Approved Drug List, December 2017

397 Pages·2017·3.6 MB·English

Acronym Expansion Remarks
R Registered product These are pharmaceutical products registered with
full dossier submission.Product safety, quality and
efficacy has been evaluated based on the
submitted documents,manufacture and product
information.After registeration it is the responsibility
Re Registered product which has of the marketting authorization holder to provide all
been given exclusivity under neccessary information required and if there is any
set condition. change in the product and to ensure that the
product is available in the market.
EA Exemption Approvals Special approvals for importing pharmaceuticals
products based on minimum evaluation of safety
and quality of the product with information of the
imports of the same.Special Approval is a
temporary approval granted for 1 year. For further
import after 1 year ,it has to be registered by full
dossier submission under the registeration criteria.
Once registered by submitting full dossier then it
will be added to the registered product list.
TA Temporary Approvals Products approved based on physicians requisition
forms and these products are in generic name with
Pre Authorization to be taken prior to import.These
products will be kept as approved products for a
period of 1 year , and as Are Authorization required
products. If needed for further import it has to be
registered by full dossier submission under the
registeration criteria.
PP Primodial Products These are the products that has been in Approved
Drug List from the beginning and which are not
registered with full dossier submission. Due to
unavailability of any alternative , these products
are kept in ADL based on the fact that it has been
in the market for some time.
Pre Authorization For all those products These are in generics and it is mentioned that Pre
required products (PA) highlighted in Green Authorization has to to be taken prior to import.
Restricted for Hospital Medicines restricted to special These medicines can only be imported by
and institutional use expertise and Health facilties designated parties.These products cannot be kept
only (HI) and clinics with registered for sale in pharmacies.Prior to Import these
medical practitioners products Pre Authorization has to be taken for all
these.
Restricted for Hospital Medicine restricted to special These medicines can only be imported by
use only (HO) expertise for hospitals only designated parties.These products cannot be kept
for sale in pharmacies.Prior to Import these
products Pre Authorization has to be taken for all
these.
Restricted for the Restricted to Use for the These medicines can only be imported to be used
National programs National programes only ( eg. by the National Programes based on a valid
only (NP) Filaria, Leprosy, Malaria, request by the concerned agency
TB,HIV,EPI, Reproductive
Health Programs etc)
CONTROLLED ( C ) Controlled Drugs which These are medicines which are controlled and can
include Narcotics and only be imported by designated parties.From these
Psychotropics (Internationally medicines Narcotics cannot be kept in pharmacies
and Nationally Controlled). for sale
OTC Over the counter medicine These are medicines that can be sold without
(OTC) prescriptions
POM Prescription only medicine These are medicines that can be sold to a valid
(POM) prescription only.
E Essential medicine These are medicines that are essential and is in
the Essential medicine list
Updated on:10th October
2017
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"
use only medicines are in dark blue text
Restricted and to be Dark Red All the "Restricted and to be used for the
used for the National National programme only" medicines are in dark
programme only red text
Pre-Authorization required before import All the "Pre-Authorization required before
import" items are highlighted in light green
Products which will be removed soon "Products which will be removed soon" are
highlighted in red colour
c

Maldives Food and Drug Authority
Ministry of Health
Male’, Republic of Maldives
Approved Drug List
Number: MTG/RE-AL/Li 0009/2017-0004
o Product Generic name Product name Manufacturer / Dosage form strength Catergory RegisTAa Essen Reg Date Remarks
N
al No Company name tion tiality
eri status
S
1 P3639 (1) GLUCOSE 11% 885 ML CONTAIN: Kabiven Peripheral 1000 Fresnius kabi AB, S- Intravenous (1) Glucose 11% 885 ml contain: Restricted for Re 15.08.2017 Can be imported by State
GLUCOSE (ANHYDROUS) PH. EUR. 97G, WATER kcal 75174 Uppsala, emulsion for Glucose (anhydrous) Ph. Eur. 97g, Water Hospital use 14.08.2022 Trading Organization Plc
FOR INJECTIONS PH. EUR TO 885 ML. Sweden Infusion for injections Ph. Eur to 885 ml. o n l y Each Shipment Only
(2) VAMIN ® 18 NOVUM 300ML CONTAIN: (2) Vamin ® 18 Novum 300ml contain: should be
ALANINE PH.EUR. 4.8G, ARGININE PH.EUR. Alanine Ph.Eur. 4.8g, Arginine Ph.Eur. accompanied
3.4G, ASPARTIC ACID PH.EUR. 1.0G, GLUTAMIC 3.4g, Aspartic acid Ph.Eur. 1.0g, Glutamic by the batch
ACID PH.EUR. 1.7G, GLYCINE PH.EUR. 2.4G, acid Ph.Eur. 1.7g, Glycine Ph.Eur. 2.4g, certificates
HISTIDINE PH.EUR. 2.0G, ISOLEUCINE PH.EUR. Histidine Ph.Eur. 2.0g, Isoleucine Ph.Eur.
1.7G, LEUCINE PH.EUR. 2.4G, LYSINE 1.7g, Leucine Ph.Eur. 2.4g, Lysine
HYDROCHLORIDE PH.EUR. 2.4G, LYSINE hydrochloride Ph.Eur. 2.4g, Lysine
HYDROCHLORIDE PH.EUR. CORRESPONDING TO hydrochloride Ph.Eur. corresponding to
LYSINE 2.7G, METHIONINE PH.EUR. 1.7G, Lysine 2.7g, Methionine Ph.Eur. 1.7g,
PHENYLALANINE PH. EUR. 2.4G, PROLINE Phenylalanine Ph. Eur. 2.4g, Proline
PH.EUR. 2.0G, SERINE PH.EUR. 1.4G, Ph.Eur. 2.0g, Serine Ph.Eur. 1.4g,
THREONINE PH.EUR.1.7G, TRYPTOPHAN Threonine Ph.Eur.1.7g, Tryptophan
PH.EUR.0.57G, TYROSINE PH.EUR. 0.07G, Ph.Eur.0.57g, Tyrosine Ph.Eur. 0.07g,
VALINE PH.EUR. 2.2G. CALCIUM CHLORIDE Valine Ph.Eur. 2.2g. Calcium chloride
2H2O PH.EUR. CORRESPONDING TO CALCIUM 2H2O Ph.Eur. corresponding to Calcium
CHLORIDE 0.22G, SODIUM chloride 0.22g, Sodium
GLYCEROPHOSPHATE glycerophosphate
PH.FRANC.CORRESPONDING TO SODIUM Ph.Franc.corresponding to Sodium
GLYCEROPHOSPHATE (ANHYDROUS) 1.5G, glycerophosphate (anhydrous) 1.5g,
MAGNESIUM SULPHATE 7H2O PH.EUR. Magnesium sulphate 7H2O Ph.Eur.
CORRESPONDING TO MAGNESIUM SULPHATE corresponding to Magnesium sulphate
0.48G, POTASSIUM CHLORIDE PH.EUR. 1.8G, 0.48g, Potassium chloride Ph.Eur. 1.8g,
SODIUM ACETATE 3H2O PH.EUR. Sodium acetate 3H2O Ph.Eur.
CORRESPONDING TO SODIUM ACETATE 1.5G, corresponding to Sodium acetate 1.5g,
WATER FOR INJECTIONS PH.EUR. TO 300ML. Water for injections Ph.Eur. to 300ml.
GLACIAL ACETIC ACID PH.EUR. Q.S.TO PH Glacial acetic acid Ph.Eur. q.s.to pH
APPROX. 5.6. (3) INTRALIPID ® approx. 5.6. (3) Intralipid
20% 255ML CONTAIN: PURIFIED SOYBEAN OIL ® 20% 255ml contain: Purified soybean
PH.EUR. 51G, PURIFIED EGG PHOSPHOLIPIDS oil Ph.Eur. 51g, Purified egg
3.1G, GLYCEROL (ANHYDROUS) PH.EUR. 5.6G, phospholipids 3.1g, Glycerol (anhydrous)
WATER FOR INJECTIONS PHEUR TO 255ML PhEur 56g Water for Injections PhEur
2 P3643 (1) GLUCOSE 19% 1053 ML CONTAINS: Kabiven 1900 kcal Fresnius kabi AB, S- Intravenous (1) Glucose 19% 1053 ml contains: Restricted for Re 15.08.2017 - Can be imported by State
GLUCOSE (ANHYDROUS) PH. EUR. 200G, WATER 75174 Uppsala, emulsion for Glucose (anhydrous) Ph. Eur. 200g, Hospital use 14.08.2022 Trading Organization Plc
FOR INJECTIONS PH. EUR TO 1053 ML. Sweden Infusion Water for injections Ph. Eur to 1053 ml. only Each Shipment Only
(2) VAMIN ® 18 NOVUM 600ML CONTAINS: (2) Vamin ® 18 Novum 600ml contains: should be
ALANINE PH.EUR. 9.6G, ARGININE PH.EUR. Alanine Ph.Eur. 9.6g, Arginine Ph.Eur. accompanied
6.8G, ASPARTIC ACID PH.EUR. 2.0G, GLUTAMIC 6.8g, Aspartic acid Ph.Eur. 2.0g, Glutamic by the batch
ACID PH.EUR. 3.4G, GLYCINE PH.EUR. 4.7G, acid Ph.Eur. 3.4g, Glycine Ph.Eur. 4.7g, certificates
HISTIDINE PH.EUR. 4.1G, ISOLEUCINE PH.EUR. Histidine Ph.Eur. 4.1g, Isoleucine Ph.Eur.
3.4G, LEUCINE PH.EUR. 4.7G, LYSINE 3.4g, Leucine Ph.Eur. 4.7g, Lysine
HYDROCHLORIDE PH.EUR. CORRESPONDING TO hydrochloride Ph.Eur. corresponding to
LYSINE 5.4G, METHIONINE PH.EUR. 3.4G, Lysine 5.4g, Methionine Ph.Eur. 3.4g,
PHENYLALANINE PH. EUR. 4.7G, PROLINE Phenylalanine Ph. Eur. 4.7g, Proline
PH.EUR. 4.1G, SERINE PH.EUR. 2.7G, Ph.Eur. 4.1g, Serine Ph.Eur. 2.7g,
THREONINE PH.EUR.3.4G, TRYPTOPHAN Threonine Ph.Eur.3.4g, Tryptophan
PH.EUR.1.1G, TYROSINE PH.EUR. 0.14G, VALINE Ph.Eur.1.1g, Tyrosine Ph.Eur. 0.14g,
PH.EUR. 4.4G. CALCIUM CHLORIDE 2H2O Valine Ph.Eur. 4.4g. Calcium chloride
PH.EUR. CORRESPONDING TO CALCIUM 2H2O Ph.Eur. corresponding to Calcium
CHLORIDE 0.44G, SODIUM chloride 0.44g, Sodium
GLYCEROPHOSPHATE glycerophosphate
PH.FRANC.CORRESPONDING TO SODIUM Ph.Franc.corresponding to Sodium
GLYCEROPHOSPHATE (ANHYDROUS) 3.0G, glycerophosphate (anhydrous) 3.0g,
MAGNESIUM SULPHATE 7H2O PH.EUR. Magnesium sulphate 7H2O Ph.Eur.
CORRESPONDING TO MAGNESIUM SULPHATE corresponding to Magnesium sulphate
0.96G, POTASSIUM CHLORIDE PH.EUR. 3.6G, 0.96g, Potassium chloride Ph.Eur. 3.6g,
SODIUM ACETATE 3H2O PH.EUR. Sodium acetate 3H2O Ph.Eur.
CORRESPONDING TO SODIUM ACETATE 2.9G, corresponding to Sodium acetate 2.9g,
WATER FOR INJECTIONS PH.EUR. TO 600ML. Water for injections Ph.Eur. to 600ml.
GLACIAL ACETIC ACID PH.EUR. Q.S.TO PH Glacial acetic acid Ph.Eur. q.s.to pH
APPROX. 5.6. approx. 5.6.
(3) INTRALIPID ® 20% 400ML CONTAINS: (3) Intralipid ® 20% 400ml contains:
PURIFIED SOYBEAN OIL PH.EUR. 80G, PURIFIED Purified soybean oil Ph.Eur. 80g, Purified
EGG PHOSPHOLIPIDS 4.8G, GLYCEROL egg phospholipids 4.8g, Glycerol
(ANHYDROUS) PH.EUR. 8.8G, WATER FOR (anhydrous) Ph.Eur. 8.8g, Water for
INJECTIONS PHEUR TO 400ML SODIUM Injections PhEur To 400ml Sodium
3 P4004 (1) GLUCOSE 19% 526 ML CONTAINS: Kabiven 900 kcal Fresnius kabi AB, S- Intravenous (1) Glucose 19% 526 ml contains: Restricted for Re 15.08.2017 Can be imported by State
GLUCOSE (ANHYDROUS) PH. EUR. 100G, WATER 75174 Uppsala, emulsion for Glucose (anhydrous) Ph. Eur. 100g, Hospital use 14.08.2022 Trading Organization Plc
FOR INJECTIONS PH. EUR TO 526 ML. Sweden Infusion Water for injections Ph. Eur to 526 ml. only Each Shipment Only
(2) VAMIN ® 18 NOVUM 300ML CONTAINS: (2) Vamin ® 18 Novum 300ml contains: should be
ALANINE PH.EUR. 4.8G, ARGININE PH.EUR. Alanine Ph.Eur. 4.8g, Arginine Ph.Eur. accompanied
3.4G, ASPARTIC ACID PH.EUR. 1.0G, GLUTAMIC 3.4g, Aspartic acid Ph.Eur. 1.0g, Glutamic by the batch
ACID PH.EUR. 1.7G, GLYCINE PH.EUR. 2.4G, acid Ph.Eur. 1.7g, Glycine Ph.Eur. 2.4g, certificates
HISTIDINE PH.EUR. 2.0G, ISOLEUCINE PH.EUR. Histidine Ph.Eur. 2.0g, Isoleucine Ph.Eur.
1.7G, LEUCINE PH.EUR. 2.4G, LYSINE 1.7g, Leucine Ph.Eur. 2.4g, Lysine
HYDROCHLORIDE PH.EUR. 2.4G, LYSINE hydrochloride Ph.Eur. 2.4g, Lysine
HYDROCHLORIDE PH.EUR. CORRESPONDING TO hydrochloride Ph.Eur. corresponding to
LYSINE 2.7G, METHIONINE PH.EUR. 1.7G, Lysine 2.7g, Methionine Ph.Eur. 1.7g,
PHENYLALANINE PH. EUR. 2.4G, PROLINE Phenylalanine Ph. Eur. 2.4g, Proline
PH.EUR. 2.0G, SERINE PH.EUR. 1.4G, Ph.Eur. 2.0g, Serine Ph.Eur. 1.4g,
THREONINE PH.EUR.1.7G, TRYPTOPHAN Threonine Ph.Eur.1.7g, Tryptophan
PH.EUR.0.57G, TYROSINE PH.EUR. 0.07G, Ph.Eur.0.57g, Tyrosine Ph.Eur. 0.07g,
VALINE PH.EUR. 2.2G. CALCIUM CHLORIDE Valine Ph.Eur. 2.2g. Calcium chloride
2H2O PH.EUR. CORRESPONDING TO CALCIUM 2H2O Ph.Eur. corresponding to Calcium
CHLORIDE 0.22G, SODIUM chloride 0.22g, Sodium
GLYCEROPHOSPHATE glycerophosphate
PH.FRANC.CORRESPONDING TO SODIUM Ph.Franc.corresponding to Sodium
GLYCEROPHOSPHATE (ANHYDROUS) 1.5G, glycerophosphate (anhydrous) 1.5g,
MAGNESIUM SULPHATE 7H2O PH.EUR. Magnesium sulphate 7H2O Ph.Eur.
CORRESPONDING TO MAGNESIUM SULPHATE corresponding to Magnesium sulphate
0.48G, POTASSIUM CHLORIDE PH.EUR. 1.8G, 0.48g, Potassium chloride Ph.Eur. 1.8g,
SODIUM ACETATE 3H2O PH.EUR. Sodium acetate 3H2O Ph.Eur.
CORRESPONDING TO SODIUM ACETATE 1.5G, corresponding to Sodium acetate 1.5g,
WATER FOR INJECTIONS PH.EUR. TO 300ML. Water for injections Ph.Eur. to 300ml.
GLACIAL ACETIC ACID PH.EUR. Q.S.TO PH Glacial acetic acid Ph.Eur. q.s.to pH
APPROX. 5.6. approx. 5.6.
(3) INTRALIPID ® 20% 200ML CONTAINS: (3) Intralipid ® 20% 200ml contains:
PURIFIED SOYBEAN OIL PH.EUR. 40G, PURIFIED Purified soybean oil Ph.Eur. 40g, Purified
EGG PHOSPHOLIPIDS 2.4G, GLYCEROL egg phospholipids 2.4g, Glycerol
(ANHYDROUS) PHEUR 44G WATER FOR (anhydrous) PhEur 44g Water for
4 P4003 (1) GLUCOSE 19% 790 ML CONTAINS: Kabiven 1400 kcal Fresnius kabi AB, S- Intravenous (1) Glucose 19% 790 ml contains: Restricted for Re 15.08.2017 Can be imported by State
GLUCOSE (ANHYDROUS) PH. EUR. 150G, WATER 75174 Uppsala, emulsion for Glucose (anhydrous) Ph. Eur. 150g, Hospital use 14.08.2022 Trading Organization Plc
FOR INJECTIONS PH. EUR TO 790 ML. Sweden Infusion Water for injections Ph. Eur to 790 ml. only Each Shipment Only
(2) VAMIN ® 18 NOVUM 450ML CONTAINS: (2) Vamin ® 18 Novum 450ml contains: should be
ALANINE PH.EUR. 7.2G, ARGININE PH.EUR. Alanine Ph.Eur. 7.2g, Arginine Ph.Eur. accompanied
5.1G, ASPARTIC ACID PH.EUR. 1.5G, GLUTAMIC 5.1g, Aspartic acid Ph.Eur. 1.5g, Glutamic by the batch
ACID PH.EUR. 2.5G, GLYCINE PH.EUR. 3.6G, acid Ph.Eur. 2.5g, Glycine Ph.Eur. 3.6g, certificates
HISTIDINE PH.EUR. 3.1G, ISOLEUCINE PH.EUR. Histidine Ph.Eur. 3.1g, Isoleucine Ph.Eur.
2.5G, LEUCINE PH.EUR. 3.6G, LYSINE 2.5g, Leucine Ph.Eur. 3.6g, Lysine
HYDROCHLORIDE PH.EUR. CORRESPONDING TO hydrochloride Ph.Eur. corresponding to
LYSINE 4.1G, METHIONINE PH.EUR. 2.5G, Lysine 4.1g, Methionine Ph.Eur. 2.5g,
PHENYLALANINE PH. EUR. 3.6G, PROLINE Phenylalanine Ph. Eur. 3.6g, Proline
PH.EUR. 3.1G, SERINE PH.EUR. 2.0G, Ph.Eur. 3.1g, Serine Ph.Eur. 2.0g,
THREONINE PH.EUR.2.5G, TRYPTOPHAN Threonine Ph.Eur.2.5g, Tryptophan
PH.EUR.0.86G, TYROSINE PH.EUR. 0.10G, Ph.Eur.0.86g, Tyrosine Ph.Eur. 0.10g,
VALINE PH.EUR. 3.3G. CALCIUM CHLORIDE Valine Ph.Eur. 3.3g. Calcium chloride
2H2O PH.EUR. CORRESPONDING TO CALCIUM 2H2O Ph.Eur. corresponding to Calcium
CHLORIDE 0.33G, SODIUM chloride 0.33g, Sodium
GLYCEROPHOSPHATE glycerophosphate
PH.FRANC.CORRESPONDING TO SODIUM Ph.Franc.corresponding to Sodium
GLYCEROPHOSPHATE (ANHYDROUS) 2.3G, glycerophosphate (anhydrous) 2.3g,
MAGNESIUM SULPHATE 7H2O PH.EUR. Magnesium sulphate 7H2O Ph.Eur.
CORRESPONDING TO MAGNESIUM SULPHATE corresponding to Magnesium sulphate
0.72G, POTASSIUM CHLORIDE PH.EUR. 2.7G, 0.72g, Potassium chloride Ph.Eur. 2.7g,
SODIUM ACETATE 3H2O PH.EUR. Sodium acetate 3H2O Ph.Eur.
CORRESPONDING TO SODIUM ACETATE 2.2G, corresponding to Sodium acetate 2.2g,
WATER FOR INJECTIONS PH.EUR. TO 450ML. Water for injections Ph.Eur. to 450ml.
GLACIAL ACETIC ACID PH.EUR. Q.S.TO PH Glacial acetic acid Ph.Eur. q.s.to pH
APPROX. 5.6. approx. 5.6.
(3) INTRALIPID ® 20% 300ML CONTAINS: (3) Intralipid ® 20% 300ml contains:
PURIFIED SOYBEAN OIL PH.EUR. 60G, PURIFIED Purified soybean oil Ph.Eur. 60g, Purified
EGG PHOSPHOLIPIDS 3.6G, GLYCEROL egg phospholipids 3.6g, Glycerol
(ANHYDROUS) PH.EUR. 6.6G, WATER FOR (anhydrous) Ph.Eur. 6.6g, Water for
INJECTIONS PHEUR TO 300ML SODIUM Injections PhEur To 300ml Sodium
5 P3640 (1) GLUCOSE 11% 1180 ML CONTAIN: Kabiven Peripheral 1400 Fresnius kabi AB, S- Intravenous (1) Glucose 11% 1180 ml contain: Restricted for Re 15.08.2017 Can be imported by State
GLUCOSE (ANHYDROUS) PH. EUR. 130G, WATER kcal 75174 Uppsala, emulsion for Glucose (anhydrous) Ph. Eur. 130g, Hospital use 14.08.2022 Trading Organization Plc
FOR INJECTIONS PH. EUR TO 1180 ML. Sweden Infusion Water for injections Ph. Eur to 1180 ml. o n l y Each Shipment Only
(2) VAMIN ® 18 NOVUM 400ML CONTAIN: (2) Vamin ® 18 Novum 400ml contain: should be
ALANINE PH.EUR. 6.4G, ARGININE PH.EUR. Alanine Ph.Eur. 6.4g, Arginine Ph.Eur. accompanied
4.5G, ASPARTIC ACID PH.EUR. 1.4.0G, 4.5g, Aspartic acid Ph.Eur. 1.4.0g, by the batch
GLUTAMIC ACID PH.EUR. 2.2G, GLYCINE Glutamic acid Ph.Eur. 2.2g, Glycine certificates
PH.EUR. 3.2G, HISTIDINE PH.EUR. 2.7G, Ph.Eur. 3.2g, Histidine Ph.Eur. 2.7g,
ISOLEUCINE PH.EUR. 2.2G, LEUCINE PH.EUR. Isoleucine Ph.Eur. 2.2g, Leucine Ph.Eur.
3.2G,LYSINE HYDROCHLORIDE PH.EUR. 3.2g,Lysine hydrochloride Ph.Eur.
CORRESPONDING TO LYSINE 3.6G, METHIONINE corresponding to Lysine 3.6g,
PH.EUR. 2.2G, PHENYLALANINE PH. EUR. 3.2G, Methionine Ph.Eur. 2.2g, Phenylalanine
PROLINE PH.EUR. 2.7G, SERINE PH.EUR. 1.8G, Ph. Eur. 3.2g, Proline Ph.Eur. 2.7g, Serine
THREONINE PH.EUR.2.2G, TRYPTOPHAN Ph.Eur. 1.8g, Threonine Ph.Eur.2.2g,
PH.EUR.0.76G, TYROSINE PH.EUR. 0.09G, Tryptophan Ph.Eur.0.76g, Tyrosine
VALINE PH.EUR. 2.9G. CALCIUM CHLORIDE Ph.Eur. 0.09g, Valine Ph.Eur. 2.9g.
2H2O PH.EUR. CORRESPONDING TO CALCIUM Calcium chloride 2H2O Ph.Eur.
CHLORIDE 0.30G, SODIUM corresponding to Calcium chloride 0.30g,
GLYCEROPHOSPHATE Sodium glycerophosphate
PH.FRANC.CORRESPONDING TO SODIUM Ph.Franc.corresponding to Sodium
GLYCEROPHOSPHATE (ANHYDROUS) 0.64G, glycerophosphate (anhydrous) 0.64g,
MAGNESIUM SULPHATE 7H2O PH.EUR. Magnesium sulphate 7H2O Ph.Eur.
CORRESPONDING TO MAGNESIUM SULPHATE corresponding to Magnesium sulphate
0.64G, POTASSIUM CHLORIDE PH.EUR. 2.4G, 0.64g, Potassium chloride Ph.Eur. 2.4g,
SODIUM ACETATE 3H2O PH.EUR. Sodium acetate 3H2O Ph.Eur.
CORRESPONDING TO SODIUM ACETATE 2.0G, corresponding to Sodium acetate 2.0g,
WATER FOR INJECTIONS PH.EUR. TO 400ML. Water for injections Ph.Eur. to 400ml.
GLACIAL ACETIC ACID PH.EUR. Q.S.TO PH Glacial acetic acid Ph.Eur. q.s.to pH
APPROX. 5.6. (3) approx. 5.6. (3) (3)
INTRALIPID ® 20% 340ML CONTAIN: Intralipid ® 20% 340ml contain:
SOYBEAN OIL PH.EUR. 68G, PURIFIED EGG soybean oil Ph.Eur. 68g, Purified egg
PHOSPHOLIPIDS 4.1G, GLYCEROL (ANHYDROUS) phospholipids 4.1g, Glycerol (anhydrous)
PH.EUR. 7.5G, WATER FOR INJECTIONS PH.EUR. Ph.Eur. 7.5g, Water for Injections Ph.Eur.
TO 340ML SODIUM HYDROXIDE PH EUR QS To 340ml Sodium hydroxide Ph Eur qs
6 P1306 4-CARBOXYMETHYLAMINO-4-AMINO- Otogesic J&J, India Ear Drops 0.84% + 1.1%(USP) + 0.4% + 76% + POM PP
DIPHENYLSULPHONE DIBUCAINE + N.N- 18%(USNF)
DIOXYMETHYLCARBOMIDE + GLYCERINE +
POLYTHENE GLYCOL (USNF)
7 P369 A and B – Strains ( Propagated on hen’s eggs) VACCINE INFLUENZA Pre-Authorization Injection POM (Controlled) Restricted and TA E 05.04.2017
equivalent to, required before import to be used for
- A/Michigan/45/2015 (H1N1) /pdm09 like the National
strain (A/Singapore /GP1908/2015,IVR-180 ) programme
- A/HongKong/4801/2014 (H3N2) Like strain only
(A/HongKong/4801/2014X-263B)
- B/Brisbane /60/2008-like strain
(B/Brisbane/60/2008, Wild type )
8 P410 ABACAVIR Abacavir Pre-Authorization Tablet 300 mg Restricted and PP Product registered based
required before import to be used for on a special request from a
the National clinician
programme
only
9 P411 ABACAVIR Abacavir Pre-Authorization Oral Liquid 100mg/5ml Restricted and PP Product registered based
required before import to be used for on a special request from a
the National clinician
programme
l
10 P2619 ABACAVIR Abacavir Pre-Authorization Oral Liquid 10 mg/ml Restricted and TA 10.07.2012 Product registered based
required before import to be used for on a special request from a
the National clinician
programme
only
11 P3793 ABCIXIMAB Abciximab Pre-authorization Injection 10mg/5ml Restricted for TA 11.10.2016- Registered by Physician
required before import Hospital use 10.10.2021 Request Form.
only
12 P2123 ACARBOSE Glucar - 50 Glenmark , India Tablet 50 mg BP POM R
13 P3045 ACARBOSE (STARCH, MICROCRYSTALLINE Acarbose (starch, Pre-Authorization Tablet 25mg POM PP E 20.05.2014
CELLULOSE, MAGNESIUM STEARATE, AND microcrystalline cellulose, required before import
COLLOIDAL SILICON DIOXIDE) magnesium stearate, and
colloidal silicon dioxide)
14 P3046 ACARBOSE (STARCH, MICROCRYSTALLINE Acarbose (starch, Pre-Authorization Tablet 100 mg POM PP E 20.05.2014
CELLULOSE, MAGNESIUM STEARATE, AND microcrystalline cellulose, required before import
COLLOIDAL SILICON DIOXIDE) magnesium stearate, and
colloidal silicon dioxide)
15 P3678 ACECLOFENAC Acelodon Swiss Garnier Life Tablet 100 mg POM Re 01.03.2016- Can be imported by AMDC
Sciences, India 28.02.2021 Pvt Ltd Only
16 P2716 ACECLOFENAC Acedol Torrent Tablet 100 mg BP POM R 19.02.2013 Registered by Life Support
Pharmaceuticals, India Pvt Ltd
17 P2423 ACECLOFENAC Aceclo Aristo India Tablet 100 mg POM R 25.10.2010 Registered by ADK
Company Pvt Ltd
18 P2275 ACECLOFENAC Acenac Medley Ltd, India. Tablet 100 mg (BP) POM R Registered by ADK
Company Pvt Ltd
19 P3140 ACECLOFENAC Aeronac Cassel Research Tablet 100 mg (BP) POM R 19.08.2014 My Chemist
Laboratories, India
20 P3508 ACECLOFENAC Acenac-SR Medley Ltd, India. Sustained 200 mg BP POM Re 19.05.2015- Can be imported by Adk
Release Tablet 18.05.2020 Company Pvt Ltd Only
21 P3267 ACECLOFENAC + LINSEED OIL +METHYL Stednac Stedman Gel 1.5% w/w( BP) + 3% (BP)+ 10%( BP) + 5%( POM R 06.01.2015 AMDC Pvt Ltd
SALICYLATE + MENTHOL GEL Pharmaceuticals, India USP)
22 P3389 ACENOCOUMAROL Acenocoumarol Pre-Authorization Tablet 2 mg POM TA 17.02.2015 Product registered based
required before import on a special request from a
clinician
23 P3390 ACENOCOUMAROL Acenocoumarol Pre-Authorization Tablet 3 mg POM TA 17.02.2015 Product registered based
required before import on a special request from a
clinician
24 P1764 ACETAZOLAMIDE IP Diamox Wyeth Limited, Plot Uncoated Tablet 250 mg POM PP
No. L-137, Phase III-A,
Verna Industrial Estate,
Verna, Goa 403 722,
India
25 P2427 ACETYL SALICYLIC ACID Delisprin 75 Aristo India Tablet (Delayed 75 mg POM R 25.10.2010 ADK Company Pvt Ltd
Release)
26 P573 ACETYL SALICYLIC ACID ASA German Remedies Tablet 50 mg POM PP E
India
27 P1411 ACETYL SALICYLIC ACID Colsprin Reckkit & Colman, Tablet 325 mg POM PP E
India
28 P1412 ACETYL SALICYLIC ACID Colsprin 100 Reckkit & Colman, Tablet 100 mg POM PP E
India
29 P1413 ACETYL SALICYLIC ACID ACETYL SALICYLIC ACID Pre-Authorization Tablet 100 mg POM PP E
required before import
30 P1414 ACETYL SALICYLIC ACID ACETYL SALICYLIC ACID Pre-Authorization Tablet 300 mg POM PP E
required before import
31 P3932 ACETYL SALICYLIC ACID (ASPIRIN) Casprin Y.S.P. Industries (M) Enteric 100 mg POM Re 01.11.2016 - Can be imported by
Sdn. Bhd. Lot 3, 5 & 7, Microencaptulat 31.10.2021 Treetop Health Pvt Ltd
Jalan P/7, Section 13, ed Capsule only
Kawasan Perindustrian
Bandar Baru bangi,
43000 Kajang, Selangor
Darul Ehsan, Malaysia
32 P122 ACETYLCYSTEINE Mucomix Samarth Life Sciences, Injection 200 mg/ml in 10ml Restricted for EA E 08.10.2017 -
India Hospital use 07.10.2018
only
33 P1927 ACETYLSALICYLIC ACID (ASPIRIN) Ecosprin-150 USV Limited, At: 137/B, Enteric coated 150 mg POM PP E
New No. 11/3, 4th (gastro-resistant)
Main Road, Indl. Town, Tablet
Rajajinagar, Bangalore -
560 044, India
34 P1926 ACETYLSALICYLIC ACID (ASPIRIN) Ecosprin-75 USV Private Limited, Enteric coated 75 mg POM PP E
INDIA (gastro-resistant)
Tablet
35 P1410 ACETYLSALICYLIC ACID IP Disprin Reckkit Benckiser Uncoated 350mg POM PP E
(India) Ltd.,At 61 & 62, Effervescent
Hootagalli Ind. Area, Tablet
Mysore -570 018 India
36 P2611 ACICLOVIR/ ACYCLOVIR Virest Hovid Bhd,Malayisa Cream 5% POM R 10.07.2012 Registered by GKT
Pharmacy
37 P2982 ACICLOVIR/ ACYCLOVIR ACYCLOVIR Pre-Authorization Injection 250mg POM PP E 20.05.2014
required before import
38 P2184 ACICLOVIR/ ACYCLOVIR Herperax 800 Micro Labs ltd Tablet 800 mg USP POM R E Registered by ADK
Company Pvt Ltd
39 P2185 ACICLOVIR/ ACYCLOVIR Herperax 200 Micro Labs ltd Tablet 200 mg POM R E Registered by ADK
Company Pvt Ltd
40 P2607 ACICLOVIR/ ACYCLOVIR Virest Hovid Bhd,Malayisa Tablet 400 mg POM R 10.07.2012 Registered by GKT
Pharmacy
41 P2608 ACICLOVIR/ ACYCLOVIR Virest Hovid Bhd,Malayisa Tablet 200 mg POM R 10.07.2012 Registered by GKT
Pharmacy
42 P2804 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline , Tablet 200 mg POM R 26.08.2013 Registered by ADK
Spain Company Pvt Ltd
43 P2805 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline , Tablet 800 mg POM R 26.08.2013 Registered by ADK
Spain Company Pvt Ltd
44 P2203 ACICLOVIR/ ACYCLOVIR Herperax Micro Labs ltd Ointment 5% POM R E Registered by ADK
Company Pvt Ltd