SmPC - Pelgraz 6 mg solution for injection in pre-filled syringe (PLGB 20075/1306): Change history
View Summary of Product Characteristics (SmPC - Pelgraz 6 mg solution for injection in pre-filled syringe (PLGB 20075/1306))
Last updated on this site: 09 Aug 2024
To register the deletion of the black symbol and explanatory statements for medicinal products in the list of medicinal products that are subject to additional monitoring. Minor spelling corrections were made to the PIL.
Last updated on this site: 09 Aug 2024
To register the deletion of the black symbol and explanatory statements for medicinal products in the list of medicinal products that are subject to additional monitoring. Minor spelling corrections were made to the PIL.
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Changes: (Updated: 09 Aug 2024)
To register the deletion of the black symbol and explanatory statements for medicinal products in the list of medicinal products that are subject to additional monitoring. Minor spelling corrections were made to the PIL.
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Changes: (Updated: 03 Oct 2023)
Description of update: To register a change in the storage condition of the finished product at room temperature (not above 25°C ± 2°C) from a "single period of up to 72 hours" to a "single period of 15 days". As a result, the leaflet and section 6.4 of the SPC have been updated.
SmPC sections updated: 6.4, 10.
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Changes: (Updated: 12 Jul 2023)
Description of update:
1. B.II.e.6.a (Type-IB) To replace needle guard from West Pharmaceuticals service with Nemera Buffalo Grove LLC for Pelgraz 6 mg/0.6 mL solution for injection in pre-filled syringe
2. B.II.e.4.c (Type-IB) To incorporate Nemera flange from Nemera Buffalo Grove LLC for Pelgraz 6 mg/0.6 mL solution for injection in pre-filled syringe
3. B.II.e.4.c (Type-IB) To replace Eris plunger rod from West Pharmaceutical services with Nemera plunger rod from Nemera Buffalo Grove LLC for Pelgraz 6 mg/0.6 mL solution for injection in pre-filled syringe 4. B.II.e.7.b (Type-IA)
To replace West Pharmaceuticals service with Nemera Buffalo Grove LLC as a supplier of Needle guard and Plunger rod for Pelgraz 6 mg/0.6 mL solution for injection in pre-filled syringe
Variation classification for Change 2:5. Change I and II: B.II.e.2.b (Type IB)- To add new
specification parameter to the specification with its
corresponding test method (one scope per specification parameter) 6. Change III: B.III.2.z (Type IB) Change to comply with Ph. Eur. or with a national pharmacopoeia of a Member State - Other change
SmPC sections updated: 6.5, 6.6, 10.
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Changes: (Updated: 21 Sep 2022)
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