Lenzetto 1.53 mg/spray, Transdermal Spray, Solution
- Name:
Lenzetto 1.53 mg/spray, Transdermal Spray, Solution
- Company:
Gedeon Richter (UK) Ltd
- 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: 27/11/20
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Gedeon Richter (UK) Ltd
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Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name Bemfola 150 IU/0.25 ml solution for injection in a pre-filled pen | Active Ingredients follitropin alfa |
| Medicine Name Bemfola 225 IU/0.375 ml solution for injection in a pre-filled pen | Active Ingredients follitropin alfa |
| Medicine Name Bemfola 300 IU/0.50 ml solution for injection in a pre-filled pen | Active Ingredients follitropin alfa |
| Medicine Name Bemfola 450 IU/0.75 ml solution for injection in a pre-filled pen | Active Ingredients follitropin alfa |
| Medicine Name Bemfola 75 IU/0.125 ml solution for injection in a pre-filled pen | Active Ingredients follitropin alfa |
| Medicine Name Esmya 5mg tablets | Active Ingredients Ulipristal acetate |
| Medicine Name Lenzetto 1.53 mg/spray, Transdermal Spray, Solution | Active Ingredients Estradiol Hemihydrate |
| Medicine Name Ramonna 1500 microgram Tablet | Active Ingredients Levonorgestrel |
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 SPC
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 PIL
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 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- New PIL for new product