| View |
|
DRP-12786
|
Sodium Chloride
|
none
|
9 mg/mL (0.9% w/v)
|
Solution for I.V. Infusion
|
Electrolyte Replenisher
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
18 June 2024
|
07 October 2027
|
| View |
|
DR-XY40807
|
Tamsulosin Hydrochloride
|
Prozelax
|
400 mcg
|
Capsule
|
Alpha-Adrenoceptor Antagonist
|
UNILAB, Inc.
|
Philippines
|
Initial (Correction)
|
07 February 2023
|
14 October 2027
|
| View |
BR-1425_PI_01.pdf
|
BR-1425
|
Pneumococcal Polysaccharide Conjugate Vaccine, 15
Valent (Adsorbed)
|
Vaxneuvance
|
Formulation: Each dose (0.5 mL) contains: Streptococcus pneumoniae polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 197, 22F, 23F, 33F- 2 ug Streptococcus pneumoniae polysaccharide serotype 6B-4 ug CRM197 -30ug
|
Suspension for Injection (IM)
|
Vaccines
|
MSD International GmbH T/A MSD Ireland (Carlow)
|
Ireland
|
Monitored Release (Re-application) [Correction]
|
08 February 2023
|
17 October 2027
|
| View |
|
DRP-12833
|
Lidocaine + Prilocaine
|
Xylocream
|
25 mg/25 mg per gram (2.5%/2.5 % w/w)
|
Topical Cream
|
Local Anesthetic (Amides)
|
Rafarm S.A.
|
Greece
|
Initial
|
12 October 2022
|
12 October 2027
|
| View |
|
DRP-12806
|
Gabapentin
|
Neuroxin
|
100mg
|
Capsule
|
Antiepileptic
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
17 October 2022
|
17 October 2027
|
| View |
DR-XY48407_PI_01.pdf
|
DR-XY48407
|
Indacaterol Acetate + Glycopyrronium Bromide + Mometasone Furoate
|
Enerzair Breezhaler
|
150mcg/50mcg/80mcg
|
Powder for inhalation in Hard capsules
|
Selective Beta-2 adrenoreceptor Agonist/
Anticholinergic/ Corticosteroid
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2025
|
| View |
|
DRP-12848
|
Sodium Valproate
|
Braiporin
|
200 mg/5 mL
|
Syrup
|
-
|
Akums Drugs & Pharmaceuticals Ltd. (Plant II)
|
India
|
Initial
|
14 October 2022
|
14 October 2027
|
| View |
|
DR-XY48408
|
Indacaterol (as acetate) + Glycopyrronium (as bromide)
+ Mometasone Furoate
|
None
|
150 mcg/ 50 mcg/ 80 mcg
|
Powder for Inhalation in Hard Capsule
|
Selective Beta-2 adrenoreceptor Agonist/
Anticholinergic/ Corticosteroid
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2025
|
| View |
|
THPRP-003
|
Clinopodium polycephalum (Clinopodium Herb) Aerial
Part Extract
|
None
|
350 mg
|
Capsule
|
Traditionally used to help stop heavy bleeding during menstrual period.
|
Phil. United Pharma Corp.
|
Philippines
|
Initial (OTC][PCPR]
|
13 October 2022
|
13 October 2027
|
| View |
DR-XY48418_PI_01.pdf
|
DR-XY48418
|
Vericiguat
|
Verquvo
|
2.5 mg
|
Film-Coated Tablet
|
-
|
Bayer AG
|
|
Monitored Release
|
13 October 2022
|
13 October 2027
|
| View |
DR-XY48419_PI_01.pdf
|
DR-XY48419
|
Vericiguat
|
Verquvo
|
5 mg
|
Film-Coated Tablet
|
-
|
Bayer AG
|
|
Monitored Release
|
13 October 2022
|
13 October 2027
|
| View |
DR-XY48420_PI_01.pdf
|
DR-XY48420
|
Vericiguat
|
Verquvo
|
10 mg
|
Film-Coated Tablet
|
-
|
Bayer AG
|
|
Monitored Release
|
13 October 2022
|
13 October 2027
|
| View |
|
DRP-12824
|
Irinotecan (as hydrochloride)
|
None
|
20 mg/ mL (500 mg/ 25 mL)
|
Concentrate Solution for Intravenous (I.V.) Infusion
|
Antineoplastic (Topoisomerase 1 (TOP1) Inhibitor]
|
Eugia Pharma Specialties Limited
|
India
|
Initial
|
11 October 2022
|
11 October 2027
|
| View |
|
DRP-12861
|
Tadalafil
|
DocFil
|
20 mg
|
Film Coated Tablet
|
-
|
Phil. United Pharma Corporation
|
Philippines
|
Initial
|
17 October 2022
|
17 October 2027
|
| View |
|
DRP-12862
|
Tadalafil
|
Golafil
|
20mg
|
Film Coated Tablet
|
Phosphodiesterase Type-5 Inhibitor
|
Phil. United Pharma Corporation
|
Philippines
|
Initial
|
17 October 2022
|
17 October 2027
|
| View |
|
DRP-12831
|
Oxytocin
|
Acutocin
|
10 IU/mL
|
Solution for Injection (I.M./I.V./S.C.)
|
Posterior Pituitary Lobe Hormone
|
Aculife Healthcare Private Limited
|
India
|
Initial
|
13 October 2022
|
13 October 2027
|
| View |
|
DRP-12837
|
Acetylcysteine
|
Mucolus
|
600mg
|
Granules For Oral Solution (Lemon Flavor)
|
Mucolytic
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
13 October 2022
|
13 October 2027
|
| View |
|
DRP-12846
|
Paracetamol
|
Pyrekon
|
10 mg/mL (1 g/100 mL)
|
Solution for Intravenous
Infusion
|
-
|
Aishwarya Lifesciences
|
India
|
Initial (Correction)
|
28 December 2022
|
14 October 2027
|
| View |
|
DRP-12847
|
Citicoline (as Sodium)
|
Colitab
|
500 mg
|
Film-Coated Tablet
|
Psychostimulant and Nootropic
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
14 October 2022
|
14 October 2027
|
| View |
|
DRP-12809
|
Ketorolac Trometamol
|
Ophthagesic
|
5mg/ mL (0.5% w/v)
|
Ophthalmic Solution (Drops)
|
Anti-inflammatory Agent, Non-Steroid
|
World Medicine Ilac Sanayi ve Ticaret A.S.
|
Turkey
|
Initial
|
07 October 2022
|
07 October 2027
|