| View |
|
DR-XY41163
|
Nebivolol (as hydrochloride)
|
Nebil
|
5mg
|
Tablet
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial (from Monitored Release (MR) status)
|
08 June 2022
|
16 August 2025
|
| View |
DR-XY39352_PI_01.pdf
|
DR-XY39352
|
Dutasteride + Tamsulosin HCl
|
Duodart
|
500mcg/400 mcg
|
Capsule
|
Benign Prostatic Hypertrophy Drug (Alpha-adrenoceptor Antagonist)
|
Catalent Germany Schorndorf GmbH
|
Germany
|
Renewal
|
08 March 2024
|
20 April 2029
|
| View |
|
BR-1089
|
Measles, Mumps, Rubella and Varicella Vaccine (Live)
|
Proquad
|
Each dose (0.5 mL) contains: Measles virus (Edmonston B) 3.00 log TCID50* Mumps virus (Jeryl Lynn B level)4.30 log TCID50
Rubella virus (Wistar RA 27/3) 3.00 log TCID50
Varicella virus (Oka/Merck) 3.99 PFU**
*50% Tissue Culture Infectious Dose
**Plaque Forming Units
|
Lyophilized Powder For Solution For Injection (SC)
|
Vaccines
|
Merck Sharp & Dohme LLC
|
U.S.A
|
Initial (from Monitored Release) [Correction]
|
11 March 2024
|
09 June 2025
|
| View |
|
DR-XY40937
|
Iodixanol
|
Visipaque
|
652 mg/mL (equivalent to 320
mg Iodine)
|
Solution For Injection
|
Contrast Medium (Iodinated X-ray Contrast Medium)
|
GE Healthcare Ireland Ltd.
|
ireland
|
Initial (from Monitored Release Extension)
|
27 May 2022
|
04 June 2025
|
| View |
|
DR-XY44333
|
Rosuvastatin (as calcium)
|
Lowas 10
|
10 mg
|
Film-Coated Tablet
|
HMG CoA reductase inhibitor
|
XL Laboratories Pvt. Ltd.
|
India
|
Initial (from Monitored Release)
|
12 April 2022
|
23 March 2025
|
| View |
|
DR-XY31546
|
Pioglitazone (as hydrochloride)
|
Prialta
|
45 mg
|
Tablet
|
Oral Hypoglycemic (Thiazolidinedione)
|
Micro Labs Limited
|
India
|
Initial (from Monitored Release)
|
25 May 2022
|
08 March 2025
|
| View |
DR-XY40717_PI_01.pdf
|
DR-XY40717
|
Prucalopride Succinate
|
Resolor
|
1 mg
|
Film-Coated Tablet
|
-
|
Janssen-Cilag S.p.A
|
Italy
|
Initial (from Monitored Release Extension status); (Re-issuance)
|
14 July 2022
|
28 February 2025
|
| View |
DR-XY40715_PI_01.pdf
|
DR-XY40715
|
Prucalopride Succinate
|
Resolor
|
2 mg
|
Film-Coated Tablet
|
Enterokinetic
|
Janssen-Cilag S.p.A
|
Italy
|
Initial (from Monitored Release Extension status)
|
11 May 2022
|
28 February 2025
|
| View |
|
DRP-3783-01
|
Montelukast (as sodium)
|
None
|
4mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist
|
The Searle Company Limited
|
Pakistan
|
Renewal
|
15 June 2022
|
05 June 2027
|
| View |
|
DR-XY36266
|
Dexketoprofen (as trometamol)
|
Ketesse
|
25 mg/mL (50 mg/2mL)
|
Solution for Injection or
Concentrate for Solution for Infusion (I.M./I.V.)
|
Anti-Inflammatory and Anti-Rheumatic Product Non-Steroid
|
A.Menarini Manufacturing Logistics and Services
S.r.l.
|
Italy
|
Renewal
|
28 May 2024
|
17 July 2029
|
| View |
|
DR-XY31941
|
Nebivolol hydrochloride
|
Nebicar
|
5 mg
|
Tablet
|
Selective Beta Blocking Agents
|
Micro Labs Limited
|
India
|
Initial (from Monitored Release)
|
06 June 2022
|
05 July 2025
|
| View |
|
DR-XY44686
|
Carboprost (as tromethamine)
|
Endoprost
|
125 mcg/0.5 mL
|
Solution for Injection (I.M.)
|
Utrotonic (Prostaglandin)
|
Bharat Serums and Vaccines Ltd.
|
India
|
Initialfrom Monitored Release)
|
31 March 2022
|
30 June 2025
|
| View |
|
DR-XY44687
|
Carboprost (As Tromethamine)
|
Endoprost
|
250 mcg/mL
|
Solution for Injection (I.M.)
|
Utrotonic (Prostaglandin)
|
Bharat Serums and Vaccines Ltd.
|
India
|
Initialfrom Monitored Release)
|
31 March 2022
|
30 June 2025
|
| View |
DRP-1762_PI_01.pdf
|
DRP-1762
|
Rosuvastatin (as calcium)
|
Rovast
|
20 mg
|
Film-Coated Tablet
|
HMG CoA Reductase Inhibitor
|
Hizon Laboratories, Inc.
|
Philippines
|
Renewal
|
07 April 2024
|
09 July 2029
|
| View |
|
DRP-2065-01
|
Rosuvastatin (as Calcium)
|
Roswin
|
20 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG CoA Reductase Inhibitor)
|
Ajanta Pharma Limited
|
India
|
Renewal
|
25 July 2024
|
29 July 2029
|
| View |
|
DR-XY38046
|
Doxofylline
|
None
|
400 mg
|
Tablet
|
Drug for Obstructive Airway Diseases (Xanthine)
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial (from Monitored Release Extension)
|
25 April 2022
|
21 June 2025
|
| View |
|
DR-XY44245
|
Triptorelin (as embonate)
|
Pamorelin
|
22.5 mg
|
Lyophilized Powder for Injection (I.M.)
|
Antineoplastic/Gonadotropin-Releasing Hormone Analogue
|
Debiopharm Research & Manufacturing S.A.
|
Switzerland
|
Renewal
|
09 October 2024
|
27 February 2030
|
| View |
|
DR-XY44247
|
Triptorelin (as embonate)
|
Pamorelin
|
11.25 mg
|
Lyophilized Powder for Injection (I.M.)
|
Antineoplastic/Gonadotropin-Releasing Hormone Analogue
|
Debiopharm Research & Manufacturing S.A.
|
Switzerland
|
Renewal
|
15 September 2024
|
27 February 2030
|
| View |
|
DR-XY44246
|
Triptorelin (as embonate)
|
Pamorelin
|
3.75 mg
|
Lyophilized Powder For Injection (IM/SC)
|
Antineoplastic/Gonadotropin-Releasing Hormone Analogue
|
Debiopharm Research & Manufacturing S.A.
|
Switzerland
|
Renewal
|
27 September 2024
|
27 February 2030
|
| View |
|
DR-XY33105
|
Methimazole
|
Tapdin
|
20 mg
|
Tablet
|
Antithyroid
|
Sydenham Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
31 January 2022
|
14 March 2027
|