Marketing authorisations granted in September 2012

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1 PL 00037/ /09/2012 ABBOTT LABORATORIES LIMITED LEVELANZ 250 MG FILM-COATED TABLETS LEVETIRACETAM 250 MILLIGRAMMES POM PL 00037/ /09/2012 ABBOTT LABORATORIES LIMITED LEVELANZ 500 MG FILM-COATED TABLETS LEVETIRACETAM 500 MILLIGRAMMES POM PL 00037/ /09/2012 ABBOTT LABORATORIES LIMITED LEVELANZ 750 MG FILM-COATED TABLETS LEVETIRACETAM 750 MILLIGRAMMES POM PL 00037/ /09/2012 ABBOTT LABORATORIES LIMITED LEVELANZ 1000 MG FILM-COATED TABLETS LEVETIRACETAM 1000 MILLIGRAMMES POM PL 00116/ /09/2012 BAXTER HEALTHCARE LIMITED BREVIBLOC PREMIXED 20MG/ML SOLUTION FOR INFUSION ESMOLOL MILLIGRAMMES POM PL 15513/ /09/2012 MCNEIL PRODUCTS LIMITED IMODIUM LIQUICAPS 2 MG SOFT CAPSULES LOPERAMIDE HYDROCHLORIDE 2.00 MILLIGRAMMES GSL PL 15513/ /09/2012 MCNEIL PRODUCTS LIMITED IMODIUM 2MG SOFT CAPSULES LOPERAMIDE HYDROCHLORIDE 2.00 MILLIGRAMMES P PL 16363/ /09/2012 MILPHARM LIMITED RABEPRAZOLE SODIUM 10 MG GASTRO-RESISTANT TABLETS RABEPRAZOLE SODIUM 10 MILLIGRAMMES POM PL 16363/ /09/2012 MILPHARM LIMITED RABEPRAZOLE SODIUM 20 MG GASTRO-RESISTANT TABLETS RABEPRAZOLE SODIUM 20 MILLIGRAMMES POM PL 30306/ /09/2012 ACTAVIS GROUP PTC EHF METHOTREXATE 25MG/ML SOLUTION FOR INJECTION OR INFUSION METHOTREXATE 25 MILLIGRAMMES PER MILLILITRE POM PL 30306/ /09/2012 ACTAVIS GROUP PTC EHF ORLISTAT 60MG CAPSULES, HARD ORLISTAT MILLIGRAMMES P PL 30306/ /09/2012 ACTAVIS GROUP PTC EHF ORLISTAT 120MG CAPSULES, HARD ORLISTAT MILLIGRAMMES POM PL 39729/ /09/2012 HENGRUI AB OXALIPLATIN 5MG/ML POWDER FOR SOLUTION FOR INFUSION OXALIPLATIN 50 MILLIGRAMMES POM PL 10590/ /09/2012 GALDERMA (UK) LIMITED PLIAGLIS 70 MG/G + 70 MG/G CREAM LIDOCAINE BASE 70.0 MILLIGRAMMES PER GRAM POM PL 10590/ /09/2012 GALDERMA (UK) LIMITED PLIAGLIS 70 MG/G + 70 MG/G CREAM TETRACAINE BASE 70.0 MILLIGRAMMES PER GRAM POM PL 17871/ /09/2012 JENSON PHARMACEUTICAL SERVICES LIMITED MANEO 100 MG PROLONGED-RELEASE TABLETS TRAMADOL HYDROCHLORIDE 100 MILLIGRAMMES POM PL 17871/ /09/2012 JENSON PHARMACEUTICAL SERVICES LIMITED MANEO 150 MG PROLONGED-RELEASE TABLETS TRAMADOL HYDROCHLORIDE 150 MILLIGRAMMES POM PL 17871/ /09/2012 JENSON PHARMACEUTICAL SERVICES LIMITED MANEO 200 MG PROLONGED-RELEASE TABLETS TRAMADOL HYDROCHLORIDE 200 MILLIGRAMMES POM PL 20075/ /09/2012 ACCORD HEALTHCARE LIMITED TOLTERODINE TARTRATE 1 MG FILM-COATED TABLET TOLTERODINE L-TARTRATE MILLIGRAMMES POM PL 20075/ /09/2012 ACCORD HEALTHCARE LIMITED TOLTERODINE TARTRATE 2 MG FILM-COATED TABLET TOLTERODINE L-TARTRATE MILLIGRAMMES POM PL 30464/ /09/2012 ATHLONE PHARMACEUTICALS LIMITED SODIUM BICARBONATE 500 MG CAPSULES, HARD SODIUM BICARBONATE 500 MILLIGRAMMES POM PL 39845/ /09/2012 GENEPHARM (EUROPE) TRADING LIMITED SILDENAFIL GENEPHARM 25 MG CHEWABLE TABLETS SILDENAFIL CITRATE MILLIGRAMMES POM 1

2 PL 39845/ /09/2012 GENEPHARM (EUROPE) TRADING LIMITED SILDENAFIL GENEPHARM 50 MG CHEWABLE TABLETS SILDENAFIL CITRATE MILLIGRAMMES POM PL 39845/ /09/2012 GENEPHARM (EUROPE) TRADING LIMITED SILDENAFIL GENEPHARM 100 MG CHEWABLE TABLETS SILDENAFIL CITRATE MILLIGRAMMES POM PL 00037/ /09/2012 ABBOTT LABORATORIES LIMITED ATYZYO 2.5MG FILM-COATED TABLETS OLANZAPINE 2.5 MILLIGRAMMES POM PL 00037/ /09/2012 ABBOTT LABORATORIES LIMITED ATYZYO 5MG FILM-COATED TABLETS OLANZAPINE 5 MILLIGRAMMES POM PL 00037/ /09/2012 ABBOTT LABORATORIES LIMITED ATYZYO 7.5MG FILM-COATED TABLETS OLANZAPINE 7.5 MILLIGRAMMES POM PL 00037/ /09/2012 ABBOTT LABORATORIES LIMITED ATYZYO 10MG FILM-COATED TABLETS OLANZAPINE 10 MILLIGRAMMES POM PL 04416/ /09/2012 SANDOZ LIMITED CAREXIL 40MG PROLONGED-RELEASE TABLETS OXYCODONE HYDROCHLORIDE 40.0 MILLIGRAMMES POM PL 04416/ /09/2012 SANDOZ LIMITED CAREXIL 80MG PROLONGED-RELEASE TABLETS OXYCODONE HYDROCHLORIDE 80.0 MILLIGRAMMES POM PL 16363/ /09/2012 MILPHARM LIMITED FLECAINIDE ACETATE 50MG TABLETS FLECAINIDE ACETATE MILLIGRAMMES POM PL 16363/ /09/2012 MILPHARM LIMITED FLECAINIDE ACETATE 100MG TABLETS FLECAINIDE ACETATE 100 MILLIGRAMMES POM PL 21341/ /09/2012 SUCAMPO PHARMA EUROPE LIMITED AMITIZA 24 MICROGRAM SOFT CAPSULES LUBIPROSTONE 24 MICROGRAMMES POM PL 39699/ /09/2012 ASPEN PHARMA TRADING LIMITED OLANZAPINE 5MG ORODISPERSIBLE TABLETS OLANZAPINE 5.00 MILLIGRAMMES POM PL 39699/ /09/2012 ASPEN PHARMA TRADING LIMITED OLANZAPINE 10MG ORODISPERSIBLE TABLETS OLANZAPINE MILLIGRAMMES POM PL 39699/ /09/2012 ASPEN PHARMA TRADING LIMITED OLANZAPINE 15MG ORODISPERSIBLE TABLETS OLANZAPINE MILLIGRAMMES POM PL 39699/ /09/2012 ASPEN PHARMA TRADING LIMITED OLANZAPINE 20MG ORODISPERSIBLE TABLETS OLANZAPINE MILLIGRAMMES POM PL 00057/ /09/2012 PFIZER LIMITED DOCETAXEL PFIZER 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION DOCETAXEL ANHYDROUS 10 MILLIGRAMMES PER MILLILITRE POM PL 20658/ /09/2012 TORRENT PHARMA GMBH RISPERIDONE 0.5 MG FILM-COATED TABLETS RISPERIDONE MILLIGRAMMES POM PL 20658/ /09/2012 TORRENT PHARMA GMBH RISPERIDONE 1 MG FILM-COATED TABLETS RISPERIDONE MILLIGRAMMES POM PL 20658/ /09/2012 TORRENT PHARMA GMBH RISPERIDONE 2 MG FILM-COATED TABLETS RISPERIDONE MILLIGRAMMES POM PL 20658/ /09/2012 TORRENT PHARMA GMBH RISPERIDONE 3MG FILM-COATED TABLETS RISPERIDONE MILLIGRAMMES POM PL 20658/ /09/2012 TORRENT PHARMA GMBH RISPERIDONE 4 MG FILM-COATED TABLETS RISPERIDONE MILLIGRAMMES POM PL 20658/ /09/2012 TORRENT PHARMA GMBH RISPERIDONE 6 MG FILM-COATED TABLETS RISPERIDONE MILLIGRAMMES POM 2

3 PL 25298/ /09/2012 BROWN & BURK UK LIMITED CYCLIZINE HYDROCHLORIDE 50 MG TABLETS CYCLIZINE HYDROCHLORIDE MILLIGRAMMES P PL 16363/ /09/2012 MILPHARM LIMITED IRBESARTAN AND HYDROCHLOROTHIAZIDE MILPHARM 150 MG/ 12.5 MG FILM-COATED TABLETHYDROCHLOROTHIAZIDE 12.5 MILLIGRAMMES POM PL 16363/ /09/2012 MILPHARM LIMITED IRBESARTAN AND HYDROCHLOROTHIAZIDE MILPHARM 150 MG/ 12.5 MG FILM-COATED TABLETIRBESARTAN 150 MILLIGRAMMES POM PL 16363/ /09/2012 MILPHARM LIMITED IRBESARTAN AND HYDROCHLOROTHIAZIDE MILPHARM 300 MG/ 12.5 MG FILM-COATED TABLETHYDROCHLOROTHIAZIDE 12.5 MILLIGRAMMES POM PL 16363/ /09/2012 MILPHARM LIMITED IRBESARTAN AND HYDROCHLOROTHIAZIDE MILPHARM 300 MG/ 12.5 MG FILM-COATED TABLETIRBESARTAN 300 MILLIGRAMMES POM PL 16363/ /09/2012 MILPHARM LIMITED IRBESARTAN AND HYDROCHLOROTHIAZIDE MILPHARM 300 MG/ 25 MG FILM-COATED TABLETS HYDROCHLOROTHIAZIDE 25 MILLIGRAMMES POM PL 16363/ /09/2012 MILPHARM LIMITED IRBESARTAN AND HYDROCHLOROTHIAZIDE MILPHARM 300 MG/ 25 MG FILM-COATED TABLETS IRBESARTAN 300 MILLIGRAMMES POM PL 16363/ /09/2012 MILPHARM LIMITED RIZATRIPTAN 10 MG ORODISPERSIBLE TABLETS RIZATRIPTAN BENZOATE MILLIGRAMMES POM PL 20620/ /09/2012 NRIM LIMITED LYMECYCLINE 408MG CAPSULES LYMECYCLINE MILLIGRAMMES POM PL 00057/ /09/2012 PFIZER LIMITED CISATRACURIUM 2 MG/ML SOLUTION FOR INJECTION/INFUSION CISATRACURIUM BESILATE 2.68 MILLIGRAMMES PER MILLILITRE POM PL 27583/ /09/2012 APOTEX EUROPE BV TOLOTEX XL 2 MG PROLONGED-RELEASE CAPSULES TOLTERODINE L-TARTRATE 2 MILLIGRAMMES POM PL 27583/ /09/2012 APOTEX EUROPE BV TOLOTEX XL 4 MG PROLONGED-RELEASE CAPSULES TOLTERODINE L-TARTRATE 4.00 MILLIGRAMMES POM PL 00289/ /09/2012 TEVA UK LIMITED CARBOCISTEINE 375 MG CAPSULES, HARD CARBOCISTEINE MILLIGRAMMES POM PL 04569/ /09/2012 GENERICS (UK) LIMITED LANSOPRAZOLE 15 MG ORODISPERSIBLE TABLETS LANSOPRAZOLE MILLIGRAMMES POM PL 04569/ /09/2012 GENERICS (UK) LIMITED LANSOPRAZOLE 30 MG ORODISPERSIBLE TABLETS LANSOPRAZOLE MILLIGRAMMES POM PL 17507/ /09/2012 AUDEN MCKENZIE LIMITED AUDAVATE 0.1% W/W OINTMENT BETAMETHASONE VALERATE PERCENT WEIGHT IN WEIGHT POM PL 17507/ /09/2012 AUDEN MCKENZIE LIMITED AUDAVATE RD 0.025% W/W CREAM BETAMETHASONE VALERATE PERCENT WEIGHT IN WEIGHT POM PL 17507/ /09/2012 AUDEN MCKENZIE LIMITED AUDAVATE RD 0.025% W/W OINTMENT BETAMETHASONE VALERATE PERCENT WEIGHT IN WEIGHT POM PL 00037/ /09/2012 ABBOTT LABORATORIES LIMITED RESYMTIA 1.5 MG HARD CAPSULES RIVASTIGMINE TARTRATE 2.4 MILLIGRAMMES POM PL 00037/ /09/2012 ABBOTT LABORATORIES LIMITED RESYMTIA 3.0 MG HARD CAPSULES RIVASTIGMINE TARTRATE 4.8 MILLIGRAMMES POM PL 00037/ /09/2012 ABBOTT LABORATORIES LIMITED RESYMTIA 4.5 MG HARD CAPSULES RIVASTIGMINE TARTRATE 7.2 MILLIGRAMMES POM PL 00037/ /09/2012 ABBOTT LABORATORIES LIMITED RESYMTIA 6.0 MG HARD CAPSULES RIVASTIGMINE TARTRATE 9.6 MILLIGRAMMES POM 3

4 PL 12063/ /09/2012 WRAFTON LABORATORIES LIMITED PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HYDROCHLORIDE 500MG/200MG/10MGUAIFENESIN MILLIGRAMMES GSL PL 12063/ /09/2012 WRAFTON LABORATORIES LIMITED PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HYDROCHLORIDE 500MG/200MG/10MPARACETAMOL MILLIGRAMMES GSL PL 12063/ /09/2012 WRAFTON LABORATORIES LIMITED PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HYDROCHLORIDE 500MG/200MG/10MPHENYLEPHRINE HYDROCHLORIDE MILLIGRAMMES GSL PL 20162/ /09/2012 LABORATOIRES THEA DEXAFREE 1 MG/ML, EYE DROPS, SOLUTION DEXAMETHASONE SODIUM PHOSPHATE MILLIGRAMMES POM PL 35533/ /09/2012 ASPIRE PHARMA LIMITED AZITHROMYCIN 500 MG POWDER FOR SOLUTION FOR INFUSION AZITHROMYCIN DIHYDRATE MILLIGRAMMES POM PL 40378/ /09/2012 APTIL PHARMA LIMITED ANASTROZOLE 1 MG FILM-COATED TABLETS ANASTROZOLE 1.00 MILLIGRAMMES POM PL 40378/ /09/2012 APTIL PHARMA LIMITED FINASTERIDE 5 MG FILM-COATED TABLETS FINASTERIDE 5.00 MILLIGRAMMES POM PL 31625/ /09/2012 EFFIK DEBUNICA 75 MICROGRAM FILM-COATED TABLETS DESOGESTREL MILLIGRAMMES POM PL 34518/ /09/2012 LABORATORIOS LEON FARMA SA DESOGESTREL 75 MICROGRAM FILM-COATED TABLETS DESOGESTREL MILLIGRAMMES POM PL 34518/ /09/2012 LABORATORIOS LEON FARMA SA DELIGES 75 MICROGRAM FILM-COATED TABLETS DESOGESTREL MILLIGRAMMES POM PL 34518/ /09/2012 LABORATORIOS LEON FARMA SA GRYSTELLA 75 MICROGRAM FILM-COATED TABLETS DESOGESTREL MILLIGRAMMES POM PL 34518/ /09/2012 LABORATORIOS LEON FARMA SA GRYSTELLA 75MICROGRAM FILM-COATED TABLETS DESOGESTREL MILLIGRAMMES POM PL 17277/ /09/2012 PHARMATHEN SA GALANTEX XL 8 MG PROLONGED RELEASE CAPSULES, HARD GALANTAMINE HYDROBROMIDE MILLIGRAMMES POM PL 17277/ /09/2012 PHARMATHEN SA GALANTEX XL 16 MG PROLONGED RELEASE CAPSULES, HARD GALANTAMINE HYDROBROMIDE MILLIGRAMMES POM PL 17277/ /09/2012 PHARMATHEN SA GALANTEX XL 24 MG PROLONGED RELEASE CAPSULES, HARD GALANTAMINE HYDROBROMIDE MILLIGRAMMES POM PL 25298/ /09/2012 BROWN & BURK UK LIMITED LEVOCETIRIZINE DIHYDROCHLORIDE 5MG FILM-COATED TABLET LEVOCETIRIZINE DIHYDROCHLORIDE 5.0 MILLIGRAMMES POM PL 30306/ /09/2012 ACTAVIS GROUP PTC EHF LOTPROSIN XL 8MG PROLONGED-RELEASE CAPSULES, HARD GALANTAMINE HYDROBROMIDE MILLIGRAMMES POM PL 30306/ /09/2012 ACTAVIS GROUP PTC EHF LOTPROSIN XL 16MG PROLONGED RELEASE CAPSULES, HARD GALANTAMINE HYDROBROMIDE MILLIGRAMMES POM PL 30306/ /09/2012 ACTAVIS GROUP PTC EHF LOTPROSIN XL 24MG PROLONGED RELEASE CAPSULES, HARD GALANTAMINE HYDROBROMIDE MILLIGRAMMES POM PL 30306/ /09/2012 ACTAVIS GROUP PTC EHF AZITHROMYCIN 250MG FILM COATED TABLETS AZITHROMYCIN DIHYDRATE MILLIGRAMMES POM PL 30306/ /09/2012 ACTAVIS GROUP PTC EHF AZITHROMYCIN 500MG FILM-COATED TABLETS AZITHROMYCIN DIHYDRATE MILLIGRAMMES POM PL 04569/ /09/2012 GENERICS (UK) LIMITED ATOVAQUONE/PROGUANIL HYDROCHLORIDE 250MG/ 100MG FILM-COATED TABLETS ATOVAQUONE 250 MILLIGRAMMES POM 4

5 PL 04569/ /09/2012 GENERICS (UK) LIMITED ATOVAQUONE/PROGUANIL HYDROCHLORIDE 250MG/ 100MG FILM-COATED TABLETS PROGUANIL HYDROCHLORIDE 100 MILLIGRAMMES POM PL 00057/ /09/2012 PFIZER LIMITED IRBESARTAN AND HYDROCHLOROTHIAZIDE PFIZER 150 MG/12.5 MG FILM-COATED TABLETS HYDROCHLOROTHIAZIDE 12.5 MILLIGRAMMES POM PL 00057/ /09/2012 PFIZER LIMITED IRBESARTAN AND HYDROCHLOROTHIAZIDE PFIZER 150 MG/12.5 MG FILM-COATED TABLETS IRBESARTAN 150 MILLIGRAMMES POM PL 00057/ /09/2012 PFIZER LIMITED IRBESARTAN AND HYDROCHLOROTHIAZIDE PFIZER 300 MG/12.5 MG FILM-COATED TABLETS HYDROCHLOROTHIAZIDE 12.5 MILLIGRAMMES POM PL 00057/ /09/2012 PFIZER LIMITED IRBESARTAN AND HYDROCHLOROTHIAZIDE PFIZER 300 MG/12.5 MG FILM-COATED TABLETS IRBESARTAN 300 MILLIGRAMMES POM PL 00057/ /09/2012 PFIZER LIMITED IRBESARTAN AND HYDROCHLOROTHIAZIDE PFIZER 300 MG/25 MG FILM-COATED TABLETS HYDROCHLOROTHIAZIDE 25 MILLIGRAMMES POM PL 00057/ /09/2012 PFIZER LIMITED IRBESARTAN AND HYDROCHLOROTHIAZIDE PFIZER 300 MG/25 MG FILM-COATED TABLETS IRBESARTAN 300 MILLIGRAMMES POM PL 00057/ /09/2012 PFIZER LIMITED PRAVASTATIN SODIUM 10 MG TABLETS PRAVASTATIN SODIUM 10 MILLIGRAMMES POM PL 00057/ /09/2012 PFIZER LIMITED PRAVASTATIN SODIUM 20 MG TABLETS PRAVASTATIN SODIUM 20 MILLIGRAMMES POM PL 00057/ /09/2012 PFIZER LIMITED PRAVASTATIN SODIUM 40 MG TABLETS PRAVASTATIN SODIUM 40 MILLIGRAMMES POM PL 16363/ /09/2012 MILPHARM LIMITED PRAVASTATIN SODIUM 10 MG TABLETS PRAVASTATIN SODIUM MILLIGRAMMES POM PL 16363/ /09/2012 MILPHARM LIMITED PRAVASTATIN SODIUM 20 MG TABLETS PRAVASTATIN SODIUM MILLIGRAMMES POM PL 16363/ /09/2012 MILPHARM LIMITED PRAVASTATIN SODIUM 40 MG TABLETS PRAVASTATIN SODIUM MILLIGRAMMES POM PL 35533/ /09/2012 ASPIRE PHARMA LIMITED GATALIN XL 8 MG PROLONGED RELEASE CAPSULES, HARD GALANTAMINE HYDROBROMIDE MILLIGRAMMES POM PL 35533/ /09/2012 ASPIRE PHARMA LIMITED GATALIN XL 16 MG PROLONGED RELEASE CAPSULES, HARD GALANTAMINE HYDROBROMIDE MILLIGRAMMES POM PL 35533/ /09/2012 ASPIRE PHARMA LIMITED GATALIN XL 24 MG PROLONGED RELEASE CAPSULES, HARD GALANTAMINE HYDROBROMIDE MILLIGRAMMES POM PL 40129/ /09/2012 RADIOPHARMACY LABORATORIUM KFT MEDI-EXAMETAZIME 500 MCG KIT FOR RADIOPHARMACEUTICAL PREPARATION EXAMETAZIME 0.50 MILLIGRAMMES POM PL 00156/ /09/2012 MARTINDALE PHARMACEUTICALS LIMITED DIPYRIDAMOLE 100MG/5ML ORAL SUSPENSION DIPYRIDAMOLE 20 MILLIGRAMMES PER MILLILITRE POM PL 31745/ /09/2012 IBIGEN SRL CLARITHROMYCIN 500 MG POWDER FOR SOLUTION FOR INFUSION CLARITHROMYCIN MILLIGRAMMES POM PL 06464/ /09/2012 WAYMADE PLC HYDROCORTISONE 10 MG TABLETS HYDROCORTISONE 10 MILLIGRAMMES POM PL 31774/ /09/2012 BLUEFISH PHARMACEUTICALS AB IRBESARTAN BLUEFISH 75 MG FILM-COATED TABLETS IRBESARTAN 75.0 MILLIGRAMMES POM PL 31774/ /09/2012 BLUEFISH PHARMACEUTICALS AB IRBESARTAN BLUEFISH 150 MG FILM-COATED TABLETS IRBESARTAN 150 MILLIGRAMMES POM 5

6 PL 31774/ /09/2012 BLUEFISH PHARMACEUTICALS AB IRBESARTAN BLUEFISH 300 MG FILM-COATED TABLETS. IRBESARTAN 300 MILLIGRAMMES POM PL 17907/ /09/2012 BRISTOL LABORATORIES LIMITED LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG FILM-COATED TABLETS LEVOCETIRIZINE DIHYDROCHLORIDE 5.00 MILLIGRAMMES POM 6

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