ΕΠΙΣΗΜΗ ΕΦΗΜΕΡΙΔΑ ΤΗΣ ΚΥΠΡΙΑΚΗΣ ΔΗΜΟΚΡΑΤΙΑΣ ΚΥΡΙΟ ΜΕΡΟΣ ΤΜΗΜΑ B

ΕΠΙΣΗΜΗ ΕΦΗΜΕΡΙΔΑ ΤΗΣ ΚΥΠΡΙΑΚΗΣ ΔΗΜΟΚΡΑΤΙΑΣ ΚΥΡΙΟ ΜΕΡΟΣ ΤΜΗΜΑ B Αριθμός 4994 Τετάρτη, 22 Φεβρουαρίου 2017 835 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

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 07/09/2018 07/09/2018 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

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

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

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: 22396 22345 22388 22398 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 05/12/2016 839 22359 ANTIVOM TABLET 16MG BENDAMUSTIN LEDPHARM POWDER BETAHISTINE DIHYDROCHLORIDE UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES SA 11/10/2016 22423 22411 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

Αρ. Άδειας 22394 22420 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 22419 22400 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 22401 FOR INJECTION 200 UNITS BOTULINUM TOXIN TYPE A ALLERGAN PHARMACEUTICALS IRELAND 06/12/2016 BOTOX POWDER FOR SOLUTION 22399 22433 22389 22376 22367 22414 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. 23/11/2016 840 22352 ELXEDA TABLET 10MG ARIPIPRAZOLE PHARMACEUTICALS 10/10/2016 22353 ELXEDA TABLET 15MG ARIPIPRAZOLE PHARMACEUTICALS 10/10/2016

Αρ. Άδ Κύκλοι Ό νομα Φ αρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας 22354 22368 ELXEDA TABLET 30MG ARIPIPRAZOLE PHARMACEUTICALS EPLERENONE ACCORD TABLET, FILM COATED 25MG EPLERENONE ACCORD HEALTHCARE LIMITED EPLERENONE ACCORD TABLET, FILM 22369 COATED 50MG EPLERENONE ACCORD HEALTHCARE LIMITED TENOFOVIR DISOPROXIL 22347 EXATRON TABLET, FILM COATED SUCCINATE, EMTRICITABINE RENEWALS MRP-DCP-NATIONAL FEIBA POWDER AND SOLVENT FOR 22343 SOLUTION FOR INFUSION 25U/ML PLASMA PROTEINS BAXALTA INNOVATIONS GMBH FEIBA POWDER AND SOLVENT FOR 22344 SOLUTION FOR INFUSION 50U/ML PLASMA PROTEINS BAXALTA INNOVATIONS GMBH FERANT SOLUTION FOR INJECTION PALONOSETRON 22422 50MCG/ML HYDROCHLORIDE MEDOCHEMIE FORMOTEROL FUMARATE DIHYDRATE, MICRONIZED, FOSTER NEXTHALER POWDER FOR BECLOMETASONE 22386 INHALATION 100MCG/6MCG DIPROPIONATE CHIESI FARMACEUTICI SPA 22395 22356 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, 22355 SOLUTION LATANOPROST PHARMACEUTICALS ISOSORBIDE MONONITRATE ACCORD 22378 TABLET 20MG ISOSORBIDE MONONITRATE ACCORD HEALTHCARE LIMITED 22346 KIVALA TABLET, FILM COATED ABACAVIR, LAMIVUDINE REMEDICA

Αρ. Άδ Κύκλοι 22402 22377 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 22383 22370 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 22404 22405 TABLET GASTRO-RESISTANT 180MG MYCOPHENOLATE SODIUM ACCORD HEALTHCARE LIMITED 22/11/2016 MYCOPHENOLIC ACID ACCORD TABLET, GASTRO-RESISTANT 360MG MYCOPHENOLATE SODIUM ACCORD HEALTHCARE LIMITED 22/11/2016 22397 22413 22412 22291 22390 22391 22392 22393 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 08/11/2016 842

Αρ. Άδ Κύκλοι Ό νομα Φ αρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας OREST EASYHALER POWDER FOR INHALATION FORMOTEROL FUMARATE 22432 80MCG/4.5MCG/INHALATION DIHYDRATE,BUDESONIDE ORION CORPORATION PAROXETINE JUBILANT TABLET, FILM PAROXETINE HYDROCHLORICE 22406 COATED 10MG HEMIHYDRATE JUBILANT PHARMACEUTICALS NV PAROXETINE JUBILANT TABLET, FILM PAROXETINE HYDROCHLORICE 22407 COATED 20MG HEMIHYDRATE JUBILANT PHARMACEUTICALS NV PAROXETINE JUBILANT TABLET, FILM PAROXETINE HYDROCHLORICE 22408 COATED 30MG HEMIHYDRATE JUBILANT PHARMACEUTICALS NV PAROXETINE JUBILANT TABLET, FILM PAROXETINE HYDROCHLORICE 22409 COATED 40MG HEMIHYDRATE JUBILANT PHARMACEUTICALS NV 22365 PROGRAF CAPSULE, HARD 0.5MG TACROLIMUS ASTELLAS PHARMACEUTICALS BE PROPOFOL HOSPIRA EMULSION FOR 22421 INJECTION / INFUSION 10MG/ML PROPOFOL HOSPIRA UK LIMITED RAMIPRIL ACCORD CAPSULE, HARD 22384 2.5MG RAMIPRIL ACCORD HEALTHCARE LIMITED RAMIPRIL ACCORD CAPSULE, HARD 22385 5MG RAMIPRIL ACCORD HEALTHCARE LIMITED TIOTROPIUM BROMIDE SPIOLTO RESPIMAT SOLUTION FOR MONOHYDRATE, OLODATEROL 22379 INHALATION HYDROCHLORIDE BOEHRINGER INGELHEIM INTERNATIONAL GMBH SPIRONOLACTONE ACCORD TABLET, 22371 FILM COATED 100MG SPIRONOLACTONE ACCORD HEALTHCARE LIMITED SPIRONOLACTONE ACCORD TABLET, 22372 FILM COATED 25MG SPIRONOLACTONE ACCORD HEALTHCARE LIMITED 22362 SULAMID TABLET 100MG AMISULPRIDE CODAL SYNTO

Αρ. Άδ Κύκλοι Ό νομα Φ αρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας 22363 SULAMID TABLET 200MG AMISULPRIDE CODAL SYNTO 22364 SULAMID TABLET 400MG AMISULPRIDE CODAL SYNTO 22361 SULAMID TABLET 50MG AMISULPRIDE CODAL SYNTO FORMOTEROL FUMARATE SYMBICORT PRESSURISED DIHYDRATE, MICRONIZED, INHALATION, SUSPENSION BECLOMETASONE 22403 160/4.5MCG/ACTUATION DIPROPIONATE ASTRAZENECAAB TENOVIRALTABLET, FILM COATED TENOFOVIR DISOPROXIL 22348 123MG SUCCINATE REMEDICA TENOVIRAL TABLET, FILM COATED TENOFOVIR DISOPROXIL 22349 163MG SUCCINATE REMEDICA TENOVIRAL TABLET, FILM COATED TENOFOVIR DISOPROXIL 22350 204MG SUCCINATE REMEDICA TENOVIRAL TABLET, FILM COATED TENOFOVIR DISOPROXIL 22351 245MG SUCCINATE REMEDICA TINTAROS TABLET, FILM COATED 22416 10MG ROSUVASTATIN CALCIUM ACTAVIS GROUP PTC EHF TINTAROS TABLET, FILM COATED 22417 20MG ROSUVASTATIN CALCIUM ACTAVIS GROUP PTC EHF TINTAROS TABLET, FILM COATED 22418 40MG ROSUVASTATIN CALCIUM ACTAVIS GROUP PTC EHF TINTAROS TABLET, FILM COATED 22415 5MG ROSUVASTATIN CALCIUM ACTAVIS GROUP PTC EHF VESICARE ORAL SUSPENSION 22366 1 MG/ML SOLIFENACIN SUCCINATE ASTELLAS PHARMACEUTICALS BE

Αρ. Άδειας Όνομα Φαρμακευτικού Προϊόντος Δραστικά Συστατικά Κάτοχος Άδειας Ημερομηνία Έκδοσης Άδειας 22374 VITAROS CREAM 2MG/G ALPROSTADIL RECORDATI IRELAND 21/10/2016 22375 VITAROS CREAM 3MG/G ALPROSTADIL RECORDATI IRELAND 21/10/2016 OLODATEROL 22387 22357 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 10/10/2016 845

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 22286 201210547 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG 22287 201210548 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG 22286 20133225 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG 22286 20133226 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG 22286 20133227 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG 22286 20133228 SINGULAIR CHEWABLE TABS 4MG 19291 20133798 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

Αρ. Άδειας SINGULAIR GRAN. FOR ORAL SUSP. 4MG 19676 20133799 SINGULAIR CHEWABLE TABS 4MG 19291 20133800 SINGULAIR GRAN. FOR ORAL SUSP. 4MG 19676 20133801 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG 22286 20138096 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG 22286 20138097 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 22025 2014389 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 2014390 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 2014391 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 2014392 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 2014393 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

Αρ. Άδειας Αρ. Τροποποίησης Κάτοχος Άδειας Περιγραφή Τροποποίησης GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 2014931 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 2014932 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 2014933 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 2014934 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 2014935 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 22025 2014936 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 2014937 RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE FLEXBUMIN SOL. FOR INF. 200G/L 20477 2014978 BAXTER HELLAS EPE FLEXBUMIN SOL. FOR INF. 250G/L 20478 2014979 BAXTER HELLAS EPE PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG 22286 20142039 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG 22286 20142040 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG 22286 20142089 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

Ap. Αδειας PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG 22286 20142090 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG 22286 20142091 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG 22286 20142092 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG 22286 20142093 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG 22286 20142094 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 20397 20142110 N V ORGANON API manufacturer name change NUVARING VAGINAL SYSTEM 20397 20142111 N V ORGANON Update CEP 849 OXALIPLATIN MEDAC POWDER FOR SOL. FOR INF. 5 MG/ML 20211 20142159 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142190 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142191 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142192 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

Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142193 RECKITT BENCKISER HELLAS CHEMICAL ABEE Tightening of specification limits GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142194 RECKITT BENCKISER HELLAS CHEMICAL ABEE Tightening of specification limits GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142195 RECKITT BENCKISER HELLAS CHEMICAL ABEE Tightening of specification limits GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142196 RECKITT BENCKISER HELLAS CHEMICAL ABEE Tightening of specification limits GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142197 RECKITT BENCKISER HELLAS CHEMICAL ABEE Tightening of specification limits GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142198 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142199 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 22025 20142200 RECKITT BENCKISER HELLAS CHEMICAL ABEE Minor changes to an approved test procedure GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142201 RECKITT BENCKISER HELLAS CHEMICAL ABEE Minor changes to an approved test procedure GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142202 RECKITT BENCKISER HELLAS CHEMICAL ABEE Minor changes to an approved test procedure GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142203 RECKITT BENCKISER HELLAS CHEMICAL ABEE Minor changes to an approved test procedure GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142204 RECKITT BENCKISER HELLAS CHEMICAL ABEE Minor changes to an approved test procedure

Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20142205 RECKITT BENCKISER HELLAS CHEMICAL ABEE HEXVIX POWDER & SOLV. FOR SOL. FOR INTRAVESICAL USE 85MG 19760 20142547 GE HEALTHCARE AS FLEXBUMIN SOL. FOR INF. 200G/L 20477 20142606 BAXTER HELLAS EPE FLEXBUMIN SOL. FOR INF. 200G/L 20477 20142615 BAXTER HELLAS EPE PMF Annual Update FLEXBUMIN SOL. FOR INF. 250G/L 20478 20142616 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 22192 20142802 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 10MG 22193 20142803 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 15MG 22194 20142804 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 20MG 22195 20142805 ACTAVIS GROUP PTC EHF RAMIMED TABLET 2.5MG 20394 20143221 MEDOCHEMIE RAMIMED TABLET 5MG 20395 20143222 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

Ap. Αδειας Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης RAMIMED TABLET 10MG 20396 20143223 MEDOCHEMIE RAMIMED TABLET 2.5MG 20394 20143224 MEDOCHEMIE RAMIMED TABLET 5MG 20395 20143225 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 20396 20143226 MEDOCHEMIE RAMIMED TABLET 2.5MG 20394 20143227 MEDOCHEMIE Introduce the PSMF RAMIMED TABLET 5MG 20395 20143228 MEDOCHEMIE Introduce the PSMF RAMIMED TABLET 10MG 20396 20143229 MEDOCHEMIE Introduce the PSMF SMOFKABIVEN EMULSION FOR INF. 20651 20143249 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20143250 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 2008-099-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 2008-099-Rev 01 from the manufacturers of glycine 852 SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20143251 SMOFKABIVEN EMULSION FOR INF. 20651 20143252 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 1998-122-Rev 03 from the manufacturers of isoleucine

SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20143253 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 1998-122-Rev 03 from the manufacturers of isoleucine SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20143254 SMOFKABIVEN EMULSION FOR INF. 20651 20143255 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20143256 SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20143257 SMOFKABIVEN EMULSION FOR INF. 20651 20143258 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20143259 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 2009-100-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 2009-100-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 2010-188-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 2010-188-Rev 02 from the manufacturers of isoleucine 853 SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20143260 SMOFKABIVEN EMULSION FOR INF. 20651 20143261 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 2008-233-Rev 03 from the manufacturers of leucine

SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20143262 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 2008-233-Rev 03 from the manufacturers of leucine SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20143263 SMOFKABIVEN EMULSION FOR INF. 20651 20143264 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20143265 SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20143266 SMOFKABIVEN EMULSION FOR INF. 20651 20143267 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20143268 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 1997-011-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 1997-011-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 2010-225-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 2010-225-Rev 01 from the manufacturers of phenylalanine 854 SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20143269 Update CEP from the manufacturers of phenylalanine SMOFKABIVEN EMULSION FOR INF. 20651 20143270 IA no B.III.1.a.4 Deletion of a Ph. Eur. Certificate of suitability; phenylalanine

Ap. Αδειας SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20143271 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. 20667 20143272 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 20MG 22286 20143295 PANTOPRAZOLE JENSON TABLET, GASTRO-RESISTANT 40MG 22286 20143296 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 21046 20143425 MERCKS GENERICS Update batch size IRINOTECAN CONCENTRATE FOR SOL. FOR INF. 20MG 21046 20143426 MERCKS GENERICS Update batch size 855 IRINOTECAN CONCENTRATE FOR SOL. FOR INF. 20MG 21046 20143427 MERCKS GENERICS Minor changes to an approved test procedure FLEXBUMIN SOL. FOR INF. 200G/L 20477 20143743 BAXTER HELLAS EPE FLEXBUMIN SOL. FOR INF. 250G/L 20478 20143744 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. 20651 20143875 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20143876 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

Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20143877 SMOFKABIVEN EMULSION FOR INF. 20651 20143879 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20143880 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. 20667 20143881 FRESENIUS ΚΑΒΙ HELLAS ΑΕ ESCITALOPRAM ACTAVIS TABLET, FILM COATED 5MG 22192 20144105 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 10MG 22193 20144106 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 15MG 22194 20144107 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 20MG 22195 20144108 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

Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης IRINOTECAN CONCENTRATE FOR SOL. FOR INF. 20MG 21046 20144109 MERCKS GENERICS Deletion of a non-significant specification parameter (L-impurity). ABSTRAL SUBLINGUAL TABS 10OMCG 20604 20144268 PROSTRAKAN update module 2.3, 3 ABSTRAL SUBLINGUAL TABS 200MCG 20605 20144269 PROSTRAKAN update module 2.3, 3 ABSTRAL SUBLINGUAL TABS 300MCG 20606 20144270 PROSTRAKAN update module 2.3, 3 ABSTRAL SUBLINGUAL TABS 400MCG 20607 20144271 PROSTRAKAN update module 2.3, 3 ABSTRAL SUBLINGUAL TABS 600MCG 20608 20144272 PROSTRAKAN update module 2.3, 3 ABSTRAL SUBLINGUAL TABS 800MCG 20609 20144273 PROSTRAKAN update module 2.3, 3 ESCITALOPRAM ACTAVIS TABLET, FILM COATED 5MG 22192 20144570 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 10MG 22193 20144571 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 15MG 22194 20144572 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 20MG 22195 20144573 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

Ap. Αδειας Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης ESCITALOPRAM ACTAVIS TABLET, FILM COATED 5MG 22192 20144574 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 10MG 22193 20144575 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 15MG 22194 20144576 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 20MG 22195 20144577 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 22192 20144578 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 10MG 22193 20144579 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 15MG 22194 20144580 ACTAVIS GROUP PTC EHF ESCITALOPRAM ACTAVIS TABLET, FILM COATED 20MG 22195 20144581 ACTAVIS GROUP PTC EHF ABSTRAL SUBLINGUAL TABS 10OMCG 20604 20144837 PROSTRAKAN ABSTRAL SUBLINGUAL TABS 200MCG 20605 20144838 PROSTRAKAN ABSTRAL SUBLINGUAL TABS 300MCG 20606 20144839 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

Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης ABSTRAL SUBLINGUAL TABS 400MCG 20607 20144840 PROSTRAKAN ABSTRAL SUBLINGUAL TABS 600MCG 20608 20144841 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 20609 20144842 PROSTRAKAN IRINOTECAN CONCENTRATE FOR SOL. FOR INF. 20MG 21046 20145385 MERCKS GENERICS IRINOTECAN CONCENTRATE FOR SOL. FOR INF. 20MG 21046 20145386 MERCKS GENERICS FLEXBUMIN SOL. FOR INF. 200G/L 20477 20145545 BAXTER HELLAS EPE FLEXBUMIN SOL. FOR INF. 250G/L 20478 20145546 BAXTER HELLAS EPE HEXVIX POWDER & SOLV. FOR SOL. FOR INTRAVESICAL USE 85MG 19760 20145723 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 20495 20146843 ACTAVIS GROUP PTC EHF VIVACE TABLET, FILM COATED 5MG 20496 20146844 ACTAVIS GROUP PTC EHF VIVACE TABLET, FILM COATED 10MG 20497 20146845 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 22025 20146846 RECKITT BENCKISER HELLAS CHEMICAL ABEE Deletion of manufacturing site for an active substance

Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20146847 RECKITT BENCKISER HELLAS CHEMICAL ABEE Change in the adress of MAH of active FLEXBUMIN SOL. FOR INF. 200G/L 20477 20147020 BAXTER HELLAS EPE Introduction of a summary of PhV system FLEXBUMIN SOL. FOR INF. 250G/L 20478 20147021 BAXTER HELLAS EPE Introduction of a summary of PhV system BLUGRAL TABLET, FILM COATED 25MG 21749 20147924 C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 50MG 21750 20147925 C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 100MG 21751 20147926 C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 25MG 21749 20147927 C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 50MG 21750 20147928 C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 100MG 21751 20147929 C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 25MG 21749 20147930 C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 50MG 21750 20147931 C A PAPLLINA & CO BLUGRAL TABLET, FILM COATED 100MG 21751 20147932 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

Ap. Αδειας Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης ZOLOFT TABS 50MG 14677 20148728 PFIZER HELLAS remove secondary packaging site for SE only ZOLOFT TABS 100MG 14678 20148729 PFIZER HELLAS remove secondary packaging site for SE only FERINJECT SOLUTION FOR INJECTION OR INFUSION 50MG IRON PER ML 20795 20148766 VIFOR FRANCE SA Additional batch size of 232kg has been added. ROFERON-A SOL. FOR INJ. IN PREF. SYR. 3MIU/0,ML 20076 20148969 G.A STAMATIS & CO Update PSMF GLUCAGEN HYPOKIT POWDER FOR SOL. FOR INJ. 1MG 20205 20149538 NOVO NORDISK NUROFEN FOR CHILDREN 4% ORANGE ORAL SUSPENSION 4% 21712 20149677 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% 21713 20149678 NUROFEN FOR CHILDREN 4% ORANGE ORAL SUSPENSION 4% 21712 20149679 NUROFEN FOR CHILDREN 4% STRAWBERRY ORAL SUSPENSION 4% 21713 20149680 NUROFEN FOR CHILDREN 4% ORANGE ORAL SUSPENSION 4% 21712 20149685 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 1996-061- Rev 08 for Shasun Pharmaceuticals Ltd. submission of updated CEP R1-CEP 1996-061- Rev 08 for Shasun Pharmaceuticals Ltd. Addition of secondary packaging site "Logosys Logistik GmbH & Co KG, Otto-Rohm-Strasse 69, 64293 Darmstadt, Germany".

Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης NUROFEN FOR CHILDREN 4% STRAWBERRY ORAL SUSPENSION 4% 21713 20149686 GAVISCON DOUBLE ACTION TABLET, CHEWABLE 22025 20149689 RECKITT BENCKISER HELLAS CHEMICAL ABEE RECKITT BENCKISER HELLAS CHEMICAL ABEE Addition of secondary packaging site "Logosys Logistik GmbH & Co KG, Otto-Rohm-Strasse 69, 64293 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. 20651 20149731 New CEP for Serine SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149732 New CEP for Serine SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149733 New CEP for Serine 862 SMOFKABIVEN EMULSION FOR INF. 20651 20149735 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149736 New CEP for Valine New CEP for Valine SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149737 New CEP for Valine SMOFKABIVEN EMULSION FOR INF. 20651 20149741 Update CEP SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149742 Update CEP

Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149743 Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149745 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149746 Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149747 Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149749 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149750 Update CEP Update CEP 863 SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149751 Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149753 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149754 Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149755 Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149757 Update CEP

Ap. Αδειας SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149758 Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149759 Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149761 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149762 Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149763 Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149765 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149766 Update CEP Update CEP 864 SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149767 Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149769 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149770 Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149771 Update CEP

Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης SMOFKABIVEN EMULSION FOR INF. 20651 20149773 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149774 Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149775 Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149777 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149778 Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149779 Update CEP 865 SMOFKABIVEN EMULSION FOR INF. 20651 20149781 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149782 Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149783 Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149785 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149786 Update CEP Update CEP

Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149787 ΑΕ Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149789 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149790 ΑΕ ΑΕ Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149791 ΑΕ Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149793 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149794 ΑΕ ΑΕ Update CEP Update CEP 866 SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149795 ΑΕ Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149797 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149798 ΑΕ ΑΕ Update CEP Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149799 ΑΕ Update CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149801 ΑΕ Update CEP

Ap. Αδειας SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149802 Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης Update CEP SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149803 SMOFKABIVEN EMULSION FOR INF. 20651 20149805 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149806 Update CEP Deletion of the manufacturer Ajinomoto Co. Inc. holding a CEP (CEP 1998-064) for the active substance proline Deletion of the manufacturer Ajinomoto Co. Inc. holding a CEP (CEP 1998-064) for the active substance proline SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149807 SMOFKABIVEN EMULSION FOR INF. 20651 20149809 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149810 Deletion CEP Deletion of the CEP 1999-159 for the active substance serine by the manufacturer Ajinomoto Co. Inc Deletion of the CEP 1999-159 for the active substance serine by the manufacturer Ajinomoto Co. Inc 867 SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149811 Deletion CEP SMOFKABIVEN EMULSION FOR INF. 20651 20149813 SMOFKABIVEN ELECTROLYTE FREE EMULSION FOR INF. 20716 20149814 Deletion of the manufacturer Ajinomoto Co. Inc. holding a CEP (CEP 1996-097) for the active substance threonine Deletion of the manufacturer Ajinomoto Co. Inc. holding a CEP (CEP 1996-097) for the active substance threonine SMOFKABIVEN PERIFERAL EMULSION FOR INF. 20667 20149815 Deletion CEP

Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης HEXVIX POWDER & SOLV. FOR SOL. FOR INTRAVESICAL USE 85MG 19760 201410313 GE HEALTHCARE AS A.1. Change in the address of the marketing authorisation holder in IT DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD 22360 201410547 PHARMASWISS CESKA REPUBLIKA SRO delete ICN Polfa Rzeszow as assembler (packager) and batch release site DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD 22360 201410548 PHARMASWISS CESKA REPUBLIKA SRO replace Temmler Werke with Haupt Pharma Amareg GmbH as an assembler (packager) DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD 22360 201410549 PHARMASWISS CESKA REPUBLIKA SRO replace Temmler Werke with Temmler Ireland as QC site DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD 22360 201410550 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 22360 201410551 PHARMASWISS CESKA REPUBLIKA SRO add Haupt Pharma Amareg GmbH as a batch release site 868 DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD 22360 201410552 PHARMASWISS CESKA REPUBLIKA SRO replace Temmler Werke with Temmler Ireland as a finished product manfacturer DICLODUO COMBI MODIFIED- RELEASE CAPSULE, HARD 22360 201410553 PHARMASWISS CESKA REPUBLIKA SRO replace Temmler Werke with Haupt Pharma Amareg GmbH as an assembler (packager) FLEXBUMIN SOL. FOR INF. 200G/L 20477 201410675 BAXTER HELLAS EPE Minor change in the manufacturing process FLEXBUMIN SOL. FOR INF. 250G/L 20478 201410676 BAXTER HELLAS EPE Minor change in the manufacturing process ATORVASTATIN PFIZER TABLET, FILM COATED 10MG 21889 201410729 PFIZER HELLAS ATORVASTATIN PFIZER TABLET, FILM COATED 20MG 21890 201410730 PFIZER HELLAS Addition of residual acetic acid specification and corresponding method Addition of residual acetic acid specification and corresponding method

Αρ. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης ATORVASTATIN PFIZER TABLET, FILM COATED 40MG 21891 201410731 PFIZER HELLAS ΑΕ ATORVASTATIN PFIZER TABLET, FILM COATED 80MG 21892 201410732 PFIZER HELLAS ΑΕ LIPITOR F.C.TABLETS 10MG 19489 201410733 PFIZER HELLAS LIPITOR F.C.TABLETS 20MG 19490 201410734 PFIZER HELLAS LIPITOR F.C.TABLETS 40MG 19491 201410735 PFIZER HELLAS LIPITOR TABLET, CHEWABLE 5MG 20727 201410736 PFIZER HELLAS LIPITOR TABLET, CHEWABLE 10MG 20728 201410737 PFIZER HELLAS LIPITOR TABLET, CHEWABLE 20MG 20729 201410738 PFIZER HELLAS LIPITOR TABLET, CHEWABLE 40MG 20730 201410739 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 21889 201410740 PFIZER HELLAS Relaxed limit for procedure ATORVASTATIN PFIZER TABLET, FILM COATED 20MG 21890 201410741 PFIZER HELLAS Relaxed limit for procedure ATORVASTATIN PFIZER TABLET, FILM COATED 40MG 21891 201410742 PFIZER HELLAS Relaxed limit for procedure

Ap. Αδειας Ap. Τροποποίησης Κάτοχος Αδειας Περιγραφή Τροποποίησης ATORVASTATIN PFIZER TABLET, FILM COATED 80MG 21892 201410743 PFIZER HELLAS Relaxed limit for procedure LIPITOR F.C.TABLETS 10MG 19489 201410744 PFIZER HELLAS Adopted Ph. Eur.limit LIPITOR F.C.TABLETS 20MG 19490 201410745 PFIZER HELLAS Adopted Ph. Eur.limit LIPITOR F.C.TABLETS 40MG 19491 201410746 PFIZER HELLAS Adopted Ph. Eur.limit LIPITOR TABLET, CHEWABLE 5MG 20727 201410747 PFIZER HELLAS Adopted Ph. Eur.limit LIPITOR TABLET, CHEWABLE 10MG 20728 201410748 PFIZER HELLAS Adopted Ph. Eur.limit LIPITOR TABLET, CHEWABLE 20MG 20729 201410749 PFIZER HELLAS Adopted Ph. Eur.limit LIPITOR TABLET, CHEWABLE 40MG 20730 201410750 PFIZER HELLAS Adopted Ph. Eur.limit ATORVASTATIN PFIZER TABLET, FILM COATED 10MG 21889 201410751 PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods for active substance 870 ATORVASTATIN PFIZER TABLET, FILM COATED 20MG 21890 201410752 PFIZER HELLAS ATORVASTATIN PFIZER TABLET, FILM COATED 40MG 21891 201410753 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 21892 201410754 PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods for active substance LIPITOR F.C.TABLETS 10MG 19489 201410755 PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods LIPITOR F.C.TABLETS 20MG 19490 201410756 PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods LIPITOR F.C.TABLETS 40MG 19491 201410757 PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods LIPITOR TABLET, CHEWABLE 5MG 20727 201410758 PFIZER HELLAS Adoption of Ph. Eur. Specifications and methods