Halcion 250 microgram Tablets
- Name:
Halcion 250 microgram Tablets
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/09/17
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Pfizer Healthcare Ireland
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 29 March 2019 SmPC
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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The SPC has been updated as follows: to update to section 5.3 Preclinical safety data – (Addition of Effect of anesthetic and sedative drugs) |
Updated on 11 September 2017 PIL
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.3 - Preclinical safety data
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
SPC: Sections 4.4, 4.5 and 5.3
Addition of warning (section 4.4) and drug interaction text (section 4.5) related to benzodiazepine/opioid interaction.
Addition of preclinical information related to carcinogenicity, mutagenesis, and impairment of fertility in section 5.3 of triazolam CDS.Updated on 11 September 2017 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
SPC: Sections 4.4, 4.5 and 5.3
Addition of warning (section 4.4) and drug interaction text (section 4.5) related to benzodiazepine/opioid interaction.
Addition of preclinical information related to carcinogenicity, mutagenesis, and impairment of fertility in section 5.3 of triazolam CDS.Updated on 11 September 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 6 September 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 8 July 2014 PIL
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Free text change information supplied by the pharmaceutical company
Update to sections 4.4, 4.6, 4.8
Updated on 8 July 2014 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to sections 4.4, 4.6, 4.8
Updated on 10 June 2014 PIL
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Free text change information supplied by the pharmaceutical company
Updates to Sections :
2. Qualitative and quantitative composition
Section updated in line with QRD Version 9
4.2 Posology and method of administration
Section updated in line with QRD Version 9
4.3. Contraindications
Section updated to include new contraindications in line with CDS.
4.4. Special warnings and precautions for use
Section updated in line with QRD Version 9
4.5. Interaction with other medicinal products and other forms of interaction
Statement on HIV protease inhibitors revised in line with CDS.
4.6. Fertility, pregnancy and lactation
Section updated in line with QRD Version 9
4.8 Undesirable effects
Section updated in line with QRD Version 9 and IMB details updated.
5.1 Pharmacodynamic properties
Section updated in line with QRD Version 9
6.6 Special precautions for disposal and other handling
Section updated in line with QRD Version 9 and IMB details updated.
Updated on 10 June 2014 SmPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updates to Sections :
2. Qualitative and quantitative composition
Section updated in line with QRD Version 9
4.2 Posology and method of administration
Section updated in line with QRD Version 9
4.3. Contraindications
Section updated to include new contraindications in line with CDS.
4.4. Special warnings and precautions for use
Section updated in line with QRD Version 9
4.5. Interaction with other medicinal products and other forms of interaction
Statement on HIV protease inhibitors revised in line with CDS.
4.6. Fertility, pregnancy and lactation
Section updated in line with QRD Version 9
4.8 Undesirable effects
Section updated in line with QRD Version 9 and IMB details updated.
5.1 Pharmacodynamic properties
Section updated in line with QRD Version 9
6.6 Special precautions for disposal and other handling
Section updated in line with QRD Version 9 and IMB details updated.