PIL- Nebivolol 5mg Tablets: Change history
View Patient Information Leaflet (PIL- Nebivolol 5mg Tablets)
Last updated on this site: 20 Jun 2023
Description of update: Grouped Variation
Variation type: IA, A.7: To register the deletion of Hetero Drugs Limited, India as a manufacturing site responsible for the manufacturing of the active substance and to register the deletion of Balkanpharma Dupnitsa AD, Bulgaria as a manufacturing site responsible for the manufacturing of the finished drug product, batch release and packaging of the finished product. Consequentially, the patient information leaflet has been updated.
Variation type: IA, B.II.b.2.a: To register the addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as a manufacturing site responsible for batch control testing site for Microbiological testing.
Variation type: IA, B.III.2.a.2: To register a change in the specification drug substance (Nebivolol hydrochloride) to fully comply with the Ph. Eur.
PIL section(s) updated - 6
Last updated on this site: 20 Jun 2023
Description of update: Grouped Variation
Variation type: IA, A.7: To register the deletion of Hetero Drugs Limited, India as a manufacturing site responsible for the manufacturing of the active substance and to register the deletion of Balkanpharma Dupnitsa AD, Bulgaria as a manufacturing site responsible for the manufacturing of the finished drug product, batch release and packaging of the finished product. Consequentially, the patient information leaflet has been updated.
Variation type: IA, B.II.b.2.a: To register the addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as a manufacturing site responsible for batch control testing site for Microbiological testing.
Variation type: IA, B.III.2.a.2: To register a change in the specification drug substance (Nebivolol hydrochloride) to fully comply with the Ph. Eur.
PIL section(s) updated - 6
-
Changes: (Updated: 20 Jun 2023)
Description of update: Grouped Variation
Variation type: IA, A.7: To register the deletion of Hetero Drugs Limited, India as a manufacturing site responsible for the manufacturing of the active substance and to register the deletion of Balkanpharma Dupnitsa AD, Bulgaria as a manufacturing site responsible for the manufacturing of the finished drug product, batch release and packaging of the finished product. Consequentially, the patient information leaflet has been updated.
Variation type: IA, B.II.b.2.a: To register the addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as a manufacturing site responsible for batch control testing site for Microbiological testing.
Variation type: IA, B.III.2.a.2: To register a change in the specification drug substance (Nebivolol hydrochloride) to fully comply with the Ph. Eur.
PIL section(s) updated - 6
-
Changes: (Updated: 22 Sep 2022)
initial upload