Lenzetto 1.53 mg/spray, Transdermal Spray, Solution
Product Information *
Company:
Gedeon Richter (UK) LtdStatus:
No Recent UpdateActive Ingredients :
*Additional information is available upon request
Legal Category:
Product subject to medical prescription which may not be renewed (A)
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 27 November 2020
File name
Lenzetto_SmPC_en_PA1330-017-001_1606492850.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Amendment to the spelling of oestrogen across the various updated sections.
- Product information modified according to the PRAC recommendation for Hormone Replacement Therapy (HRT) products on breast cancer.
Updated on 27 November 2020
File name
Lenzetto_PIL_en_PA1330-017-001_1606492314.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- Update throughtout the PIL to amend the spelling of estrogen to oestrogen.
- Product information updated according to PRAC recommendation for Hormone Replacement Therapy (HRT) products on breast cancer.
Updated on 30 September 2020
File name
Lenzetto_SmPC_en_PA1330-017-001-clean_1601468630.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to the fill volume
Updated on 30 September 2020
File name
Lenzetto_PIL_en_PA1330-017-001_1601468514.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
Change in the overall fill volume from 8.1 ml to 6.5 ml.
Updated on 17 September 2020
File name
Lenzetto_SmPC_en_PA1330-017-001-2020_02_1600350198.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 September 2020
File name
Lenzetto_PIL_en_PA1330-017-001-2018-06-12_1600350124.pdf
Reasons for updating
- New PIL for new product