Public Assessment Report
UKPAR
Telmisartan and Hydrochlorothiazide Crescent
40mg/12.5mg Tablets
Telmisartan and Hydrochlorothiazide Crescent
80mg/12.5mg Tablets
Telmisartan and Hydrochlorothiazide Crescent
80mg/25mg Tablets
(Telmisartan, hydrochlorothiazide)
UK Licence No: PL 20416/0347-0348 & 385
Crescent Pharma Limited
Telmisartan and Hydrochlorothiazide Crescent 40mg/12.5 mg,
80mg/12.5 mg and 80mg/25mg Tablets
PL 20416/0347-0348 & 0385
LAY SUMMARY
Telmisartan and Hydrochlorothiazide Crescent 40mg/12.5mg Tablets
Telmisartan and Hydrochlorothiazide Crescent 80mg/12.5mg Tablets
Telmisartan and Hydrochlorothiazide Crescent 80mg/25mg Tablets
(Telmisartan, hydrochlorothiazide)
This is a summary of the Public Assessment Report (PAR) for Telmisartan and Hydrochlorothiazide
Crescent 40mg/12.5mg Tablets (PL 20426/0347), Telmisartan/Hydrochlorothiazide Crescent
80mg/12.5mg Tablets (PL 20426/0348) and Telmisartan/Hydrochlorothiazide Crescent 80mg/25mg
Tablets (PL 20426/0385). It explains how the applications for these tablets were assessed and their
authorisation recommended, as well as the conditions of use. It is not intended to provide practical
advice on how to use Telmisartan and Hydrochlorothiazide Crescent 40mg/12.5mg, 80mg/12.5mg and
80mg/25mg Tablets.
The products may be referred to as ‘Telmisartan and Hydrochlorothiazide Tablets’ in this Lay summary.
For practical information about using Telmisartan and Hydrochlorothiazide Tablets, patients should read
the package leaflet or contact their doctor or pharmacist.
What are Telmisartan and Hydrochlorothiazide Tablets and what are they used for?
Telmisartan and Hydrochlorothiazide 40mg/12.5mg, 80mg/12.5mg and 80mg/25mg Tablets are ‘generic
medicines’. This means that Telmisartan and Hydrochlorothiazide 40mg/12.5mg, 80mg/12.5mg and
80mg/25mg Tablets are similar to ‘reference medicines’ already authorised in the European Union (EU)
called Micardis Plus 40 mg/12.5 mg, 80 mg/12.5 mg and 80 mg/25 mg tablets. Micardis Plus
40 mg/12.5 mg, 80 mg/12.5 mg 80 mg/25 mg tablets may be referred to as ‘Micardis Plus tablets’.
Telmisartan and Hydrochlorothiazide 40mg/12.5mg and 80mg/12.5mg Tablets are used to treat high
blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when
telmisartan is used alone.
Telmisartan and Hydrochlorothiazide 80mg/25mg Tablets are used to treat high blood pressure
(essential hypertension) in adults whose blood pressure is not adequately controlled by Telmisartan and
Hydrochlorothiazide 80mg/12.5mg Tablets or in patients who have been previously stabilised by
telmisartan and hydrochlorothiazide, when given separately.
How do Telmisartan and Hydrochlorothiazide Tablets work?
These products contain a combination of two active substances in one tablet - telmisartan and
hydrochlorothiazide. Both of these substances help to control high blood pressure. Telmisartan belongs
to a group of medicines called angiotensin II receptor antagonists. Angiotensin-II is a substance
produced in the body which causes blood vessels to narrow thus increasing the blood pressure.
Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and the blood pressure is
lowered. Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause the
urine output to increase, leading to a lowering of the blood pressure.
How are Telmisartan and Hydrochlorothiazide tablets used?
Telmisartan and Hydrochlorothiazide Tablets should be swallowed with some water or other nonalcoholic drink. The tablets can be taken with or without food.
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The patient should always take Telmisartan and Hydrochlorothiazide Tablets exactly as his/her doctor
has advised. The patient should check with his/her doctor or pharmacist if not sure.
The recommended dose of Telmisartan and Hydrochlorothiazide tablets is one tablet a day. It is
important that patients take Telmisartan and Hydrochlorothiazide tablets every day until otherwise
advised by a doctor.
Please read section 3 of the package leaflet for detailed information on dosing recommendations, the
route of administration and the duration of treatment.
Telmisartan and Hydrochlorothiazide Tablets can only be obtained with a prescription.
What benefits of Telmisartan and Hydrochlorothiazide Tablets have been shown in studies?
Because Telmisartan and Hydrochlorothiazide Tablets are generic medicines, studies in patients have
been limited to tests to determine that they are bioequivalent to the reference medicines, Micardis Plus
tablets. Two medicines are bioequivalent when they produce the same levels of the active substance in
the body.
What are the possible side effects of Telmisartan and Hydrochlorothiazide Tablets?
Because Telmisartan and Hydrochlorothiazide Tablets are generic medicines, their possible side effects
are taken as being the same as those of the reference medicines, Micardis Plus tablets.
For the full list of all side effects reported with Telmisartan and Hydrochlorothiazide Tablets, see section
4 of the package leaflet.
For the full list of restrictions, see the package leaflet.
Why were Telmisartan and Hydrochlorothiazide Tablets approved?
It was concluded that, in accordance with EU requirements, Telmisartan and Hydrochlorothiazide
Tablets have been shown to have comparable quality and to be bioequivalent to Micardis Plus tablets.
Therefore, the MHRA decided that, as for Micardis Plus tablets, the benefits outweigh the identified
risks and recommended that Telmisartan and Hydrochlorothiazide Tablets can be approved for use.
What measures are being taken to ensure the safe and effective use of Telmisartan and
Hydrochlorothiazide Tablets?
A Risk Management Plan (RMP) has been developed to ensure that Telmisartan and
Hydrochlorothiazide Tablets are used as safely as possible. Based on this plan, safety information has
been included in the Summaries of Product Characteristics (SmPCs) and the package leaflet for these
products, including the appropriate precautions to be followed by healthcare professionals and patients.
Known side effects are continuously monitored. Furthermore, new safety signals reported by
patients/healthcare professionals will be monitored and reviewed continuously.
Other information about Telmisartan and Hydrochlorothiazide Tablets
Marketing Authorisations were granted for Telmisartan/Hydrochlorothiazide Tablets on 05 October
2016.
The full PAR for Telmisartan and Hydrochlorothiazide Tablets follows this summary.
For more information about treatment with Telmisartan and Hydrochlorothiazide Tablets read the
package leaflet, or contact your doctor or pharmacist.
This summary was last updated in December 2016.
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SCIENTIFIC DISCUSSION
TABLE OF CONTENTS
I
II
III
IV
V
VI
Introduction
Quality aspects
Non-clinical aspects
Clinical aspects
User consultation
Overall conclusion, benefit/risk assessment and recommendation
Steps taken after authorisation-summary
Page 5
Page 6
Page 8
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Page 11
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Page 19
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Scientific discussion
I
INTRODUCTION
Based on the review of the data on quality, safety and efficacy the MHRA granted Crescent Pharma
Limited Marketing Authorisations for the medicinal products Telmisartan and Hydrochlorothiazide
40mg/12.5 mg, 80 mg/12.5 mg and 80 mg/25mg Tablets (PL 20416/0347, 0348 and 0385) on
05 October 2016. These products are Prescription Only Medicines (POM) indicated for the treatment of
essential hypertension.
Telmisartan and Hydrochlorothiazide 40mg/12.5mg and 80mg/12.5mg Tablets are indicated in adults
whose blood pressure is not adequately controlled on telmisartan alone.
Telmisartan and Hydrochlorothiazide 80mg/25mg Tablets are indicated in adults whose blood pressure
is not adequately controlled on Telmisartan and Hydrochlorothiazide 80mg/12.5mg tablets or adults who
have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
These applications were submitted under Article 10(1) of Directive 2001/83/EC, as amended, claiming
to be generic medicinal products of the reference products of Micardis Plus 40 mg/12.5 mg tablets,
80 mg/12.5 mg tablets and 80 mg/25 mg tablets, which were initially granted Marketing Authorisations
to Boehringer Ingelheim International GmbH in the EU, via the Centralised Procedure, on 23 April
2002.
These products contain a combination of the active substances telmisartan and hydrochlorothiazide. The
combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a
greater degree than either component alone.
Telmisartan is a specific angiotensin II receptor subtype 1 (AT1) antagonist. It displaces angiotensin II
with very high affinity from its binding site at the AT1 receptor subtype and does not exhibit any partial
agonist activity at the AT1 receptor. Telmisartan selectively binds the AT1 receptor. The binding is
long-lasting. Telmisartan does not show affinity for other receptors, including AT2 and other less
characterised AT receptors. The functional role of these receptors is not known, nor is the effect of their
possible overstimulation by angiotensin II, whose levels are increased by telmisartan. Plasma
aldosterone levels are decreased by telmisartan. Telmisartan does not inhibit human plasma renin or
block ion channels. Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the
enzyme which also degrades bradykinin. Therefore, it is not expected to potentiate bradykinin-mediated
adverse effects.
Hydrochlorothiazide is a thiazide diuretic. The mechanism of the antihypertensive effect of thiazide
diuretics is not fully known. Thiazides have an effect on the renal tubular mechanisms of electrolyte
reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity,
increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss,
and decreases in serum potassium. Presumably through blockade of the renin-angiotensin-aldosterone
system, co-administration of telmisartan tends to reverse the potassium loss associated with these
diuretics. With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about
4 hours, while the action persists for approximately 6-12 hours. Epidemiological studies have shown that
long-term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and
morbidity.
To support these applications, one single-dose, bioequivalence study comparing the applicant’s test
product Telmisartan/Hydrochlorothiazide 80 mg/25 mg tablets with the reference product Micardis Plus
80 mg/25 mg tablets (Boehringer Ingelheim International GmbH, Germany) under fasting conditions.
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The bioequivalence study is stated to have been conducted in accordance with Good Clinical Practice
(GCP) guidelines.
With the exception of the bioequivalence study, no new non-clinical or clinical data were submitted,
which is acceptable given that the applications were based on being generic medicinal products of
originator products that have been in clinical use for over 10 years.
The MHRA has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in
place at all sites responsible for the manufacture, assembly and batch release of these products.
No new or unexpected safety concerns arose during review of information provided by the Marketing
Authorisation Holder and it was, therefore, judged that the benefits of taking Temisartan and
Hydrochlorothiazide Tablets, outweigh the risks.
II
QUALITY ASPECTS
II.1 Introduction
The submitted documentation concerning the proposed product is of sufficient quality and meets the
current EU regulatory requirements.
The quality overall summary has been written by an appropriately qualified person and is a suitable
summary of the pharmaceutical aspects of the dossier.
Telmisartan and Hydrochlorothiazide 40mg/12.5mg tablets are white to off-white, oblong tablets,
approximately 12.5 mm x 6.5 mm and debossed with “H4” on one side. Each tablet contains 40 mg
telmisartan converted in situ to telmisartan sodium and 12.5 mg hydrochlorothiazide.
Telmisartan and Hydrochlorothiazide 80mg/12.5mg Tablets are white to off-white, oblong tablets,
approximately 16.1 mm x 7.8 mm and debossed with “H8”. Each tablet contains 80 mg telmisartan
converted in situ to telmisartan sodium and 12.5 mg hydrochlorothiazide.
Telmisartan and Hydrochlorothiazide 80mg/25mg tablets are white to off white, oblong tablets,
approximately 16.1 x 7.8 mm and debossed with “H9” on the same side. Each tablet contains 80 mg
telmisartan converted in situ to telmisartan sodium and 25mg hydrochlorothiazide. The tablet can be
divided into equal doses.
Other ingredients consist of the pharmaceutical excipients, namely sodium hydroxide, mannitol, maize
starch, cellulose microcrystalline, carmellose calcium, Povidone (K-29/32), silicon dioxide and sodium
stearyl fumarate.
The finished products are packaged in oriented polyamide/polyvinylchloride-aluminium blisters of
28 tablets.
Satisfactory specifications and Certificates of Analysis have been provided for all packaging
components. All primary packaging complies with the current European regulations concerning
materials in contact with food.
II.2 Drug substance
Telmisartan
rINN:
Telmisartan
Chemical name(s): 4'-[[4-Methyl-6-(1-methyl-1H-benzimidazol- 2yl)-2- propyl-1H-benzimidazol-1yl] methyl] biphenyl-2-carboxylic acid
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Telmisartan and Hydrochlorothiazide Crescent 40mg/12.5 mg,
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Structure:
Molecular formula:
Molecular weight:
Appearance:
Solubility:
Polymorphism
C33H30N4O2
514.6
White or slightly yellowish, crystalline powder
Soluble in 1M sodium hydroxide, sparingly soluble in methylene chloride,
slightly soluble in methanol, practically insoluble in water
Telmisartan exhibits polymorphism
Hydrochlorothiazide
rINN:
Hydrochlorothiazide
Chemical name(s): 6-Chloro-3,4-dihydro-2H-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide.
Structure:
Molecular formula:
Molecular weight:
Appearance:
Solubility:
C7H8ClN3O4S2
297.7
White or almost white, crystalline powder.
Very slightly soluble in water, soluble in acetone, sparingly soluble in ethanol
(96 %). It dissolves in dilute solutions of alkali hydroxides.
All aspects of the manufacture and control of the active substances telmisartan and hydrochlorothiazide
are covered by European Directorate for the Quality of Medicines and Healthcare (EDQM) Certificates
of Suitability (CEPs).
II.3 Medicinal Product
Pharmaceutical Development
The objective of the development programme was to formulate globally acceptable and stable products
that could be considered generic medicinal products of the currently licensed products, Micardis Plus
40 mg/12.5 mg tablets, 80 mg/12.5 mg tablets and 80 mg/25 mg tablets (Boehringer Ingelheim
International GmbH, Germany).
Suitable pharmaceutical development data have been provided for these applications. Comparative in
vitro dissolution and impurity profiles have been provided for the applicant’s products versus the
reference products.
All excipients comply with their respective European Pharmacopoeia monographs. Certificates of
Analysis have been provided for all excipients, showing compliance with their respective specifications.
None of the excipients are sourced from animal or human origin. No genetically modified organisms
(GMO) have been used in the preparation of these products.
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Manufacturing Process
Satisfactory batch formulae have been provided for the manufacture of the products, along with an
appropriate description of the manufacturing process. The manufacturing process has been validated
with full production-scale batches that have shown satisfactory results.
Control of Finished Product
The finished product specifications are satisfactory. Test methods have been described and have been
adequately validated. Batch data have been provided and comply with the release specifications.
Certificates of Analysis have been provided for all working standards used.
Stability of the product
Finished product stability studies were performed in accordance with current guidelines on batches of
finished product packed in the packaging proposed for marketing. Based on the results, a shelf-life of
36 months has been approved, with the special storage conditions ‘Store in the original package in order
to protect from light and moisture.’
II.4 Discussion on chemical, pharmaceutical and biological aspects
It is recommended that Marketing Authorisations are granted for Telmisartan and Hydrochlorothiazide
Tablets.
III
NON-CLINICAL ASPECTS
III.1 Introduction
The pharmacodynamic, pharmacokinetic and toxicological properties of telmisartan and
hydrochlorothiazide are well known. No new non-clinical data have been submitted for these
applications and none are required.
The applicant has provided an overview based on published literature. The non-clinical overview has
been written by an appropriately qualified person and is satisfactory, providing an appropriate review of
the product’s pharmacology and toxicology.
III.2 Pharmacology
No new pharmacology data are required for these applications and none have been submitted.
III.3 Pharmacokinetics
No new pharmacokinetic data are required for these applications and none have been submitted.
III.4 Toxicology
No new toxicology data are required for these applications and none have been submitted.
III.5 Ecotoxicity/Environmental Risk Assessment (ERA)
Suitable justification has been provided for non-submission of an Environmental Risk Assessment. As
the products are intended for generic substitution with products that are already marketed, no increase in
environmental exposure to telmisartan and hydrochlorothiazide is anticipated. Thus, the justification for
non-submission of an Environmental Risk Assessment is accepted.
III.6 Discussion of the non-clinical aspects
It is recommended that Marketing Authorisations are granted for Telmisartan and Hydrochlorothiazide
Tablets, from a non-clinical point of view.
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IV.
CLINICAL ASPECTS
IV.1 Introduction
The clinical pharmacology of telmisartan and hydrochlorothiazide is well-known. With the exception of
the bioequivalence study detailed below, no new clinical studies have been performed and none are
required for applications of this type.
In accordance with the regulatory requirements CPMP/EWP/QWP/1401/98 Rev 1/Corr**, Guideline on
the Investigation of Bioequivalence, the applicant submitted one bioequivalence study to support the
application, comparing the applicant’s test product Telmisartan HCT 80/25mg tablets versus the
reference product Micardis Plus 80/25mg tablets (Boehringer Ingelheim Limited, Germany) in healthy
male and female volunteers under fasting conditions.
The applicant’s clinical overview has been written by an appropriately qualified person and is
considered acceptable.
IV.2 Pharmacokinetics
In support of these applications, the applicant submitted the following bioequivalence study:
A single dose, open label, replicated crossover bioequivalence study comparing the
pharmacokinetics of the test product, Telmisartan/Hydrochlorothiazide 80 mg/25 mg tablets to
those of the reference product, Micardis Plus 80 mg/25 mg tablets (Boehringer Ingelheim
International GmbH, Germany), in healthy, adult, human volunteers, under fasting conditions.
The subjects were administered a single oral dose (1 tablet of 80mg/25 mg) of either treatment with
240 ml of water after at least an 8-hour overnight fast. Blood samples were collected before, up to and
including 72 hours after each administration. The washout period between the treatment phases was
14 days. The pharmacokinetic results are presented below.
A summary of the main pharmacokinetic results is presented in the tables below:
Table 1
90% confidence intervals of Telmisartan (N=34)
Table 2
90% confidence intervals of Hydrochlorothiazide (N=34)
Conclusion of the bioequivalence study
The Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev 1/Corr**)
defines the confidence limits for ratio of geometric means for acceptance of bioequivalence as 80.00%
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to 125.00% for AUC and Cmax values. The results of the study showed that AUC and Cmax for
Telmisartan and Hydrochlorothiazide of the test product fall within the acceptance criteria range of
80.00% - 125.00%. Although a wider range for Cmax of 69.84% – 143.19 % was also acceptable, Cmax
fell within the conventional acceptance interval. These data support the claim that the applicant’s
80mg/25mg strength test product is bioequivalent to the reference product Micardis Plus 80mg/25 mg
Tablets (Boehringer Ingelheim International GmbH, Germany) in male volunteers under fasting
conditions.
Biowaiver for the 40mg/12.5mg and 80mg/12.5mg strength products can be accepted on clinical and
quality grounds.
IV.3 Pharmacodynamics
The clinical pharmacodynamics properties of telmisartan and hydrochlorothiazide are well-known. No
new pharmacodynamic data were submitted and none are required for applications of this type.
IV.4 Clinical efficacy
The clinical efficacy of telmisartan and hydrochlorothiazide is well-known. No new efficacy data are
presented and none are required for applications of this type.
IV.5 Clinical Safety
With the exception of the safety data generated during the bioequivalence study, no new safety data
were submitted and none are required for application of this type. No new or unexpected safety issues
arose during the bioequivalence study.
IV.6 Risk Management Plan (RMP)
The MAH has submitted a Risk Management Plan, in accordance with the requirements of Directive
2001/83/EC as amended, describing the pharmacovigilance activities and interventions designed to
identify, characterise, prevent or minimise risks relating to Telmisartan and Hydrochlorothiazide
Tablets.
A summary of safety concerns, as approved in the RMP, are listed below:
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Routine pharmacovigilance and risk minimisation activities are proposed for all safety concerns.
IV.7 Discussion of the clinical aspects
It is recommended that Marketing Authorisations are granted for Telmisartan and Hydrochlorothiazide
Tablets.
V.
USER CONSULTATION
The package leaflet has been evaluated in accordance with the requirements of Articles 59(3) and 61(1)
of Directive 2001/83/EC, as amended. The results indicate that the package leaflet is well-structured and
organised, easy to understand and written in a comprehensive manner. The test shows that patients/users
are able to act upon the information that it contains.
VI
OVERALL CONCLUSION AND BENEFIT-RISK ASSESSMENT
QUALITY
The quality characteristics of Telmisartan and Hydrochlorothiazide Tablets are well-defined and
controlled. The specifications and batch analytical results indicate consistency from batch to batch.
There are no outstanding quality issues that would have a negative impact on the benefit/risk balance.
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NON-CLINICAL
No new non-clinical data were submitted. As the pharmacokinetics, pharmacodynamics and toxicology
of telmisartan and hydrochlorothiazide are well-known, no additional data were required.
EFFICACY
With the exception of the bioequivalence study, no new data were submitted and none are required for
applications of this type.
Bioequivalence has been demonstrated between the applicant’s 80mg/25mg strength tablets and the
reference product Micardis Plus 80mg/25mg tablets (Boehringer Ingelheim International GmbH,
Germany) under fasting conditions.
A biowaiver for the 40mg/12.5mg and 80mg/12.5mg strength products was accepted on clinical and
quality grounds.
SAFETY
With the exception of the safety data from the bioequivalence study, no new data were submitted and
none are required for applications of this type. As the safety profiles of telmisartan and
hydrochlorothiazide are well known, no additional data were required. No new or unexpected safety
concerns arose from the bioequivalence study.
PRODUCT LITERATURE
The SmPCs, PIL and labelling are satisfactory, and consistent with those for the reference products,
where appropriate, and consistent with current guidelines.
BENEFIT/RISK ASSESSMENT
The quality of the product is acceptable, and no new non-clinical or clinical safety concerns have been
identified. The data supplied support the claim that the applicant’s products and the reference products
are interchangeable. Extensive clinical experience with telmisartan and hydrochlorothiazide is
considered to have demonstrated the therapeutic value of the compounds. The benefit-risk assessment is
therefore considered to be positive.
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In accordance with Directive 2010/84/EU, the current version of the SmPCs and PIL are available on the
MHRA website. The current labelling is presented below
Telmsartan and Hydrochlorothiazide 40mg/12.5 mg Tablets:
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Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg Tablets:
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Telmisartan/Hydrochlorothiazide Crescent 80mg/25mg Tablets
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Telmisartan and Hydrochlorothiazide Crescent
40mg/12.5mg Tablets
Telmisartan and Hydrochlorothiazide Crescent
80mg/12.5mg Tablets
Telmisartan and Hydrochlorothiazide Crescent
80mg/25mg Tablets
(Telmisartan, hydrochlorothiazide)
PL 20416/0347-0348 & 385
STEPS TAKEN AFTER INITIAL PROCEDURE - SUMMARY
Date
submitted
Application
type
Scope
Outcome
19