Official announcements
Replacement
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Medicines
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14/04/2011
The licensee informed its supplied customers by telephone from April 12 to 14, 2011, that the valves of the affected gas cylinders are malfunctioning, so that there is a risk of under/overdosing of oxygen. The affected gas cylinders will be replaced.
Replacement
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Medicines
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13/04/2011
In a letter dated April 12, 2011, the marketing authorization holder informed its customers that visible particles had been detected in two batches after the expiry date of 18 months had been exceeded. As a precautionary measure, all batches that…
Recall
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Medicines
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01/04/2011
In a letter dated March 30, 2011, the marketing authorization holder informed its supplied customers of a precautionary recall, as isolated precipitations of the active ingredient within the shelf life of the prepared infusion solution specified in…
messages in brief
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08/03/2011
Prevenar (active ingredient: pneumococcal polysaccharides of serotype 4, 6B, 9V, 14, 18C, 19F and 23F, conjugated to CRM197 carrier protein, adsorbed) has been licensed since 2001 under the centralized procedure in all EU member states for children…
messages in brief
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03/03/2011
[Translate to english:] EudraCT - Umstellung auf Version 8
Replacement
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Medicines
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21/02/2011
The marketing authorization holder informed its supplied customers by letter dated Feb. 21, 2011, that information for use in Norwegian language was enclosed in this batch, which is intended for the drug Sarotex tablets.
Replacement
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Medicines
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10/02/2011
The marketing authorization holder has informed its supplied customers that results from stability data indicate a possible shortfall of the required active ingredient content by the end of the shelf life. The affected batch currently meets all…
Safety warnings
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Blood & Tissue
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04/02/2011
Increased caution should be exercised in travelers with compatible symptomatology.
Replacement
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Medicines
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03/02/2011
The marketing authorization holder informed its supplied customers in a letter dated February 3, 2011, that empty or almost empty prefilled syringes had been discovered in individual packages of the above batch and that the batch would therefore be…
messages in brief
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02/02/2011
AGES PharmMed is receiving a high number of requests to act as Reference Member State for the Mutual Recognition and Decentralised Procedure. The routine of allocating time slots for DC procedures allows better scheduling of applications and…
