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Dalam Mesyuarat Pbkd Kali Ke – 355 Tarikh Mesyuarat : 2 April 2021

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Dalam Mesyuarat Pbkd Kali Ke – 355 Tarikh Mesyuarat : 2 April 2021 SENARAI PRODUK – PRODUK YANG TELAH DILULUSKAN OLEH PIHAK BERKUASA KAWALAN DADAH (PBKD) DALAM MESYUARAT PBKD KALI KE – 355 TARIKH MESYUARAT : 2 APRIL 2021 No Mal Number Name Holder Manufacturer Status Category Registration Expiry Date Date 1 MAL21046001AZ COVID-19 Vaccine KEMENTERIAN SK bioscience Co., NEW PRODUCT BIOLOGICS-VACCINES 02-04-2021 02-04-2022 AstraZeneca Solution for KESIHATAN MALAYSIA Ltd.(KOREA,SOUTH) APPROVED Injection (CONDITIONAL REGISTRATION) 2 MAL21046009AZ Bilaxten 10mg Orodispersible A. MENARINI A. Menarini NEW PRODUCT NEW CHEMICAL ENTITY- 02-04-2021 02-04-2026 Tablets SINGAPORE PTE. LTD. Manufacturing APPROVED NEW CHEMICAL Logistics and Services ENTITY/RADIOPHARMACE S.r.l.(ITALY) UTICAL SUBSTANCE 3 MAL21046008AZ Bilaxten 2.5 mg/ml Oral A. MENARINI BERLIN-CHEMIE NEW PRODUCT NEW CHEMICAL ENTITY- 02-04-2021 02-04-2026 Solution SINGAPORE PTE. LTD. AG(GERMANY) APPROVED NEW CHEMICAL ENTITY/RADIOPHARMACE UTICAL SUBSTANCE 4 MAL21046002ACZ CABOMETYX 20mg film- ZUELLIG PHARMA PATHEON NEW PRODUCT NEW CHEMICAL ENTITY- 02-04-2021 02-04-2026 coated tablets SDN BHD INC.(CANADA) APPROVED NEW CHEMICAL ENTITY/RADIOPHARMACE UTICAL SUBSTANCE 5 MAL21046003ACZ CABOMETYX 40mg film- ZUELLIG PHARMA PATHEON NEW PRODUCT NEW CHEMICAL ENTITY- 02-04-2021 02-04-2026 coated tablets SDN BHD INC(CANADA) APPROVED NEW CHEMICAL ENTITY/RADIOPHARMACE UTICAL SUBSTANCE 6 MAL21046004ACZ CABOMETYX 60mg film- ZUELLIG PHARMA PATHEON NEW PRODUCT NEW CHEMICAL ENTITY- 02-04-2021 02-04-2026 coated tablets SDN BHD INC(CANADA) APPROVED NEW CHEMICAL ENTITY/RADIOPHARMACE UTICAL SUBSTANCE 7 MAL21046005ACZ Alunbrig (Brigatinib) 30mg Takeda Malaysia Sdn PENN NEW PRODUCT NEW CHEMICAL ENTITY- 02-04-2021 02-04-2026 Film-Coated Tablet Bhd PHARMACEUTICAL APPROVED NEW CHEMICAL SERVICES ENTITY/RADIOPHARMACE LIMITED(UNITED UTICAL SUBSTANCE KINGDOM) 8 MAL21046006ACZ Alunbrig (Brigatinib) 90mg Takeda Malaysia Sdn PENN NEW PRODUCT NEW CHEMICAL ENTITY- 02-04-2021 02-04-2026 Film-Coated Tablet Bhd PHARMACEUTICAL APPROVED NEW CHEMICAL SERVICES ENTITY/RADIOPHARMACE LIMITED(UNITED UTICAL SUBSTANCE KINGDOM) 9 MAL21046007ACZ Alunbrig (Brigatinib) 180mg Takeda Malaysia Sdn PENN NEW PRODUCT NEW CHEMICAL ENTITY- 02-04-2021 02-04-2026 Film-Coated Tablet Bhd PHARMACEUTICAL APPROVED NEW CHEMICAL SERVICES ENTITY/RADIOPHARMACE LIMITED(UNITED UTICAL SUBSTANCE KINGDOM) 10 MAL16085045AZ Albunorm 5%, 50 g/l, Pharmaniaga OCTAPHARMA RE- BIOLOGICS- 23-08-2021 23-08-2026 Solution for Infusion Marketing Sdn Bhd PHARMAZEUTIKA REGISTRATION BIOLOGICAL/BIOTECH/BIO PRODUKTIONSGES.M. (RENEWAL) SIMILAR B.H.(AUSTRIA) 11 MAL16085046AZ Albunorm 20%, 200 g/l, Pharmaniaga OCTAPHARMA RE- BIOLOGICS- 23-08-2021 23-08-2026 Solution for Infusion Marketing Sdn Bhd PHARMAZEUTIKA REGISTRATION BIOLOGICAL/BIOTECH/BIO PRODUKTIONSGES.M. (RENEWAL) SIMILAR B.H.(AUSTRIA) 12 MAL16085049AZ Albunorm 25%, 250 g/l, Pharmaniaga OCTAPHARMA RE- BIOLOGICS- 23-08-2021 23-08-2026 Solution for Infusion Marketing Sdn Bhd PHARMAZEUTIKA REGISTRATION BIOLOGICAL/BIOTECH/BIO PRODUKTIONSGES.M. (RENEWAL) SIMILAR B.H.(AUSTRIA) 13 MAL16085048ASZ Albunorm 5%, 50 g/l, Pharmaniaga Octapharma RE- BIOLOGICS- 23-08-2021 23-08-2026 Solution for Infusion Marketing Sdn Bhd Produktionsgesellscha REGISTRATION BIOLOGICAL/BIOTECH/BIO ft Deutschland (RENEWAL) SIMILAR mbH(GERMANY) 14 MAL16085050ASZ Albunorm 20%, 200 g/l, Pharmaniaga Octapharma RE- BIOLOGICS- 23-08-2021 23-08-2026 Solution for Infusion Marketing Sdn Bhd Produktionsgesellscha REGISTRATION BIOLOGICAL/BIOTECH/BIO ft Deutschland (RENEWAL) SIMILAR mbH(GERMANY) 15 MAL16085047ASZ Albunorm 25%, 250 g/l, Pharmaniaga Octapharma RE- BIOLOGICS- 23-08-2021 23-08-2026 Solution for Infusion Marketing Sdn Bhd S.A.S.(FRANCE) REGISTRATION BIOLOGICAL/BIOTECH/BIO (RENEWAL) SIMILAR 16 MAL16085029AZ NovoEight 500IU Powder and NOVO NORDISK Novo Nordisk RE- BIOLOGICS- 23-08-2021 23-08-2026 Solvent for Solution for PHARMA (MALAYSIA) A/S(DENMARK) REGISTRATION BIOLOGICAL/BIOTECH/BIO Injection SDN. BHD. (RENEWAL) SIMILAR 17 MAL16085031AZ NovoEight® 250IU Powder NOVO NORDISK Novo Nordisk RE- BIOLOGICS- 23-08-2021 23-08-2026 and Solvent for Solution for PHARMA (MALAYSIA) A/S(DENMARK) REGISTRATION BIOLOGICAL/BIOTECH/BIO Injection SDN. BHD. (RENEWAL) SIMILAR 18 MAL16085030AZ NovoEight 1000IU Powder NOVO NORDISK Novo Nordisk RE- BIOLOGICS- 23-08-2021 23-08-2026 and Solvent for Solution for PHARMA (MALAYSIA) A/S(DENMARK) REGISTRATION BIOLOGICAL/BIOTECH/BIO Injection SDN. BHD. (RENEWAL) SIMILAR 19 MAL16075050AZ Toujeo 300 units/ml Solution SANOFI-AVENTIS Sanofi-Aventis RE- BIOLOGICS- 26-07-2021 26-07-2026 for Injection in Pre-Filled Pen (MALAYSIA) SDN. Deutschland REGISTRATION BIOLOGICAL/BIOTECH/BIO BHD. GmbH(GERMANY) (RENEWAL) SIMILAR 20 MAL19962530AZ EPREX PREFILLED SYRINGE JOHNSON & JOHNSON CILAG RE- BIOLOGICS- 31-07-2021 31-07-2026 2000IU/0.5ML SDN BHD AG(SWITZERLAND) REGISTRATION BIOLOGICAL/BIOTECH/BIO (RENEWAL) SIMILAR 21 MAL19962532AZ EPREX PREFILLED SYRINGE JOHNSON & JOHNSON CILAG RE- BIOLOGICS- 31-07-2021 31-07-2026 4000IU/0.4ML SDN BHD AG(SWITZERLAND) REGISTRATION BIOLOGICAL/BIOTECH/BIO (RENEWAL) SIMILAR 22 MAL19962533AZ EPREX PREFILLED SYRINGE JOHNSON & JOHNSON CILAG RE- BIOLOGICS- 31-07-2021 31-07-2026 10000IU/ML SDN BHD AG(SWITZERLAND) REGISTRATION BIOLOGICAL/BIOTECH/BIO (RENEWAL) SIMILAR 23 MAL20013455AZ SII Diphtheria and Tetanus SM SERUM INSTITUTE OF RE- BIOLOGICS- 10-06-2021 10-06-2026 Vaccine Adsorbed (Pediatric)- PHARMACEUTICALS INDIA PRIVATE REGISTRATION BIOLOGICAL/BIOTECH/BIO 10 doses SDN. BHD. LIMITED(INDIA) (RENEWAL) SIMILAR 24 MAL20013454AZ SII DIPHTHERIA,TETANUS SM SERUM INSTITUTE OF RE- BIOLOGICS- 10-06-2021 10-06-2026 &PERTUSSIS VACCINE PHARMACEUTICALS INDIA PRIVATE REGISTRATION BIOLOGICAL/BIOTECH/BIO ADSORBED-20 DOSES SDN. BHD. LIMITED(INDIA) (RENEWAL) SIMILAR 25 MAL20013453AZ SII Diphtheria,Tetanus- SM SERUM INSTITUTE OF RE- BIOLOGICS- 10-06-2021 10-06-2026 Pertussis Vaccine Adsorbed - PHARMACEUTICALS INDIA PRIVATE REGISTRATION BIOLOGICAL/BIOTECH/BIO 10 doses SDN. BHD. LIMITED(INDIA) (RENEWAL) SIMILAR 26 MAL20061574AZ LEVEMIR FLEXPEN 100U/ML, NOVO NORDISK NOVO NORDISK RE- BIOLOGICS- 31-07-2021 31-07-2026 3ML PHARMA (MALAYSIA) A/S(DENMARK) REGISTRATION BIOLOGICAL/BIOTECH/BIO SDN. BHD. (RENEWAL) SIMILAR 27 MAL20061585ARZ Influvac Suspension for ABBOTT Abbott Biologicals RE- BIOLOGICS- 28-08-2021 28-08-2026 Injection LABORATORIES (M) B.V.(NETHERLANDS) REGISTRATION BIOLOGICAL/BIOTECH/BIO SDN. BHD. (RENEWAL) SIMILAR 28 MAL20112161AZ Flebogamma 5% DIF GRIFOLS MALAYSIA INSTITUTO GRIFOLS RE- BIOLOGICS- 28-08-2021 28-08-2026 SDN. BHD. S.A.(SPAIN) REGISTRATION BIOLOGICAL/BIOTECH/BIO (RENEWAL) SIMILAR 29 MAL18106049AZ Hertraz 440mg Powder for MYLAN HEALTHCARE Biocon Limited(INDIA) COH Approved BIOLOGICS- 15-10-2018 15-10-2023 Concentrate SDN. BHD. BIOLOGICAL/BIOTECH/BIO SIMILAR 30 MAL21016002AZ Pontevia 120 mg solution for ZUELLIG PHARMA ELI LILLY AND COH Approved BIOLOGICS- 08-01-2021 08-01-2026 injection in pre-filled pen SDN BHD COMPANY(UNITED BIOLOGICAL/BIOTECH/BIO STATES) SIMILAR 31 MAL21016001AZ Pontevia 120 mg solution for ZUELLIG PHARMA ELI LILLY AND COH Approved BIOLOGICS- 08-01-2021 08-01-2026 injection in pre-filled syringe SDN BHD COMPANY(UNITED BIOLOGICAL/BIOTECH/BIO STATES) SIMILAR 32 MAL11085010NCR VitaHealth CoQ10 100mg VITAHEALTH BIOTECH Alpha Laboratories RE- HEALTH SUPPLEMENT- 27-08-2021 27-08-2026 Plus Softgel SDN BHD (NZ) Limited(NEW REGISTRATION GENERAL ZEALAND) (RENEWAL) 33 MAL11085011NCR NUVIT Grande Platinum Y.S.P. INDUSTRIES (M) Alpha Laboratories RE- HEALTH SUPPLEMENT- 27-08-2021 27-08-2026 Sheep Placenta Complex SDN BHD (NZ) Limited(NEW REGISTRATION GENERAL Enteric Coated Softgel ZEALAND) (RENEWAL) 34 MAL16035031NC beyonde LifeSential S-O-D OMNICONNECT THE BRITISH RE- HEALTH SUPPLEMENT- 02-04-2021 02-04-2026 Plus Coenzyme Q10 and WORLDWIDE SDN. DISPENSARY (L.P.) REGISTRATION GENERAL Sodium Copper Chlorophyllin BHD. CO., LTD.(THAILAND) (RENEWAL) Tablet 35 MAL16045007N Nn OptiVizion Tablet YANLING NATURAL YANLING NATURAL RE- HEALTH SUPPLEMENT- 07-04-2021 07-04-2026 HYGIENE SDN. BHD. HYGIENE SDN. REGISTRATION GENERAL BHD.(MALAYSIA) (RENEWAL) 36 MAL16055011N Flavettes Effervescent Vital DUOPHARMA DUOPHARMA RE- HEALTH SUPPLEMENT- 13-05-2021 13-05-2026 Effervescent Tablet (Orange) MANUFACTURING MANUFACTURING REGISTRATION GENERAL (BANGI) SDN BHD (BANGI) SDN (RENEWAL) BHD(MALAYSIA) 37 MAL16045002NC GNC PROBIOTIC COMPLEX 75 ONI Global (Malaysia) Cultech RE- HEALTH SUPPLEMENT- 07-04-2021 07-04-2026 BILLION CFUs CAPSULE Sdn Bhd Limited(UNITED REGISTRATION GENERAL KINGDOM) (RENEWAL) 38 MAL16075039NCR Kordel's Fish Oil 1500mg plus CAMBERT(M) SDN GMP RE- HEALTH SUPPLEMENT- 30-07-2021 30-07-2026 Vitamin D3 Softgels BHD PHARMACEUTICALS REGISTRATION GENERAL LTD(NEW ZEALAND) (RENEWAL) 39 MAL16075040NCR BLACKMORES BUFFERED C BLACKMORES Lipa Pharmaceuticals RE- HEALTH SUPPLEMENT- 30-07-2021 30-07-2026 SUSTAINED RELEASE TABLETS (MALAYSIA) SDN. Limited(AUSTRALIA) REGISTRATION GENERAL BHD. (RENEWAL) 40 MAL16065006NC GNC PROBIOTIC COMPLEX ONI Global (Malaysia) Cultech RE- HEALTH SUPPLEMENT- 03-06-2021 03-06-2026 10BILLION CFUs CAPSULE Sdn Bhd Limited(UNITED REGISTRATION GENERAL KINGDOM) (RENEWAL) 41 MAL16055022N MRT CALMAG TABLET MORETH SDN. BHD. MORETH SDN. RE- HEALTH SUPPLEMENT- 24-05-2021 24-05-2026 BHD.(MALAYSIA) REGISTRATION GENERAL (RENEWAL) 42 MAL16055012NC GNC PROBIOTIC COMPLEX ONI Global (Malaysia) Cultech RE- HEALTH SUPPLEMENT- 13-05-2021 13-05-2026 100 BILLION CFUs CAPSULE Sdn Bhd Limited(UNITED REGISTRATION GENERAL KINGDOM) (RENEWAL) 43 MAL16085010N natural Factors Miny-Gel Fish NUVANTA
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