Symtuza 800 mg/150 mg/200 mg/10 mg film coated tablets
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 09 March 2023
File name
20230309 Type IB EN SYMTUZA 800 mg 150 mg film coated tablets PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Approval Var type IB update existing warning on nephrotoxicity related to Tenofovir Alafenamide Fumarate + editorial changes EMEA/H/C/004391/IB/0049
Updated on 09 March 2023
File name
20230309 Type IB EN Symtuza 800 mg 150 mg 200 mg 10 mg film-coated tablets SmPC.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Approval Var type IB update existing warning on nephrotoxicity related to Tenofovir Alafenamide Fumarate + editorial changes EMEA/H/C/004391/IB/0049
Updated on 09 December 2022
File name
20221110 WS 2342 EN Symtuza 800 mg 150 mg 200 mg 10 mg film-coated tablets SmPC.pdf
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
- 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
Approval of variation type II - WS2342- crystal nephropathy + CHMP-requested text on HIV transmission and breastfeeding - day 27 - 7Dec2022
Updated on 09 December 2022
File name
20221110 WS2342 EN SYMTUZA 800 mg 150 mg film coated tablets PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Approval of variation type II - WS2342- crystal nephropathy + CHMP-requested text on HIV transmission and breastfeeding - day 27 - 7Dec2022
Updated on 16 June 2022
File name
20220615 Symtuza PIL WS2250.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
EU Approval EMEA/H/C/4391/WS/2250
Updated on 16 June 2022
File name
20220615 Symtuza PIL WS2250.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
EU Approval EMEA/H/C/4391/WS/2250
Updated on 16 June 2022
File name
20220615 EN Symtuza 800 mg 150 mg 200 mg 10 mg film-coated tablets SmPC.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
EU Approval EMEA/H/C/4391/WS/2250
Updated on 31 May 2022
File name
2022-05-24 EN Symtuza 800 mg 150 mg 200 mg 10 mg film-coated tablets SmPC.pdf
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Renewal Approval in EU EMEA/H/C/004391/R/0040
Updated on 31 May 2022
File name
2022-05-24 Symtuza PIL Renewal.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
Renewal Approval in EU EMEA/H/C/004391/R/0040
Updated on 20 January 2022
File name
20220113 EN Symtuza 800 mg 150 mg 200 mg 10 mg film coated tablets SmPC.pdf
Reasons for updating
- 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 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 January 2022
File name
20220113 EN Symtuza 800 mg 150 mg 200 mg 10 mg film coated tablets PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 15 October 2021
File name
Symtuza NI_IE SPC-CLEAN 2021 09.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.5 Interaction with other medicinal products and other forms of interaction
Interaction table
Table 1: Interactions between the individual components of Symtuza and other medicinal products
Corticosteroids - updated to address co-administration of cutaneous administered corticosteroids sensitive to CYP3A inhibition in section 4.5 (interaction table)
Updates are in red
Deleted: “Clinical monitoring is recommended when co-administering Symtuza with corticosteroids.”
|
Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone) |
Based on theoretical considerations DRV/COBI is expected to increase these corticosteroid plasma concentrations. (CYP3A inhibition) |
Concomitant use of Symtuza and corticosteroids (all routes of administration) that are metabolised by CYP3A may increase the risk for development of systemic corticosteroid effects, including Cushing’s syndrome and adrenal suppression.
Co-administration with CYP3A-metabolised corticosteroids is not recommended unless the potential benefit to the patient outweighs the risk, in which case patients should be monitored for systemic corticosteroid effects.
Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone should be considered, particularly for long-term use. |
Updated on 15 October 2021
File name
Symtuza NI_IE PIL-CLEAN 2021 09.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
The effects of other medicines might be influenced if you take Symtuza. Tell your doctor if you take:
Corticosteroids including betamethasone,budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the skin, eyes, joints and muscles and other inflammatory conditions. These medicines are generally taken orally, inhaled, injected or applied to the skin. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.
Updates are in red
Deleted “(to control asthma)”
-Last revision date : 09/2021
Updated on 07 May 2021
File name
NI & IRE PIL Symtuza 03 May 2021- CLEAN.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Symtuza.
You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your physician the precautions needed to avoid infecting other people.
People taking Symtuza may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.
People taking Symtuza may develop a skin rash. Infrequently a rash may become severe or potentially life‑threatening. Please contact your doctor whenever you develop a rash.
Although kidney problems have not been observed with Symtuza, there is a possibility that you may experience kidney problems when taking Symtuza over a long period of time.
Talk to your doctor before taking Symtuza. Tell your doctor immediately, if any of these apply to you.
- if you have had problems with your liver, including hepatitis B or C infection. Your doctor may evaluate how severe your liver disease is before deciding if you can take Symtuza.
Iif you have hepatitis B infection, your liver problems may become worse after you stop taking Symtuza. It is important not to stop taking Symtuza without talking to your doctor first.if you have had problems with your kidneys.if you have had kidney disease or if tests have shown problems with your kidneys, before or during treatment. Before starting treatment and during treatment with Symtuza, your doctor may order blood tests to monitor how your kidneys work. Your doctor will consider if Symtuza is the right medicine for you.- if you have diabetes. Symtuza might increase sugar levels in the blood.
if you notice any symptoms of infection (e.g. swollen lymph nodes and fever). In some patients with advanced HIV infection and who had unusual infections due to a weakened immune system (opportunistic infection), signs and symptoms of inflammation from previous infections
Updated on 07 May 2021
File name
NI & IRE SmPC Symtuza 03May2021 - CLEAN.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
4.4 Special warnings and precautions for use
Nephrotoxicity
A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3). It is recommended that renal function is assessed in all patients prior to, or when, initiating therapy with Symtuza and that it is also monitored during therapy in all patients as clinically appropriate. In patients who develop clinically significant decreases in renal function or evidence of proximal renal tubulopathy, discontinuation of Symtuza should be considered.
Updated on 01 February 2021
File name
IRE PIL Symtuza 800 mg, 150 mg, 200 mg, 10 mg_20Jan2021_CLEAN.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 01 February 2021
File name
UK IRE SmPC Symtuza 800mg 150mg 200 mg 10 mg_20Jan2021-CLEAN.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 October 2020
File name
EN-Symtuza-SPC-1883-clean-approved.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 October 2020
File name
EN-Symtuza-PIL-clean-approved.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - use in children/adolescents
Updated on 08 July 2019
File name
IRE PIL Symtuza 800 mg, 150 mg, 200 mg, 10 mg_03Jul19_Clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 06 July 2019
File name
UK & IRE SmPC Symtuza 800mg, 150mg, 200 mg, 10 mg_01Jul19-Clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 July 2019
File name
UK & IRE SmPC Symtuza 800mg, 150mg, 200 mg, 10 mg_03Jul19-Clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 May 2019
File name
IRE PIL Symtuza 800 mg, 150 mg, 200 mg, 10 mg Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 08 May 2019
File name
UK & IRE SmPC Symtuza 800mg, 150mg, 200 mg, 10 mg -Clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 November 2018
File name
IRE Symtuza-PIL C07-Nov 2018-Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 27 November 2018
File name
Symtuza-SmPC-C08-20 Nov-18_clean.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
4.3 Contraindications
- Added dabigatran,
4.5 Interaction with other medicinal products and other forms of interaction
|
ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR |
||
|
Apixaban Edoxaban
Rivaroxaban |
Based on theoretical considerations co‑administration of DRV/COBI with these anticoagulants may increase concentrations of the anticoagulant, which may lead to an increased bleeding risk. (CYP3A and/or P‑glycoprotein inhibition) |
Co‑administration of Symtuza and these anticoagulants is not recommended. |
|
Dabigatran Ticagrelor |
Based on theoretical considerations co‑administration of DRV/COBI with dabigatran or ticagrelor may increase concentrations of the anticoagulant. (CYP3A and/or P‑glycoprotein inhibition). |
Concomitant administration of Symtuza with dabigatran or ticagrelor is contraindicated (see section 4.3).
Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended. |
|
Glecaprevir/pibrentasvir |
Based on theoretical considerations DRV/COBI may increase the exposure to glecaprevir and pibrentasvir. (P‑gp, BCRP and/or OATP1B1/3 inhibition) |
It is not recommended to co‑administer Symtuza with glecaprevir/pibrentasvir. |
Updated on 30 October 2018
File name
IRE Symtuza-PIL C06-24Oct18-Clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change in co-marketing arrangement
Updated on 29 October 2018
File name
Symtuza-SmPC-C07-24Oct18-Clean-approved.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
4.4 Special warnings and precautions for use
Immune reactivation syndrome
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.8).
4.8 Undesirable effects
Immune reconstitution inflammatory syndrome
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Updated on 29 October 2018
File name
Symtuza-SmPC-C07-Oct 2018-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
4.4 Special warnings and precautions for use
Immune reactivation syndrome
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.8).
Updated on 26 September 2018
File name
Symtuza-SmPC-C06-21Sep18-Clean-approved.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Section 6.3
Shelf life increased for 2 to 3 years
Updated on 11 July 2018
File name
Symtuza-SmPC-C04-12Apr18-CLEAN-approved.docx
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 – Addition of pregnancy and postpartum section to inform about low darunavir exposure and consideration for alternative regimen.
Section 4.4 – Addition of pregnancy data (low darunavir exposure, cobicistat levels decrease and may not provide sufficient boosting); advice not to initiate during pregnancy or switch to alternative regimen.
Section 4.6 - addition of pregnancy data: low darunavir exposure which may be associated with an increased risk of treatment failure and an increased risk of HIV transmission to the child; advice not to initiate during pregnancy or switch to alternative regimen.
Section 5.2 – addition of pregnancy and postpartum data.
Updated on 11 July 2018
File name
Symtuza-PIL C05-06jul18-clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 29 May 2018
File name
Symtuza-SmPC-C04-12Apr18-CLEAN-approved.docx
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
· Administrative changes to sections 4.1, 4.2, 4.4, 4.5, 4.7, 4.8, 5.1.
· Section 4.7 deletion of “no or negligible influence on the ability to drive and use machines” statement.
· Section 4.8 Changes to frequency of adverse reactions; addition of increased low density lipoprotein (common); dyslipidaemia and hyperglycemia (both uncommon)
· Section 5.1 addition of ATC code; addition of AMBER and EMERALD trial data
Updated on 29 May 2018
File name
Symtuza-PIL C04-12Apr18-CLEAN-approved.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 March 2018
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.9 - Overdose
- 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
4.3 Contraindications
- , simvastatin, and lovastatin and lomitapide (see section 4.5)
4.5 Interaction with other medicinal products and other forms of interaction
Co‑administration of Symtuza and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and cobicistat and may result in increased plasma concentrations of darunavir and cobicistat (e.g. systemic azole antifungals like ketoconazole and clotrimazole). These interactions are described in the interaction table below.
|
Clonazepam |
Based on theoretical considerations Symtuza is expected to (inhibition of CYP3A) |
Clinical monitoring is recommended when co‑administering Symtuza with clonazepam. |
|
ANTIPSYCHOTICS/NEUROLEPTICS |
||
|
Perphenazine Risperidone Thioridazine
Lurasidone Pimozide Quetiapine Sertindole |
Based on theoretical considerations DRV/COBI is expected to increase these neuroleptic plasma concentrations. (CYP3A, CYP2D6 and/or P‑gp inhibition inhibition)
|
Clinical monitoring is recommended when co‑administering Symtuza with perphenazine, risperidone or thioridazine. For these neuroleptics, consider reducing the dose of the neuroleptic upon co‑administration with Symtuza.
The combination of lurasidone, pimozide, quetiapine or sertindole and Symtuza is contraindicated (see section 4.3). |
|
HMG CO‑A REDUCTASE INHIBITORS |
||
|
Atorvastatin Fluvastatin Pitavastatin Pravastatin Rosuvastatin
Lovastatin Simvastatin |
Atorvastatin (10 mg once daily): atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin ND
Rosuvastatin (10 mg once daily): rosuvastatin AUC ↑ 93% rosuvastatin Cmax ↑ 277% rosuvastatin Cmin ND
Based on theoretical considerations DRV/COBI is expected to increase the (CYP3A inhibition and/or transport) |
Concomitant use of a HMG CoA reductase inhibitor and Symtuza may increase plasma concentrations of the lipid lowering agent, which may lead to adverse reactions such as myopathy. When administration of HMG CoA reductase inhibitors and Symtuza is desired, it is recommended to start with the lowest dose and titrate up to the desired clinical effect while monitoring for safety.
Concomitant use of Symtuza with lovastatin and simvastatin is contraindicated (see section 4.3). |
|
OTHER LIPID MODIFYING AGENTS |
||
|
Lomitapide |
Based on theoretical considerations, Symtuza is expected to increase the exposure of lomitapide when co-administered. (CYP3A inhibition) |
Co-administration is contraindicated (see section 4.3) |
|
OESTROGEN‑BASED CONTRACEPTIVES |
||
|
Drospirenone Ethinylestradiol (3 mg/0.02 mg once daily)
Ethinyl estradiol
Norethindrone |
drospirenone AUC ↑ 58% drospirenone Cmax ↑ 15% drospirenone Cmin ND
ethinylestradiol AUC ¯ 30% ethinylestradiol Cmax ¯ 14% ethinylestradiol Cmin ND
Based on theoretical considerations DRV/COBI may alter
|
Alternative or additional contraceptive measures are recommended when oestrogen based contraceptives are co administered with Symtuza. Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency. When Symtuza is coadministered with a drospirenone-containing product, clinical monitoring is recommended due to the potential for hyperkalaemia.
|
4.9 Overdose
Treatment of overdose with Symtuza consists of general supportive measures, including monitoring of vital signs as well as observation of the clinical status of the patient. If indicated, elimination of unabsorbed active substance is to be achieved by emesis.
Updated on 23 March 2018
File name
PIL_17319_798.pdf
Reasons for updating
- New PIL for new product
Updated on 23 March 2018
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 06 November 2017
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- 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
6.5 Nature and contents of container
White, high density polyethylene (HDPE) bottle with a silica gel desiccant (contained in a separate sachet or canister) fitted with polypropylene (PP) child resistant closure with induction seal.
Pack size of oneEach bottle containsing 30 tablets.
Pack size of one bottle or three bottles per carton.
Not all pack sizes may be marketed
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/17/1225/001- 30 film-coated tablets
EU/1/17/1225/002- 90 film-coated tablets (3 x 30)
Updated on 06 November 2017
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 02 October 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 02 October 2017
Reasons for updating
- New PIL for new product