View |
|
DR-XY45839
|
Flurbiprofen
|
Strepsils MaxPro
|
8.75mg
|
Lozenge (Honey and Lemon Flavor)
|
Throat Preparation (for sore throat)
|
Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.
|
Thailand
|
Automatic Renewal
|
04 February 2022
|
05 April 2027
|
View |
|
DR-XY45840
|
Hydroxyethyl Starch + Sodium Chloride
|
Sanbe Hest 130
|
60mg/ 9mg permL (30g/ 4.5g per 500mL) (6%/ 0.9% w/v)
|
Solution for IV Infusion
|
Plasma Expander/Blood Substitute
|
PT Sanbe Farma
|
Indonesia
|
Automatic Renewal
|
08 February 2022
|
30 March 2027
|
View |
|
DR-XY45841
|
Hydroxyethyl Starch + Sodium Chloride
|
Sanbe Hest 200
|
60mg/ 9mg permL (30g/ 4.5g per 500mL) (6%/ 0.9% w/v)
|
Solution for IV Infusion
|
Plasma Expander/Blood Substitute
|
PT Sanbe Farma
|
Indonesia
|
Automatic Renewal
|
23 February 2022
|
30 March 2027
|
View |
DR-XY45842_PI_01.pdf
|
DR-XY45842
|
Ibrutinib
|
Imbruvica
|
140 mg
|
Capsule
|
-
|
Catalent CTS, Inc.
|
United States of America
|
Monitored Release (Variation)
|
09 May 2023
|
09 May 2028
|
View |
|
DR-XY45843
|
Paracetamol
|
Tempra Forte
|
250mg/ 5 mL
|
Syrup
|
Analgesic/Antipyretic (Anilide)
|
Interphil Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
04 April 2022
|
12 April 2027
|
View |
DR-XY45844_PI_01.pdf
|
DR-XY45844
|
Ruxolitinib (as phosphate)
|
Jakavi
|
10 mg
|
Tablet
|
-
|
Novartis Pharma Stein AG
|
Switzerland
|
Initial (from monitored Release status)
|
12 January 2024
|
04 April 2027
|
View |
|
DR-XY45845
|
Cefotaxime (as sodium)
|
Ceforin
|
1g
|
Powder for Injection
|
Antibacterial (Cephalosporin)
|
Haikou Pharmaceutical Factory Co., Ltd.
|
China
|
Automatic Renewal
|
31 March 2022
|
03 April 2027
|
View |
|
DR-XY45846
|
Strontium ranelate
|
Onita
|
2g
|
Granules for Oral Suspension
|
Anti Osteoporosis
|
PharmEvo (Pvt.) Ltd.
|
Pakistan
|
Renewal
|
20 June 2022
|
03 April 2027
|
View |
|
DR-XY45847
|
Saccharomyces boulardii
|
Actiflor
|
250mg
|
Lyophilized Powder for Oral Suspension
|
Anti diarrheal
|
PharmEvo (Pvt.) Ltd.
|
Pakistan
|
Renewal
|
21 June 2022
|
03 April 2027
|
View |
|
DR-XY45849
|
Metronidazole + Miconazole nitrate
|
Trimic
|
500mg/100mg
|
Vaginal Suppository
|
Antiprotozoal/Antibacterial/Antifungal
|
Bliss GVS Pharma Limited
|
India
|
Automatic Renewal
|
04 April 2022
|
11 April 2027
|
View |
|
DR-XY45852
|
PARACETAMOL + CAFFEINE + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE
|
GRIPGO
|
500 mg / 30 mg/ 10 mg/ 2 mg
|
Tablet
|
ANALGESIC / ANTIPYRETIC / ANTIHISTAMINE / NASAL DECONGESTANT
|
Kusum Healthcare Private Limited
|
India
|
Renewal
|
09 March 2024
|
12 April 2029
|
View |
|
DR-XY45858
|
Nadifloxacin
|
Nadixa
|
10 mg/g (1% w/w)
|
Cream
|
Antibacterial (Fluoroquinolone)
|
Ferrer Internacional, S.A.
|
Spain
|
Initial
|
28 March 2022
|
12 April 2027
|
View |
|
DR-XY45859
|
Fluconazole
|
Flusum
|
5mg/ g (0.5% w/w)
|
Gel
|
ANTIFUNGAL
|
Kusum Healthcare Private Limited
|
India
|
Automatic Renewal
|
04 February 2022
|
26 April 2027
|
View |
|
DR-XY45862
|
Citicoline Sodium
|
Neurovell
|
125mg/ mL
|
Solution for Injection (IV/IM)
|
Psychostimulant/Nootropic
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Automatic Renewal
|
28 February 2022
|
27 April 2027
|
View |
|
DR-XY45863
|
Citicoline Sodium
|
Neurovell
|
125mg/ mL
|
Solution for Injection (IV/IM)
|
Psychostimulant/Nootropic
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Automatic Renewal
|
04 March 2022
|
27 April 2027
|
View |
|
DR-XY45868
|
Lactulose
|
Alvolaxus
|
3.3g/ 5mL (10g/ 15mL)
|
Oral Solution
|
Laxative
|
Fresenius Kabi Deutschland GmbH
|
Austria
|
Automatic Renewal
|
08 November 2022
|
31 May 2027
|
View |
|
DR-XY45870
|
Oxaliplatin
|
None
|
5mg/ mL
|
Concentrate Solution fro Infusion
|
Antineoplastic (Platinum Compound)
|
Zydus Hospira Oncology Pvt. Ltd.
|
India
|
Renewal
|
20 May 2022
|
09 May 2027
|
View |
|
DR-XY45872
|
Testosterone undecanoate
|
Nebido
|
250mg/ mL (1 g/ 4mL)
|
Solution for Injection (I.M.)
|
Sex Hormone (Androgen)
|
Bayer Pharma AG
|
Germany
|
Renewal
|
18 May 2022
|
08 May 2027
|
View |
|
DR-XY45873
|
Ascorbic Acid
|
Vitarex-C
|
250mg/ mL (500mg/2mL)
|
Solution for IV Injection
|
Vitamin
|
Grand Pharmaceutical (China) Co., Ltd.
|
China
|
Automatic Renewal
|
05 July 2022
|
08 May 2027
|
View |
|
DR-XY45875
|
Ezetimibe
|
Lupieze
|
10mg
|
Tablet
|
Cholesterol Absorption Inhibitor
|
Lupin Limited
|
India
|
Automatic Renewal
|
16 March 2022
|
10 May 2027
|