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Medicine and Therapeutic Goods Section, Maldives Food and Drug Authority
Document Number: MFDA/ 2010/CDL/001
Revision Number: 002 Revision Date: 4th
July 2010
Contact Number: 3345721 Fax Number: 3304670
Page 1 of 3
Maldives Food and Drug Authority
Republic of Maldives
Controlled Drug List
LIST OF DRUGS ALLOWED TO BE IMPORTED UNDER THE LEGISLATION NO.17/77 OF THE REPUBLIC
OF MALDIVES WITH PRIOR AUTHORISATION FROM THE MALDIVES FOOD AND DRUG AUTHORITY.
ALL ITEMS ARE STATED AS THEIR GENERIC NAME WITH CORRESPONDING BRAND EXAMPLES
No
. Generic Name Brand Name and Strength
1 Alprazolam Tab Alprax 0.25mg
Tab Alprax 0.5mg
Tab Alprax SR 0.5mg,1mg,1.5mg
2 Chlordiazepoxide Tab Librium 10mg
3 Chlordiazepoxide + Clidinium Tab Librax 5+2.5mg
4 Chlorazepate Cap. Tranxene 5mg
Cap. Tranxene 10mg
5 Clonazepam Tab. Retrovil 500µg
Tab. Retrovil 2mg
6 Clobazam Tab Frisium 5mg
Tab Frisium 10mg
Tab Frisium 15mg
7 Diazepam Tab Valium 2mg
Tab Valium 5mg
Tab Valium 10mg
Inj Valium 10mg/2ml
Tab Calmpose 2mg.5mg
Inj. Calmpose 2mg/2ml
Syr. Calmpose 10mg/2ml
Suppository 10mg, 2.5mg, 5mg
Medicine and Therapeutic Goods Section, Maldives Food and Drug Authority
Document Number: MFDA/ 2010/CDL/001
Revision Number: 002 Revision Date: 4th
July 2010
Contact Number: 3345721 Fax Number: 3304670
Page 2 of 3
8 Lorazepam Tab Ativan 1mg
Tab Ativan 2mg
9 Midazolam
Inj Dormicum 5mg/ml/
Inj Mezolam 5mg/1ml
10 Oxazepam Tab Serapex 15mg
11 Phenobarbitone Tab Gardenal 30mg
Tab Gardenal 60mg
Inj Gardenal 30mg/2ml
Gardenal Syr 20mg/5ml
12 Pentazocine Tab Sosegon 25mg
Inj Sosegon 30mg/ml
Tab Fortwin 25mg
Inj Fortwin 30mg/ml
13
All Tablet, Suspensions and
etc...Containing Codeine Phosphate.
10 mg and above
• Phensedyl Cough Linctus
• Mits Linctus Codeine
• Corex Cough Syrup
• Codeine Phosphate
Narcotics
14 Morphine Inj Morphine 15mg/ml
Tab Morphine
15 Pethidine Inj Pethidine 50mg/ml
16 Fentanyl Inj 50mcg/ml
17 Methadone 2.5mg/ml
18 Oxycodone
Medicine and Therapeutic Goods Section, Maldives Food and Drug Authority
Document Number: MFDA/ 2010/CDL/001
Revision Number: 002 Revision Date: 4th
July 2010
Contact Number: 3345721 Fax Number: 3304670
Page 3 of 3
Cough, and Analgesic Preparations containing codine or pholcodeine have been allowed to be
prescribed and dispensed according to the current list of Approved Drugs. However these products
are required to contain not more than 8mg of codein or 5mg pholcodeine per tablet, capsule or per
5ml of a liquid preparation.
Paracetamol with 8mg codeine e.g. Panadeine* and pholcodeine Linctus are the only medicines
currently allowed to be sold as non-prescription OTC drugs.
Other combinations containing codeine or pholcodeine stated elsewhere in the Approved Drugs
have to be sold on ordinary prescription (double prescription is not required) with the following
details to be recorded by the dispensing pharmacy.
1. Date of dispensing and quantity dispensed.
2. Name of Patient and address.
3. Name of Physician
4. Signature of the dispenser
Important Note:-
Currently the above drugs are imported and distributed by State Trading Organization. However
this does not include cough and analgesic preparations which should not contain not more than
8mg of codeine or 5mg pholcodeine per tablet, capsule or per 5ml of a liquid preparation.
• Only grade 1 pharmacies are allowed to dispense psychotropic drugs which currently
include Benzodiazepines, Barbiturates, and Pentazocine. Grade 1 pharmacies obtain these
medicines from STO with prior authorization from Ministry of Health.
• Currently import and use of Narcotic drugs is confined to Hospitals, and Health Centers.

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Medicine list controlled

  • 1. Medicine and Therapeutic Goods Section, Maldives Food and Drug Authority Document Number: MFDA/ 2010/CDL/001 Revision Number: 002 Revision Date: 4th July 2010 Contact Number: 3345721 Fax Number: 3304670 Page 1 of 3 Maldives Food and Drug Authority Republic of Maldives Controlled Drug List LIST OF DRUGS ALLOWED TO BE IMPORTED UNDER THE LEGISLATION NO.17/77 OF THE REPUBLIC OF MALDIVES WITH PRIOR AUTHORISATION FROM THE MALDIVES FOOD AND DRUG AUTHORITY. ALL ITEMS ARE STATED AS THEIR GENERIC NAME WITH CORRESPONDING BRAND EXAMPLES No . Generic Name Brand Name and Strength 1 Alprazolam Tab Alprax 0.25mg Tab Alprax 0.5mg Tab Alprax SR 0.5mg,1mg,1.5mg 2 Chlordiazepoxide Tab Librium 10mg 3 Chlordiazepoxide + Clidinium Tab Librax 5+2.5mg 4 Chlorazepate Cap. Tranxene 5mg Cap. Tranxene 10mg 5 Clonazepam Tab. Retrovil 500µg Tab. Retrovil 2mg 6 Clobazam Tab Frisium 5mg Tab Frisium 10mg Tab Frisium 15mg 7 Diazepam Tab Valium 2mg Tab Valium 5mg Tab Valium 10mg Inj Valium 10mg/2ml Tab Calmpose 2mg.5mg Inj. Calmpose 2mg/2ml Syr. Calmpose 10mg/2ml Suppository 10mg, 2.5mg, 5mg
  • 2. Medicine and Therapeutic Goods Section, Maldives Food and Drug Authority Document Number: MFDA/ 2010/CDL/001 Revision Number: 002 Revision Date: 4th July 2010 Contact Number: 3345721 Fax Number: 3304670 Page 2 of 3 8 Lorazepam Tab Ativan 1mg Tab Ativan 2mg 9 Midazolam Inj Dormicum 5mg/ml/ Inj Mezolam 5mg/1ml 10 Oxazepam Tab Serapex 15mg 11 Phenobarbitone Tab Gardenal 30mg Tab Gardenal 60mg Inj Gardenal 30mg/2ml Gardenal Syr 20mg/5ml 12 Pentazocine Tab Sosegon 25mg Inj Sosegon 30mg/ml Tab Fortwin 25mg Inj Fortwin 30mg/ml 13 All Tablet, Suspensions and etc...Containing Codeine Phosphate. 10 mg and above • Phensedyl Cough Linctus • Mits Linctus Codeine • Corex Cough Syrup • Codeine Phosphate Narcotics 14 Morphine Inj Morphine 15mg/ml Tab Morphine 15 Pethidine Inj Pethidine 50mg/ml 16 Fentanyl Inj 50mcg/ml 17 Methadone 2.5mg/ml 18 Oxycodone
  • 3. Medicine and Therapeutic Goods Section, Maldives Food and Drug Authority Document Number: MFDA/ 2010/CDL/001 Revision Number: 002 Revision Date: 4th July 2010 Contact Number: 3345721 Fax Number: 3304670 Page 3 of 3 Cough, and Analgesic Preparations containing codine or pholcodeine have been allowed to be prescribed and dispensed according to the current list of Approved Drugs. However these products are required to contain not more than 8mg of codein or 5mg pholcodeine per tablet, capsule or per 5ml of a liquid preparation. Paracetamol with 8mg codeine e.g. Panadeine* and pholcodeine Linctus are the only medicines currently allowed to be sold as non-prescription OTC drugs. Other combinations containing codeine or pholcodeine stated elsewhere in the Approved Drugs have to be sold on ordinary prescription (double prescription is not required) with the following details to be recorded by the dispensing pharmacy. 1. Date of dispensing and quantity dispensed. 2. Name of Patient and address. 3. Name of Physician 4. Signature of the dispenser Important Note:- Currently the above drugs are imported and distributed by State Trading Organization. However this does not include cough and analgesic preparations which should not contain not more than 8mg of codeine or 5mg pholcodeine per tablet, capsule or per 5ml of a liquid preparation. • Only grade 1 pharmacies are allowed to dispense psychotropic drugs which currently include Benzodiazepines, Barbiturates, and Pentazocine. Grade 1 pharmacies obtain these medicines from STO with prior authorization from Ministry of Health. • Currently import and use of Narcotic drugs is confined to Hospitals, and Health Centers.