Summary of Product Characteristics (SmPC)

Last Updated on May 3, 2023

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 NameRegistration No.HolderDocuments
Anoro Ellipta
Dry Powder Inhaler
088874M/s. GlaxoSmithKline Pakistan Limited,
35-Dockyard Road, West Wharf, Karachi.
SmPC
Incruse Ellipta
Dry Powder Inhaler
086486M/s. GlaxoSmithKline Pakistan Limited,
35-Dockyard Road, West Wharf, Karachi.
SmPC
LEDVIR
90 mg/400 mg Tablets)

Film Coated Tablets
085249AGP Limited
B-23-C, S.I.T.E., Karachi.
SmPC
Myhep 400 mg/100 mg Tablets
Film Coated Tablets
088369AGP Limited
B-23-C, S.I.T.E., Karachi.
SmPC
Seroquel 25mg Tablets
Film Coated Tablets
025269ICI Pakistan Limited, 5-West Wharf Karachi.SmPC
Seroquel 100mg Tablets
Film Coated Tablets
025270ICI Pakistan Limited, 5-West Wharf Karachi.SmPC
Seroquel 200mg Tablets
Film Coated Tablets
025298ICI Pakistan Limited, 5-West Wharf Karachi.SmPC
Epirubicin HCl Karma 2mg/ml solution for injection T
Solution for Injection
103763M/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
101953M/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
110567M/s Pfizer Pakistan Limited, 12 Dockyard Road, West Wharf, KarachiSmPC
DBL Docetaxel 20 mg/2ml Injection
concentrate for solution for infusion
110566M/s Pfizer Pakistan Limited, 12 Dockyard Road, West Wharf, KarachiSmPC
Eliquis 2.5mg Tablets
Film coated Tablets
105618M/s Pfizer Pakistan Limited, B-2, S.I.T.E., KarachiSmPC
Eliquis 5mg Tablets
Film coated Tablets
105619M/s Pfizer Pakistan Limited, B-2, S.I.T.E., KarachiSmPC