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Approved Drug List 2018, October

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Approved Drug List 2018, October c Maldives Food and Drug Authority Ministry of Health Male’, Republic of Maldives Approved Drug List Number: MTG/RE-AL/Li 0009/2018-0009 Acronym Expansion Remarks R Registered product These are pharmaceutical products registered and approved with full dossier submission. Product safety, quality and efficacy has been evaluated based on the submitted documents and certificates of the manufacture and the product Once registered and approved, it is the Re Registered product which has responsibility of the marketing authorization holder to been given exclusivity under set provide all necessary information required and if there is any condition. change in the product/packaging etc., and to ensure that the product is available in the market. EA Exemption Approvals These are special approvals for importing pharmaceutical products based on minimum evaluation of safety and quality of the product with information of the imports and availability in the market of the same. This approval is a temporary approval granted for a period of 1 year. For further import after 1 year, it has to be registered by full dossier submission under the registration criteria. Once registered by submitting full dossier then it will be added to the registered product list. TA Temporary Approvals These are the Products approved based on physicians requisition forms submitted by clinicians, and these products are in generic name and Pre Authorization has to be taken prior to import.These products will be kept as approved products for a period of 1 year , and as pre authorization required products. If needed for further import it has to be registered by full dossier submission under the registeration criteria. PP Primordial Products These are the products that has been in Approved Drug List from the beginning as approved products but not registered with full dossier submission. This has been kept in the Approved Drug List due to the unavailability of any alternative, plus that these products are kept on the fact that it has been in the market for a long time. Pre Authorization For all those products highlighted These are in generics and it is mentioned that Pre required products (PA) in Green Authorization has to be taken prior to import. Pre- authorization is an approval taken to import these products and it has to be taken for each product and for every shipment for import. Rec. Name: Approved Drug List Rec. No.: MTG/RE-AL/Li 0009 Issue No.: 02 Issued Date: 12/02/2018 MTG Division, MFDA Rev. No.: 08 Rev.Date:15.10.2018 Authorized By: DDG, Pharmaceuticals Section: Regulation 1 Restricted for Hospital Medicines restricted to special These are the medicines that can only be imported by and institutional use only expertise and Health facilties and designated parties.These products cannot be kept for sale in (HI) clinics with registered medical pharmacies. practitioners Restricted for Hospital use Medicine restricted to special These are the medicines that can only be imported by only (HO) expertise for hospitals only designated parties.These products cannot be kept for sale in pharmacies. Restricted for the National Restricted to Use for the National These medicines can only be imported to be used by the programs only (NP) programes only (eg. Filaria, National Programes based on a valid request by the Leprosy, Malaria, TB,HIV,EPI, concerned agency Reproductive Health Programs etc) CONTROLLED ( C ) Controlled Drugs which include These are medicines which are controlled and can only be Narcotics and Psychotropics imported by designated parties.From these medicines (Internationally and Nationally Narcotics cannot be kept in pharmacies for sale Controlled). OTC Over the counter medicine (OTC) These are the medicines that can be sold without prescriptions POM Prescription only medicine (POM) These are medicines that can be sold to a valid prescription only. E Essential medicine These are medicines that are essential and is in the most recent National Essential medicine list Updated on: 15th October 2018 Color codes Category Text/Highlighted Colour Explanation Prescription Only Black All the "POM" drugs are in black text Medicine (POM) Over the Counter (OTC) Blue All the "OTC" drugs are in blue text CONTROLLED Purple All the "Controlled" medicine are in purple text Restricted for Hospital Dark Blue All the "Restricted for Hospital use only & Restricted use only & Restricted for Hospital use/institutional use only" medicines are for Hospital in dark blue text use/institutional use only Restricted and to be Dark Red All the "Restricted and to be used for the National used for the National program only" medicines are in dark red text program only Pre-Authorization required before import All the "Pre-Authorization required before import" items are highlighted in light green Products proposed to be removed after evaluation "Products proposed to be removed after evaluation" are highlighted in red colour 1. For the Products in this list where the formulation is mentioned, that specific formulation only can be imported 2. For those products in which the fomulation is not mentioned, the product imported should be of export quality and not specified for a specific market Rec. Name: Approved Drug List Rec. No.: MTG/RE-AL/Li 0009 Issue No.: 02 Issued Date: 12/02/2018 MTG Division, MFDA Rev. No.: 08 Rev.Date:15.10.2018 Authorized By: DDG, Pharmaceuticals Section: Regulation 2 List 1: Registered Product List These are pharmaceutical products registered and approved with full dossier submission. Product safety, quality and efficacy has been evaluated based on the submitted documents and certificates of the manufacture and the product Once registered and approved, it is the responsibility of the marketing authorization holder to provide all necessary information required and if there is any change in the product/packaging etc., and to ensure that the product is available in the market. Product Generic name Product name Manufacturer / Company Dosage form Strength Catergory Status Registered Remarks No name Date Serial No. Essentiality 1 P2123 ACARBOSE BP Glucar - 50 Glenmark Pharmaceuticals Tablet 50 mg POM R E Ltd., India 2 P2423 ACECLOFENAC Aceclo Aristo India Tablet 100 mg POM R 25.10.2010 Registered by ADK Company Pvt Ltd 3 P3678 ACECLOFENAC BP Acelodon 100 Swiss Garnier Life Sciences, Tablet 100 mg POM Re 01.03.2016- Market Exclusivity No. 21-23, Industrial Area, 28.02.2021 given to AMDC Pvt Ltd Mehatpur, Dist: UNA, (H.P.)- Only 174 315, India 4 P2716 ACECLOFENAC BP Acedol Torrent Pharmaceuticals, Tablet 100 mg POM R 19.02.2013 Registered by Life India Support Pvt Ltd 5 P2275 ACECLOFENAC BP Acenac Medley Pharmaceuticals Ltd, Tablet 100 mg POM R Registered by ADK India. Company Pvt Ltd 6 P3140 ACECLOFENAC BP Aeronac Cassel Research Laboratories, Tablet 100 mg POM R 19.08.2014 My Chemist India 7 P3508 ACECLOFENAC BP Acenac-SR Medley Pharmaceuticals Ltd, Sustained Release 200 mg POM Re 19.05.2015- Market Exclusivity India. Tablet 18.05.2020 given to ADK Company Pvt Ltd only 8 P3267 ACECLOFENAC BP + LINSEED OIL BP + Stednac Stedman Pharmaceuticals Pvt. Gel 1.5% w/w + 3.0% + 10% + 5% POM R 06.01.2015 Registered by AMDC METHYL SALICYLATE BP + MENTHOL GEL Ltd., India Pvt Ltd USP 9 P2427 ACETYL SALICYLIC ACID Delisprin 75 Aristo India Tablet (Delayed 75 mg POM R E 25.10.2010 Registered by ADK Release) Company Pvt Ltd 10 P3932 ACETYL SALICYLIC ACID (ASPIRIN) Casprin Y.S.P. Industries (M) Sdn. Bhd. Enteric Micro- 100 mg POM Re E 01.11.2016 - Market Exclusivity Lot 3, 5 & 7, Jalan P/7, Section encaptulated 31.10.2021 given to Treetop 13, Kawasan Perindustrian Capsule Health Pvt Ltd only Bandar Baru bangi, 43000 Kajang, Selangor Darul Ehsan, Malaysia Rec. Name: Approved Drug List Rec. No.: MTG/RE-AL/Li 0009 Issue No.: 02 Issued Date: 12/02/2018 MTG Division, MFDA Rev. No.: 08 Rev.Date: 15.10.2018 Authorized By: DDG, Pharmaceuticals Section: Regulation 1 11 P4329 ACICLOVIR / ACYCLOVIR BP Virox SM Pharmaceuticals Sdn. Bhd. Tablet 200mg POM Re E 02.10.2018 - Market Exclusivity Lot 88, Sungai Petani 01.10.2023 given to Green Industrial Estate, 08000 Pharmacy Godown Sungai Petani, Kedah, only Malaysia 12 P4330 ACICLOVIR / ACYCLOVIR BP Virox SM Pharmaceuticals Sdn. Bhd. Tablet 400mg POM Re E 02.10.2018 - Market Exclusivity Lot 88, Sungai Petani 01.10.2023 given to Green Industrial Estate, 08000 Pharmacy Godown Sungai Petani, Kedah, only Malaysia 13 P2611 ACICLOVIR/ ACYCLOVIR Virest Hovid Bhd, Malaysia Cream 5% POM R E 10.07.2012 Registered by GKT Pharmacy 14 P2185 ACICLOVIR/ ACYCLOVIR Herperax 200 Micro Labs ltd., India Tablet 200 mg POM R E Registered by ADK Company Pvt Ltd 15 P2607 ACICLOVIR/ ACYCLOVIR Virest Hovid Bhd, Malaysia Tablet 400 mg POM R E 10.07.2012 Registered by GKT Pharmacy 16 P2608 ACICLOVIR/ ACYCLOVIR Virest Hovid Bhd, Malaysia Tablet 200 mg POM R E 10.07.2012 Registered by GKT Pharmacy 17 P2804 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline , Spain Tablet 200 mg POM R E 26.08.2013 Registered by ADK Company Pvt Ltd 18 P2805 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline , Spain Tablet 800 mg POM R E 26.08.2013 Registered by ADK Company Pvt Ltd 19 P2203 ACICLOVIR/ ACYCLOVIR Herperax Micro Labs ltd Ointment 5% POM R E Registered by ADK Company Pvt Ltd 20 P3214 ACICLOVIR/ ACYCLOVIR Zovirax Glaxo Operations, UK Cream 5% w/w POM R E 06.11.2014 State Trading Organization 21 P606 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline Injection 250mg/vial POM R E 06.11.2014 State Trading Manufacturing S.p.A, Italy Organization 22 P1832 ACICLOVIR/ ACYCLOVIR Declovir cream HOE Pharmaceutical Cream 5.00% POM R E Manufacturing (M) Sdn. Bhd., Malaysia 23 P1974 ACICLOVIR/ ACYCLOVIR Virux Square Formulations Tablet 200 mg POM R E Ltd.
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