ΕΠΙΣΗΜΗ ΕΦΗΜΕΡΙΔΑ ΤΗΣ ΚΥΠΡΙΑΚΗΣ ΔΗΜΟΚΡΑΤΙΑΣ ΚΥΡΙΟ ΜΕΡΟΣ ΤΜΗΜΑ B

Transcript

1 ΕΠΙΣΗΜΗ ΕΦΗΜΕΡΙΔΑ ΤΗΣ ΚΥΠΡΙΑΚΗΣ ΔΗΜΟΚΡΑΤΙΑΣ ΚΥΡΙΟ ΜΕΡΟΣ ΤΜΗΜΑ B Αριθμός 4994 Τετάρτη, 22 Φεβρουαρίου Αριθμός 1186 ΑΝΑΝΕΩΣΕΙΣ ΕΙΔΙΚΩΝ ΑΔΕΙΩΝ ΚΥΚΛΟΦΟΡΙΑΣ ΠΟΥ ΕΧΟΥΝ ΕΓΚΡΙΘΕΙ ΑΠΟ ΤΟ ΣΥΜΒΟΥΛΙΟ ΦΑΡΜΑΚΩΝ Το Συμβούλιο Φαρμάκων, - σύμφωνα με τις πρόνοιες του άρθρου 13A των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων, 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 Όνομα φαρμακευτικού Κάτοχος ειδικής άδειας κυκλοφορίας Ισχύς άδειας S00204 IBUPROFEN ORAL SUSPENSION 100MG/5ML PINEWOOD LABORATORIES 05/06/2018 S00215 TRAVOGEN VAGINAL CREAM 10MG/G BAYER HELLAS ABEE 23/07/2018 S00222 CORTOPIN HYDROCORTISONE CREAM 1% W /W PINEWOOD LABORATORIES 27/07/2018 S00227 AVOMINE TABLET 25MG MANX PHARMA,UK 27/07/2018 S00235 TAVOR TABLET 1 MG PFIZER HELLAS 07/08/2018

2 836 Αρ. Ειδικής άδειας κυκλοφορίας S00257 S00258 Όνομα φαρμακευτικού ENDOXAN POWDER FOR SOLUTION FOR INFUSION 1000MG/VIAL UROMITEXAN SOLUTION FOR INJECTION 100MG/ML Κάτοχος ειδικής άδειας Ισχύς άδειας κυκλοφορίας BAXTER (HELLAS) EPE 22/10/2018 BAXTER (HELLAS) EPE 22/10/2018 S00264 IKOBEL EYE DROPS, SOLUTION 3MG/ML RAFARM S.A. 19/10/2018 S00267 MITOMYCIN-C KYOWA POWDER FOR SOLUTION FOR INJECTION 20MG/VIAL MEDILINK PHARMACEUTICALS 18/10/2018 S00278 GOLDEN EYE EYE DROPS, SOLUTION 0.1% W/V CAMBRIDGE HEALTHCARE SUPPLIES LIMITED 18/10/2018 S00279 GOLDEN EYE EYE OINTMENT 0.15% W/V CAMBRIDGE HEALTHCARE SUPPLIES LIMITED 18/10/2018 S00286 S00287 HOLOXAN POWDER FOR SOLUTION FOR INFUSION 1000MG/VIAL HOLOXAN POWDER FOR SUSPENSION FOR INFUSION 2000MG/VIAL BAXTER (HELLAS) EPE 25/10/2018 BAXTER (HELLAS) EPE 25/10/2018 S00567 CODEINE PHOSPHATE TABLET 30MG BRISTOL LABORATORIES 14/10/2018 S00581 S00706 GADOVIST PFS SOLUTION FOR INJECTION 1MMOL/ML ZITHROMAX TABLET, FILM COATED 250MG BAYER HELLAS ABEE 14/10/2018 PFIZER HELLAS 28/06/2018 S00723 LOCERYL NAIL LACQUER CUTANEOUS SOLUTION 5% W/V GALDERMA INTERNATIONAL,FRANCE 03/08/2018 S00724 S00727 SOLU-CORTEF POWDER FOR SOLUTION FOR INJECTION 100MG/VIAL BRIMONTAL EYE DROPS, SOLUTION 2MG/ML PFIZER HELLAS 04/08/2018 RAFARM S.A. 05/08/2018 S00728 RELIEF CAPSULE, HARD 4MG S00729 RELIEF GEL 0.25% IASIS PHARMACEUTICALS HELLAS SA IASIS PHARMACEUTICALS HELLAS SA 07/09/ /09/2018 S00730 RELIEF SOLUTION FOR INJECTION 2MG/ML IASIS PHARMACEUTICALS HELLAS SA 07/09/2018 S00731 VISTAMETHASONE EAR/EYE/NOSE DROPS, SOLUTION MARTINDALE PHARMACEUTICALS 31/08/2018 S00832 PROPYLTHIOURACIL TABLET 50MG WOCKHARDT UK 11/06/2018 S01006 DEEP RELIEF PAIN RELIEF GEL C A PAPLLINAS 23/03/2018 S01012 BUVASTIN SYRUP 1.5MG/ML COSTAKIS TSISIOS & CO 18/06/2018

3 837 Αρ. Ειδικής άδειας κυκλοφορίας Όνομα φαρμακευτικού Κάτοχος ειδικής άδειας κυκλοφορίας Ισχύς άδειας S01017 FLEET READY-TO-USE ENEMA CASEN RECORDATI SL 11/06/2018 S01022 CANESTEN VAGINAL TABLET 500MG BAYER HELLAS ABEE 15/06/2018 S01023 S01024 TOBRAMYCIN SOLUTION FOR INJECTION 40MG/ML DISODIUM PAMIDRONATE SOLUTION FOR INFUSION, CONCENTRATE FOR 15MG/ML HOSPIRA UK LIMITED 07/08/2018 WOCKHARDT UK 05/08/2018 S01028 CANESTEN VAGINAL CREAM 2% BAYER HELLAS ABEE 26/08/2018 S01029 S01031 S01032 THIOPENTAL ROTEXMEDICA POWDER FOR INJECTION 1000MG/VIAL METHYLERGOMETRIN ROTEXMEDICA SOLUTION FOR INJECTION 0.2MG/ML CALCITONIN 100IU-ROTEXMEDICA SOLUTION FOR INJECTION 100IU/ML ROTEXMEDICA GMBH 24/08/2018 ROTEXMEDICA GMBH 09/09/2018 ROTEXMEDICA GMBH 09/09/2018

4 838 Αριθμός 1187 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 Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Ειδικής Άδειας Ημερομηνία Έκδοσης Ειδικής Άδειας S01092 MICOLETTE MICROENEMA GLYCEROL, SODIUM CITRATE, SODIUM LAURYL SULFOACETATE PINEWOOD LABORATORIES 10/10/2016 S01093 ACETAZOLAMIDE TABLET 250MG ACETAZOLAMIDE CRESCENT PHARMA LIMITED, UNITS 3 & 4 10/10/2016 S01094 BETAFUSIN CREAM FUSIDIC ACID, BETAMETHASONE VALERATE PHARMEX SA 11/10/2016 S01095 S01096 LINEZOLIDA FARMOZ TABLET, FILM COATED 600MG MAXILIN POWDER FOR SOLUTION FOR INFUSION 500MG/VIAL FARMOZ-SOCIEDADE TECNICO- LINEZOLID 11/10/2016 MEDICINAL,S.A, PORTUGAL CLARITHROMYCIN ANFARM HELLAS SA 11/10/2016 S01097 DEHYDROCORTISON TABLET 5MG PREDNISONE ANTIBIOTIC-RAZGRAD AD 11/10/2016 S01098 PREDNISONE KERN PHARMA TABLET 5MG PREDNISONE KERN PHARMA S.L. 28/11/2016

5 Αριθμός 1188 ΑΔΕΙΕΣ ΚΥΚΛΟΦΟΡΙΑΣ ΠΟΥ ΕΧΟΥΝ ΕΚΔΟΘΕΙ ΑΠΟ ΤΟ ΣΥΜΒΟΥΛΙΟ ΦΑΡΜΑΚΩΝ Το Συμβούλιο Φαρμάκων, σύμφωνα με τις πρόνοιες του άρθρου 9 των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων του 2001 (70(Ι)/2001) όπως εκάστοτε τροποποιείται, και σύμφωνα με τα στοιχεία που υπέβαλαν οι αιτητές, εκδίδει Αδειες Φαρμακευτικών Προϊόντων με τα πιο κάτω στοιχεία: Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Αδειας ADACEL SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE ALBIOMIN 20% SOLUTION FOR TETANUS TOXOID, FILAMENTOUS HMAGGLUTININ (FHA), PERTUSSIS TOXOID(PT), PERTACTIN (PRN), DIPHTHERIA TOXOID, ADSORBED ON ALUMINIUM PHOSPHATE,FIMBRI TYPES 2 Ημερομηνία Έκδοσης Αδειας AND 3 SANOFI PASTEUR SA 24/11/2016 INFUSION 200G/L HUMAN PLASMAPROTEIN BIOTEST PHARMA GMBH 07/10/2016 ALBUMEON SOLUTION FOR INFUSION 200G/I ALBUMIN HUMAN CSL BEHRING GMBH 23/11/2016 AMIODARONE AUROBINDO TABLET 200MG AMIODARONE HYDROCHLORIDE AUROBINDO PHARMA (MALTA) LIMITED 05/12/ ANTIVOM TABLET 16MG BENDAMUSTIN LEDPHARM POWDER BETAHISTINE DIHYDROCHLORIDE UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES SA 11/10/ FOR CONCENTRATE FOR SOLUTION FOR INFUSION 2.5MG/ML BENDAMUSTINE ACCORD POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION 2.5MG/ML BENDAMUSTIN HYDROCHLORIDE O.S.K. LEDPHARM 12/12/2016 BENDAMUSTIN HYDROCHLORIDE MONOHYDRATE ACCORD HEALTHCARE LIMITED 22/11/2016

6 Αρ. Άδειας Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Αδειας BETASERC TABLET, ORODISPERSIBLE 24MG BOSENTAN AUROBINDO TABLET, FILM BETAHISTINE Ημερομηνία Έκδοσης Αδειας DIHYDROCHLORIDE VARNAVAS HADJI PAN AYIS 21/11/2016 COATED 125MG BOSENTAN MONOHYDRATE AUROBINDO PHARMA (MALTA) LIMITED 23/11/2016 BOSENTAN AUROBINDO TABLET, FILM COATED 62.5MG BOSENTAN MONOHYDRATE AUROBINDO PHARMA (MALTA) LIMITED 23/11/2016 BOTOX POWDER FOR SOLUTION FOR INJECTION 100 UNITS BOTULINUM TOXIN TYPE A ALLERGAN PHARMACEUTICALS IRELAND 06/12/2016 BOTOX POWDER FOR SOLUTION FOR INJECTION 200 UNITS BOTULINUM TOXIN TYPE A ALLERGAN PHARMACEUTICALS IRELAND 06/12/2016 BOTOX POWDER FOR SOLUTION FOR INJECTION 50 UNITS BOTULINUM TOXIN TYPE A ALLERGAN PHARMACEUTICALS IRELAND 06/12/2016 BUDENOFALK UNO GASTRO- RESISTANT GRANULES 9MG BUDESONIDE DR. FALK PHARMA GMBH 28/12/2016 SODIUM PICOSULFATE, CITRAFLEET POWDER FOR ORAL MAGNESIUM OXIDE LIGHT, SOLUTION CITRIC ACID CASEN RECORDATI SL 23/11/2016 COPAXONE SOLUTION FOR INJECTION IN PREFILLED SYRINGES 40MG/ML GLATIRAMER ACETATE TEVA PHARMACEUTICALS 12/10/2016 CORTIMENT TABLET, PROLONGED- RELEASE 9MG BUDESONIDE, MICRONIZED FERRING HELLAS MEPE 17/10/2016 DEMOLOX POWDER FOR SOLUTION FOR INJECTION/INFUSION 40MG/VIAL ESOMEPRAZOLE SODIUM DEMO S.A. 23/11/ ELXEDA TABLET 10MG ARIPIPRAZOLE PHARMACEUTICALS 10/10/ ELXEDA TABLET 15MG ARIPIPRAZOLE PHARMACEUTICALS 10/10/2016

7 Αρ. Άδ Κύκλοι Ό νομα Φ αρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας ELXEDA TABLET 30MG ARIPIPRAZOLE PHARMACEUTICALS EPLERENONE ACCORD TABLET, FILM COATED 25MG EPLERENONE ACCORD HEALTHCARE LIMITED EPLERENONE ACCORD TABLET, FILM COATED 50MG EPLERENONE ACCORD HEALTHCARE LIMITED TENOFOVIR DISOPROXIL EXATRON TABLET, FILM COATED SUCCINATE, EMTRICITABINE RENEWALS MRP-DCP-NATIONAL FEIBA POWDER AND SOLVENT FOR SOLUTION FOR INFUSION 25U/ML PLASMA PROTEINS BAXALTA INNOVATIONS GMBH FEIBA POWDER AND SOLVENT FOR SOLUTION FOR INFUSION 50U/ML PLASMA PROTEINS BAXALTA INNOVATIONS GMBH FERANT SOLUTION FOR INJECTION PALONOSETRON MCG/ML HYDROCHLORIDE MEDOCHEMIE FORMOTEROL FUMARATE DIHYDRATE, MICRONIZED, FOSTER NEXTHALER POWDER FOR BECLOMETASONE INHALATION 100MCG/6MCG DIPROPIONATE CHIESI FARMACEUTICI SPA GAVISCON STRAWBERRY FLAVOUR TABLET CHEWABLE ALGIN, CALCIUM CARBONATE, SODIUM BICARBONATE RECKITT BENCKISER HELLAS CHEMICAL ABEE GISOLOM EYE DROPS, SOLUTION 50mcg/ml LATANOPROST PHARMACEUTICALS GISOLOM PLUS EYE DROPS, TIMOLOL MALEATE, SOLUTION LATANOPROST PHARMACEUTICALS ISOSORBIDE MONONITRATE ACCORD TABLET 20MG ISOSORBIDE MONONITRATE ACCORD HEALTHCARE LIMITED KIVALA TABLET, FILM COATED ABACAVIR, LAMIVUDINE REMEDICA

8 Αρ. Άδ Κύκλοι Ό νομα Φ αρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας LEVOSERT INTRA UTERINE SYSTEM 52MG (20MCG/24h) LIDOCAINE ACCORD SOLUTION FOR LEVONORGESTREL ALLERGAN PHARMACEUTICALS INTERNATIONAL Ημερομηνία Έκδοσης Άδειας 29/11/2016 INJECTION 10MG/ML LIDOCAINE HYDROCHLORIDE ACCORD HEALTHCARE LIMITED 26/10/2016 LIDOCAINE ACCORD SOLUTION FOR INJECTION 20MG/ML LIDOCAINE HYDROCHLORIDE ACCORD HEALTHCARE LIMITED 03/11/2016 LINEZOLID ACCORD TABLET, FILM COATED 600MG LINEZOLID ACCORD HEALTHCARE LIMITED 08/10/2016 MYCOPHENOLIC ACID ACCORD TABLET GASTRO-RESISTANT 180MG MYCOPHENOLATE SODIUM ACCORD HEALTHCARE LIMITED 22/11/2016 MYCOPHENOLIC ACID ACCORD TABLET, GASTRO-RESISTANT 360MG MYCOPHENOLATE SODIUM ACCORD HEALTHCARE LIMITED 22/11/ NITRAZEPAM ACCORD TABLET 5MG NITRAZEPAM ACCORD HEALTHCARE LIMITED 04/12/2016 OLANZAPINE AUROBINDO TABLET 10MG OLANZAPINE AUROBINDO PHARMA (MALTA) LIMITED 21/11/2016 OLANZAPINE AUROBINDO TABLET 5MG OLANZAPINE AUROBINDO PHARMA (MALTA) LIMITED 21/11/2016 OMALIN ORAL SOLUTION IRON PROTEIN ACETYL UNI-PHARMA KLEON TSETIS PHARMACEUTICAL 800MG/15ML VIAL ASPARTILATE LABORATORIES SA 25/10/2016 ONELAR GASTRO-RESISTANT CAPSULE, HARD 20MG DULOXETINE HYDROCHLORIDE MEDOCHEMIE 08/11/2016 ONELAR GASTRO-RESISTANT CAPSULE, HARD 30MG DULOXETINE HYDROCHLORIDE MEDOCHEMIE 08/11/2016 ONELAR GASTRO-RESISTANT CAPSULE, HARD 40MG DULOXETINE HYDROCHLORIDE MEDOCHEMIE 08/11/2016 ONELAR GASTRO-RESISTANT CAPSULE, HARD 60MG DULOXETINE HYDROCHLORIDE MEDOCHEMIE 08/11/

9 Αρ. Άδ Κύκλοι Ό νομα Φ αρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας OREST EASYHALER POWDER FOR INHALATION FORMOTEROL FUMARATE MCG/4.5MCG/INHALATION DIHYDRATE,BUDESONIDE ORION CORPORATION PAROXETINE JUBILANT TABLET, FILM PAROXETINE HYDROCHLORICE COATED 10MG HEMIHYDRATE JUBILANT PHARMACEUTICALS NV PAROXETINE JUBILANT TABLET, FILM PAROXETINE HYDROCHLORICE COATED 20MG HEMIHYDRATE JUBILANT PHARMACEUTICALS NV PAROXETINE JUBILANT TABLET, FILM PAROXETINE HYDROCHLORICE COATED 30MG HEMIHYDRATE JUBILANT PHARMACEUTICALS NV PAROXETINE JUBILANT TABLET, FILM PAROXETINE HYDROCHLORICE COATED 40MG HEMIHYDRATE JUBILANT PHARMACEUTICALS NV PROGRAF CAPSULE, HARD 0.5MG TACROLIMUS ASTELLAS PHARMACEUTICALS BE PROPOFOL HOSPIRA EMULSION FOR INJECTION / INFUSION 10MG/ML PROPOFOL HOSPIRA UK LIMITED RAMIPRIL ACCORD CAPSULE, HARD MG RAMIPRIL ACCORD HEALTHCARE LIMITED RAMIPRIL ACCORD CAPSULE, HARD MG RAMIPRIL ACCORD HEALTHCARE LIMITED TIOTROPIUM BROMIDE SPIOLTO RESPIMAT SOLUTION FOR MONOHYDRATE, OLODATEROL INHALATION HYDROCHLORIDE BOEHRINGER INGELHEIM INTERNATIONAL GMBH SPIRONOLACTONE ACCORD TABLET, FILM COATED 100MG SPIRONOLACTONE ACCORD HEALTHCARE LIMITED SPIRONOLACTONE ACCORD TABLET, FILM COATED 25MG SPIRONOLACTONE ACCORD HEALTHCARE LIMITED SULAMID TABLET 100MG AMISULPRIDE CODAL SYNTO

10 Αρ. Άδ Κύκλοι Ό νομα Φ αρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας SULAMID TABLET 200MG AMISULPRIDE CODAL SYNTO SULAMID TABLET 400MG AMISULPRIDE CODAL SYNTO SULAMID TABLET 50MG AMISULPRIDE CODAL SYNTO FORMOTEROL FUMARATE SYMBICORT PRESSURISED DIHYDRATE, MICRONIZED, INHALATION, SUSPENSION BECLOMETASONE /4.5MCG/ACTUATION DIPROPIONATE ASTRAZENECAAB TENOVIRALTABLET, FILM COATED TENOFOVIR DISOPROXIL MG SUCCINATE REMEDICA TENOVIRAL TABLET, FILM COATED TENOFOVIR DISOPROXIL MG SUCCINATE REMEDICA TENOVIRAL TABLET, FILM COATED TENOFOVIR DISOPROXIL MG SUCCINATE REMEDICA TENOVIRAL TABLET, FILM COATED TENOFOVIR DISOPROXIL MG SUCCINATE REMEDICA TINTAROS TABLET, FILM COATED MG ROSUVASTATIN CALCIUM ACTAVIS GROUP PTC EHF TINTAROS TABLET, FILM COATED MG ROSUVASTATIN CALCIUM ACTAVIS GROUP PTC EHF TINTAROS TABLET, FILM COATED MG ROSUVASTATIN CALCIUM ACTAVIS GROUP PTC EHF TINTAROS TABLET, FILM COATED MG ROSUVASTATIN CALCIUM ACTAVIS GROUP PTC EHF VESICARE ORAL SUSPENSION MG/ML SOLIFENACIN SUCCINATE ASTELLAS PHARMACEUTICALS BE

11 Αρ. Άδειας Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας Ημερομηνία Έκδοσης Άδειας VITAROS CREAM 2MG/G ALPROSTADIL RECORDATI IRELAND 21/10/ VITAROS CREAM 3MG/G ALPROSTADIL RECORDATI IRELAND 21/10/2016 OLODATEROL YANIMO RESPIMAT SOLUTION FOR INHALATION ZORMID EYE DROPS, SOLUTION 20MG/ML HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE BOEHRINGER INGELHEIM INTERNATIONAL GMBH 15/11/2016 DORZOLAMIDE HYDROCHLORIDE PHARMACEUTICALS 10/10/

12 Αριθμός 1189 ΤΡΟΠΟΠΟΙΗΣΕΙΣ ΑΔΕΙΩΝ ΚΥΚΛΟΦΟΡΙΑΣ ΠΟΥ ΕΧΟΥΝ ΕΓΚΡΙΟΕΙ ΑΠΟ ΤΟ ΣΥΜΒΟΥΛΙΟ ΦΑΡΜΑΚΩΝ Το Συμβούλιο Φαρμάκων, σύμφωνα με τις πρόνοιες του άρθρου 31 των περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) Νόμων του 2001 (70(Ι)/2001) όπως εκάστοτε τροποποιείται, ενέκρινε τις πιο κάτω τροποποιήσεις: Όνομα φαρμακευτικού Ap. Άδειας PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG SINGULAIR CHEWABLE TABS 4MG Ap. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES MERCK SHARP & DOHME B.V Change in batch size Change in batch size Change in the specification parameter Change in the specification parameter Minor changes to an approved test procedure Minor changes to an approved test procedure To update the product information with the e-code for the excipient "mannitol" and to detail the description of the pharmaceutical form for the oral granules. 846

13 Αρ. Άδειας SINGULAIR GRAN. FOR ORAL SUSP. 4MG SINGULAIR CHEWABLE TABS 4MG SINGULAIR GRAN. FOR ORAL SUSP. 4MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης MERCK SHARP & DOHME B.V MERCK SHARP & DOHME B.V MERCK SHARP & DOHME B.V JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES To update the product information with the e-code for the excipient "mannitol" and to detail the description of the pharmaceutical form for the oral granules. To update the product information with the e-code for the excipient "mannitol" and to detail the description of the pharmaceutical form for the oral granules. To update the product information with the e-code for the excipient "mannitol" and to detail the description of the pharmaceutical form for the oral granules. Change address of the MAH in PT Change address of the MAH in PT 847 GAVISCON DOUBLE ACTION TABLET, CHEWABLE GAVISCON DOUBLE ACTION TABLET, CHEWABLE GAVISCON DOUBLE ACTION TABLET, CHEWABLE GAVISCON DOUBLE ACTION TABLET, CHEWABLE GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE To update the specification of the excipient xylitol DC Change to in-process tests Change to in-process tests Change to in-process tests Change to in-process tests

14 Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης GAVISCON DOUBLE ACTION TABLET, CHEWABLE GAVISCON DOUBLE ACTION TABLET, CHEWABLE GAVISCON DOUBLE ACTION TABLET, CHEWABLE GAVISCON DOUBLE ACTION TABLET, CHEWABLE GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE Change in the specification parameters and/or limits of the finished product Change in the specification parameters and/or limits of the finished product Change in the specification parameters and/or limits of the finished product Change in the specification parameters and/or limits of the finished product Change in the specification parameters and/or limits of the finished product GAVISCON DOUBLE ACTION TABLET, CHEWABLE GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE FLEXBUMIN SOL. FOR INF. 200G/L BAXTER HELLAS EPE FLEXBUMIN SOL. FOR INF. 250G/L BAXTER HELLAS EPE PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES Change in the specification parameters and/or limits of the finished product Change in the specification parameters and/or limits of the finished product Change in the manufacture of the Finished Product Change in the manufacture of the Finished Product To register a batch control testing site To register a batch control testing site To add a secondary packaging site 848

15 Ap. Αδειας PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES To add a secondary packaging site To add a primary packaging site To add a primary packaging site To add a finished product manufacturing site To add a finished product manufacturing site NUVARING VAGINAL SYSTEM N V ORGANON API manufacturer name change NUVARING VAGINAL SYSTEM N V ORGANON Update CEP 849 OXALIPLATIN MEDAC POWDER FOR SOL. FOR INF. 5 MG/ML GAVISCON DOUBLE ACTION TABLET, CHEWABLE GAVISCON DOUBLE ACTION TABLET, CHEWABLE GAVISCON DOUBLE ACTION TABLET, CHEWABLE MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE The change in reference standard Oxaliplatin impurity B, and the differences in preparation of the test solutions. Minor change in the manufacturing process of the active substance Addition of a new specification parameter Tightening of specification limits

16 Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE Tightening of specification limits GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE Tightening of specification limits GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE Tightening of specification limits GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE Tightening of specification limits GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE Tightening of specification limits GAVISCON DOUBLE ACTION TABLET, CHEWABLE GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE Tightening of specification limits Minor changes to an approved test procedure 850 GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE Minor changes to an approved test procedure GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE Minor changes to an approved test procedure GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE Minor changes to an approved test procedure GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE Minor changes to an approved test procedure GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE Minor changes to an approved test procedure

17 Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE HEXVIX POWDER & SOLV. FOR SOL. FOR INTRAVESICAL USE 85MG GE HEALTHCARE AS FLEXBUMIN SOL. FOR INF. 200G/L BAXTER HELLAS EPE FLEXBUMIN SOL. FOR INF. 200G/L BAXTER HELLAS EPE PMF Annual Update FLEXBUMIN SOL. FOR INF. 250G/L BAXTER HELLAS EPE PMF Annual Update Minor changes to an approved test procedure The address of the manufacturer of the solvent for the finished product, Fresenius Kabi Norge AS, is changed from Svinesundsveien 80, 1753 Halden, Norway to Svinesundsveien 80, 1788 Halden, Norway. Addition of Baxter SA, Boulevard Rene Branquart 80, 7860 Lessines, Belgium as secondary packaging site. ESCITALOPRAM ACTAVIS TABLET, FILM COATED 5MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 10MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 15MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 20MG ACTAVIS GROUP PTC EHF RAMIMED TABLET 2.5MG MEDOCHEMIE RAMIMED TABLET 5MG MEDOCHEMIE The indication Generalized Anxiety Disorder is added as this is no longer subject to patent. The indication Generalized Anxiety Disorder is added as this is no longer subject to patent. The indication Generalized Anxiety Disorder is added as this is no longer subject to patent. The indication Generalized Anxiety Disorder is added as this is no longer subject to patent. Deletion of manufacturing site responsible for batch release, Actavis hf., Iceland Deletion of manufacturing site responsible for batch release, Actavis hf., Iceland

18 Ap. Αδειας Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης RAMIMED TABLET 10MG MEDOCHEMIE RAMIMED TABLET 2.5MG MEDOCHEMIE RAMIMED TABLET 5MG MEDOCHEMIE Deletion of manufacturing site responsible for batch release, Actavis hf., Iceland Deletion of manufacturing site responsible for batch release, Actavis hf., Malta Deletion of manufacturing site responsible for batch release, Actavis hf., Malta RAMIMED TABLET 10MG MEDOCHEMIE RAMIMED TABLET 2.5MG MEDOCHEMIE Introduce the PSMF RAMIMED TABLET 5MG MEDOCHEMIE Introduce the PSMF RAMIMED TABLET 10MG MEDOCHEMIE Introduce the PSMF SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Deletion of manufacturing site responsible for batch release, Actavis hf., Malta IA no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R0-CEP Rev 01 from the manufacturers of glycine IA no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R0-CEP Rev 01 from the manufacturers of glycine 852 SMOFKABIVEN PERIFERAL EMULSION FOR INF SMOFKABIVEN EMULSION FOR INF Update CEP from the manufacturers of Glycine IA no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R1-CEP Rev 03 from the manufacturers of isoleucine

19 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης FRESENIUS ΚΑΒΙ HELLAS ΑΕ ΙΑ no Β.ΙΙΙ.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R1-CEP Rev 03 from the manufacturers of isoleucine SMOFKABIVEN PERIFERAL EMULSION FOR INF SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF SMOFKABIVEN PERIFERAL EMULSION FOR INF SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF FRESENIUS ΚΑΒΙ HELLAS ΑΕ FRESENIUS ΚΑΒΙ HELLAS ΑΕ FRESENIUS ΚΑΒΙ HELLAS ΑΕ FRESENIUS ΚΑΒΙ HELLAS ΑΕ FRESENIUS ΚΑΒΙ HELLAS ΑΕ FRESENIUS ΚΑΒΙ HELLAS ΑΕ Update CEP from the manufacturers of isoleucine IA no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R0-CEP Rev 03 from the manufacturer of isoleucine IA no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R0-CEP Rev 03 from the manufacturer of isoleucine Update CEP from the manufacturers of isoleucine IA no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R0-CEP Rev 02 from the manufacturers of isoleucine IA no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R0-CEP Rev 02 from the manufacturers of isoleucine 853 SMOFKABIVEN PERIFERAL EMULSION FOR INF SMOFKABIVEN EMULSION FOR INF FRESENIUS ΚΑΒΙ HELLAS ΑΕ FRESENIUS ΚΑΒΙ HELLAS ΑΕ Update CEP from the manufacturers of isoleucine IA no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R0-CEP Rev 03 from the manufacturers of leucine

20 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης ΑΕ ΙΑ no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R0-CEP Rev 03 from the manufacturers of leucine SMOFKABIVEN PERIFERAL EMULSION FOR INF SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF SMOFKABIVEN PERIFERAL EMULSION FOR INF SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP from the manufacturers of leucine IA no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R1-CEP Rev 04 from the manufacturers of leucine IA no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R1-CEP Rev 04 from the manufacturers of leucine Update CEP from the manufacturers of leucine IA no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R0-CEP Rev 01 from the manufacturers of phenylalanine IA no B.III.1.a.2 Submission of an updated Ph. Eur. Certificate of suitability with no R0-CEP Rev 01 from the manufacturers of phenylalanine 854 SMOFKABIVEN PERIFERAL EMULSION FOR INF Update CEP from the manufacturers of phenylalanine SMOFKABIVEN EMULSION FOR INF IA no B.III.1.a.4 Deletion of a Ph. Eur. Certificate of suitability; phenylalanine

21 Ap. Αδειας SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης IA no B.III.1.a.4 Deletion of a Ph. Eur. Certificate of suitability; phenylalanine SMOFKABIVEN PERIFERAL EMULSION FOR INF PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG JENSON PHARMACEUTICAL SERVICES JENSON PHARMACEUTICAL SERVICES Deletion of a Ph. Eur. Certificate of suitability; phenylalanine To add a batch control testing site To add a batch control testing site IRINOTECAN CONCENTRATE FOR SOL. FOR INF. 20MG MERCKS GENERICS Update batch size IRINOTECAN CONCENTRATE FOR SOL. FOR INF. 20MG MERCKS GENERICS Update batch size 855 IRINOTECAN CONCENTRATE FOR SOL. FOR INF. 20MG MERCKS GENERICS Minor changes to an approved test procedure FLEXBUMIN SOL. FOR INF. 200G/L BAXTER HELLAS EPE FLEXBUMIN SOL. FOR INF. 250G/L BAXTER HELLAS EPE Minor change in the manufacturing process of the active substance Minor change in the manufacturing process of the active substance SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Change in the adress of the marketing authorisation holder in BE and NL Change in the adress of the marketing authorisation holder in BE and NL

22 Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης SMOFKABIVEN PERIFERAL EMULSION FOR INF SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF FRESENIUS ΚΑΒΙ HELLAS ΑΕ FRESENIUS ΚΑΒΙ HELLAS ΑΕ FRESENIUS ΚΑΒΙ HELLAS ΑΕ A.1. Change in the adress of the marketing authorisation holder in BE and NL. Change in the adress of the marketing authorisation holder in BE and NL Change in the adress of the marketing authorisation holder in BE and NL SMOFKABIVEN PERIFERAL EMULSION FOR INF FRESENIUS ΚΑΒΙ HELLAS ΑΕ ESCITALOPRAM ACTAVIS TABLET, FILM COATED 5MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 10MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 15MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 20MG ACTAVIS GROUP PTC EHF A.1. Change in the adress of the marketing authorisation holder in BE and NL. Tightening of the end of shelf-life limits for some of the identified impurities of the finished product Escitalopram 5mg, 10mg, 15mg and 20mg tablets following a request from the UK authorities during MRPs DK/H/1450/01-04/DC Tightening of the end of shelf-life limits for some of the identified impurities of the finished product Escitalopram 5mg, 10mg, 15mg and 20mg tablets following a request from the UK authorities during MRPs DK/H/1450/01-04/DC Tightening of the end of shelf-life limits for some of the identified impurities of the finished product Escitalopram 5mg, 10mg, 15mg and 20mg tablets following a request from the UK authorities during MRPs DK/H/1450/01-04/DC Tightening of the end of shelf-life limits for some of the identified impurities of the finished product Escitalopram 5mg, 10mg, 15mg and 20mg tablets following a request from the UK authorities during MRPs DK/H/1450/01-04/DC 856

23 Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης IRINOTECAN CONCENTRATE FOR SOL. FOR INF. 20MG MERCKS GENERICS Deletion of a non-significant specification parameter (L-impurity). ABSTRAL SUBLINGUAL TABS 10OMCG PROSTRAKAN update module 2.3, 3 ABSTRAL SUBLINGUAL TABS 200MCG PROSTRAKAN update module 2.3, 3 ABSTRAL SUBLINGUAL TABS 300MCG PROSTRAKAN update module 2.3, 3 ABSTRAL SUBLINGUAL TABS 400MCG PROSTRAKAN update module 2.3, 3 ABSTRAL SUBLINGUAL TABS 600MCG PROSTRAKAN update module 2.3, 3 ABSTRAL SUBLINGUAL TABS 800MCG PROSTRAKAN update module 2.3, 3 ESCITALOPRAM ACTAVIS TABLET, FILM COATED 5MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 10MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 15MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 20MG ACTAVIS GROUP PTC EHF Addition of a secondary packaging site: Actavis ehf. Reykjavikurvegur 78, IS-220 Hafnarfjor0ur, Iceland Addition of a secondary packaging site: Actavis ehf. Reykjavikurvegur 78, IS-220 Hafnarfjor0ur, Iceland Addition of a secondary packaging site: Actavis ehf. Reykjavikurvegur 78, IS-220 Hafnarfjor0ur, Iceland Addition of a secondary packaging site: Actavis ehf. Reykjavikurvegur 78, IS-220 Hafnarfjor0ur, Iceland 857

24 Ap. Αδειας Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης ESCITALOPRAM ACTAVIS TABLET, FILM COATED 5MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 10MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 15MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 20MG ACTAVIS GROUP PTC EHF Addition of a primary packaging site: Actavis ehf. Reykjavikurvegur 78, IS-220 Hafnarfjor0ur, Iceland Addition of a primary packaging site: Actavis ehf. Reykjavikurvegur 78, IS-220 Hafnarfjor0ur, Iceland Addition of a primary packaging site: Actavis ehf. Reykjavikurvegur 78, IS-220 Hafnarfjor0ur, Iceland Addition of a primary packaging site: Actavis ehf. Reykjavikurvegur 78, IS-220 Hafnarfjor0ur, Iceland ESCITALOPRAM ACTAVIS TABLET, FILM COATED 5MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 10MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 15MG ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 20MG ACTAVIS GROUP PTC EHF ABSTRAL SUBLINGUAL TABS 10OMCG PROSTRAKAN ABSTRAL SUBLINGUAL TABS 200MCG PROSTRAKAN ABSTRAL SUBLINGUAL TABS 300MCG PROSTRAKAN Addition of: Actavis ehf. Reykjavikurvegur 78, IS- 220 Hafnarfjor0ur, Iceland Addition of: Actavis ehf. Reykjavikurvegur 78, IS- 220 Hafnarfjor0ur, Iceland Addition of: Actavis ehf. Reykjavikurvegur 78, IS- 220 Hafnarfjor0ur, Iceland Addition of: Actavis ehf. Reykjavikurvegur 78, IS- 220 Hafnarfjor0ur, Iceland The updated RMP version 4.0, Abstral (ProStrakan), is approvable. The updated RMP version 4.0, Abstral (ProStrakan), is approvable. The updated RMP version 4.0, Abstral (ProStrakan), is approvable. 858

25 Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης ABSTRAL SUBLINGUAL TABS 400MCG PROSTRAKAN ABSTRAL SUBLINGUAL TABS 600MCG PROSTRAKAN The updated RMP version 4.0, Abstral (ProStrakan), is approvable. The updated RMP version 4.0, Abstral (ProStrakan), is approvable. ABSTRAL SUBLINGUAL TABS 800MCG PROSTRAKAN IRINOTECAN CONCENTRATE FOR SOL. FOR INF. 20MG MERCKS GENERICS IRINOTECAN CONCENTRATE FOR SOL. FOR INF. 20MG MERCKS GENERICS FLEXBUMIN SOL. FOR INF. 200G/L BAXTER HELLAS EPE FLEXBUMIN SOL. FOR INF. 250G/L BAXTER HELLAS EPE HEXVIX POWDER & SOLV. FOR SOL. FOR INTRAVESICAL USE 85MG GE HEALTHCARE AS Change QPPV The updated RMP version 4.0, Abstral (ProStrakan), is approvable. new API manufacturer supported by a DMF for Irinotecan HCL trihydrate: LAURUS Labs Private Limited (India) report of the Lauru's specification and test methods for the testing upon receipt by the manufacturer of the finished product Change in the test procedure for the finished product Change in the test procedure for the finished product 859 VIVACE TABLET, FILM COATED 2.5MG ACTAVIS GROUP PTC EHF VIVACE TABLET, FILM COATED 5MG ACTAVIS GROUP PTC EHF VIVACE TABLET, FILM COATED 10MG ACTAVIS GROUP PTC EHF UPDATE THE SPC AND PIL ACCORDING TO AT-31 REFERRAL UPDATE THE SPC AND PIL ACCORDING TO AT-31 REFERRAL UPDATE THE SPC AND PIL ACCORDING TO AT-31 REFERRAL GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE Deletion of manufacturing site for an active substance

26 Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE Change in the adress of MAH of active FLEXBUMIN SOL. FOR INF. 200G/L BAXTER HELLAS EPE Introduction of a summary of PhV system FLEXBUMIN SOL. FOR INF. 250G/L BAXTER HELLAS EPE Introduction of a summary of PhV system BLUGRAL TABLET, FILM COATED 25MG C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 50MG C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 100MG C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 25MG C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 50MG C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 100MG C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 25MG C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 50MG C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 100MG C A PAPLLINA & CO B.ll.b.4.B Change in the batch size (including batch size ranges) of the finished product, B.ll.b.4.B Change in the batch size (including batch size ranges) of the finished product, B.ll.b.4.B Change in the batch size (including batch size ranges) of the finished product, The API supplier Hetero Drugs Limited has been granted a CEP certificate The API supplier Hetero Drugs Limited has been granted a CEP certificate The API supplier Hetero Drugs Limited has been granted a CEP certificate change of specificartion of a former non EU Pharmacopoeial substance to fully comply with the Ph.Eur. change of specificartion of a former non EU Pharmacopoeial substance to fully comply with the Ph.Eur. change of specificartion of a former non EU Pharmacopoeial substance to fully comply with the Ph.Eur. 860

27 Ap. Αδειας Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης ZOLOFT TABS 50MG PFIZER HELLAS remove secondary packaging site for SE only ZOLOFT TABS 100MG PFIZER HELLAS remove secondary packaging site for SE only FERINJECT SOLUTION FOR INJECTION OR INFUSION 50MG IRON PER ML VIFOR FRANCE SA Additional batch size of 232kg has been added. ROFERON-A SOL. FOR INJ. IN PREF. SYR. 3MIU/0,ML G.A STAMATIS & CO Update PSMF GLUCAGEN HYPOKIT POWDER FOR SOL. FOR INJ. 1MG NOVO NORDISK NUROFEN FOR CHILDREN 4% ORANGE ORAL SUSPENSION 4% RECKITT BENCKISER HELLAS CHEMICAL ABEE The variation concerns change to method technique for FT-IR from Novo Nordisk method (cuvette) to Ph.Eur. (ATR) for the raw materials Pluronic PE 6100 and Polypropylene glycol P2000. removal of testing frequency for BASF and Shasun - NUROFEN FOR CHILDREN 4% STRAWBERRY ORAL SUSPENSION 4% NUROFEN FOR CHILDREN 4% ORANGE ORAL SUSPENSION 4% NUROFEN FOR CHILDREN 4% STRAWBERRY ORAL SUSPENSION 4% NUROFEN FOR CHILDREN 4% ORANGE ORAL SUSPENSION 4% RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE removal of testing frequency for BASF and Shasun - submission of updated CEP R1-CEP Rev 08 for Shasun Pharmaceuticals Ltd. submission of updated CEP R1-CEP Rev 08 for Shasun Pharmaceuticals Ltd. Addition of secondary packaging site "Logosys Logistik GmbH & Co KG, Otto-Rohm-Strasse 69, Darmstadt, Germany".

28 Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης NUROFEN FOR CHILDREN 4% STRAWBERRY ORAL SUSPENSION 4% GAVISCON DOUBLE ACTION TABLET, CHEWABLE RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE Addition of secondary packaging site "Logosys Logistik GmbH & Co KG, Otto-Rohm-Strasse 69, Darmstadt, Germany". To add Logosys Logistik GmbH & Co KG, Otto- Rohm-Strasse 69, 64293, Darmstadt, Germany as an assembler (secondary packager) to the product licence. SMOFKABIVEN EMULSION FOR INF New CEP for Serine SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF New CEP for Serine SMOFKABIVEN PERIFERAL EMULSION FOR INF New CEP for Serine 862 SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF New CEP for Valine New CEP for Valine SMOFKABIVEN PERIFERAL EMULSION FOR INF New CEP for Valine SMOFKABIVEN EMULSION FOR INF Update CEP SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP

29 Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης SMOFKABIVEN PERIFERAL EMULSION FOR INF Update CEP SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF Update CEP SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP Update CEP 863 SMOFKABIVEN PERIFERAL EMULSION FOR INF Update CEP SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF Update CEP SMOFKABIVEN EMULSION FOR INF Update CEP

30 Ap. Αδειας SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF Update CEP SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF Update CEP SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP Update CEP 864 SMOFKABIVEN PERIFERAL EMULSION FOR INF Update CEP SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF Update CEP

31 Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF Update CEP SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF Update CEP 865 SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF Update CEP SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP Update CEP

32 Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης SMOFKABIVEN PERIFERAL EMULSION FOR INF ΑΕ Update CEP SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF ΑΕ ΑΕ Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF ΑΕ Update CEP SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF ΑΕ ΑΕ Update CEP Update CEP 866 SMOFKABIVEN PERIFERAL EMULSION FOR INF ΑΕ Update CEP SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF ΑΕ ΑΕ Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF ΑΕ Update CEP SMOFKABIVEN EMULSION FOR INF ΑΕ Update CEP

33 Ap. Αδειας SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Update CEP Deletion of the manufacturer Ajinomoto Co. Inc. holding a CEP (CEP ) for the active substance proline Deletion of the manufacturer Ajinomoto Co. Inc. holding a CEP (CEP ) for the active substance proline SMOFKABIVEN PERIFERAL EMULSION FOR INF SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Deletion CEP Deletion of the CEP for the active substance serine by the manufacturer Ajinomoto Co. Inc Deletion of the CEP for the active substance serine by the manufacturer Ajinomoto Co. Inc 867 SMOFKABIVEN PERIFERAL EMULSION FOR INF Deletion CEP SMOFKABIVEN EMULSION FOR INF SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF Deletion of the manufacturer Ajinomoto Co. Inc. holding a CEP (CEP ) for the active substance threonine Deletion of the manufacturer Ajinomoto Co. Inc. holding a CEP (CEP ) for the active substance threonine SMOFKABIVEN PERIFERAL EMULSION FOR INF Deletion CEP

34 Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης HEXVIX POWDER & SOLV. FOR SOL. FOR INTRAVESICAL USE 85MG GE HEALTHCARE AS A.1. Change in the address of the marketing authorisation holder in IT DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD PHARMASWISS CESKA REPUBLIKA SRO delete ICN Polfa Rzeszow as assembler (packager) and batch release site DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD PHARMASWISS CESKA REPUBLIKA SRO replace Temmler Werke with Haupt Pharma Amareg GmbH as an assembler (packager) DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD PHARMASWISS CESKA REPUBLIKA SRO replace Temmler Werke with Temmler Ireland as QC site DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD PHARMASWISS CESKA REPUBLIKA SRO To replace Temmler Werke with C.P.M. Contract Pharma GmbH as a batch release site DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD PHARMASWISS CESKA REPUBLIKA SRO add Haupt Pharma Amareg GmbH as a batch release site 868 DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD PHARMASWISS CESKA REPUBLIKA SRO replace Temmler Werke with Temmler Ireland as a finished product manfacturer DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD PHARMASWISS CESKA REPUBLIKA SRO replace Temmler Werke with Haupt Pharma Amareg GmbH as an assembler (packager) FLEXBUMIN SOL. FOR INF. 200G/L BAXTER HELLAS EPE Minor change in the manufacturing process FLEXBUMIN SOL. FOR INF. 250G/L BAXTER HELLAS EPE Minor change in the manufacturing process ATORVASTATIN PFIZER TABLET, FILM COATED 10MG PFIZER HELLAS ATORVASTATIN PFIZER TABLET, FILM COATED 20MG PFIZER HELLAS Addition of residual acetic acid specification and corresponding method Addition of residual acetic acid specification and corresponding method

35 Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης ATORVASTATIN PFIZER TABLET, FILM COATED 40MG PFIZER HELLAS ΑΕ ATORVASTATIN PFIZER TABLET, FILM COATED 80MG PFIZER HELLAS ΑΕ LIPITOR F.C.TABLETS 10MG PFIZER HELLAS LIPITOR F.C.TABLETS 20MG PFIZER HELLAS LIPITOR F.C.TABLETS 40MG PFIZER HELLAS LIPITOR TABLET, CHEWABLE 5MG PFIZER HELLAS LIPITOR TABLET, CHEWABLE 10MG PFIZER HELLAS LIPITOR TABLET, CHEWABLE 20MG PFIZER HELLAS LIPITOR TABLET, CHEWABLE 40MG PFIZER HELLAS Addition of residual acetic acid specification and corresponding method Addition of residual acetic acid specification and corresponding method Addition of residual acetic acid specification and corresponding method Addition of residual acetic acid specification and corresponding method Addition of residual acetic acid specification and corresponding method Addition of residual acetic acid specification and corresponding method Addition of residual acetic acid specification and corresponding method Addition of residual acetic acid specification and corresponding method Addition of residual acetic acid specification and corresponding method 869 ATORVASTATIN PFIZER TABLET, FILM COATED 10MG PFIZER HELLAS Relaxed limit for procedure ATORVASTATIN PFIZER TABLET, FILM COATED 20MG PFIZER HELLAS Relaxed limit for procedure ATORVASTATIN PFIZER TABLET, FILM COATED 40MG PFIZER HELLAS Relaxed limit for procedure

36 Ap. Αδειας Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης ATORVASTATIN PFIZER TABLET, FILM COATED 80MG PFIZER HELLAS Relaxed limit for procedure LIPITOR F.C.TABLETS 10MG PFIZER HELLAS Adopted Ph. Eur.limit LIPITOR F.C.TABLETS 20MG PFIZER HELLAS Adopted Ph. Eur.limit LIPITOR F.C.TABLETS 40MG PFIZER HELLAS Adopted Ph. Eur.limit LIPITOR TABLET, CHEWABLE 5MG PFIZER HELLAS Adopted Ph. Eur.limit LIPITOR TABLET, CHEWABLE 10MG PFIZER HELLAS Adopted Ph. Eur.limit LIPITOR TABLET, CHEWABLE 20MG PFIZER HELLAS Adopted Ph. Eur.limit LIPITOR TABLET, CHEWABLE 40MG PFIZER HELLAS Adopted Ph. Eur.limit ATORVASTATIN PFIZER TABLET, FILM COATED 10MG PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods for active substance 870 ATORVASTATIN PFIZER TABLET, FILM COATED 20MG PFIZER HELLAS ATORVASTATIN PFIZER TABLET, FILM COATED 40MG PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods for active substance Adoption of Ph. Eur. Specifications and methods for active substance ATORVASTATIN PFIZER TABLET, FILM COATED 80MG PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods for active substance LIPITOR F.C.TABLETS 10MG PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods LIPITOR F.C.TABLETS 20MG PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods LIPITOR F.C.TABLETS 40MG PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods LIPITOR TABLET, CHEWABLE 5MG PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods