Indivina 1 mg/5 mg tablets | SPC | Orion Pharma (Ireland) Ltd

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Indivina 1 mg/5 mg tablets

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Name:
Indivina 1 mg/5 mg tablets
Company:
Orion Pharma (Ireland) Ltd
Active Ingredients:
Estradiol valerate, Medroxyprogesterone Acetate
Legal Category:
Product subject to medical prescription which may not be renewed (A)

Summary of Product Characteristics last updated on medicines.ie: 7/7/2016

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1. NAME OF THE MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

3. PHARMACEUTICAL FORM

4. CLINICAL PARTICULARS

5. PHARMACOLOGICAL PROPERTIES

6. PHARMACEUTICAL PARTICULARS

7. MARKETING AUTHORISATION HOLDER

8. MARKETING AUTHORISATION NUMBER(S)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10. DATE OF REVISION OF THE TEXT

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Medicine Name Indivina	Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 1 mg/2.5 mg tablets	Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 1 mg/5 mg tablets	Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 2 mg/5 mg tablets	Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
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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 7 July 2016 PIL

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

The safety information in sections 4.4 and 4.8 of the SPC in relation to the risks of ovarian cancer has been updated.

Updated on 7 July 2016 SPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The safety information in sections 4.4 and 4.8 of the SPC in relation to the risks of ovarian cancer has been updated.

Updated on 7 July 2016

Reasons for updating

New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 September 2015 PIL

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use has been updated to include: Hereditary angioedema in the sub- section 'Conditions which need supervision' Venous thromboembolism sub-section has been updated to include patients with a history of VTE Other conditions sub-section has been updated to include information on chloasma. Section 4.8 the table has been updated and information on myocardial infarction and gall bladder disease has been added to 'Other adverse reactions have been reported in association with estrogen/progestagen treatment'. US WHI studies - additional risk of breast cancer after 5 years’ use table is updated

Updated on 3 September 2015 SPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updated on 28 February 2014 PIL

Reasons for updating

Change to section 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

The Storage conditions have been updated. the product should now be stored below 25^oC (previously 30^oC)

Updated on 28 February 2014 SPC

Reasons for updating

Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The Storage conditions have been updated. the product should now be stored below 25^oC (previously 30^oC)

Updated on 2 May 2012 PIL

Reasons for updating

New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

New individual SmPC for product (was previously in a combined SmPC).

The SmPC is updated in line with core safety text for HRT products

Updated on 2 May 2012 SPC

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

New individual SmPC for product (was previously in a combined SmPC).

The SmPC is updated in line with core safety text for HRT products