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Senarai Kelulusan Mesyuarat Pbkd 285 (Produk Quest 2)

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Senarai Kelulusan Mesyuarat Pbkd 285 (Produk Quest 2) SENARAI KELULUSAN MESYUARAT PBKD 285 (PRODUK QUEST 2) 1.SILA SEMAK MAKLUMAT PRODUK, JIKA TERDAPAT SEBARANG KESILAPAN SILA HUBUNGI SEKSYEN KOORDINASI REGULATORI 2.Sebarang kesilapan (jika ada) sila maklumkan dalam tempoh DUA minggu daripada tarikh Mesyuarat PBKD. Jika tiada sebarang aduan kesilapan diterima dalam tempoh tersebut, maklumat-maklumat ini akan dianggap sebagai betul. Sebarang aduan selepas tempoh tersebut TIDAKAKAN DILAYAN. 3.Pihak tuan perlu memohon Sijil Indikasi bagi tujuan Iklan. 4.Sila ambil maklum bahawa sekiranya produk tuan telah diluluskan, sila berurusan terus dengan Bahagian APB & Perlesenan untuk tujuan permohonan lesen, memandangkan surat kelulusan TIDAK AKAN dikeluarkan. 5.Jika terdapat kesilapan pada maklumat produk, sila nyatakan dengan jelas perkara-perkara berikut: 1. Nama Produk 2. No. LOI 3. No. Pendaftaran Produk 4.No. Mesyuarat PBKD 5. Maklumat yang sebenar : a. Nama Produk b. Nama & Alamat Pemegang c. Nama & Alamat Pengilang 6.LESEN MENGILANG: A.BAGI PRODUK YANG DIKILANGKAN DI MALAYSIA, PENGILANGAN PRODUK TERSEBUT BOLEH DILAKUKAN HANYA SETELAH NAMA PRODUK DISENARAIKAN DI DALAM LESEN PENGILANG. B.SILA HUBUNGI BAHAGIAN APB & PERLESENAN BAGI TUJUAN PERMOHONAN LESEN MENGILANG 7.LESEN MENGIMPORT: A.BAGI PRODUK YANG DIIMPORT, SILA PASTIKAN SEBELUM PRODUK DIBAWA MASUK KE DALAM MALAYSIA, NAMA PRODUK TERSEBUT MESTILAH DISENARAIKAN DI DALAM LESEN MENGIMPORT TERLEBIH DAHULU. B.SILA HUBUNGI BAHAGIAN APB & PERLESENAN BAGI TUJUAN PERMOHONAN LESEN MENGIMPORT (PIHAK TUAN PERLU PASTIKAN E-MAIL TERSEBUT BOLEH MENERIMA FORMAT HTML) 8.LESEN MENGILANG: A.BAGI PRODUK YANG DIKILANGKAN DI MALAYSIA, PENGILANGAN PRODUK TERSEBUT BOLEH DILAKUKAN HANYA SETELAH NAMA PRODUK DISENARAIKAN DI DALAM LESEN PENGILANG. B.SILA HUBUNGI BAHAGIAN APB & PERLESENAN BAGI TUJUAN PERMOHONAN LESEN MENGILANG 9.LESEN MENGIMPORT: A.BAGI PRODUK YANG DIIMPORT, SILA PASTIKAN SEBELUM PRODUK DIBAWA MASUK KE DALAM MALAYSIA, NAMA PRODUK TERSEBUT MESTILAH DISENARAIKAN DI DALAM LESEN MENGIMPORT TERLEBIH DAHULU. B.SILA HUBUNGI BAHAGIAN APB & PERLESENAN BAGI TUJUAN PERMOHONAN LESEN MENGIMPORT BPFK Rep.Id REG20 Tarikh Mesyuarat : 27/02/2015 Bil NO. RUJUKAN NAMA KELUARAN : NAMA PEMEGANG : NAMA PENGILANG : No.Mesy Trkh Sah Pendaftaran NO. (Status Keluaran) PENDAFTARAN ALAMAT: ALAMAT: GUARANA 500MG VEGICAP 21ST CENTURY PRODUCTS 21ST CENTURY 1 1999114010T 285 Pendaftaran Semula CAPSULE SDN. BHD. LABORATORIES, INC. 2445 W,12TH STREET, UNIT MAL20001368TR NO. 9, JALAN SS 13/6A 2015-07-30 --- 2020-07-30 2, TEMPE, ARIZONA 85281 139274 47500 SUBANG JAYA 21ST CENTURY PRODUCTS 21ST CENTURY 2 2004040642133 Guggul 500 mg Plus 285 Pendaftaran Semula SDN. BHD. LABORATORIES, INC. 2445 W,12TH STREET, UNIT MAL05051088TR NO. 9, JALAN SS 13/6A 2015-05-28 --- 2020-05-28 2, TEMPE, ARIZONA 85281 121503 47500 SUBANG JAYA A. MENARINI SINGAPORE Legacy Pharmaceutical 3 1989040309X SOLCOSERYL JELLY 285 Pendaftaran Semula PTE. LTD. Switzerland GmbH LEVEL 2, NO. 10, JALAN MAL19912930XC Ruhrbergstrasse 21 2015-07-03 --- 2020-07-03 BERSATU 13/4 126774 46200 PETALING JAYA CH-4127 Birsfelden Kaletra 100mg/25mg Film- AbbVie Deutschland GmbH & Co. 4 2008092970027 ABBVIE SDN BHD 285 Pendaftaran Semula Coated Tablet KG NO. 24, JALAN PEMAJU U1/15, SEKSYEN U1,HICOM- MAL10063000A Knoll Strasse 2015-06-25 --- 2020-06-25 GLENMARIE INDUSTRIAL PARK 220544 40150 SHAH ALAM 67061 Ludwigshafen0 ACE HEALTH PRODUCTS ACE HEALTH PRODUCTS SDN. 5 2004080580059 CordyMax Capsule 500mg 285 Pendaftaran Semula SDN. BHD. BHD. 1, JALAN P2/16, SEKSYEN 2 1, JALAN P2/16, SEKSYEN 2 MAL05032677T BANDAR TEKNOLOGI 2015-03-23 --- 2020-03-23 BANDAR TEKNOLOGI KAJANG KAJANG 113826 43500 SEMENYIH 43500 SEMENYIH ACE HEALTH PRODUCTS ACE HEALTH PRODUCTS SDN. 6 2004092292776 40 Plus 285 Pendaftaran Semula SDN. BHD. BHD. 1, JALAN P2/16, SEKSYEN 2 1, JALAN P2/16, SEKSYEN 2 MAL05041919T BANDAR TEKNOLOGI 2015-04-30 --- 2020-04-30 BANDAR TEKNOLOGI KAJANG KAJANG 117965 43500 SEMENYIH 43500 SEMENYIH ACE HEALTH PRODUCTS ACE HEALTH PRODUCTS SDN. 7 20040447443T PHYTOFEM 285 Pendaftaran Semula SDN. BHD. BHD. 1, JALAN P2/16, SEKSYEN 2 1, JALAN P2/16, SEKSYEN 2 MAL20041017TE BANDAR TEKNOLOGI 2014-08-08 --- 2019-08-08 BANDAR TEKNOLOGI KAJANG KAJANG 73181 43500 SEMENYIH 43500 SEMENYIH ACE HEALTH PRODUCTS ACE HEALTH PRODUCTS SDN. 8 20040449673T BIO-MAN 285 Pendaftaran Semula SDN. BHD. BHD. 1, JALAN P2/16, SEKSYEN 2 1, JALAN P2/16, SEKSYEN 2 MAL20041195TE BANDAR TEKNOLOGI 2014-10-17 --- 2019-10-17 BANDAR TEKNOLOGI KAJANG KAJANG 85104 43500 SEMENYIH 43500 SEMENYIH ACE HEALTH PRODUCTS ACE HEALTH PRODUCTS SDN. 9 20040447441T TRIMMBELLE 285 Pendaftaran Semula SDN. BHD. BHD. 1, JALAN P2/16, SEKSYEN 2 1, JALAN P2/16, SEKSYEN 2 MAL20041194TE BANDAR TEKNOLOGI 2014-10-17 --- 2019-10-17 BANDAR TEKNOLOGI KAJANG KAJANG 85207 43500 SEMENYIH 43500 SEMENYIH 10 2009082673990 Oseltamivir Capsule 75 mg ACTAVIS SDN BHD STRIDES ARCOLAB LTD 285 Pendaftaran Semula SITE NO.36/7,SURAGAJA 304,Level 3,Uptown 2 2,Jalan MAL09111816A KKANAHALLI,INDLAVADI 2014-11-18 --- 2019-11-18 SS21/37, Damansara Uptown, CROSS,ANEKAL TALUK 218855 47400 Petaling Jaya BANGALORE INFUSOL FS (Sodium 11 2009110804526 Chloride 0.225% w/v AIN MEDICARE SDN. BHD. AIN MEDICARE SDN BHD 285 Pendaftaran Semula Intravenous Infusion BP) JALAN 6/44 KAW. LOT 4933 & 4934, JALAN 6/44, MAL10070594X PERINDUSTRIAN KAWASAN PERINDUSTRIAN 2015-07-30 --- 2020-07-30 PENGKALAN CHEPA 2 PENGKALAN CHEPA 2 220646 16100 PENGKALAN CHEPA 16100 PENGKALAN CHEPA SABIT BANANI INDUSTRIES 12 2009102800758 JAMU SERI BONDA AKID Q HERBS INDUSTRY 285 Pendaftaran Semula SDN BHD NO. BT 4 & 5, KAWASAN LOT 286, TAMAN KOTA VILLE INDUSTRI MARA, FASA 2, MAL10043746TC 2015-04-30 --- 2020-04-30 INDAH, DUSUN LANGGAR JALAN PADANG TEMBAK, PENGKALAN CHEPA, 219492 16250 WAKAF BHARU 16100 KOTA BHARU TIMOLAST 0.5% (Timolol ALCON LABORATORIES 13 2004022727956 Maleate) Ophthalmic Gel ALCON LABORATORIES INC. 285 Pendaftaran Semula (MALAYSIA) SDN. BHD. Forming Solution NO. 1001A & 1001D, 9TH FLOOR WISMA GLOMAC 3 MAL05061506A KOMPLEKS KELANA 6201, SOUTH FREEWAY 2015-07-02 --- 2020-07-02 CENTRE POINT NO. 3, JALAN SS7/19, KELANA JAYA 127245 47301 PETALING JAYA 76134 FORT WORTH ALPHAGAN OPHTHALMIC ALLERGAN 14 1997040827A Allergan Malaysia Sdn Bhd 285 Pendaftaran Semula SOLUTION 0.2% PHARMACEUTICALS IRELAND Level 5-02, Block A, PJ8, CASTLEBAR ROAD MAL20001013A 2015-05-28 --- 2020-05-28 No.23, Jalan Barat, Seksyen 8, WESTPORT COUNTY MAYO 108826 46050 Petaling Jaya Alphagan P Ophthalmic 15 2003082630211 Allergan Malaysia Sdn Bhd Allergan Sales, LLC 285 Pendaftaran Semula Solution 0.15 % Level 5-02, Block A, PJ8, MAL05041841A WACO, TEXAS 76712, U.S.A 2015-04-30 --- 2020-04-30 No.23, Jalan Barat, Seksyen 8, 117968 46050 Petaling Jaya nil Waco, ALWAYS GREEN PHARMA 16 2003070061T BIO WEI TUNG LING PB Natur Sdn. Bhd. 285 Pendaftaran Semula SDN. BHD. NO. 13, JALAN KIP 10 NO. 13, JALAN KIP 10, TAMAN MAL20051319T TAMAN PERINDUSTRIAN KIP 2015-02-03 --- 2020-02-03 PERINDUSTRIAN KIP KEPONG 109087 52200 KUALA LUMPUR 52200 KEPONG PHARMAZEUTISCHE FABRIK 17 2004062266136 Eucarbon Herbal Tablet 500mg ANTAH PHARMA SDN. BHD. 285 Pendaftaran Semula MONTAVIT GesmbH MAL05072134TCR *NO. 3, JALAN 19/1 SALZBERGSTRAße 96 A-6060 2015-07-30 --- 2020-07-30 127161 46300 PETALING JAYA 0 0 EASY PLUS RAINFOREST HERBS ASIA BOTANICALS SDN. 18 2004090186827 PHARMACEUTICAL (M) SDN. 285 Change of Manufacturing Site PEGAGA PLUS BHD. BHD. NO. 31, JALAN APOLLO NO. 105, JALAN TIMOR 6, U5/188 SEKSYEN U5, MAL05072142TC MERGONG BARRAGE, 2010-07-29 --- 2015-07-29 BANDAR PINGGIRAN LENCONG BARAT SUBANG 126986 40150 SHAH ALAM 05400 ALOR SETAR EASY PLUS RAINFOREST HERBS ASIA BOTANICALS SDN. 19 2004090186717 PHARMACEUTICAL (M) SDN. 285 Change of Manufacturing Site TONGKAT ALI PLUS BHD. BHD. NO. 31, JALAN APOLLO NO. 105, JALAN TIMOR 6, U5/188 SEKSYEN U5, MAL05072141TC MERGONG BARRAGE, 2010-07-29 --- 2015-07-29 BANDAR PINGGIRAN LENCONG BARAT SUBANG 126987 40150 SHAH ALAM 05400 ALOR SETAR EASY PLUS RAINFOREST HERBS MISAI ASIA BOTANICALS SDN. 20 2004090186779 PHARMACEUTICAL (M) SDN. 285 Change of Manufacturing Site KUCING PLUS BHD. BHD. NO. 31, JALAN APOLLO NO. 105, JALAN TIMOR 6, U5/188 SEKSYEN U5, MAL05061623TC MERGONG BARRAGE, 2010-07-01 --- 2015-07-01 BANDAR PINGGIRAN LENCONG BARAT SUBANG 127354 40150 SHAH ALAM 05400 ALOR SETAR EASY PLUS RAINFOREST HERBS ASIA BOTANICALS SDN. 21 2004090186794 PHARMACEUTICAL (M) SDN. 285 Change of Manufacturing Site HEMPEDU BUMI PLUS BHD. BHD. NO. 31, JALAN APOLLO NO. 105, JALAN TIMOR 6, U5/188 SEKSYEN U5, MAL05061624TC MERGONG BARRAGE, 2010-07-01 --- 2015-07-01 BANDAR PINGGIRAN LENCONG BARAT SUBANG 127355 40150 SHAH ALAM 05400 ALOR SETAR EASY PLUS ASIA BOTANICALS SDN. 22 2005021508978 TONEX capsule 300mg PHARMACEUTICAL (M) SDN. 285 Change of Manufacturing Site BHD. BHD. NO. 31, JALAN APOLLO NO. 105, JALAN TIMOR 6, U5/188 SEKSYEN U5, MAL05101729TC MERGONG BARRAGE, 2010-10-28 --- 2015-10-28 BANDAR PINGGIRAN LENCONG BARAT SUBANG 142692 40150 SHAH ALAM 05400 ALOR SETAR EASY PLUS Tongkat Ali Ginseng Plus ASIA BOTANICALS SDN. 23 2005021508981 PHARMACEUTICAL (M) SDN. 285 Change of Manufacturing Site capsule 300mg BHD. BHD. NO. 31, JALAN APOLLO NO. 105, JALAN TIMOR 6, U5/188 SEKSYEN U5, MAL05101731TC MERGONG BARRAGE, 2010-10-28 --- 2015-10-28 BANDAR PINGGIRAN LENCONG BARAT SUBANG 142693 40150 SHAH ALAM 05400 ALOR SETAR EASY PLUS ASIA BOTANICALS SDN. 24 2005021508972 Eurythan Capsule 300mg PHARMACEUTICAL (M) SDN. 285 Change of Manufacturing Site BHD. BHD. NO. 31, JALAN APOLLO NO. 105, JALAN TIMOR 6, U5/188 SEKSYEN U5, MAL05101728TC MERGONG BARRAGE, 2010-10-28 --- 2015-10-28 BANDAR PINGGIRAN LENCONG BARAT SUBANG 142694 40150 SHAH ALAM 05400 ALOR SETAR EASY PLUS RAINFOREST HERBS ASIA BOTANICALS SDN. 25 2004090186815 PHARMACEUTICAL (M) SDN. 285 Change of Manufacturing Site SENDUDUK PLUS BHD. BHD. NO. 31, JALAN APOLLO NO. 105, JALAN TIMOR 6, U5/188 SEKSYEN U5, MAL05092324TC MERGONG BARRAGE, 2010-09-30 --- 2015-09-30 BANDAR PINGGIRAN LENCONG BARAT SUBANG 139387 40150 SHAH ALAM 05400 ALOR SETAR EASY PLUS ORTHOSIPHENE COMPLEX ASIA BOTANICALS SDN. 26 2004121619958 PHARMACEUTICAL (M) SDN. 285 Change of Manufacturing Site Capsule 350mg BHD. BHD. NO. 31, JALAN APOLLO NO.
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