PIL- Isosorbide mononitrate 20mg, 40mg Tablets: Change history
View Patient Information Leaflet (PIL- Isosorbide mononitrate 20mg, 40mg Tablets)
Last updated on this site: 26 Oct 2023
Description of update:
1. To register the addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as a manufacturing site responsible for quality control testing of the finished product. Consequentially, the patient information leaflet has been updated.
2. To register the addition of Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow, Middlesex, HA1 4HF United Kingdom as a manufacturing site responsible for batch release of the finished product. Consequentially, the patient information leaflet has been updated.
PIL sections updated: 6.
Last updated on this site: 26 Oct 2023
Description of update:
1. To register the addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as a manufacturing site responsible for quality control testing of the finished product. Consequentially, the patient information leaflet has been updated.
2. To register the addition of Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow, Middlesex, HA1 4HF United Kingdom as a manufacturing site responsible for batch release of the finished product. Consequentially, the patient information leaflet has been updated.
PIL sections updated: 6.
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Changes: (Updated: 26 Oct 2023)
Description of update:
1. To register the addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as a manufacturing site responsible for quality control testing of the finished product. Consequentially, the patient information leaflet has been updated.
2. To register the addition of Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow, Middlesex, HA1 4HF United Kingdom as a manufacturing site responsible for batch release of the finished product. Consequentially, the patient information leaflet has been updated.
PIL sections updated: 6.
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Changes: (Updated: 20 Mar 2023)
Description of update:
The following change(s) has been notified:
IA (B.III.1.a.2) variation application to update European Pharmacopoeia certificate of suitability (R1-CEP 2013-172-Rev 01) from approved manufacturer ALBANY MOLECULAR RESEARCH Hyderabad Pvt. Ltd.
IA (B.III.1.a.2) variation application to update European Pharmacopoeia certificate of suitability (R1-CEP 2013-172-Rev 02) from approved manufacturer ALBANY MOLECULAR RESEARCH Hyderabad Pvt. Ltd.
Type IA (A.7) for deletion of Astron Research Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom as batch testing site.
Type IA (A.7) for deletion of Accord Healthcare Limited, UK 1st floor, Sage House, 319 Pinner Road, Harrow, HA1 4HF, United Kingdom as batch release site.
PIL sections updated: 6.
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Changes: (Updated: 20 Sep 2022)
initial upload