Parallel Import (PI) Licences Granted in September 2016

Parallel Import (PI) Licences Granted in September 2016

Parallel import (PI) licences granted in September 2016 PL Number Grant Date Licence Holder Licensed Name(s) Active Ingredient Quantity Units Legal Status* PLPI 10383/2185 01/09/2016 PRIMECROWN LIMITED CAMPRAL EC ACAMPROSATE CALCIUM 333 MILLIGRAMMES POM PLPI 10383/2194 01/09/2016 PRIMECROWN LIMITED CELECTOL 400MG TABLETS/ CELIPROLOL HYDROCHLORIDE 400MG TABLETS CELIPROLOL HYDROCHLORIDE 400.000 MILLIGRAMMES POM PLPI 15184/1617 01/09/2016 LEXON (UK) LIMITED MIRENA 20 MICROGRAMS/24 HOURS INTRAUTERINE DELIVERY SYSTEM LEVONORGESTREL 52.000 MILLIGRAMMES POM PLPI 15184/1662 01/09/2016 LEXON (UK) LIMITED TRANSTEC 35 MICROGRAMS-H TRANSDERMAL PATCH BUPRENORPHINE 20.000 MILLIGRAMMES POM PLPI 15184/1675 01/09/2016 LEXON (UK) LIMITED CHLORTALIDONE 50MG TABLETS CHLORTALIDONE 50.000 MILLIGRAMMES POM PLPI 16369/1693 01/09/2016 G-PHARMA LIMITED FUCITHALMIC 1% W/W VISCOUS EYE DROPS FUSIDIC ACID 10.000 MILLIGRAMMES PER GRAM POM PLPI 16369/1693 01/09/2016 G-PHARMA LIMITED FUSIDIC ACID 1% W/W VISCOUS EYE DROPS FUSIDIC ACID 10.000 MILLIGRAMMES PER GRAM POM PLPI 22961/0159 01/09/2016 EXPONO LIMITED DOSTINEX 0.5 MG TABLETS / CABERGOLINE 0.5 MG TABLETS CABERGOLINE 0.500 MILLIGRAMMES POM PLPI 27777/0019 01/09/2016 VITAL SUPPLIES (UK) LIMITED SPIOLTO RESPIMAT 2.5 MICROGRAM/2.5 MICROGRAM, INHALATION SOLUTION OLODATEROL HYDROCHLORIDE 2.7 MICROGRAMMES POM PLPI 27777/0019 01/09/2016 VITAL SUPPLIES (UK) LIMITED SPIOLTO RESPIMAT 2.5 MICROGRAM/2.5 MICROGRAM, INHALATION SOLUTION TIOTROPIUM BROMIDE MONOHYDRATE 3.1 MICROGRAMMES POM PLPI 33532/0713 01/09/2016 MPT PHARMA LIMITED CREON 25000 CAPSULES PANCREATIN 300.000 MILLIGRAMMES POM PLPI 33532/0716 01/09/2016 MPT PHARMA LIMITED FLORINEF 0.1MG TABLETS FLUDROCORTISONE ACETATE 0.1 MILLIGRAMMES POM PLPI 33532/0716 01/09/2016 MPT PHARMA LIMITED FLUDROCORTISONE ACETATE 0.1MG TABLETS FLUDROCORTISONE ACETATE 0.1 MILLIGRAMMES POM PLPI 33532/0717 01/09/2016 MPT PHARMA LIMITED CRESTOR 5MG FILM-COATED TABLETS ROSUVASTATIN 5 MILLIGRAMMES POM PLPI 33532/0717 01/09/2016 MPT PHARMA LIMITED ROSUVASTATIN 5MG FILM-COATED TABLETS ROSUVASTATIN 5 MILLIGRAMMES POM PLPI 40593/0028 01/09/2016 SHAKESPEARE PHARMA LIMITED METHOTREXATE 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METHOTREXATE 7.5 MILLIGRAMMES POM PLPI 40593/0028 01/09/2016 SHAKESPEARE PHARMA LIMITED METOJECT PEN 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METHOTREXATE 7.5 MILLIGRAMMES POM PLPI 40593/0029 01/09/2016 SHAKESPEARE PHARMA LIMITED METHOTREXATE 15 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METHOTREXATE 15.00 MILLIGRAMMES POM PLPI 40593/0029 01/09/2016 SHAKESPEARE PHARMA LIMITED METOJECT PEN 15 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METHOTREXATE 15.00 MILLIGRAMMES POM PLPI 40593/0030 01/09/2016 SHAKESPEARE PHARMA LIMITED METHOTREXATE 20 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METHOTREXATE 20.00 MILLIGRAMMES POM PLPI 40593/0030 01/09/2016 SHAKESPEARE PHARMA LIMITED METOJECT PEN 20 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METHOTREXATE 20.00 MILLIGRAMMES POM PLPI 19065/0523 02/09/2016 ECOSSE PHARMACEUTICALS LIMITED FLUTIFORM 250 MICROGRAM/10 MICROGRAM PER ACUTATION PRESSURISED INHALATION, SUSPENSION FLUTICASONE PROPIONATE 0.25 MILLIGRAMMES POM PLPI 19065/0523 02/09/2016 ECOSSE PHARMACEUTICALS LIMITED FLUTIFORM 250 MICROGRAM/10 MICROGRAM PER ACUTATION PRESSURISED INHALATION, SUSPENSION FORMOTEROL FUMARATE DIHYDRATE 0.01 MILLIGRAMMES POM PLPI 20492/0515 02/09/2016 CD PHARMA LIMITED ACTIQ 400 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR FENTANYL CITRATE 628.4 MICROGRAMMES POM PLPI 20636/2787 02/09/2016 STAR PHARMACEUTICALS LIMITED MOMETASONE FUROATE 50 MICROGRAMS/ACTUATION NASAL SPRAY, SUSPENSION MOMETASONE FUROATE 50 MICROGRAMMES PER ACTUATION POM PLPI 20636/2787 02/09/2016 STAR PHARMACEUTICALS LIMITED NASONEX 50 MICROGRAMS/ACTUATION NASAL SPRAY, SUSPENSION MOMETASONE FUROATE 50 MICROGRAMMES PER ACTUATION POM PLPI 10383/2189 07/09/2016 PRIMECROWN LIMITED HALF SINEMET CR 25MG/100MG PROLONGED-RELEASE TABLETS CARBIDOPA ANHYDROUS 25.00 MILLIGRAMMES POM PLPI 10383/2189 07/09/2016 PRIMECROWN LIMITED HALF SINEMET CR 25MG/100MG PROLONGED-RELEASE TABLETS LEVODOPA 100.00 MILLIGRAMMES POM PLPI 15184/1665 07/09/2016 LEXON (UK) LIMITED ACTIQ 200 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR FENTANYL 200 MICROGRAMMES POM PLPI 15184/1669 07/09/2016 LEXON (UK) LIMITED GANCICLOVIR 0.15% W/W EYE GEL GANCICLOVIR 1.5 MILLIGRAMMES POM PLPI 15184/1669 07/09/2016 LEXON (UK) LIMITED VIRGAN 0.15% W/W EYE GEL GANCICLOVIR 1.5 MILLIGRAMMES POM PLPI 19488/1796 07/09/2016 S AND M MEDICAL LIMITED METEX PEN 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METHOTREXATE 7.5 MILLIGRAMMES POM * POM = Prescription Only Medicine 1 P = Pharmacy G = General Sale List Parallel import (PI) licences granted in September 2016 PL Number Grant Date Licence Holder Licensed Name(s) Active Ingredient Quantity Units Legal Status* PLPI 19488/1796 07/09/2016 S AND M MEDICAL LIMITED METHOTREXATE 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METHOTREXATE 7.5 MILLIGRAMMES POM PLPI 19488/1796 07/09/2016 S AND M MEDICAL LIMITED METOJECT PEN 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METHOTREXATE 7.5 MILLIGRAMMES POM PLPI 20636/2769 07/09/2016 STAR PHARMACEUTICALS LIMITED MATORIDE XL 36 MG PROLONGED-RELEASE TABLETS METHYLPHENIDATE HYDROCHLORIDE 36.000 MILLIGRAMMES POM PLPI 20636/2893 07/09/2016 STAR PHARMACEUTICALS LIMITED CELECTOL 200 MG TABLETS CELIPROLOL HYDROCHLORIDE 200 MILLIGRAMMES POM PLPI 20636/2893 07/09/2016 STAR PHARMACEUTICALS LIMITED CELIPROLOL HYDROCHLORIDE 200 MG TABLETS CELIPROLOL HYDROCHLORIDE 200 MILLIGRAMMES POM PLPI 20636/2897 07/09/2016 STAR PHARMACEUTICALS LIMITED DESMOMELT 120 MICROGRAMS ORAL LYOPHILISATE DESMOPRESSIN ACETATE 135 MICROGRAMMES POM PLPI 20636/2897 07/09/2016 STAR PHARMACEUTICALS LIMITED DESMOPRESSIN 120 MICROGRAMS ORAL LYOPHILISATE DESMOPRESSIN ACETATE 135 MICROGRAMMES POM PLPI 20636/2936 07/09/2016 STAR PHARMACEUTICALS LIMITED HALDOL 5 MG/ML INJECTION HALOPERIDOL 5 MILLIGRAMMES PER MILLILITRE POM PLPI 20636/2936 07/09/2016 STAR PHARMACEUTICALS LIMITED HALOPERIDOL 5 MG/ML INJECTION HALOPERIDOL 5 MILLIGRAMMES PER MILLILITRE POM PLPI 20636/2937 07/09/2016 STAR PHARMACEUTICALS LIMITED HALDOL 5 MG/ML INJECTION HALOPERIDOL 5 MG/ML INJECTION HALOPERIDOL 5 MILLIGRAMMES PER MILLILITRE POM PLPI 21828/0694 07/09/2016 LANDMARK PHARMA LIMITED ACAMPROSATE CALCIUM 333MG GASTRO-RESISTANT TABLETS ACAMPROSATE CALCIUM 333.000 MILLIGRAMMES POM PLPI 21828/0694 07/09/2016 LANDMARK PHARMA LIMITED CAMPRAL EC 333MG GASTRO-RESISTANT TABLETS ACAMPROSATE CALCIUM 333.000 MILLIGRAMMES POM PLPI 33532/0679 07/09/2016 MPT PHARMA LIMITED LEVOMEPROMAZINE HYDROCHLORIDE 25MG/ML SOLUTION FOR INJECTION/INFUSION LEVOMEPROMAZINE HYDROCHLORIDE 25.000 MILLIGRAMMES PER MILLILITRE POM PLPI 33532/0679 07/09/2016 MPT PHARMA LIMITED NOZINAN 25MG/ML SOLUTION FOR INJECTION/INFUSION LEVOMEPROMAZINE HYDROCHLORIDE 25.000 MILLIGRAMMES PER MILLILITRE POM PLPI 33532/0704 07/09/2016 MPT PHARMA LIMITED SERETIDE 500 ACCUHALER FLUTICASONE PROPIONATE MICRONISED 500.000 MICROGRAMMES POM PLPI 33532/0704 07/09/2016 MPT PHARMA LIMITED SERETIDE 500 ACCUHALER SALMETEROL XINAFOATE MICRONISED 72.5 MICROGRAMMES POM PLPI 40593/0047 07/09/2016 SHAKESPEARE PHARMA LIMITED CHLORTALIDONE 50 MG TABLETS CHLORTALIDONE 50.000 MILLIGRAMMES POM PLPI 45233/0016 07/09/2016 ORIGINALIS BV VERSATIS 5% MEDICATED PLASTER LIDOCAINE 700.000 MILLIGRAMMES POM PLPI 19488/1807 08/09/2016 S AND M MEDICAL LIMITED PROVERA 10MG TABLETS MEDROXYPROGESTERONE ACETATE 10.000 MILLIGRAMMES POM PLPI 19488/1810 08/09/2016 S AND M MEDICAL LIMITED ELIDEL 10 MG/G CREAM PIMECROLIMUS 10.000 MILLIGRAMMES PER GRAM POM PLPI 20636/2764 08/09/2016 STAR PHARMACEUTICALS LIMITED CYCLOPHOSPHAMIDE INJECTION 1 G CYCLOPHOSPHAMIDE 1.00 GRAMMES POM PLPI 20636/2764 08/09/2016 STAR PHARMACEUTICALS LIMITED ENDOXANA INJECTION 1 G CYCLOPHOSPHAMIDE 1.00 GRAMMES POM PLPI 20636/2835 08/09/2016 STAR PHARMACEUTICALS LIMITED METEX PEN 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METHOTREXATE 7.50 MILLIGRAMMES POM PLPI 20636/2835 08/09/2016 STAR PHARMACEUTICALS LIMITED METHOTREXATE 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METHOTREXATE 7.50 MILLIGRAMMES POM PLPI 20636/2835 08/09/2016 STAR PHARMACEUTICALS LIMITED METOJECT PEN 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METHOTREXATE 7.50 MILLIGRAMMES POM PLPI 20636/2902 08/09/2016 STAR PHARMACEUTICALS LIMITED PENTASA SLOW RELEASE 500 MG TABLETS MESALAZINE 500 MILLIGRAMMES POM PLPI 20774/1490 08/09/2016 QUADRANT PHARMACEUTICALS LIMITED PULMICORT 200 TURBOHALER BUDESONIDE 200.00 MICROGRAMMES POM PLPI 33532/0682 08/09/2016 MPT PHARMA LIMITED TILDIEM 60MG MODIFIED RELEASE TABLETS DILTIAZEM HYDROCHLORIDE 60 MILLIGRAMMES POM PLPI 33532/0700 08/09/2016 MPT PHARMA LIMITED HUMULIN M3 100 IU-ML SUSPENSION FOR INJECTION IN CARTRIDGE INSULIN ISOPHANE BIPHASIC 100.000 INTERNATIONAL UNITS PER ML POM PLPI 33532/0706 08/09/2016 MPT PHARMA LIMITED FUCITHALMIC 1 % W/W VISCOUS EYE DROPS FUSIDIC ACID 10.000 MILLIGRAMMES PER GRAM POM PLPI 33532/0706 08/09/2016 MPT PHARMA LIMITED FUSIDIC ACID 1 % W/W VISCOUS EYE DROPS FUSIDIC ACID 10.000 MILLIGRAMMES PER GRAM POM PLPI 40739/0095 08/09/2016 ENNOGEN HEALTHCARE LIMITED CYCLIZINE LACTATE 50 MG/ML INJECTION CYCLIZINE LACTATE 50 MILLIGRAMMES PER MILLILITRE POM * POM = Prescription Only Medicine 2 P = Pharmacy G = General Sale List Parallel import (PI) licences granted in September 2016 PL Number Grant Date Licence Holder Licensed Name(s) Active Ingredient Quantity Units Legal Status* PLPI 20492/0530 09/09/2016 CD PHARMA LIMITED DUROGESIC DTRANS 12 MICROGRAMS/HR TRANSDERMAL

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