 Αριθμός 4585 ΤΡΟΠΟΠΟΙΗΣΕΙΣ ΑΔΕΙΩΝ ΚΥΚΛΟΦΟΡΙΑΣ ΠΟΥ ΕΧΟΥΝ ΕΓΚΡΙΘΕΙ ΑΠΟ ΤΟ ΣΥΜΒΟΥΛΙΟ ΦΑΡΜΑΚΩΝ Όνομα φαρμακευτικού NEXIUM GASTRO RESISTANT GRANULES FOR Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης ORAL SUSP. 10MG 20461 20124189 ASTRAZENECA AB NEXIUM GASTRO RESISTANT GRANULES FOR ORAL SUSP. 10MG 20461 20124891 ASTRAZENECA AB IRBESARTAN ACCORD TABLET, FILM COATED 150MG 21645 20127075 IRBESARTAN ACCORD TABLET, FILM COATED 150MG 21645 20127078 IRBESARTAN ACCORD TABLET, FILM COATED 150MG 21645 20127535 ACCORD HEALTHCARE Implementation of wording regarding bone fracture and hypomagnesaemia Update of SmPC section 4.5 and PL - drug interaction with clopidogrel LIMITED Inclusion pack styles of 30 tablets ACCORD HEALTHCARE LIMITED Inclusion pack styles of 90 tablets ACCORD HEALTHCARE LIMITED Updated the SPC in line with the reference product. The PIL was amended BENYLIN MUCUS COUGH WARM HONEY & LEMON FLAVOUR SYRUP 100MG/5ML 21632 201210409 JOHNSON & JOHNSON HELLAS CONSUMER AE To change the name of the medicinal product in Slovakia

3427 Όνομα φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης BENYLIN MUCUS COUGH WARM HONEY & LEMON FLAVOUR SYRUP 100MG/5ML 21632 201210410 BENYLIN MUCUS COUGH WARM HONEY & LEMON FLAVOUR SYRUP 100MG/5ML 21632 201210411 SUBUTEX SUBLINGUAL JOHNSON & JOHNSON HELLAS CONSUMER AE JOHNSON & JOHNSON HELLAS CONSUMER AE To change the name of the medicinal product in Poland To change the name of the medicinal product in Greece. TABLETS 0,4MG 20071 20132418 RB PHARMACEUTICALS LTD Update SPC and PIL in line with CCDS SUBUTEX SUBLINGUAL TABLETS 2MG 20072 20132419 RB PHARMACEUTICALS LTD Update SPC and PIL in line with CCDS SUBUTEX SUBLINGUAL TABLETS 8MG 20073 20132420 RB PHARMACEUTICALS LTD Update SPC and PIL in line with CCDS BENYLIN MUCUS COUGH WARM HONEY & LEMON FLAVOUR SYRUP 100MG/5ML 21632 20132770 DONEPEZIL ACCORD TABLET, FILM COATED 5MG 21471 20133239 DONEPEZIL ACCORD TABLET, FILM COATED 10MG 21472 20133240 REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION JOHNSON & JOHNSON HELLAS CONSUMER AE ACCORD HEALTHCARE LIMITED ACCORD HEALTHCARE LIMITED To extend the shelf life of the finished product from '2 years' to '3 years'. Consequently section 6.3 (Shelf life) of the SPC has been updated. Change the address of the manufacturer of the active substance Change the address of the manufacturer of the active substance FOR INFUSION 1MG/VIAL 21442 20133744 HOSPIRA UK LIMITED Address change of MAH in PT

3428 Όνομα φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 2MG 21443 20133745 HOSPIRA UK LIMITED Address change of MAH in PT REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 5MG/VIAL 21444 20133746 HOSPIRA UK LIMITED Address change of MAH in PT REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 1MG/VIAL 21442 20133747 HOSPIRA UK LIMITED Address change of MAH in BE REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 2MG 21443 20133748 HOSPIRA UK LIMITED Address change of MAH in BE REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 5MG/VIAL 21444 20133749 HOSPIRA UK LIMITED Address change of MAH in BE REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 1MG/VIAL 21442 20133750 HOSPIRA UK LIMITED Address change of MAH in LU REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 2MG 21443 20133751 HOSPIRA UK LIMITED Address change of MAH in LU

3429 Όνομα φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 5MG/VIAL 21444 20133752 HOSPIRA UK LIMITED Address change of MAH in LU REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 1MG/VIAL 21442 20133753 HOSPIRA UK LIMITED Address change of MAH in NL REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 2MG 21443 20133754 HOSPIRA UK LIMITED Address change of MAH in NL REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 5MG/VIAL 21444 20133755 HOSPIRA UK LIMITED Address change of MAH in NL REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 1MG/VIAL 21442 20133756 HOSPIRA UK LIMITED Introduce the PSMF and new QPPV REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 2MG 21443 20133757 HOSPIRA UK LIMITED Introduce the PSMF and new QPPV REMIFENTANYL HOSPIRA POWDER FOR SUSPENSION FOR INFUSION 5MG/VIAL 21444 20133758 HOSPIRA UK LIMITED Introduce the PSMF and new QPPV

3430 Όνομα φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης LIPITOR F.C.TABLETS 10MG 19489 20134604 PFIZER HELLAS AE Update PI LIPITOR F.C.TABLETS 20MG 19490 20134605 PFIZER HELLAS AE Update PI LIPITOR F.C.TABLETS 40MG 19491 20134606 PFIZER HELLAS AE Update PI PRILIGY TABLET, FILM JANSSEN-CILAG COATED 30MG 21464 20135078 INTERNATIONAL NV Add a secondary packaging site PRILIGY TABLET, FILM JANSSEN-CILAG COATED 60MG 21465 20135079 INTERNATIONAL NV Add a secondary packaging site PRILIGY TABLET, FILM JANSSEN-CILAG COATED 30MG 21464 20135080 INTERNATIONAL NV Add a primary packaging site PRILIGY TABLET, FILM JANSSEN-CILAG COATED 60MG 21465 20135081 INTERNATIONAL NV Add a primary packaging site PRILIGY TABLET, FILM JANSSEN-CILAG COATED 30MG 21464 20135082 INTERNATIONAL NV Add testing and release site PRILIGY TABLET, FILM JANSSEN-CILAG COATED 60MG 21465 20135083 INTERNATIONAL NV Add testing and release site BENYLIN MUCUS COUGH WARM HONEY & LEMON JOHNSON & JOHNSON To change the name of the medicinal product in FLAVOUR SYRUP 100MG/5ML 21632 20135328 HELLAS CONSUMER AE Czech Republic BENYLIN MUCUS COUGH WARM HONEY & LEMON JOHNSON & JOHNSON To change the name of the medicinal product in FLAVOUR SYRUP 100MG/5ML 21632 20135329 HELLAS CONSUMER AE Slovakia

3431 Όνομα φαρμακευτικού BENYLIN MUCUS COUGH WARM HONEY & LEMON Αρ. Άδειας FLAVOUR SYRUP 100MG/5ML 21632 20135332 BENYLIN MUCUS COUGH WARM HONEY & LEMON FLAVOUR SYRUP 100MG/5ML 21632 20135333 BENYLIN MUCUS COUGH WARM HONEY & LEMON FLAVOUR SYRUP 100MG/5ML 21632 20135334 BENYLIN MUCUS COUGH WARM HONEY & LEMON FLAVOUR SYRUP 100MG/5ML 21632 20135335 BENYLIN MUCUS COUGH WARM HONEY & LEMON FLAVOUR SYRUP 100MG/5ML 21632 20135336 Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης JOHNSON & JOHNSON HELLAS CONSUMER AE JOHNSON & JOHNSON HELLAS CONSUMER AE JOHNSON & JOHNSON HELLAS CONSUMER AE JOHNSON & JOHNSON HELLAS CONSUMER AE JOHNSON & JOHNSON HELLAS CONSUMER AE Update of the SPC. As a consequence, the PIL has been updated. Update of the SPC. As a consequence, the PIL has been updated. Update of the SPC. As a consequence, the PIL has been updated. Update of the SPC. As a consequence, the PIL has been updated. Update of the SPC. As a consequence, the PIL has been updated. NEXIUM GASTRO RESISTANT GRANULES FOR ORAL SUSP. 10MG 20461 20135434 ASTRAZENECA AB Update SPC section 4.8 DONEPEZIL ACCORD TABLET, FILM COATED 5MG 21471 20138243 DONEPEZIL ACCORD TABLET, FILM COATED 10MG 21472 20138244 ACCORD HEALTHCARE LIMITED Change EU QPPV ACCORD HEALTHCARE LIMITED Change EU QPPV

3432 Όνομα φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης BENYLIN MUCUS COUGH WARM HONEY & LEMON JOHNSON & JOHNSON Change the name of the medicinal product in FLAVOUR SYRUP 100MG/5ML 21632 201440 HELLAS CONSUMER AE Bulgaria BENYLIN MUCUS COUGH WARM HONEY & LEMON JOHNSON & JOHNSON To change the name of the medicinal product in FLAVOUR SYRUP 100MG/5ML 21632 201441 HELLAS CONSUMER AE Romania NEXIUM GASTRO RESISTANT GRANULES FOR ORAL SUSP. 10MG 20461 2014394 ASTRAZENECA AB Update PI RANITIDINE ACCORD TABLET, FILM COATED ACCORD HEALTHCARE New Ph. Eur. Certificate of Suitability from a 150MG 21642 2014585 LIMITED new manufacturer RANITIDINE ACCORD TABLET, FILM COATED ACCORD HEALTHCARE New Ph. Eur. Certificate of Suitability from a 300MG 21643 2014586 LIMITED new manufacturer BILAZ TABLET 20MG 21475 20141320 MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA Delete manufacturing site for the active substance RANITIDINE ACCORD TABLET, FILM COATED ACCORD HEALTHCARE 150MG 21642 20143079 LIMITED Additional Batch control/testing site

VILIMEN TABLET, FILM COATED 10MG 21872 20143477 TERIX LABS LTD Add a batch release site VILIMEN TABLET, FILM COATED 20MG 21873 20143478 TERIX LABS LTD Add a batch release site 3433 Όνομα φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης RANITIDINE ACCORD TABLET, FILM COATED 300MG 21643 20143080 ACCORD HEALTHCARE LIMITED Additional Batch control/testing site PRETERAX F.C. TABS 2,5MG/0,625MG 19761 20143518 PRETERAX TABS 4MG/1,25MG 19763 20143519 COVERSYL PLUS ARGININE TABLET, FILM COATED 2.5MG/0.625MG 20256 20143520 COVERSYL PLUS ARGININE F.C. TABS 5/1,25MG 20257 20143521 PRETERAX F.C. TABS 2,5MG/0,625MG 19761 20143522 PRETERAX TABS 4MG/1,25MG 19763 20143523 COVERSYL PLUS ARGININE TABLET, FILM COATED 5MG/1.25MG 20256 20143524 LES LABORATOIRES SERVIER LES LABORATOIRES SERVIER LES LABORATOIRES SERVIER LES LABORATOIRES SERVIER LES LABORATOIRES SERVIER LES LABORATOIRES SERVIER LES LABORATOIRES SERVIER One to implement changes approved in August 2013 for perindopril One to implement changes approved in August 2013 for perindopril One to implement changes approved in August 2013 for perindopril One to implement changes approved in August 2013 for perindopril One to implement changes approved in February 2014 for indapamide One to implement changes approved in February 2014 for indapamide One to implement changes approved in February 2014 for indapamide

3434 Όνομα Update CEP for active subtance Fluticasone φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης COVERSYL PLUS ARGININE F.C. TABS 5/1,25MG 20257 20143525 LES LABORATOIRES SERVIER One to implement changes approved in February 2014 for indapamide SYNAZE NASAL SPRAY, MEDA PHARMACEUTICALS SUSPENSION 21884 20143728 SA Change of batch size SYNAZE NASAL SPRAY, MEDA PHARMACEUTICALS SUSPENSION 21884 20143730 SA Minor change to an approved test procedure SYNAZE NASAL SPRAY, MEDA PHARMACEUTICALS propionate from an already approved SUSPENSION 21884 20143732 SA manufacturer SYNAZE NASAL SPRAY, MEDA PHARMACEUTICALS Update CEP for active subtance Azelastine HCl SUSPENSION 21884 20143734 SA from an already approved manufacturer FUNGUSTATIN CAPS 150MG 13273 20143749 PFIZER HELLAS AE Update SPC and PIL (new interaction) FUNGUSTATIN INF.2MG/ML 13275 20143750 PFIZER HELLAS AE Update SPC and PIL (new interaction) PRILIGY TABLET, FILM JANSSEN-CILAG Introduction of a manufacturer of the active COATED 30MG 21464 20143978 INTERNATIONAL NV substance PRILIGY TABLET, FILM JANSSEN-CILAG Introduction of a manufacturer of the active COATED 60MG 21465 20143979 INTERNATIONAL NV substance GAVISCON DOUBLE ACTION ORAL SUSPENSION 21163 20143999 RECKITT BENCKISER HEALTHCARE (UK) Change in name of MA in HU VENLAFAXIN TAD P/R CAPS 75MG 20343 20144252 TAD PHARMA GMBH Change the composition (excipients) of the finished prodcut

3435 Όνομα φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης VENLAFAXIN TAD P/R CAPS 150MG 20344 20144253 TAD PHARMA GMBH Change the composition (excipients) of the finished prodcut VENLAFAXIN TAD P/R CAPS 75MG 20343 20144254 TAD PHARMA GMBH Change in the manufacturing process VENLAFAXIN TAD P/R CAPS 150MG 20344 20144255 TAD PHARMA GMBH Change in the manufacturing process VENLAFAXIN TAD P/R CAPS 75MG 20343 20144256 TAD PHARMA GMBH Change in the manufacturing process VENLAFAXIN TAD P/R CAPS 150MG 20344 20144257 TAD PHARMA GMBH Change in the manufacturing process DONEPEZIL ACCORD ACCORD HEALTHCARE TABLET, FILM COATED 5MG 21471 20144302 LIMITED Addition of a secondary packaging site DONEPEZIL ACCORD ACCORD HEALTHCARE TABLET, FILM COATED 10MG 21472 20144303 LIMITED Addition of a secondary packaging site VALCYTE F.C. TABS 450MG 20089 20144310 G.A STAMATIS & CO Update SPC VALCYTE PWD FOR ORAL SOL. 50MG 20549 20144311 G A STAMATIS & CO LTD Update SPC REMODULIN SOL. FOR INF. 1MG/ML 20272 20144346 UNITED THERAPEUTICS EUROPE LTD Change in manufacturing process REMODULIN SOL. FOR INF. 2,5MG/ML 20273 20144347 UNITED THERAPEUTICS EUROPE LTD Change in manufacturing process

3436 Όνομα Update of section 4.5 of SPC regarding the Update of section 4.5 of SPC regarding the φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης REMODULIN SOL. FOR INF. 5MG/ML 20274 20144348 UNITED THERAPEUTICS EUROPE LTD Change in manufacturing process REMODULIN SOL. FOR INF. 10MG/ML 20275 20144349 UNITED THERAPEUTICS EUROPE LTD Change in manufacturing process ROFERON-A SOL. FOR INJ. IN PREF. SYR. 3MIU/0,ML 20076 20144853 G.A STAMATIS & CO To add two side effects of unknown frequency in SPC 4.8: mania and ischaemic colitis. LEVOFLOXACIN NORIDEM SOLUTION FOR INFUSION 5MG/ML 21277 20145022 NORIDEM ENTERPRISES LTD Update SPC and PIL - Referral FUNGUSTATIN CAPS 150MG 13273 20145572 PFIZER HELLAS AE action of fluconazole on CYP219 enzyme FUNGUSTATIN INF.2MG/ML 13275 20145573 PFIZER HELLAS AE action of fluconazole on CYP219 enzyme VALCYTE PWD FOR ORAL Extension of the shelf-life of the powder for oral SOL. 50MG 20549 20145592 G A STAMATIS & CO LTD solution from 2 years to 3 years VALCYTE F.C. TABS 450MG 20089 20145593 G.A STAMATIS & CO VALCYTE F.C. TABS 450MG 20089 20145594 G.A STAMATIS & CO VALCYTE F.C. TABS 450MG 20089 20145595 G.A STAMATIS & CO Update of the dossier to comply with the provisions of an updated general monograph of the Ph. Eur for the finished product Uniformity of dosage units is introduced to replace the currently registered method Update of the test procedure to comply with the updated general monograph in the Ph. Eur.

3437 Όνομα φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης VALCYTE F.C. TABS 450MG 20089 20145596 G.A STAMATIS & CO Addition of a secondary packaging site for IT VALCYTE PWD FOR ORAL SOL. 50MG 20549 20145597 G A STAMATIS & CO LTD Addition of a secondary packaging site for IT VALCYTE F.C. TABS 450MG 20089 20145598 G.A STAMATIS & CO Addition of batch confirmation for IT VALCYTE PWD FOR ORAL SOL. 50MG 20549 20145599 G A STAMATIS & CO LTD Addition of batch confirmation for IT VALCYTE F.C. TABS 450MG 20089 20145600 G.A STAMATIS & CO Addition information for the microbial testing VALCYTE PWD FOR ORAL SOL. 50MG 20549 20145601 G A STAMATIS & CO LTD Addition information for the microbial testing VALCYTE F.C. TABS 450MG 20089 20145602 G.A STAMATIS & CO Addition information for the microbial testing VALCYTE PWD FOR ORAL SOL. 50MG 20549 20145603 G A STAMATIS & CO LTD Addition information for the microbial testing SINGODEM TABLET, CHEWABLE 4MG 21428 20145983 HELM AG SINGODEM TABLET, CHEWABLE 5MG 21429 20145984 HELM AG To extend the shelf life of the finished product from 2 years to 4 years To extend the shelf life of the finished product from 2 years to 4 years SINGODEM TABLET, CHEWABLE 10MG 21430 20145985 HELM AG To extend the shelf life of the finished product from 2 years to 4 years PRILIGY TABLET, FILM COATED 30MG 21464 20146360 PRILIGY TABLET, FILM COATED 60MG 21465 20146361 JANSSEN-CILAG INTERNATIONAL NV JANSSEN-CILAG INTERNATIONAL NV Change the shape of the container (immediate packaging) Change the shape of the container (immediate packaging)

3438 Όνομα Update of section 5.3 by adding information Update of section 5.3 by adding information φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης FUNGUSTATIN CAPS 150MG 13273 20146528 PFIZER HELLAS AE regarding mutagenesis FUNGUSTATIN INF.2MG/ML 13275 20146529 PFIZER HELLAS AE regarding mutagenesis SALOFALK SUPPOSITORY 1G 20945 20147093 DR. FALK PHARMA GMBH Update of the PI CIPROFLOXACIN KABI SOL. FOR INF. 2MG/ML 20160 20147169 FRESENIUS KABI HELLAS AE Update SPC and PIL (EMA/PRAC/337405/2014 ) CIPROFLOXACIN KABI SOL. FOR INF. 2MG/ML 20159 20147170 FRESENIUS KABI HELLAS AE Update SPC and PIL (EMA/PRAC/337405/2014 ) CIPROFLOXACIN KABI SOL. FOR INF. 2MG/ML 20160 20147172 FRESENIUS KABI HELLAS AE Update SPC and PIL (NO/H/PSUR/0010/002) CIPROFLOXACIN KABI SOL. FOR INF. 2MG/ML 20159 20147173 FRESENIUS KABI HELLAS AE Update SPC and PIL (NO/H/PSUR/0010/002) GLUCAGEN HYPOKIT POWDER FOR SOL. FOR INJ. 1MG 20205 20147264 NOVO NORDISK Update of the PI CELECOXIB SANDOZ CAPSULE, HARD 200MG 22225 20147884 SANDOZ GMBH add pack size 10 CELECOXIB SANDOZ CAPSULE, HARD 200MG 22225 20147885 SANDOZ GMBH add pack size 30

SUBUTEX SUBLINGUAL TABLETS 0,4MG 20071 20148341 RB PHARMACEUTICALS LTD Minor change to the restricted part of an ASMF SUBUTEX SUBLINGUAL TABLETS 2MG 20072 20148342 RB PHARMACEUTICALS LTD Minor change to the restricted part of an ASMF 3439 Όνομα φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης CELECOXIB SANDOZ CAPSULE, HARD 200MG 22225 20147886 SANDOZ GMBH add pack size 50 CELECOXIB SANDOZ CAPSULE, HARD 200MG 22225 20147887 SANDOZ GMBH add pack size 60 CELECOXIB SANDOZ CAPSULE, HARD 200MG 22225 20147888 SANDOZ GMBH add pack size 90 CELECOXIB SANDOZ CAPSULE, HARD 200MG 22225 20147889 SANDOZ GMBH add pack size 100 FUNGUSTATIN CAPS 150MG 13273 20148094 PFIZER HELLAS AE Change in the name of the manufacturer FUNGUSTATIN INF.2MG/ML 13275 20148095 PFIZER HELLAS AE Change in the name of the manufacturer SUBUTEX SUBLINGUAL TABLETS 8MG 20073 20148343 RB PHARMACEUTICALS LTD Minor change to the restricted part of an ASMF SUBUTEX SUBLINGUAL TABLETS 0,4MG 20071 20148344 RB PHARMACEUTICALS LTD Minor changes to an approved test procedure SUBUTEX SUBLINGUAL TABLETS 2MG 20072 20148345 RB PHARMACEUTICALS LTD Minor changes to an approved test procedure SUBUTEX SUBLINGUAL TABLETS 8MG 20073 20148346 RB PHARMACEUTICALS LTD Minor changes to an approved test procedure

SUBUTEX SUBLINGUAL TABLETS 2MG 20072 20148354 RB PHARMACEUTICALS LTD Change in physical description of iodine 3440 Όνομα φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης SUBUTEX SUBLINGUAL Addition of a new specification parameter to the TABLETS 0,4MG 20071 20148347 RB PHARMACEUTICALS LTD specification with its corresponding test method SUBUTEX SUBLINGUAL Addition of a new specification parameter to the TABLETS 2MG 20072 20148348 RB PHARMACEUTICALS LTD specification with its corresponding test method SUBUTEX SUBLINGUAL Addition of a new specification parameter to the TABLETS 8MG 20073 20148349 RB PHARMACEUTICALS LTD specification with its corresponding test method SUBUTEX SUBLINGUAL Addition of a new specification parameter to the TABLETS 0,4MG 20071 20148350 RB PHARMACEUTICALS LTD specification with its corresponding test method SUBUTEX SUBLINGUAL Addition of a new specification parameter to the TABLETS 2MG 20072 20148351 RB PHARMACEUTICALS LTD specification with its corresponding test method SUBUTEX SUBLINGUAL Addition of a new specification parameter to the TABLETS 8MG 20073 20148352 RB PHARMACEUTICALS LTD specification with its corresponding test method SUBUTEX SUBLINGUAL TABLETS 0,4MG 20071 20148353 RB PHARMACEUTICALS LTD Change in physical description of iodine SUBUTEX SUBLINGUAL TABLETS 8MG 20073 20148355 RB PHARMACEUTICALS LTD Change in physical description of iodine SUBUTEX SUBLINGUAL TABLETS 0,4MG 20071 20148356 RB PHARMACEUTICALS LTD SUBUTEX SUBLINGUAL TABLETS 2MG 20072 20148357 RB PHARMACEUTICALS LTD Addition of a new specification parameter to the specification with its corresponding test method Addition of a new specification parameter to the specification with its corresponding test method

SUBUTEX SUBLINGUAL TABLETS 0,4MG 20071 20148365 RB PHARMACEUTICALS LTD Changes to a test procedure 3441 Όνομα φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης SUBUTEX SUBLINGUAL Addition of a new specification parameter to the TABLETS 8MG 20073 20148358 RB PHARMACEUTICALS LTD specification with its corresponding test method SUBUTEX SUBLINGUAL TABLETS 0,4MG 20071 20148359 RB PHARMACEUTICALS LTD Tightening of specification limits SUBUTEX SUBLINGUAL TABLETS 2MG 20072 20148360 RB PHARMACEUTICALS LTD Tightening of specification limits SUBUTEX SUBLINGUAL TABLETS 8MG 20073 20148361 RB PHARMACEUTICALS LTD Tightening of specification limits SUBUTEX SUBLINGUAL TABLETS 0,4MG 20071 20148362 RB PHARMACEUTICALS LTD Widening of the approved specifications limits SUBUTEX SUBLINGUAL TABLETS 2MG 20072 20148363 RB PHARMACEUTICALS LTD Widening of the approved specifications limits SUBUTEX SUBLINGUAL TABLETS 8MG 20073 20148364 RB PHARMACEUTICALS LTD Widening of the approved specifications limits SUBUTEX SUBLINGUAL TABLETS 2MG 20072 20148366 RB PHARMACEUTICALS LTD Changes to a test procedure SUBUTEX SUBLINGUAL TABLETS 8MG 20073 20148367 RB PHARMACEUTICALS LTD Changes to a test procedure SUBUTEX SUBLINGUAL TABLETS 0,4MG 20071 20148368 RB PHARMACEUTICALS LTD Tightening of specification limit

3442 Όνομα Change in the name of a manufacturer φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης SUBUTEX SUBLINGUAL TABLETS 2MG 20072 20148369 RB PHARMACEUTICALS LTD Tightening of specification limit SUBUTEX SUBLINGUAL TABLETS 8MG 20073 20148370 RB PHARMACEUTICALS LTD Tightening of specification limit SUBUTEX SUBLINGUAL TABLETS 0,4MG 20071 20148371 RB PHARMACEUTICALS LTD Minor changes to an approved test procedure SUBUTEX SUBLINGUAL TABLETS 2MG 20072 20148372 RB PHARMACEUTICALS LTD Minor changes to an approved test procedure SUBUTEX SUBLINGUAL TABLETS 8MG 20073 20148373 RB PHARMACEUTICALS LTD Minor changes to an approved test procedure SUBUTEX SUBLINGUAL TABLETS 0,4MG 20071 20148374 RB PHARMACEUTICALS LTD Minor changes to an approved test procedure SUBUTEX SUBLINGUAL TABLETS 2MG 20072 20148375 RB PHARMACEUTICALS LTD Minor changes to an approved test procedure SUBUTEX SUBLINGUAL TABLETS 8MG 20073 20148376 RB PHARMACEUTICALS LTD Minor changes to an approved test procedure PRETERAX TABS LES LABORATOIRES (including batch release, analysis, and 4MG/1,25MG 19763 20148512 SERVIER packaging) of the finished product SINGODEM TABLET, Removal a manufacturer of the active CHEWABLE 4MG 21428 20148549 HELM AG substance

3443 Όνομα add Logosys Logistik GmbH & Co KG, Otto- Rohm-Strasse 69, 64293, Darmstadt, Germany φαρμακευτικού Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης SINGODEM TABLET, Removal a manufacturer of the active CHEWABLE 5MG 21429 20148550 HELM AG substance SINGODEM TABLET, Removal a manufacturer of the active CHEWABLE 10MG 21430 20148551 HELM AG substance VISANNETTE TABS 2MG 20744 20148602 BAYER HELLAS ABEE 6th interim report of the VIPOS study QLAIRA F.C. TABS 3MG 20525 20148603 BAYER HELLAS Submit of the 9th INAS-SCORE interim report VALCYTE F.C. TABS 450MG 20089 20148971 G.A STAMATIS & CO Replacement PSMF and QPPV VALCYTE PWD FOR ORAL SOL. 50MG 20549 20148972 G A STAMATIS & CO LTD Replacement PSMF and QPPV GAVISCON DOUBLE ACTION ORAL SUSPENSION 21711 20149688 RECKITT BENCKISER HELLAS CHEMICAL ABEE as an assembler (secondary packager) to the product licence. PRETERAX F.C. TABS LES LABORATOIRES Change in the name of a secondary packaging 2,5MG/0,625MG 20256 201410003 SERVIER in IT market only COVERSYL PLUS ARGININE F.C. TABS 5/1,25MG 20257 201410004 LES LABORATOIRES SERVIER Change in the name of a secondary packaging in IT market only COVERSYL F.C. TABS 5MG 20030 201410011 LES LABORATOIRES SERVIER Change in the name of a secondary packaging in IT market only COVERSYL F.C. TABS 10MG 20031 201410012 LES LABORATOIRES SERVIER Change in the name of a secondary packaging in IT market only