Last Updated on November 5, 2024
The Drug Regulatory Authority of Pakistan has started compilation of Summaries of Product Characteristics (SmPC) of approved drug products. This page contains information of registered drug products which include the links for the summary of product characteristics (SmPC) and the package leaflet or patient information leaflet.
The Summary of Product Characteristics (SmPC) are living documents and provides the basis of information for the healthcare professional on how to use the drug product. This information is updated throughout the life-cycle of drug product as new data emerges. The package leaflet or patient information leaflet are also based on the SmPC information.
- Important Note:
- If a patient or his/her caregiver has any questions about a product they should contact their doctor or pharmacist. Patients should not stop taking any prescribed medicines without consulting their healthcare professionals. Suspected adverse reactions to a medicine can be reported to Pharmacovigilance Centers via our online reporting channels.
- Please note that the product information provided here reflects a copy of the Summary of Product Characteristics and outline the conditions under which the product should be used as well as information on its known safety. While efforts are being made to ensure the information accuracy, however, errors and omissions are accepted. If any inconsistency is brought to our attention, rectifications will be made immediately. The product lists are made available for information purposes only.
| Product Name | Registration No. | Holder | Documents |
|---|---|---|---|
| Anoro Ellipta Dry Powder Inhaler | 088874 | M/s. GlaxoSmithKline Pakistan Limited, 35-Dockyard Road, West Wharf, Karachi. | SmPC |
| Incruse Ellipta Dry Powder Inhaler | 086486 | M/s. GlaxoSmithKline Pakistan Limited, 35-Dockyard Road, West Wharf, Karachi. | SmPC |
| LEDVIR 90 mg/400 mg Tablets) Film Coated Tablets | 085249 | AGP Limited B-23-C, S.I.T.E., Karachi. | SmPC |
| Myhep 400 mg/100 mg Tablets Film Coated Tablets | 088369 | AGP Limited B-23-C, S.I.T.E., Karachi. | SmPC |
| Seroquel 25mg Tablets Film Coated Tablets | 025269 | ICI Pakistan Limited, 5-West Wharf Karachi. | SmPC |
| Seroquel 100mg Tablets Film Coated Tablets | 025270 | ICI Pakistan Limited, 5-West Wharf Karachi. | SmPC |
| Seroquel 200mg Tablets Film Coated Tablets | 025298 | ICI Pakistan Limited, 5-West Wharf Karachi. | SmPC |
| Epirubicin HCl Karma 2mg/ml solution for injection T Solution for Injection | 103763 | M/s Lab Diagnostic Systems (SMC) Pvt Ltd Plot no 36-A, PSIC, SIE, Taxila, Rawalpindi | SmPC |
| Epirubicin HCl Karma 10mg/ml solution for injection T Solution for Injection | 101953 | M/s Lab Diagnostic Systems (SMC) Pvt Ltd Plot no 36-A, PSIC, SIE, Taxila, Rawalpindi | SmPC |
| DBL Docetaxel 80mg/8ml Injection concentrate for solution for infusion | 110567 | M/s Pfizer Pakistan Limited, 12 Dockyard Road, West Wharf, Karachi | SmPC |
| DBL Docetaxel 20 mg/2ml Injection concentrate for solution for infusion | 110566 | M/s Pfizer Pakistan Limited, 12 Dockyard Road, West Wharf, Karachi | SmPC |
| Eliquis 2.5mg Tablets Film coated Tablets | 105618 | M/s Pfizer Pakistan Limited, B-2, S.I.T.E., Karachi | SmPC |
| Eliquis 5mg Tablets Film coated Tablets | 105619 | M/s Pfizer Pakistan Limited, B-2, S.I.T.E., Karachi | SmPC |
| Vabysmo Faricimab | 120547 | M/s Roche Pakistan Ltd. 37-B 1st Floor, Block-6 P.E.C.H.S. P.O Box 20021 Karachi-75400 Pakistan | SmPC |
| Yuflyma 40 mg solution for injection Adalimumab | 120507 | M/s The Schazoo Pharmaceutical Laboratories Pvt. Ltd, Kalalwala 20 Km Lahore, Jaranwala Road, District Sheikhupura | SmPC |
| CAPD/DPCA 2 Stay Safe Link Peritoneal Dialysis Solution | 039884 | M/s Fresenius Medical Care Pakistan (Private) Ltd, 27-C-III, 1st Floor, TAMC Building, MM Alam Road, Gulberg-III Lahore | SmPC |
| CAPD/DPCA 2 Stay Safe Link Peritoneal Dialysis Solution | 039886 | M/s Fresenius Medical Care Pakistan (Private) Ltd, 27-C-III, 1st Floor, TAMC Building, MM Alam Road, Gulberg-III Lahore | SmPC |
| CAPD/DPCA 2 Stay Safe Link Peritoneal Dialysis Solution | 039887 | M/s Fresenius Medical Care Pakistan (Private) Ltd, 27-C-III, 1st Floor, TAMC Building, MM Alam Road, Gulberg-III Lahore | SmPC |
| ALECENSA CAPSULE 150MG | 106847 | M/S ROCHE PAKISTAN LIMITED, 1ST FLOOR, 37-B, BLOCK-6, P.E.C.H.S, KARACHI. | SmPC |
| EVRYSDI POWDER FOR ORAL SOLUTION 60MG/80ML | 110525 | M/S ROCHE PAKISTAN LIMITED, 1ST FLOOR, 37-B, BLOCK-6, P.E.C.H.S, KARACHI. | SmPC |
| ROZLYTREK CAPSULE 200MG | 110523 | M/S ROCHE PAKISTAN LIMITED, 1ST FLOOR, 37-B, BLOCK-6, P.E.C.H.S, KARACHI. | SmPC |
| ROZLYTREK CAPSULE 100MG | 110524 | M/S ROCHE PAKISTAN LIMITED, 1ST FLOOR, 37-B, BLOCK-6, P.E.C.H.S, KARACHI. | SmPC |
| TAMIFLU 75MG CAPSULES | 039619 | M/S ROCHE PAKISTAN LIMITED, 1ST FLOOR, 37-B, BLOCK-6, P.E.C.H.S, KARACHI. | SmPC |
| TARCEVA 25MG TABLETS | 043001 | M/S ROCHE PAKISTAN LIMITED, 1ST FLOOR, 37-B, BLOCK-6, P.E.C.H.S, KARACHI. | SmPC |
| TARCEVA 100MG TABLETS | 043002 | M/S ROCHE PAKISTAN LIMITED, 1ST FLOOR, 37-B, BLOCK-6, P.E.C.H.S, KARACHI. | SmPC |
| TARCEVA 150MG TABLETS | 043003 | M/S ROCHE PAKISTAN LIMITED, 1ST FLOOR, 37-B, BLOCK-6, P.E.C.H.S, KARACHI. | SmPC |
| VITA-C Injection 500mg Solution for Injection | 122463 | M/s AMB HK Enterprises (Pvt) Ltd., 2nd Floor, Plaza 60, Commercial Block-K, Phase-1 DHA, Lahore | SmPC |
| Cefitrin 1gm Injection | 115689 | M/s AMB HK Enterprises (Pvt) Ltd., 2nd Floor, Plaza 60, Commercial Block-K, Phase-1 DHA, Lahore | SmPC |
| Imaticor Tablet 400mg | 122435 | M/s AMB HK Enterprises (Pvt) Ltd., 2nd Floor, Plaza 60, Commercial Block-K, Phase-1 DHA, Lahore | SmPC |
| Evorane 100ml | 115712 | M/s AMB HK Enterprises (Pvt) Ltd., 2nd Floor, Plaza 60, Commercial Block-K, Phase-1 DHA, Lahore | SmPC |
| Omulcer 40mg Injection Lyophilized Powder for Injection | 122464 | M/s AMB HK Enterprises (Pvt) Ltd., 2nd Floor, Plaza 60, Commercial Block-K, Phase-1 DHA, Lahore | SmPC |
| Salbin Inhaler | 115774 | M/s AMB HK Enterprises (Pvt) Ltd., 2nd Floor, Plaza 60, Commercial Block-K, Phase-1 DHA, Lahore | SmPC |
| ReliTrexed 500mg Lyophilized Powder for Injection | 110545 | M/S. HELIX PHARMA (PVT) LTD., HAKIMSONS HOUSE, A/56, S.I.T.E. MANGHOPIR ROAD, KARACHI. | SmPC |
| ReliTrexed 100mg Lyophilized Powder for Injection | 110546 | M/S. HELIX PHARMA (PVT) LTD., HAKIMSONS HOUSE, A/56, S.I.T.E. MANGHOPIR ROAD, KARACHI. | SmPC |
| ERLOTIREL 100 TABLETS | 110564 | M/S. HELIX PHARMA (PVT) LTD., HAKIMSONS HOUSE, A/56, S.I.T.E. MANGHOPIR ROAD, KARACHI. | SmPC |
| Erlotirel 150 Tablets | ,110565 | M/S. HELIX PHARMA (PVT) LTD., HAKIMSONS HOUSE, A/56, S.I.T.E. MANGHOPIR ROAD, KARACHI. | SmPC |
| RELICITABINE 500 TABLET | 088875 | M/S. HELIX PHARMA (PVT) LTD., HAKIMSONS HOUSE, A/56, S.I.T.E. MANGHOPIR ROAD, KARACHI. | SmPC |
| RELICITABINE 150 TABLET | 088876 | M/S. HELIX PHARMA (PVT) LTD., HAKIMSONS HOUSE, A/56, S.I.T.E. MANGHOPIR ROAD, KARACHI. | SmPC |
| Briganix 180 Tablet | 122443 | M/s Himmel Pharmaceuticals (Pvt) Ltd, Ground Floor, 6-Judicial Colony, Phase-I (Ext) Shahrah Nazaria e Pakistan, Lahore | SmPC |
| Briganix 90 Tablet | 122444 | M/s Himmel Pharmaceuticals (Pvt) Ltd, Ground Floor, 6-Judicial Colony, Phase-I (Ext) Shahrah Nazaria e Pakistan, Lahore | SmPC |
| Cabozanix 20mg Capsule | 122431 | M/s Himmel Pharmaceuticals (Pvt) Ltd, Ground Floor, 6-Judicial Colony, Phase-I (Ext) Shahrah Nazaria e Pakistan, Lahore | SmPC |
| Cabozanix 60mg tablet | 122432 | M/s Himmel Pharmaceuticals (Pvt) Ltd, Ground Floor, 6-Judicial Colony, Phase-I (Ext) Shahrah Nazaria e Pakistan, Lahore | SmPC |
| Niraparix 100mg | 122445 | M/s Himmel Pharmaceuticals (Pvt) Ltd, Ground Floor, 6-Judicial Colony, Phase-I (Ext) Shahrah Nazaria e Pakistan, Lahore | SmPC |
| Palbonix 100mg Capsules | 122452 | M/s Himmel Pharmaceuticals (Pvt) Ltd, Ground Floor, 6-Judicial Colony, Phase-I (Ext) Shahrah Nazaria e Pakistan, Lahore | SmPC |
| Elidel 1% Cream | 122426 | M/s AGP Limited, B-23-C, SITE, Karachi | SmPC |
| Lectrum 7.50mg. Lyophilized for Injection | 115757 | M/s AGP Limited, B-23-C, SITE, Karachi | SmPC |
| Lectrum 3.75mg. Lyophilized for Injection | 115758 | M/s AGP Limited, B-23-C, SITE, Karachi | SmPC |
| Myhep 400mg Tablets | 080165 | M/s AGP Limited, B-23-C, SITE, Karachi | SmPC |
| Utrogestan 100mg Soft Capsule. | 116847 | M/s AGP Limited, B-23-C, SITE, Karachi | SmPC |
| Utrogestan 200mg Soft Capsule. | 116848 | M/s AGP Limited, B-23-C, SITE, Karachi | SmPC |
| Utrogestan 300mg Soft Capsules | 122460 | M/s AGP Limited, B-23-C, SITE, Karachi | SmPC |
| BENDAMUSTINE SEACROSS 100MG. POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION. | 103774 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| Capecitabine Normon 500 mg film-coated tablets | 081801 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| CASPOFUNGIN NORMON 70MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION. | 110551 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| CASPOFUNGIN NORMON 50MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION. | 110552 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| Biodoce Injection 20mg. | 114249 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| Biodoce Injection 80mg. | 114250 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| EXEMESTANE NORMON 25MG TABLET | 084588 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| IMATINIB NORMON 100MG TABLETS | 087621 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| IMATINIB NORMON 400MG TABLET | 087622 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| LUTRATE 1MONTH DEPOT (3.75MG) INJECTION | 081805 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| LUTRATE 3 MONTH DEPOT (22.5MG) POWDER FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION. | 086482 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| ONDANSETRON NORMON 8MG INJECTION | 081802 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| BIOPAC 100MG INJECTION | 078127 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| BIOPAC 300MG INJECTION | 078128 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| BIOPAC 30MG/5ML INJECTION | 082058 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| TEMOEIRGEN 100MG CAPSULE | 081803 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| TEMOEIRGEN 20MG CAPSULE | 081804 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| TEMOEIRGEN 250MG CAPSULE | 081778 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |
| ZOLEDRONIC ACID NORMON 4MG/5ML INJECTABLE | 082059 | M/S. MERIXIL PHARMA, OFFICE NO. 28, 2ND FLOOR, ROSE PLAZA I-8 MARKAZ, ISLAMABAD. | SmPC |